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					Outcome Evaluation Pilot Projects




                                         Evaluation and
                                     Needs Assessment
                                     of Clinical Training
                                    Using Chart Review
Outcome Evaluation Pilot Project:
                                                                  One in a series of

Evaluation and                                                    three innovative
                                                                  outcome-oriented

Needs Assessment                                                  evaluation projects
                                                                  for use in the

of Clinical Training                                              AETC network.


Using Chart Review



For more information about the Florida/Caribbean AETC, contact:
Martha Friedrich, Ph.D.
Associate Director & Evaluator
Florida/Caribbean AETC
USF Center for HIV Education and Research
University of South Florida
13301 Bruce B. Downs Boulevard, MHC-1715
Tampa, FL 33612
(813) 974-9004
mfriedrich@fmhi.usf.edu
AETC National Evaluation Center      Florida/Caribbean AETC



                                  Contents
                                  I. Introduction to the Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
                                  The AETC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
                                  The NEC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
                                  Pilot Evaluation Projects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
                                  II. Overview of This Pilot Evaluation Project . . . . . . . . . . . . . . . . . . . . . . . . . . 5
                                  Chart Reviews at the Florida/Caribbean AETC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
                                  Chart Review Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
                                  III. Evaluation Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
                                  Purpose and Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
                                  Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
                                  Data Analysis Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
                                  List of Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
                                  Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
                                  Implementation Timeline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
                                  IV. Results from Pilot Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
                                  Methods/Description of Pilot Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
                                  Human Research Protections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
                                  Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
                                  Lessons Learned from the Pilot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
                                  Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
                                     Sample Tools
                                     A. Chart Review Procedures Check List
                                     B. Letter of Agreement
                                     C. Facilities Assessment
                                     D. Chart Review Tool – Adult
                                     E. Chart Review Tool – Adolescent
                                     F. Chart Review Tool – Child
                                     G. Chart Review Tool – HIV-exposed Infant
                                     H. Chart Review Guidelines with Supplemental Guidelines Tables
                                     I. Scoring Guidelines
                                     J. Chart Review – Interview One (Baseline)
                                     K. Chart Review – Interview Two (Follow-up)
                                     Sample Reports
                                     L. Report of Scores at Baseline & Follow-up




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I. Introduction to the Series
The AETC Program

T
     he AIDS Education and Training Center (AETC) Program of the Ryan White
     CARE Act (RWCA) provides the critical link to education and training that
     can improve access to and quality of HIV care. Administered by the federal
Health Resources and Services Administration’s HIV/AIDS Bureau (HRSA/HAB),
the AETC Program is a network of 11 regional centers that provides education
and training programs to health care providers treating persons with HIV/AIDS.             The AETC Program is a
Through a national network of more than 130 local performance sites (LPSs), the
AETCs provide the link to experts who can train and support clinical providers.            network of 11 regional
Training is targeted to providers who serve minority populations, the homeless, rural      centers that provides
communities, incarcerated persons, and Ryan White CARE Act-funded sites. AETCs
focus on training primary health care clinicians (physicians, physician assistants,        education and training
nurses, nurse practitioners, dentists, pharmacists); training activities are based on
assessed local needs. Emphasis is placed on interactive, hands-on training and clini-      programs to health care
cal consultation to assist providers with complex issues related to the management         providers treating
of highly active antiretroviral therapy.
AETCs collaborate with CARE Act-funded organizations, area health education
                                                                                           persons with HIV/AIDS.
centers, community-based HIV/AIDS organizations, and medical and health pro-
fessional organizations. The AETCs serve all 50 States, the District of Columbia,
the U.S. Virgin Islands, Puerto Rico, and the six U.S. Pacific Jurisdictions. During
the 2003-2004 grant year, more than 143,000 participants attended AETC training
events. Clinicians trained by AETCs have been shown to be more competent with
regard to HIV issues and more willing than other primary care providers to treat
people living with HIV disease.
The AETC program also has four national centers: the National Minority AETC
(NMAETC), which builds capacity for HIV care and training among minority health
care professionals and health care professionals serving communities of color; the
National HIV/AIDS Clinicians’ Consultation Center (NCCC), providing consultation
to HIV care providers and providers treating individuals occupationally exposed to
blood-borne pathogens; the National Resource Center (NRC), which offers education
and training resources for the regional AETCs, both via the internet and in national
and regional professional conferences; and the National Evaluation Center (NEC).

The NEC
The AETC National Evaluation Center (NEC) is mandated to provide evaluation
development and technical support to its regional and national AETC partners. Its
mission is to provide leadership in the development, design, testing and dissemina-
tion of evaluation models for determining the effect that AETC programs have on
provider behavior and clinical practice.
Unlike the other AETCs, the NEC works in collaborative arrangement with HRSA/
HAB. Through this arrangement, the NEC has focused specifically on assessing
the effectiveness of AETC programs in improving the clinical practice behaviors
of HIV-treating clinicians who receive AETC training. Since its re-establishment in

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AETC National Evaluation Center     Florida/Caribbean AETC


                                  2004, the NEC has worked closely with HRSA/HAB and the regional and national
                                  AETCs to enhance the evaluation infrastructure of the AETC Program. The NEC has
                                  conducted a comprehensive inventory of outcome-oriented AETC evaluation activi-
                                  ties; hosted evaluation-oriented professional development meetings and conference
                                  calls; delivered technical assistance on evaluation, program planning, and related
                                  topics; and developed a training curriculum on the many aspects of evaluation for
                                  AETC staff and faculty.
                                  In one of its most significant activities, the NEC has collaborated with several regional
                                  AETCs to develop and disseminate innovative, outcomes-oriented “Pilot Project”
                                  evaluation studies. This manual describes one of those projects.

                                  Pilot Evaluation Projects
                                  Between June 2005 and January 2007, the NEC collaborated with three regional
                                  AETC training centers to design and test pilot evaluation studies. The pilot projects
                                  were conceived to provide an opportunity in which outcomes-oriented evaluation
                                  techniques could be refined and proven effective, and subsequently documented and
                                  made available to the entire AETC network for replication and adaptation.
                                  Selection of regional AETC collaborators was based on several criteria, including
All of the pilot projects         evaluation infrastructure at the regional AETC, ability to replicate the evaluation
offer useful guidance,            technique in other AETCs, and openness to innovation and collaboration. Ulti-
                                  mately, the NEC worked with three AETC regions to conduct pilot projects focused
tools, and lessons                on evaluating training outcomes within the respective region. One project updated
                                  an existing evaluation method being used in the region, by adding greater depth
learned to assess                 to the primary data collection instruments. Another added a new outcomes-based
training effects.                 component to a proven-effective evaluation technique. The third project developed
                                  an entirely new data analysis system, but used pre-existing data.
                                  At several stages in this process, the pilot projects were reviewed by an Advisory
                                  Committee. The Committee was comprised of the following members:
                                    •   Directors and evaluators from the pilot AETC regions
                                    •   Representatives of the national AETC centers
                                    •   Ad hoc regional AETC evaluators
                                    •   Independent technical advisors
                                    •   HRSA/HAB representatives
                                    •   NEC staff members
                                  Guidance was actively solicited from the Advisory Committee throughout this
                                  process. For each of the pilot projects, members were asked for feedback on sev-
                                  eral key areas including study design, need for project, feasibility, and potential for
                                  replication.
                                  Measuring training effects requires a comprehensive approach to evaluation that
                                  includes diverse research tools and techniques. Each of the pilot projects offers tools
                                  and techniques to be adapted to and for other uses across the AETCs and beyond.
                                  No single evaluation technique will fit perfectly into a new training setting. However,
                                  we hope that these projects offer guidance, tools, and lessons learned that may be
                                  applied in other contexts to measure the outcomes of clinical training.


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II. Overview of this Pilot Evaluation Project
Chart Reviews at the Florida/Caribbean AETC

T
     he Florida/Caribbean AIDS Education and Training Center (AETC) receives
     funding from the Health Resources and Services Administration (HRSA) to
     conduct training for HIV/AIDS clinicians in Florida, Puerto Rico, and the U.S.
Virgin Islands. For the last several years, the Florida/Caribbean AETC has used
faculty expertise in quality of care assessment to help medical providers receiv-
ing RWCA funds in their region to conduct required quality reviews. In addition              Based on the results of
to assisting clinics in meeting quality improvement requirements, this approach,             the chart review and
which involves systematic chart reviews, provides an opportunity for the AETC to
offer clinical feedback and training. Based on the results of the chart review and the       the needs of the clinic,
needs of the clinic, the AETC can develop a specific training plan to address clinical
areas in need of attention. The systematic quality review approach was originally            the AETC can develop a
designed for review of adult HIV-infected patients’ records. Subsequently, the ap-           specific training plan.
proach has been expanded to include HIV-infected adolescents and children, and
HIV-exposed infants.

Chart Review Overview
This evaluation approach uses chart review and case conferencing to achieve sev-
eral evaluation and programmatic aims. The techniques are used for training plan
development (needs assessment), outcomes measurement, and clinical quality
management.
This approach requires several stages. Prior to the first review, the AETC works with
a clinic to determine the best time to conduct chart reviews and deliver trainings.
A team of AETC faculty then goes into each clinic and performs a comprehensive
review of a randomly selected group of charts to determine how well standards
of care are being met. The results of this review serve as a structured and specific
training needs assessment. The chart review is followed by an AETC-led feedback
session, during which AETC faculty point out the strengths of the health care team
providing HIV services as well as areas identified through the review process that
could be strengthened and would result in improved health care for the patients.
Options for training and consultation are offered. When appropriate, these are
presented as a quality improvement project for the clinic in a plan-do-study-act
format. A case conference is then provided to assist clinic staff in solving selected
clinical problems. A written summary of the findings are sent within a week and a
phone interview is conducted three weeks after the review to assess the clinic staff ’s
perceptions of the process.
Subsequently, the clinical site can opt to receive training and services as outlined in
the training plan. Approximately 12 months following the first training interven-
tion, outcome evaluation data are collected by a second review of medical records
which are compared to the baseline data. The change in clinical care, as reported in
the medical records, is the measure of outcomes that resulted from the intervention.
These steps are discussed in further detail below.


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AETC National Evaluation Center     Florida/Caribbean AETC



                                  III. Evaluation Plan
                                  Purpose and Introduction

                                  A
                                        s noted above, this evaluation approach uses chart reviews to achieve several
                                        evaluation and programmatic aims. The techniques are used for training plan
It is critical that the                 development (needs assessment), outcomes measurement, and clinical qual-
                                  ity management. Chart review is a valuable technique to assess clinical practice. It
clinic staff understand           can provide detailed insight into clinical knowledge and skills, emphasizing areas of
that this process is              strength and needed improvement. This pilot evaluation project uses chart review
                                  for these purposes, working with local HIV-treating clinics to determine training
not an audit.                     needs and identify post-training improvements.
                                  Despite the clear benefits of chart review, it is a process that may make some par-
                                  ticipants initially uncomfortable. It is critical that the clinic staff understand that
                                  this process is not an audit. The Florida/Caribbean AETC does not have any desire
                                  or authority to seek out deficits and require remediation. Rather, the reviews are
                                  simply an opportunity for the clinics to have an outsider’s perspective on the clini-
                                  cal care being offered, followed by a collaborative discussion of how best to meet
                                  standards of care.
                                  Generally, the chart review process follows this format:
                                    •   Pre-review preparation
                                    •   On-site review
                                    •   Feedback session
                                    •   Case conference
                                    •   Written report
                                    •   Post-review interview
                                    •   Training
                                    •   Follow-up on-site review

                                  Methods
                                  Pre-review Preparation
                                  The AETC may be invited to perform a review by the clinic director or an agency
                                  responsible for monitoring all the RWCA-funded clinics in a community for quality
                                  assurance. Once the invitation has been secured, a letter of agreement can be signed
                                  (see Appendix). The letter should address payment if there is any, confidentiality assur-
                                  ances, and who will receive the reports. The coordinator selects a date that is acceptable
                                  to the clinic staff and recruits a team of AETC faculty. The coordinator prepares the
                                  clinic for the review by sending a letter confirming the details and, ideally, visiting the
                                  clinic in advance to meet the staff and see the space that will be available. Instructions
                                  for pulling charts in advance of the AETC faculty visit are provided.
                                  The coordinator prepares the team by completing the facility assessment form
                                  (see Appendix). The facility assessment collects information on staffing patterns,
                                  patient scheduling, clinic visit times and community resources (labs, subspecialty
                                  availability, etc.).


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  Evaluation and Needs Assessment of Clinical Training Using Chart Review                      AETC National Evaluation Center


Team
All AETC chart reviews are conducted by AETC faculty with one identified (physi-
cian) team leader. Ideally, the team members are not from the same community as
the clinic and providers are geographically diverse. All participating faculty will have
signed a Confidentiality Agreement Statement and completed training in the use of
the chart review instrument. Training includes an item-by-item discussion of scoring
criteria to assure that the reviewers are fully familiar with the instructions for use
of the chart review instrument. Non-clinicians can participate as long as a clinician
is present to score the parts of the instrument that require clinical judgment. The
number of faculty on a team varies with the size of the clinic. Usually, if a full day
is dedicated to reviewing charts, one team member for each clinician seeing HIV
patients is adequate.
Reviewers are provided with hotel information and directions to the clinic and cell
phone numbers are collected to communicate last-minute changes and help with
navigation.

Sample
In advance of the team arriving, clinic staff will select and set aside charts in accordance
with a predetermined plan. As many charts as possible should be pulled. Charts should
be chosen at random, except that they must include charts from new patients, charts
from patients with co-infections and charts from female patients. Patients who have
been seen at the clinic for less than six months are excluded from the review. A mini-
mum of five charts per provider should be reviewed. Only the current volume of multi-
volume charts will be reviewed but earlier volumes may be requested during the                    Reviewers use a
review. Having a clinician provide a “tour” of a sample medical record can help save
time during the actual review.
                                                                                                  detailed guide that
                                                                                                  directs them through a
On-site Review
Chart review data can be recorded either on paper or using the database available                 comprehensive analysis
as part of this pilot project (see the Appendix for more information on the database              of each patient’s chart.
and instructions for use). If the computer database is used, faculty should each be
supplied with a laptop with the chart review database loaded onto it or should be
given the software to load onto their own laptops. If the chart review is completed
using paper review forms, the facilitator should make sure that each faculty member
has enough forms for the planned number of reviews.
The reviews take place in whatever space the clinic can make available, usually a
conference room, in which privacy can be assured. Discussion of findings and prepa-
ration for the feedback session and report should take place away from the clinic,
again in a private place, at the end of the first day. During this meeting, the team
reviews the scores if they are available as well as their general impressions of their
findings. Lists of strengths and weakness are compiled. If questions remain they can
be answered by reviewing additional charts the following day.
Reviewers use a detailed guide that directs them through a comprehensive analysis
of each patient’s chart. When reviewing charts, reviewers are instructed to focus on
the last 12-18 months of care (with some exceptions, such as when data on initial
laboratory screens are requested). Reviewers are also instructed to complete every

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                                  item on the review form, to ensure a full picture can be provided to the clinic about
                                  how care is provided at that site. Complete details for completing reviews are con-
                                  tained in the Chart Review Guidelines (see appendix).

                                  Feedback Session
                                  The feedback session with clinic staff is conducted by the (physician) team leader
                                  who has observed at least one session conducted by the Clinical Director. To avoid
                                  appearing overwhelming, it is usually best if no more than two other AETC repre-
                                  sentatives are present. If other faculty members assist in the review of charts, they
We are working                    will not be present at the feedback session.
towards maximizing                The feedback session begins with introductions. The team leader then explains the
                                  purpose of the review and the differences between a review and an audit. For example,
strengths and providing           an audit focuses on details in the charts, the review focuses on the comprehensive
education and support             pattern of care offered in the clinic. An audit is designed to identify deviations from
                                  standards. The review is designed to elucidate the strengths and weaknesses of the
for improvements.                 clinic with respect to the DHHS guidelines and CDC recommendations. An audit
                                  identifies deficits; we are working towards maximizing strengths and providing
                                  education and support for improvements.
                                  The team leader then presents a description of the areas in which best practices
                                  are being followed. At least five minutes should be spent on positive feedback in order
                                  to allow staff to relax and reduce any potential defensiveness. The positive feedback
                                  should be provided with genuine enthusiasm and whenever possible should imply
                                  that they are superior to other clinics (for example, “your consistency in providing
                                  X was really extraordinary — I don’t think we’ve ever seen a clinic before where
                                  every single patient got X”). This will open up an opportunity for clinic staff to
                                  explain how they achieved this success and result in a livelier exchange through the
                                  rest of the session. To ease probable apprehensive about being judged by “experts,”
                                  be sure to acknowledged their own expertise. This session should always remain a
                                  collaboration rather than an exam. Problems or gaps in treatment or documentation
                                  are presented as uncertainties or questions rather than deficiencies. For example,
                                  the evaluation team may say:
                                    • “It isn’t clear to us how medication changes are being monitored. There are
                                      MARs in charts but they don’t seem to correspond with the information in
                                      the progress notes.”
                                    • “We noted some screening for STDs. Are you aware that the CDC recom-
                                      mends annual testing for STDs for all sexually active patients in communities
                                      with high prevalence of STDs such as yours?”
                                    • “We couldn’t tell from the charts how you deal with clients who repeatedly
                                      miss appointments.”
                                  Team members are cautioned to be very clear when recommendations are being
                                  made that are considered best practices by the team but are not part of the DHHS
                                  guidelines, eg., anal cytology or CMV serology.
                                  Discussions of specific issues found in individual charts are avoided. If there is some
                                  critical problem found in a chart that requires action, it is brought to the attention
                                  of an appropriate clinician privately. If possible, no patient charts are in the room
                                  at the time of the feedback session.
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A feedback session points out the strengths of the health care team providing HIV ser-
vices as well as areas identified through the review process that could be strengthened
and would result in improved health care for the patients. Because faculty members
come from different types of clinics in different parts of the AETC region, they can
offer valuable insight into problem solving. They also provide a variety of tools to
help clinic staff maintain the highest quality of care including pocket treatment
guides and chart tools. Options of training and consultation are offered to support
continued excellence in care as well as to assist with changes that would improve
quality of care. Brochures and other AETC promotional materials are available at
the case conference but not the feedback session.

Case Conference
Following the feedback session, clinic staff are asked to present cases with which
they have had some difficulty and a discussion is conducted during which they
demonstrate how they solved the problem or the AETC faculty assist in problem
solving. An informal atmosphere is maintained and, when possible, lunch is served.
This CME event is another opportunity to establish a collegial relationship which
will help assure that the AETC is welcomed in the clinic in the future.

Chart Review Reporting
Someone in the review team should be assigned the task of completing several
standard AETC training forms:
  • Record Review – One Event Record (ER form; check Individual Consulta-
    tion) and one Participant Information Form (PIF; complete for the primary
    provider for that chart); fill out one form of each type for each chart.
  • Exit Interview/Feedback Session – One Event Record (ER form; check Techni-
    cal Assistance) and multiple Participant Information Forms (PIFs; complete
    one for each participant in the session); includes chart review feedback ses-
    sions (exit interview) and the time spent discussing the results.
  • Report Preparation – One Event Record (ER form); AETC faculty preparing
    the chart review reports should complete an ER form for that activity.                       AETC faculty
  • Case Conference – Event Record (ER form; check Group Consultation) and
    multiple Participant Information Forms (PIFs; one for each person present).                  members can offer

Written Report
                                                                                                 valuable insight into
In addition to standard forms, someone on the team completes a draft of the final                problem solving.
report the day of the feedback session. After the review, the draft report is finalized,
signed by the physician team leader and mailed to the clinic within one week. Copies
of the report and all the original chart review instruments and note sheets are sent to
the AETC Central Office where they are filed in a locked cabinet.

Training
As mentioned above, the preliminary feedback session emphasizes the development
of a training plan to address possible gaps in services at the clinic. The procedures
for scoring the chart reviews will identify topic-specific training needs. During this
session, a contact person at the clinic is identified to coordinate follow-up. If possible,
some plans for future training or consultation are made at the close of the session.

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AETC National Evaluation Center     Florida/Caribbean AETC


                                  If development of a training plan is not possible at the time of the feedback session,
                                  the project coordinator makes contact within two weeks to schedule training.
                                  In the months following this session, the AETC and the clinic work together to deliver
                                  trainings tailored to the findings of the chart review. Trainings usually span several
                                  of the AETC training levels, including didactic sessions, skills-building workshops,
                                  clinical preceptorships, and clinical consultations.

                                  Post-review Interview
                                  Three weeks after the review, a member of the evaluation staff calls and performs a
                                  phone interview to assess satisfaction with the review process (see Appendix for post-
                                  review evaluation). There are different forms to use after the first review (Baseline)
                                  and subsequent reviews (Follow-up).

                                  Follow-up On-site Review
                                  Training outcomes are assessed by comparing scores from the reviews conducted at
                                  baseline to reviews conducted at a designated interval after baseline (recommend
                                  18-months). At this point, the AETC will have an established relationship with the
                                  clinic and will be able to set up a time to conduct the follow-up review. The 18-
                                  month review is conducted using the same procedures as the baseline review. An
The AETC and the                  automatically generated report compares scores across the two time points, which
                                  provides general trend information for the feedback session and can then be used by
clinic work together              the AETC for evaluation purposes only; because delivering clinical concepts rather
to deliver trainings              than scores helps the clinic focus on the content areas, numeric scores and percent
                                  change over time are not returned to the clinic.
tailored to the findings
of the chart review.              Data Analysis Plan
                                  Scores are generated to reflect whether the clinical behavior reflected in a chart is
                                  consistent with standards of care (largely federal guidelines, although developments
                                  in the field sometimes supersede portions of them). To calculate composite scores
                                  for each clinical subset (see list below) and for the chart as a whole, correct answers
                                  are used to determine the percent correct for the area or chart. The percent correct
                                  is determined by dividing the number of correct answers by the sum of correct and
                                  incorrect answers (that is, the N/As are not included in the denominator). For ex-
                                  ample, all of the items pertaining to labs are scored and the total correct is summed
                                  and divided by the total scored to comprise the total score for “Labs.” Some individual
                                  items are used to calculate scores in more than one clinical area.
                                  Clinical subsets used in scoring:
                                    •   Labs
                                    •   Vaccines/PPD
                                    •   Charting/Monitoring
                                    •   Health Maintenance/Education
                                    •   ARV Therapy
                                    •   OI Prophylaxis
                                    •   Co-morbidities
                                    •   Initial office visits
                                    •   Prevention

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Note on additional analysis: In addition to comparing scores at baseline to scores at
follow-up, it is possible to combine clinical change scores with process data collected
with standard AETC forms to understand if there are training strategies that have
influenced changes in scores. Contact the AETC NEC for more information.

List of Materials
These forms and tools have been organized in the order that one would use them               Because of the
when conducting a similar evaluation. They are as follows:                                   unique clinical needs
  •   Chart Review Procedures Check-List
  •   Letter of Agreement                                                                    of young patients, three
  •   Facilities Assessment                                                                  additional tools have
  •   Chart Review Instrument – Adult
  •   Chart Review Instrument – Adolescent                                                   been developed.
  •   Chart Review Instrument – Child
  •   Chart Review Instrument – HIV-exposed Infant
  •   Chart Review Guidelines with Supplemental Guidelines Tables
  •   Scoring Guidelines
  •   Chart Review – Interview One (Baseline)
  •   Chart Review – Interview Two (Follow-up)

Chart Review Procedures Check-List
This checklist provides a way to track the activities and data collection points com-
prising this evaluation approach.

Letter of Agreement
This may be omitted in cases when the AETC has an established relationship with
the clinic.

Facilities Assessment
This provides background information for the reviewers before arriving.

Chart Review Instrument – Adult
This study uses several chart review tools, each used depending on the needs of
the particular clinical site. The primary tool used is the “Chart Review Instrument
– Adult.” This tool can be used to collect data from all adult HIV-infected patients
being seen in the clinic. The tool collects information in several domains: Labs
(with subcategories); Vaccines/PPD; Charting/Monitoring; Health Maintenance/
Education; ARV Therapy; and Opportunistic Infection Prophylaxis.

Chart Review Instruments - Pediatrics
Because of the unique clinical needs of young patients, three additional tools have
been developed: Chart Review Instrument – Adolescent; Chart Review Instrument
– HIV Infected Child; and Chart Review Instrument – HIV Exposed Infant. These
three instruments have the same general categories, but take into account the unique
clinical indications for the particular patient population.


                                                                                             Page 11
AETC National Evaluation Center     Florida/Caribbean AETC


                                  Chart Review Guidelines
                                  For all these tools, chart reviewers are provided thorough Chart Review Guidelines,
                                  a highly detailed manual explaining the correct way to complete each item on the
                                  chart review instruments.

                                  Scoring Guidelines
                                  Guidelines provide the “key” to the items in the chart instruments so that items can
                                  be combined into subscores and total score.

                                  Follow-up Interview Tools
                                  In addition to these chart review tools, two brief follow-up interview tools are used
                                  to assess the utility of this process for the clinical site. Two different interviews have
                                  been developed, and are called “Chart Review – Interview One” and “Chart Review
                                  – Interview Two.” These are used for quality improvement for the AETC.

                                  Limitations
                                  Chart review provides an in-depth look at clinical practice in a clinic. Nevertheless,
                                  the approach has some limitations. Information reflected in a medical chart does
                                  not always completely concord with clinical practice, often because clinicians are
                                  too busy to document all activities comprehensively. This should be considered by
                                  AETC faculty using this approach as a training needs assessment; asking clinic staff
A key ingredient to               to reflect on the findings of the initial chart review can clarify whether what has
                                  been documented in charts reflects actual practice. When it does not, part of the
using this approach               training should cover use of tracking tools, such as flow sheets, to better document
                                  and track clinical practice.
effectively is training
                                  As the pilot of this approach demonstrates, a key ingredient to using this approach
chart reviewers.                  effectively is training chart reviewers. Consistency in procedures and understanding
                                  of scoring criteria is critical to generating scores that are reliable across time.

                                  Implementation Timeline

                                   Arrange baseline       Conduct baseline       Deliver trainings      Conduct follow-up
                                   chart review           chart reviews          over several months    chart reviews
                                                          at clinic              or a year, in accord   at clinic
                                   Conduct facility
                                                                                 with training plan
                                   assessment             Provide feedback                              Prepare and deliver
                                                          in formal meeting                             final report
                                   Complete informed
                                                          at clinic
                                   consent (when                                                        Conduct post-
                                   needed)                Develop training                              training interview(s)
                                                          plan
                                                                                                            Follow-Up
                                        Pre-Chart              Baseline
                                                                                      Training             Chart Review
                                         Review              Chart Review
                                                                                                           (18-months)




                   Page 12
  Evaluation and Needs Assessment of Clinical Training Using Chart Review                AETC National Evaluation Center



IV. Results from the Pilot Test
Methods/Description of Pilot Activities

T
     o test this approach, the Florida/Caribbean AETC conducted baseline and fol-
     low-up reviews in two metropolitan areas in two rounds using the procedures
     outlined above.
Ten to twenty patient charts were reviewed at each clinic. Two rounds of pilot testing
were completed. In the first round, 10 clinics were included. In the second round,
four clinics participated. Chart reviews were completed at baseline and 12-months
in both metropolitan areas.

Human Research Protections
The Florida/Caribbean AETC secured approval to conduct the pilot from their                 The review of records
institutional review board. To protect patient and provider confidentiality, medical
records were available only to AETC on-site review staff. The review of records took        took place in a private
place in a private room and charts were kept on premises. The data collected were
                                                                                            room and charts were
entered and stored in a database designed specifically for this study. This database
did not include any personal identifiers associated with the data stored within it.         kept on premises.
Instead, subject numbers were randomly assigned to records. No record was kept
linking unique subject numbers and patient names. This database was stored at the
AETC central office and was only accessible to faculty/staff.
Note: If you plan to use the data from this project for dissemination, human subjects
approval is required. Contact the NEC for model language or for assistance in com-
pleting an application to your local Human Subjects Research review committee.

Results
Table 1 presents the results from the first pilot in ten clinics:
                                       Baseline           12-Months      Change
 Labs                                   64.1                 66.5         + 2.4
 Vaccines and PPD                       40.0                 42.9         + 2.9
 Charting/Monitoring                    66.6                 64.2         - 2.2
 Health Maint/Education                 63.6                 60.7         - 2.9
 ARV Therapy                            61.8                 60.0         - 1.8
 O I Prophylaxis                        74.2                 77.6         + 3.4
 Co-Morbidities                         42.9                 50.0         + 7.1
 Initial Office Visit                   65.0                 61.4         - 3.6
 Outpatient Monitoring                  63.6                 66.6         + 3.0
 Prevention                             17.6                 45.7        + 28.1
 OVERALL                                62.2                 63.5         + 1.3

Table 1: Results from 10 Clinics in a Metropolitan Area
The results appeared disappointing in all categories except prevention, even though
the AETC reviewers and the clinic staff all believed that improvements had been made.
To explore the discrepancy, the AETC evaluator working on the project conducted

                                                                                            Page 13
 AETC National Evaluation Center       Florida/Caribbean AETC


                                     some post-project interviews with faculty and found that there were wide variations
                                     in scoring practices and as a result, the instrument was working best as a qualitative
                                     assessment for faculty, but that the quantitative results were not reliable.
                                     After this discovery, the evaluator rewrote the guidelines for use of the instrument to
                                     provide more specific scoring instructions and increased the amount of training that
                                     AETC reviewers received. This procedure was designed to ensure that all reviewers
                                     were fully aware of the scoring criteria and procedures.
                                     In the second phase of the pilot, in a metropolitan area with four clinics, results
                                     reflect improvements, which the evaluator and AETC faculty believe are reliable,
                                     reflecting real improvements in clinical practice across clinics (Table 2).

Lessons Learned                                                               Baseline           12-Months      Change
                                      Labs                                     71.2                 81.3         +10.1
• Chart review is valuable way
                                      Vaccines and PPD                         49.8                 75.6         +25.8
  to assess quality of care,
                                      Charting/Monitoring                      65.0                 77.5         +12.5
  training needs and training
  outcomes.                           Health Maint/Education                   59.6                 71.0         +11.4
                                      ARV Therapy                              82.9                 92.3         +9.4
• Training clinicians to conduct
                                      O I Prophylaxis                          70.2                 77.3         +7.1
  chart-review is an important
                                      Co-Morbidities                           51.0                 82.0         +31.0
  and ongoing task.
                                      Initial Office Visit                     60.9                 73.1         +12.2
• To ensure reliability of results    Outpatient Monitoring                    66.4                 79.4         +13.0
  across time, chart reviewers
                                      Prevention                               61.3                 76.0         +14.7
  must be well-trained and
                                      OVERALL                                  65.8                 78.7         +12.9
  supported in conducting the
  reviews.                           Table 2: Results from Four Clinics in a Metropolitan Area
• Working with a clinic to
  implement this method not
  only provides evidence for
                                     Lessons Learned from the Pilot
  multiple uses, it also allows      Provide precise scoring criteria for each item: Clinicians may have their own ideas about
  trainers to develop relation-      what to look for in a chart to document a particular activity or about when an activity
  ships with clinic administra-      is not needed or required. During the pilot period, a group of faculty members who
  tors and staff. Across AETCs,      had been conducting reviews for more than a year collectively re-wrote the entire
  longitudinal training is           instrument and instructions to reduce ambiguity and response bias.
  considered the best way to
  create and sustain changes in      Provide on-going training and support to staff conducting the evaluation procedures:
  clinical practice contributing     It became evident during the review of data that reviewers did not refer to the
  to better quality of HIV care.     guidelines but used their own judgment when scoring. Requiring a training session
                                     in which the scoring criteria for each item are discussed in addition to providing it
                                     in writing is essential. Refresher training should be required periodically.
                                     Anticipate Time for Training: In addition to the importance of consistently training
                                     chart reviewers, the pilot yielded an additional finding regarding implementation.
                                     Implementation of the training plan in all sites took longer than expected. For this
                                     reason and because it takes time for clinical practice change to manifest in patient
                                     charts, the AETC determined that an interval of 18-months between data collection
                                     points was preferable and yielded more robust results.




                         Page 14
 Evaluation and Needs Assessment of Clinical Training Using Chart Review   AETC National Evaluation Center



V. Appendix
Sample Tools
A.   Chart Review Procedures Check List
B.   Letter of Agreement
C.   Facilities Assessment
D.   Chart Review Tool – Adult
E.   Chart Review Tool – Adolescent                                             New Tool!
F.   Chart Review Tool – Child
G.   Chart Review Tool – HIV-exposed Infant                                     Along with the paper
H.   Chart Review Guidelines with Supplemental Guidelines Tables
I.   Scoring Guidelines                                                         versions of the tools
J.   Chart Review – Interview One (Baseline)
K.   Chart Review – Interview Two (Follow-up)                                   provided, this package

Sample Reports                                                                  contains a disk with
L. Report of Scores at Baseline & Follow-up                                     a pre-programmed
                                                                                database. The data-
                                                                                base contains the four
                                                                                chart review tools
                                                                                and a report function
                                                                                to produce scores at
                                                                                baseline, follow-up
                                                                                and a comparison
                                                                                across time.




                                                                              Page 15
                            Chart Review Procedures Checklist

 Name of Clinic:
 Name of Clinic Coordinator:
 Phone:                                                  Email:
 Date of Scheduled Review:
 Exit Interview Attendees:
 Case Conference Attendees:

                    Task                                     Date       Date
                                                           Expected   Completed
                    Schedule

                    Speak with Title I Coordinator

                    Letter Mailed to Clinic

                    Speak with Clinic Coordinator

                    Notify AETC Faculty/Staff

                    Update internal calendar

                    Make hotel reservations

                    Send maps to Faculty/staff

                    Pre-review visit/phone call
                    Case Conference
                    Make Arrangements for Lunch
                    Supplies
                    PIFs
                    Sign-in Sheet
                    Handouts
                    Post-Review
                    Complete TA Forms
                    (Chart Review & Exit Interview)
                    Submit completed Review Tools
                    to Central Office
                    Submit CEC/CME forms
                    to UM for Case Conference
                    Submit TA Forms, GCC and PIFs
                    to Central Office
                    Report
                    Follow-up call for training
                    Follow-up evaluation




Florida/Caribbean AETC Chart Review                                               A-1
Confirmed Team Members:




            9/1/04 version




A-2                          Florida/Caribbean AETC Chart Review
                                      Letter of Agreement

DATE
AGENCY CONTACT
CLINIC
ADDRESS

Dear ________________:

The Florida/Caribbean AIDS Education and Training Center (AETC) will be visiting
your clinic to provide technical assistance. The purpose of this assistance is to ensure
that    all primary care services are in compliance with DHHS guidelines. This technical
assistance visit will provide valuable feedback to medical staff on strengths of the clinic
and recommendations for improving care. Areas for improvement that would benefit
from training from AETC faculty will be identified. AETC staff are scheduled to visit
        clinic name      on      date      .

An approximate schedule will include:

        Date
        9 AM – 4:30 PM                  AETC staff review records at clinical site/s

        Date
        9 AM – 11 AM                    AETC staff review records at clinical site/s

        11 AM – 12 PM                   Exit interview with AETC staff, clinic medical
                                        director, administrator and other administrative
                                        staff.

        12 PM – 1:30 PM                 Case conference at clinic name         (all
                                        physicians/clinicians invited)

Prior to the review, an AETC representative will contact you to get information about the
clinic and about chart organization. Clinic staff will be asked to provide a “tour” of the
chart, identifying the expected location of specific information found in the charts.

During the review, AETC staff will need a quiet, secure location in which to review
records and maintain client confidentiality. The records pulled for review should be
representative of the clinic population served in terms of race, gender, etc. They should
include: charts of patients relatively new to the clinic (6 months – 1 year receiving
services); some charts with patients co-infected with hepatitis B and/or C; and charts of
long-standing patients. For patients for which the medical record has multiple volumes,
all volumes should be pulled.

AETC staff will conduct an exit interview with the Medical Director and other
appropriate clinical and administrative staff after the chart review has been completed.



Florida/Caribbean AETC Chart Review                                                        B-1
Observed patterns of care will be described and areas in need of improvements will be
identified. Training and/or technical assistance will be offered based on our findings or
your staff requests.

As part of the case conference, please have clinical providers prepare to present two
cases. Cases chosen for presentation will hopefully reflect complex and problematic
issues or those with particularly interesting clinical presentation. AETC will provide
CMEs and lunch for the case conference. Please let Diana Travieso Palow
(dpalow@med.miami.edu) know how many will be participating in this part of the visit.

As always, your cooperation and participation are greatly appreciated. We hope this will
be an enjoyable and instructive session for all who take part in it. If you have any
questions regarding this review, please do not hesitate to contact me at (305) 243-2898.

Sincerely,




B-2                                                       Florida/Caribbean AETC Chart Review
                  Florida/Caribbean AETC Facility Assessment

Name of facility_____________________________
Address ______________________________________________________
        ___________________________________Zip code____________

Phone _______________Fax ___________________ E-Mail ____________
Date(s) of Review ___________________________
Clinic Coordinator’s name ___________________________
Person(s) being interviewed (name, degree, title)
______________________________________________________
______________________________________________________

Description of clinical services offered on-site
________________________________________________________________
________________________________________________________________
________________________________________________________________

Do you provide care for pregnant women? ______________________________

Key personnel (names, titles)
________________________________________________________________
________________________________________________________________
________________________________________________________________

Number of clinical staff ______

In the past year, estimate the percentage of all your patients who are:
_____ African American/Black               ____ Rural patients
_____ American Indian/Alaskan Native       ____ Medicaid covered
_____ Asian                                ____ Uninsured
_____ Caucasian                            ____ Migrants/Seasonal farm workers
_____ Hispanic                             ____ Non-US citizens

Do you receive RWCA reimbursement for HIV/AIDS services? _____
      If yes, since when? ___________ What Title(s)_____________

Does a patient’s initial intake routinely include sexual history and substance
abuse history? __________________
      Who does this assessment? ________________________

For adult HIV/AIDS patients, do you provide on site
      ____ dental care?
      ____ mental health care?
      ____ case management?
      ____ nutrition services?
      ____ care for HIV-infected pregnant women?

Florida/Caribbean AETC Chart Review                                              C- 1
If HIV+ patients are referred:
       What is it for:
       ____ Paps
       ____ Eye Exams
       Where are they sent? ____________

      Why are these patients referred?
           Lack of funding ____
           Lack of expertise ____
           Other (specify) _________________________________

      If more than one, which of these has been the greatest obstacle to
      providing care?

Is HIV care provided in:
       A designated HIV clinic? ____
       As part of an STD clinic? ____
       As part of an ID clinic? ____
       Other (specify) _________________________________
       How often is the clinic held? ____________________________

      Who is providing the care:
            In-house staff____
            Part-time HIV/ID specialist____

      How long have you been providing HIV care at this facility? _____
      How many patients per week are treated____
      What percentage are male ____ What percentage are pediatric ____

How many of the clinic patients are active cIients? _____

What is the time allotment per patient; First visit _____ F/U _____

Are labs done on site or are patients sent to a designated lab or drawing center?
________________________________________________________________

Are labs routinely scheduled prior to the appointment with the physician? ____

What are this facility’s greatest strengths in providing HIV care?
________________________________________________________________
________________________________________________________________
________________________________________________________________

What are this facility’s greatest weaknesses in providing HIV care?
________________________________________________________________
________________________________________________________________
________________________________________________________________



C-2                                               Florida/Caribbean AETC Chart Review
How does the institution support continuing education/training for clinical staff?
____ pays for continuing education on-site
____ pays for continuing education off-site
____ pharmaceutical sales reps allowed
____ Other ___________________________________________________

Has any HIV education has been provided here?
____ by AETC
____ by Positive HealthCare
____ by pharmaceutical company
____ Other ___________________________________________________

The Florida AETC provides training and consultation to providers in a variety of
formats. Would you be interested in any of the following:

Providers leave their facility to attend educational events _______
Providers attend a specialty HIV clinic and observe patient care _______
AETC faculty provide educational presentations such as updates with case
conferences to staff here at your facility ______
AETC faculty consultants come to your facility and work side by side with clinic
staff as they see patients _______
AETC telephone HIV Clinicians’ consultation service _________
Written material regarding the treatment of HIV/AIDS __________
Other training: ______________________________

Number of facility clinicians who should receive HIV-related clinical training:

Physicians                                _____
Physician Assistants                      _____
Midwives                                  _____
Nurse Practitioners                       _____
Nurses                                    _____
Dentists                                  _____
Dental Assistants/Hygienists              _____
Pharmacists                               _____


Comments




Florida/Caribbean AETC Chart Review                                               C- 3
                                      Chart Review - Adult

 Date:                                 Reviewer:
 Clinic:                               Subject Number:
 Age:               Sex:               Race/Ethnicity:   Hispanic/Latino or
                                                         Spanish Origin?

 Provider:


Viral LoadYes              No
1. Every 3-4 months
2. Within 2-8 weeks of ARV change
3. Most recent viral load
CD4 countYes            No
1. Every 3-4 months
2. Most recent CD4
Resistance testingYes          No
1. Prior to initiating or changing therapy
2. If VL > 1000 && < 1 log drop after 8 weeks following initiation or change, and
non-adherence excluded.
3. Was patient appropriate for resistance test per VL && drug pressure
CBC/diff/plateletsYes           No
1. After initiating or changing therapy
2. q 3-4 months if on ART
3. Abnormalities addressed
CMPYes            No
1. At baseline
2. q 3-4 months if on ART
3. Abnomalities addressed
4. If Glucose elevated, was HgbA1c or 2 hr. GTT done?
Lipid profileYes           No
1. HDL/LDL/triglycerides pre ART
2. HDL/LDL/triglycerides q 3-4 mos if on ART
3. Fasting status documented for lipid assessment
4. If cholesterol/triglycerides elevated were NCEP guidelines followed
sYes         No




Florida/Caribbean AETC Chart Review                                                 D-1
1. Hepatitis A total antibody (HAVAb) or IgG
2. Hepatitis B surface antigen (HBsAg)
    2a. if positive, Hep B VL tested
3. Hepatitis B surface antibody (HBsAb)
4. Hepatitis B core antibody (HBcAb) total or IgG
5. Hepatitis C antibody (HCVAb)
    5a. if positive, Hep C VL tested
    5b. if VL positive, genotype determined
    5c. if positive, treatment plan in record
    5d. if negative and active IDU, (HCV Ab) repeated in the past 12 months
6. If unexplained chronic LFT elevation, were Hep C viral loads checked
Other LabsYes             No
1. G6PD (if AA or middle-eastern)
2. Toxo IgG
    2a. If negative, repeated when CD4 < 100
3. CMV IgG (optional)
4. Labs ordered within 4 weeks prior to scheduled office visit
5. Baseline Syphilis screening (RPR, VDRL)
    5a. If positive, treated or evidence of past treatment
6. Syphilis screening in the past 12 months or documentation that patient is not sexually active
(optional, based on regional prevalence)
7. Chlamydia screening in the past 12 months or documentation that patient is not sexually active
(optional, based on regional prevalence)
8. Gonorrhea screening in the past 12 months or documentation that patient is not sexually active
(optional, based on regional prevalence)
Vaccines and PPDYes              No
1. Hepatitis A vaccination completed or in process (2 shots)
2. Hepatitis B vaccination completed or in process (3 shots)
3. Influenza vaccine in the past 12 months
4. PPD in the past 12 months (or chest x-ray or cough && symptom eval)
5. Pneumoccocal vaccine 2 shots, 5-6 years apart
Charting/Monitoring IYes              No




D-2                                                         Florida/Caribbean AETC Chart Review
1. Complete initial history and physical examination
2. Symptom-targeted exam
3. Problem list utilized
4. Organized and complete medication list present
    4a. Dosage and frequency documented
    4b. Start and stop dates documented
5. Drug allergies clearly noted
6. Documentation of all past ARV
7. Missed appointments addressed
8. Consultation reports in record
9. Advance directives in chart or discussed
10. Records from previous provider
Chart Review - Adult
Charting/Monitoring IIYes           No
11. Oral exam in the past 12 months
12. Chest exam in the past 12 months
13. Abdomen exam in the past 12 months
14. Genito-rectal exam in the past 12 months
15. Lymph Node exam in the past 12 months
16. Neurologic exam in the past 12 months
17. Skin exam in the past 12 months
18. Weight assessed routinely
    18a. Weight loss addressed
ARV TherapyYes             No
1. ARV within the last year
2. ARV initiated according to DHHS Guidelines
3. ARV regimen consistent with current DHHS Guidelines
4. All medications correctly dosed and combined
5. Were medications adjusted for
    5a. renal impairment
    5b. hepatic impairment
    5c. weight
6. Increasing viral load addressed
7. Decreasing CD4 addressed
8. Adverse effects to treatment documented
                                            (continued)




Florida/Caribbean AETC Chart Review                       D-3
9. If VL NOT < limit of detection at 5-6 months, addressed
10. Child bearing status considered in ARV selection
11. If patient pregnant, and VL > 1,000:
    11a. Attempts to start or change regimen
    11b. ARV consistent with Guidelines for pregnancy
Opportunistic Infection ProphylaxisYes            No
1. If CD4 < 200, or <14% was patient on PCP prophylaxis
2. If CD4 increased above 200, is PCP prophylaxis continued for 3-6 months and
then discontinued if CD4 remains > 100
3. If CD4 < 100, and pt is toxo IgG pos, patient on toxo prophylaxis
4. If CD4 increased above 100, is toxo prophylaxis continued for 3-6 months and
then discontinued if CD4 remains > 100
5. If CD4 < 50, was patient on MAC prophylaxis
6. If CD4 increased above 100, is MAC prophylaxis continued for 3-6 months and
then discontinued if CD4 remains > 100
7. If CD4 <50, was eye exam performed
Health Maintenance/EducationYes             No
1. Pap smear in the past 12 months (female)
2. Anal cytology
3. Colon cancer screening referral, (50+ years old)
    3a. Abnormalities addressed
4. Age appropriate mammograms, (female, age 40)
    4a. Abnormalities addressed
5. PSA, (male, 50+ years old)
6. Education or Counseling: Nutrition
7. Education or Counseling: Dental health
8. Education or Counseling: Medication/treatment adherence
9. Education or Counseling: Prevention (sex/drugs)
10. Education or Counseling: Birth control
11. Education or Counseling: Drugs, alcohol, tobacco
12. Education or Counseling: Mental health
13. Education or Counseling: Exercise

Comments:




D-4                                                       Florida/Caribbean AETC Chart Review
                                      Chart Review – Adolescent


 Date:                                   Reviewer:
 Clinic:                                 Subject Number:
 Age:               Sex:                 Race/Ethnicity:   Hispanic/Latino or
                                                           Spanish Origin?

 Provider:


1. Every 3-4 months
2. Within 2-8 weeks of ARV change
3. Most recent viral load
CD4 countYes            No
1. Every 3-4 months
2. Most recent CD4
Resistance testingYes          No
1. Prior to initiating or changing therapy
2. If VL > 1000 && < 1 log drop after 8 weeks following initiation or change, and
non-adherence excluded.
3. Was patient appropriate for resistance test per VL && drug pressure
CBC/diff/plateletsYes           No
1. After initiating or changing therapy
2. q 3-4 months if on ART
3. Abnormalities addressed
CMPYes            No
1. At baseline
2. q 3-4 months if on ART
3. Abnomalities addressed
4. If Glucose elevated, was HgbA1c or 2 hr. GTT done?
Lipid profileYes           No
1. HDL/LDL/triglycerides pre ART
2. HDL/LDL/triglycerides q 3-4 mos if on ART
3. Fasting status documented for lipid assessment
4. If cholesterol/triglycerides elevated were NCEP guidelines followed
epatitisYes          No




Florida/Caribbean AETC Chart Review                                                 E-1
1. Hepatitis A total antibody (HAVAb) or IgG
2. Hepatitis B surface antigen (HBsAg)
    2a. if positive, Hep B VL tested
3. Hepatitis B surface antibody (HBsAb)
4. Hepatitis B core antibody (HBcAb) total or IgG
5. Hepatitis C antibody (HCVAb)
    5a. if positive, Hep C VL tested
    5b. if VL positive, genotype determined
    5c. if positive, treatment plan in record
    5d. if negative and active IDU, (HCV Ab) repeated in the past 12 months
6. If unexplained chronic LFT elevation, were Hep C viral loads checked
Other LabsYes             No
1. G6PD (if AA or middle-eastern)
2. Toxo IgG
    2a. If negative, repeated when CD4 < 100
3. CMV IgG
4. Labs ordered within 4 weeks prior to scheduled office visit
5. Baseline Syphilis screening (RPR, VDRL)
    5a. If positive, treated or evidence of past treatment
6. Syphilis screening in the past 12 months or documentation that patient is not sexually active
(optional, based on regional prevalence)
7. Chlamydia screening in the past 12 months or documentation that patient is not sexually active
(optional, based on regional prevalence)
8. Gonorrhea screening in the past 12 months or documentation that patient is not sexually active
(optional, based on regional prevalence)

1. DTaP according to age and schedule
2. IPV according to age and schedule
3. HIB according to age and schedule
4. Prevnar according to age and schedule
5. Hepatitis A vaccination completed or in process (2 shots)
6. Hepatitis B vaccination completed or in process (3 shots)
7. Influenza vaccine in the past 12 months
8. PPD in the past 12 months (or chest x-ray or cough && symptom eval)
9. Pneumoccocal vaccine 2 shots, 5-6 years apart
10. Meningococcal vaccine at 11 yr - 12 yr or at entry to college
Charting/Monitoring IYes           No




E-2                                                         Florida/Caribbean AETC Chart Review
1. Complete initial history and physical examination
2. Symptom-targeted exam
3. Height and weight at each clinic visit
    3a. If significant weight loss or weight gain for age, nutritional consult
    3b. If in low height percentile for age, diff diagnosis considered
4. Problem list utilized
5. Organized and complete medication list present
    5a. Dosage and frequency documented
    5b. Start and stop dates documented
6. Drug allergies clearly noted
7. Documentation of all past ARV
8. Missed appointments addressed
9. Consultation reports in record
10. Advance directives in chart or discussed
11. Evidence of anticipatory guidance to parents/caregivers
12. Records from previous provider
13. Oral exam in the past 12 months
14. Chest exam in the past 12 months
15. Abdomen exam in the past 12 months
16. Genito-rectal exam in the past 12 months
17. Lymph Node exam in the past 12 months
18. Neurologic exam in the past 12 months
19. Skin exam in the past 12 months
ARV TherapyYes             No
1. ARV within the last year
2. ARV initiated according to DHHS Guidelines
3. ARV regimen consistent with current DHHS Guidelines
4. All medications correctly dosed and combined
5. Were medications adjusted for
    5a. surface area or weight
    5b. renal impairment
    5c. hepatic impairment
    5d. Tanner staging
6. Increasing viral load addressed
7. Decreasing CD4 addressed
8. Adverse effects to treatment documented
                                              (continued)




Florida/Caribbean AETC Chart Review                                              E-3
9. If VL NOT < limit of detection at 5-6 months, addressed
10. Child bearing status considered in ARV selection
11. If patient pregnant, and VL > 1,000:
    11a. Attempts to start or change regimen
    11b. ARV consistent with Guidelines for pregnancy
Opportunistic Infection ProphylaxisYes            No
1. If CD4 < 200, or <14% was patient on PCP prophylaxis
2. If CD4 increased above 200, is PCP prophylaxis continued for 3-6 months and
then discontinued if CD4 remains > 100
3. If CD4 < 100, and pt is toxo IgG pos, patient on toxo prophylaxis
4. If CD4 increased above 100, is toxo prophylaxis continued for 3-6 months and
then discontinued if CD4 remains > 100
5. If CD4 < 50, was patient on MAC prophylaxis
6. If CD4 increased above 100, is MAC prophylaxis continued for 3-6 months and
then discontinued if CD4 remains > 100
7. If CD4 <50, was eye exam performed
Health Maintenance/EducationYes             No
1. Pap smear in the past 12 months (female)
2. Anal cytology
3. Education or Counseling: Nutrition
4. Education or Counseling: Dental health
5. Education or Counseling: Medication/treatment adherence
6. Education or Counseling: Prevention (sex/drugs)
7. Education or Counseling: Birth control
8. Education or Counseling: Drugs, alcohol, tobacco
9. Education or Counseling: Mental health
10. Education or Counseling: Exercise

Comments:




E-4                                                       Florida/Caribbean AETC Chart Review
                                      Chart Review - Infected Child

 Date:                                    Reviewer:
 Clinic:                                  Subject Number:
 Age:               Sex:                  Race/Ethnicity:    Hispanic/Latino or
                                                             Spanish Origin?

 Provider:

Yes          No          NA
1. Proof of positivity in chart
2. Patient classification (select one)
3. Pediatric classification correct and correctly revised
Viral LoadYes           No        NA
1. Every 3-4 months
2. Within 2-8 weeks of ARV change
3. Most recent viral load
CD4 countYes            No        NA
1. Every 3-4 months
2. Most recent CD4
3. CD4% every 3-4 months
4. Most recent CD4%
Resistance testingYes           No       NA
1. Prior to initiating or changing therapy
2. If VL > 1000 && < 1 log drop after 8 weeks following initiation or change, and
non-adherence excluded.
3. Was patient appropriate for resistance test per VL && drug pressure
CBC/diff/plateletsYes           No       NA
1. After initiating or changing therapy
2. q 3-4 months if on ART
3. Abnormalities addressed
CMPYes            No        NA
1. At baseline
2. q 3-4 months if on ART
3. Abnomalities addressed
4. Amylase and lipase at baseline and q 3-4 mos if on ART




Florida/Caribbean AETC Chart Review                                                 F-1
1. Hepatitis A total antibody (HAVAb) or IgG if infected with Hep B or Hep C
2. Hepatitis B surface antigen (HBsAg)
    2a. if positive, Hep B VL tested
3. Hepatitis B surface antibody (HBsAb)
4. Hepatitis B core antibody (HBcAb) total or IgG
5. Hepatitis C antibody (HCVAb)
    5a. if positive, Hep C VL tested
    5b. if VL positive, genotype determined
    5c. if positive, treatment plan in record
Maternal recordsYes             No       NA
1. Maternal toxo serology in record
2. Maternal syphilis in record
    2a. If positive, obtained RPR and treated as needed
3. Maternal GC/chlamydia in record
4. Maternal CMV serology in record
5. Maternal HBsAg in record
    5a. If positive, immune globulin
6. Maternal HCV Ab
    6a. If positive, Hep C PCR on infant at birth, 6 weeks, and 6 mos
    6b. If PCR positive, genotype determined
    6c. If PCR positive, Hep C viral load test
HepatitisYes           No       NA
Chart Review - Infected Child
Vaccines and PPDYes              No       NA
1. DTaP according to age and schedule
2. IPV according to age and schedule
3. HIB according to age and schedule
4. Prevnar according to age and schedule
5. Hepatitis A vaccination completed or in process (2 shots)
6. Hepatitis B vaccination completed or in process (3 shots)
7. Influenza vaccine in the past 12 months
8. PPD in the past 12 months (or chest x-ray or cough && symptom eval)
9. Varicella vaccine at 1 year if CD4 > 25% (two dose series)
10. MMR at 12-15 mos (2 shots, 1-2 months apart) if CD4 > 15%
11. Pneumoccocal vaccine 2 shots, 5-6 years apart
12. Meningococcal vaccine at 11 yr - 12 yr or at entry to college
Charting/Monitoring IYes              No      NA



F-2                                                       Florida/Caribbean AETC Chart Review
1. Complete initial history and physical examination
2. Symptom-targeted exam
3. Height and weight at each clinic visit
   3a. If significant weight loss or weight gain for age, nutritional consult
   3b. If in low height percentile for age, diff diagnosis considered
4. Head circumference at each visit
   4a. If in low HC percentiles, developmental delay or neurological exam
5. Problem list utilized
6. Organized and complete medication list present
   6a. Dosage and frequency documented
   6b. Start and stop dates documented
7. Drug allergies clearly noted
8. Documentation of all past ARV
9. Missed appointments addressed
10. Consultation reports in record
11. Advance directives in chart or discussed
12. Evidence of anticipatory guidance to parents/caregivers
13. Developmental Assessment (refer if abnormal)
14. Records from previous provider
15. Oral exam in the past 12 months
16. Chest exam in the past 12 months
17. Abdomen exam in the past 12 months
18. Genito-rectal exam in the past 12 months
19. Lymph Node exam in the past 12 months
20. Neurologic exam in the past 12 months
21. Skin exam in the past 12 months
ARV TherapyYes            No         NA




Florida/Caribbean AETC Chart Review                                             F-3
1. ARV within the last year
2. ARV initiated according to DHHS Guidelines
3. ARV regimen consistent with current DHHS Guidelines
4. All medications correctly dosed and combined
5. Were medications adjusted for
    5a. surface area or weight
    5b. renal impairment
    5c. hepatic impairment
    5d. Tanner staging
6. Increasing viral load addressed
7. Decreasing CD4 addressed
8. Adverse effects to treatment documented
9. If VL NOT < limit of detection at 5-6 months, addressed
Opportunistic InfectionYes          No        NA
1. PCP prophylaxis according to Guidelines
2. MAC prophylaxis according to Guidelines
3. Ophthalmologic exam if CD4 < 50
4. CMV prophylaxis if retinitis or prior infection
5. Prophylaxis for severe or frequent recurrences of herpes simplex
6. Toxo prophylaxis according to Guidelines
7. TB prophylaxis according to Guidelines
Health MaintenanceYes            No       NA
1. Education or Counseling: Nutrition
2. Education or Counseling: Dental health
3. Education or Counseling: Drugs, alcohol, tobacco
4. Education or Counseling: Mental health

Comments:




F-4                                                         Florida/Caribbean AETC Chart Review
                                  Chart Review - Exposed Infant


 Date:                                 Reviewer:
 Clinic:                               Subject Number:
 Age:               Sex:               Race/Ethnicity:   Hispanic/Latino or
                                                         Spanish Origin?

 Provider:




1. Three HIV DNA-PCR (at ages:< 48 hrs; 1-2 mos; 3-6 mos)
2. ELISA and Western Blot at 12 - 18 mos
   2a. If positive, repeat test
3. Patient classification by 18 mos
   3a. seroreverted
4. CBC/diff/platelets at birth, 2 weeks and 6 weeks if on prophylactic AZT
 4a. Abnormalities addressed
5. Urine CMV at birth
Maternal recordsYes             No     NA
1. Maternal toxo serology in record
2. Maternal syphilis in record
   2a. If positive, obtained RPR and treated as needed
3. Maternal GC/chlamydia in record
4. Maternal CMV serology in record
5. Maternal HBsAg in record
   5a. If positive, immune globulin
6. Maternal HCV Ab
   6a. If positive, Hep C PCR on infant at birth, 6 weeks, and 6 mos
   6b. If PCR positive, genotype determined
   6c. If PCR positive, Hep C viral load test
7. Mother's viral load at delivery
8. Mother's ARV history
9. Method of delivery
10. If Cesarean section done, indication stated




Florida/Caribbean AETC Chart Review                                           G-1
1. DTaP according to age and schedule
2. IPV according to age and schedule
3. HIB according to age and schedule
4. Prevnar according to age and schedule
5. Hepatitis B vaccination completed or in process (3 shots)
6. Influenza vaccine in the past 12 months
7. Varicella vaccine at 1 year if CD4 > 25% (two dose series)
8. MMR at 12-15 mos (2 shots, 1-2 months apart) if CD4 > 15%
9. Pneumococcal vaccine at age 2
Charting/MonitoringYes              No       NA
1. Complete initial history and physical examination
2. Symptom-targeted exam
3. Height and weight at each clinic visit
    3a. If significant weight loss or weight gain for age, nutritional consult
    3b. If in low height percentile for age, diff diagnosis considered
4. Head circumference at each visit
    4a. If in low HC percentiles, developmental delay or neurological exam
5. Problem list utilized
6. Organized and complete medication list present
    6a. Dosage and frequency documented
    6b. Start and stop dates documented
7. Drug allergies clearly noted
8. Missed appointments addressed
9. Consultation reports in record
10. Developmental milestones documented, referred if abnormal
11. Records from previous provider
Care of the exposed neonateYes             No        NA
1. Evidence of AZT chemoprophylaxis
    1a. pre-partum
    1b. intra-partum
    1c. post-partum
    1d. continued 6 weeks
    1e. dose given according to weight
    1f. evidence of tolerance assessed
    1g. mother/caregiver instructed
2. PCP prophylaxis initiated at 6 weeks
    2a. Discontinued if HIV DNA by PCR negative after 4 months
3. Mother instructed about breastfeeding
4. Perinatal infections documented

G-2                                                            Florida/Caribbean AETC Chart Review
                                                       Chart Review Guidelines




 #    Item Text                       Instructions:                                                    Infant   Child   Adol   Adult
 1    Date of Chart Review            Insert date of review                                              x       x       x      x
 1    Reviewer                        Insert your name                                                   x       x       x      x
 1    Clinic                                                                                             x       x       x      x
 1    Subject Number                                                                                     x       x       x      x
 1    Age                                                                                                x       x       x      x
 1    Sex                                                                                                x       x       x      x
 1    Race/Ethnicity                                                                                     x       x       x      x
      Hispanic/Latino or
 1                                                                                                       x       x       x      x
      Spanish Origin
 1    Provider                                                                                           x       x       x      x
      Three HIV DNA PCR (at
 2    ages:< 48 hrs; 1-2 mos;         HIV RNA assay also acceptable                                      x
      3-6 mos)
      ELISA and Western Blot
 2                                                                                                       x
      at 12 - 18 mos
                                      Confirmatory test to be done as soon as
 2    If positive, repeat test                                                                           x
                                      possible
                                      See Tables 1 1994 Revised Human
                                      Immunodeficiency Virus Pediatric Classification
                                      System: Immune Categories Based on Age-
                                      Specific CD4 Cell Count and Percentage &
      Patient classification by       Table 2 1994 Revised Human
 2                                                                                                       x
      18 mos                          Immunodeficiency Virus Pediatric Classification
                                      System: Clinical Categories, Guidelines for the
                                      Use of Antiretroviral Agents in Pediatric HIV
                                      Infection October 26, 2006
                                      (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf)
                                      Seroverted-child is born with mother’s
      Seroreverted (HIV
                                      antibodies but is HIV negative
 2    negative Eliza/absence                                                                             x
      of maternal antibodies)
      CBC/diff/platelets at
      birth, 2 weeks and 6
 2                                                                                                       x
      weeks if on prophylactic
      AZT
                                      Abnormalities include: absolute neutrophil
 2    Abnormalities addressed         count (ANC) < 750, Hgb < 10 g/dl, platelets <                      x
                                      120,000
 2    Urine CMV at birth                                                                                 x
      Proof of positivity in          ELISA, Western blot, HIV DNA PCR, HIV RNA
 2                                                                                                               x
      chart                           assay
                                      See Tables 1 1994 Revised Human
                                      Immunodeficiency Virus Pediatric Classification
                                      System: Immune Categories Based on Age-
                                      Specific CD4 Cell Count and Percentage &
      Patient classification          Table 2 1994 Revised Human
 2                                                                                                               x
      (select one)                    Immunodeficiency Virus Pediatric Classification
                                      System: Clinical Categories. Guidelines for the
                                      Use of Antiretroviral Agents in Pediatric HIV
                                      Infection October 26, 2006
                                      (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf)




Florida/Caribbean AETC Chart Review                                                                                                    H-1
#     Item Text                  Instructions:                                                    Infant   Child   Adol   Adult
                                 See Tables 1 1994 Revised Human
                                 Immunodeficiency Virus Pediatric Classification
                                 System: Immune Categories Based on Age-
      Pediatric classification   Specific CD4 Cell Count and Percentage &
2     correct and correctly      Table 2 1994 Revised Human                                                 x
      revised                    Immunodeficiency Virus Pediatric Classification
                                 System: Clinical Categories. Guidelines for the
                                 Use of Antiretroviral Agents in Pediatric HIV
                                 Infection October 26, 2006
                                 (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf)
                                 Viral load and CD4 should be assessed every 3
                                 - 4 months. However, if longer interval is due to
                                 patient missing appointments and tests are
3     Every 3-4 months                                                                                      x       x       x
                                 done at closest appointment, score yes. If there
                                 is an order for the test but no result in the chart,
                                 score yes.
                                 ARV change = One or more ARV medications
      Within 2-8 weeks of ARV
3                                either discontinued or added to regimen. NA if                             x       x       x
      change
                                 no medication change during the review period.
3     Most recent CD4            Score undetectable if < 400.                                               x       x       x
                                 Viral load and CD4 should be assessed every 3
                                 - 4 months. However, if longer interval is due to
                                 patient missing appointments and tests are
4     Every 3-4 months                                                                                      x       x       x
                                 done at closest appointment, score yes. If there
                                 is an order for the test but no result in the chart,
                                 score yes.
4     Most recent CD4                                                                                       x       x       x
4     CD4% every 3-4 months                                                                                 x
4     Most recent CD4%                                                                                      x
      Prior to initiating or
5                                                                                                           x       x       x
      changing therapy
      If VL > 1000 & < 1 log
      drop after 8 weeks
                                 If documented that patient was non-adherent,
5     following initiation or                                                                               x       x       x
                                 score NA
      change, and non-
      adherence excluded.
                                 There must be a sufficient number of viral
                                 copies available (> 500-1000 copies/mL with
                                 current methodologies) to amplify sufficient
                                 product for resistance testing. Even with higher
                                 copy numbers, occasional isolates cannot be
      Patient appropriate for
                                 amplified for testing. Patients should be on
5     resistance test per VL &                                                                              x       x       x
                                 therapy when resistance testing is performed. If
      drug pressure
                                 the pressure of a drug is removed, the mixed
                                 viral population is likely to revert to the
                                 predominant “wild-type” virus that, by definition,
                                 is favored in its growth over mutated isolates in
                                 the mixture.
                                 Includes total WBC, HGB/Hct differential, and
                                 platelet count. ARV change = One or more
      After initiating or
6                                ARV medications either discontinued or added                               x       x       x
      changing therapy
                                 to regimen. NA if no medication change during
                                 the review period.
                                 Includes total WBC, HGB/Hct differential, and
6     q 3-4 months if on ART                                                                                x       x       x
                                 platelet count

H-2                                                                                               Florida/Caribbean AETC Chart Review
                                                      Chart Review Guidelines


 #    Item Text                       Instructions:                                         Infant   Child   Adol   Adult
                                      Abnormalities include: absolute neutrophil count
                                      (ANC) < 750, hemoglobin <12.0 g/dl for males
                                      or <11.0 g/dl for females. Abnormalities
 6    Abnormalities addressed                                                                         x
                                      addressed can be scored yes if re-testing is
                                      ordered, treatment is offered or a rationale for
                                      neither is provided.
                                      Chemistry minimum requirements = Glu, Alb,
 7    At baseline                     Bili, Alt (SGOT), AST (SGPT), Creat, BUN,                       x       x      x
                                      CO2.
                                      Chemistry minimum requirements = Glu, Alb,
 7    q 3-4 months if on ART          Bili, Alt (SGOT), AST (SGPT), Creat, BUN,                       x       x      x
                                      CO2.
                                      Abnormalities = fasting Glu > 126; Albumin
                                      below normal on lab; Bili – above normal on lab
                                      sheet; AST/ALT > 2 times the upper limit of
                                      normal; Creat. Above the limit of normal on 2 or
                                      more labs in the past 12 months, BUN Above
      Abnormalities                   the limit of normal on 2 or more labs in the past
 7                                                                                                    x       x      x
      addressed                       12 months, CO2 – trending downward over a 12
                                      month review and if below 18 on more. NA if
                                      yes on 13 and no abnormalities. NA if no or NA
                                      in the previous question than two occasions, it
                                      should be considered or addressed in the
                                      assessments of lab by the doctor.
      If glucose elevated, was
 7    HgbA1c or 2 hr. GTT             Score NA if patient is being treated for diabetes.                      x      x
      done
      Amylase and lipase at
 7    baseline and q 3-4 mos if                                                                       x
      on ART
                                      Cholesterol and triglycerides should be
                                      assessed at baseline and within 6 months after
      HDL/LDL/triglycerides           ARV change. Monitoring should occur every six
 8                                                                                                            x      x
      pre ART                         months if on HAART and every 12 months if not
                                      on HAART and > 35 years old. NA if < 35 years
                                      old and not on HAART.
      HDL/LDL/triglycerides q
 8                                                                                                            x      x
      6 mos if on ART
      Fasting status
                                      NA if lipids not assessed. If fasting not noted but
 8    documented for lipid                                                                                    x      x
                                      time of blood draw is early morning, score yes.
      assessment
      If                              Answer yes if treatment rendered with lipid or
      cholesterol/triglycerides       cholesterol lowering therapy per the NCEP
      elevated were National          guidelines. See Management of Dyslipidemia &
 8                                                                                                            x      x
      Cholesterol Education           HIV, AIDS Education & Training Centers.
      Program (NCEP)                  (http://www.aidsetc.org/pdf/p02-et/et-03-
      guidelines followed             00/dyslipidemia.pdf)
                                      This should be IgG, NOT IgM. This should be
      Hepatitis A total
 9                                    done as an initial screen, not necessarily within                       x      x
      antibody (HAVAb) or IgG
                                      the past 12 months.
      Hepatitis A total
      antibody (HAVAb) or IgG
 9                                    This should be IgG, NOT IgM                                     x
      if infected with Hep B or
      Hep C



Florida/Caribbean AETC Chart Review                                                                                         H-3
#     Item Text                  Instructions:                                               Infant   Child   Adol   Adult
      Hepatitis B surface        These should be done as an initial screen, not
9                                                                                                      x       x       x
      antigen (HBsAg)            necessarily within the past 12 months
      if positive, Hep B VL      These should be done as an initial screen, not
9                                                                                                      x       x       x
      tested                     necessarily within the past 12 months
      Hepatitis B surface        These should be done as an initial screen, not
9                                                                                                      x       x       x
      antibody (HBsAb)           necessarily within the past 12 months
      Hepatitis B core           This should be IgG, NOT IgM. This should be
9     antibody (HBcAb) total     done as an initial screen, not necessarily within                     x       x       x
      or IgG                     the past 12 months.
      Hepatitis C antibody
9                                                                                                      x       x       x
      (HCVAb)
      if positive, Hep C VL
9                                                                                                      x       x       x
      tested
      if VL positive, genotype
9                                                                                                      x       x       x
      determined
                                 Treatment plan =peginterferon alfa (Pegasys®
      if positive, treatment     or Peg-Intron®) and ribavirin (Copegus® or
9                                                                                                      x       x       x
      plan in record             Rebetol®) or referral to gastroenterology or
                                 hepatology.
                                 Assume that a patient is not an active IDU
      if negative and active     unless there is a note in the chart indicating
9     IDU, (HCV Ab) repeated     otherwise. If it has been less than 12 months                                 x       x
      in the past 12 months      since the baseline, this question should be
                                 scored NA.
      If unexplained chronic
                                 Chronic LFT elevation = ALT and AST > 4 X
9     LFT elevation, were Hep                                                                                  x       x
                                 normal twice in a row.
      C viral loads checked
                                 If patient is not African American or Middle
                                 Eastern score NA. G6PD (glucose-6-phosphate
      G6PD (if African
                                 dehydrogenase deficiency) test is an optional
10    American or Middle                                                                                       x       x
                                 test. If the clinic has a policy stating that G6PD
      Eastern)
                                 testing is not a part of their screening lab,
                                 please so note under comments.
                                 This should be IgG, not IgM. Assume IgG if it
                                 just indicates toxo screen. This should be done
10    Toxo IgG                                                                                                         x
                                 only as an initial screen, not necessarily within
                                 the last 18 months.
                                 If CD4 < 100 for initial draw, score yes for both
                                 2 and 3. If already on appropriate toxo
                                 prophylaxis, score NA. See TABLE 1.
                                 Prophylaxis to prevent first episode of
                                 opportunistic disease among adults and
      If negative, repeated      adolescents infected with human
10                               immunodeficiency virus (HIV) Guidelines for the                                       x
      when CD4 < 100
                                 Prevention of Opportunistic Infections Among
                                 HIV-Infected Persons – 2002
                                 Recommendations of the U.S. Public Health
                                 Service and the Infectious Diseases Society of
                                 America
                                 (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
                                 This should be IgG, not IgM. Assume IgG if it
                                 just indicates CMV screen. This should be done
10    CMV IgG (optional)                                                                                               x
                                 only as an initial screen, not necessarily within
                                 the last 18 months.


H-4                                                                                          Florida/Caribbean AETC Chart Review
                                                      Chart Review Guidelines


 #    Item Text                       Instructions:                                            Infant   Child   Adol   Adult
                                      This should be IgG, not IgM. Assume IgG if it
10    CMV IgG                                                                                            x       x
                                      just indicates CMV screen.
      Labs ordered within 4
                                      This is to assure that provider has current lab
10    weeks prior to scheduled                                                                                   x      x
                                      results at the time of visit.
      office visit
      Baseline syphilis
10                                                                                                               x      x
      screening (RPR, VDRL)
                                      Recommended therapy for primary and
                                      secondary syphilis is benzathine penicillin G 2.4
                                      million units intramuscularly given as a single
                                      dose. Optional-Benzathine penicillin G
                                      administered q wk X 3 wks as recommended for
                                      late syphilis If the patient has a penicillin allergy,
                                      doxycycline 100 mg orally twice a day for 14
                                      days can be given to nonpregnant patients.
                                      Treatment using a single 2 gram dose of
                                      azithromycin to treat lesion syphilis has resulted
                                      in treatment failures due to macrolide high-level
                                      resistance in San Francisco, and is not
                                      presently recommended unless there is no other
                                      recourse. The treatment for early latent syphilis
                                      is the same as primary and secondary syphilis.
                                      Recommendations for treating late latent
      If positive, treated or         syphilis in nonallergic patients who have normal
10    evidence of past                CSF examinations (if performed) include                                    x      x
      treatment                       benzathine penicillin G 7.2 million units total,
                                      administered as three doses of 2.4 million units
                                      IM at 1-week intervals. For nonpregnant
                                      patients who have late latent syphilis and are
                                      allergic to penicillin, doxycycline 100mg orally
                                      for four weeks is recommended. For the
                                      treatment of neurosyphilis, aqueous crystalline
                                      penicillin G 18-24 million units a day,
                                      administered as 3-4 million units IV every 4
                                      hours for 10-14 days is recommended. For
                                      unclear cases, especially with discordant clinical
                                      and serologic findings, consultation with an
                                      expert in the management of syphilis is
                                      suggested. Sexually Transmitted Diseases
                                      Treatment Guidelines, 2006
                                      (http://www.cdc.gov/MMWR/PREVIEW/MMWRHTML/rr5511
                                      a1.htm)
      Syphilis screening in the       Assume that all adult patients are sexually
      past 12 months or               active unless noted in history or progress note
      documentation that              that patient denies being sexually active. NA if
10                                                                                                               x      x
      patient is not sexually         not sexually active
      active (optional, based
      on regional prevalence)
      Chlamydia screening in          Assume that all adult patients are sexually
      the past 12 months or           active unless noted in history or progress note
      documentation that              that patient denies being sexually active. NA if
10                                                                                                               x      x
      patient is not sexually         not sexually active
      active (optional, based
      on regional prevalence)




Florida/Caribbean AETC Chart Review                                                                                            H-5
#     Item Text                    Instructions:                                                  Infant   Child   Adol   Adult
      Gonorrhea screening in
      the past 12 months or        Assume that all adult patients are sexually
      documentation that           active unless noted in history or progress note
10                                                                                                                  x       x
      patient is not sexually      that patient denies being sexually active. NA if
      active (optional, based      not sexually active
      on regional prevalence)
      Maternal toxo serology       This should be IgG, NOT IgM. Assume IgG if it
11                                                                                                  x       x
      in record                    just indicates toxo screen.
      Maternal syphilis
11                                                                                                  x       x
      serology in record
      If positive, obtained RPR
11                                                                                                  x       x
      and treated as needed
      Maternal GC/Chlamydia
11                                                                                                  x       x
      test results in record
      Maternal CMV serology
11                                                                                                  x       x
      in record
      Maternal HBsAg in
11                                                                                                  x       x
      record
                                   HBIG (0.5 ml) given within 12 hours of birth.
      If positive, was             Doses and Schedules: Hepatitis B, National
11    infant/child treated with    Digestive Diseases Information Clearinghouse                     x       x
      immune globulin              (NDDIC), NIH,
                                   (http://digestive.niddk.nih.gov/ddiseases/pubs/vaccinationsh
                                   epab/index.htm)
11    Maternal HCV Ab                                                                               x       x
      If positive, Hep C PCR on
11    infant at birth, 6 weeks,                                                                     x       x
      and 6 mos
      If PCR positive,
11                                                                                                  x       x
      genotype determined
      If PCR positive, Hep C
11                                                                                                  x       x
      viral load test
      Mother's HIV viral load at
11                                                                                                  x
      delivery
11    Mother's ARV history                                                                          x
      Method of delivery
11                                 Vaginal vs. Cesarean section                                     x
      documented
      If Cesarean section
11                                 Example: HIV VL>1000, fetal distress                             x
      done, indication stated
                                   See Recommended Immunization Schedule for
                                   Persons Aged 0–6 Years—UNITED STATES •
                                   2007, Recommended Immunization Schedule
      DTaP according to age        for Persons Aged 7–18 Years, Catch-up
12                                 Immunization Schedule for Persons Aged 4                         x       x       x
      and schedule
                                   Months–18 Years Who Start Late or Who Are
                                   More Than 1 Month Behind,
                                   (http://www.cdc.gov/vaccines/recs/schedules/downlo
                                   ads/child/2007/child-schedule-color-print.pdf)




H-6                                                                                               Florida/Caribbean AETC Chart Review
                                                       Chart Review Guidelines


 #    Item Text                       Instructions:                                                     Infant   Child   Adol   Adult
                                      See Recommended Immunization Schedule for
                                      Persons Aged 0–6 Years—UNITED STATES •
                                      2007, Recommended Immunization Schedule
      IPV according to age and        for Persons Aged 7–18 Years, Catch-up Immu-
12                                    nization Schedule for Persons Aged 4 Months–                        x       x       x
      schedule
                                      18 Years Who Start Late or Who Are More Than
                                      1 Month Behind,
                                      http://www.cdc.gov/vaccines/recs/schedules/downloads/chil
                                      d/2007/child-schedule-color-print.pdf)
                                      See Recommended Immunization Schedule for
                                      Persons Aged 0–6 Years—UNITED STATES •
                                      2007, Recommended Immunization Schedule
      HIB according to age            for Persons Aged 7–18 Years, Catch-up
12                                    Immunization Schedule for Persons Aged 4                            x       x       x
      and schedule
                                      Months–18 Years Who Start Late or Who Are
                                      More Than 1 Month Behind,
                                      http://www.cdc.gov/vaccines/recs/schedules/downloads/chil
                                      d/2007/child-schedule-color-print.pdf
                                      See Recommended Immunization Schedule for
                                      Persons Aged 0–6 Years—UNITED STATES •
                                      2007, Recommended Immunization Schedule
      Prevnar according to age        for Persons Aged 7–18 Years, Catch-up
12                                    Immunization Schedule for Persons Aged 4                            x       x       x
      and schedule
                                      Months–18 Years Who Start Late or Who Are
                                      More Than 1 Month Behind,
                                      (http://www.cdc.gov/vaccines/recs/schedules/downloads/chil
                                      d/2007/child-schedule-color-print.pdf)
      Hepatitis A vaccination
12    completed or in process         NA if Hep A antibody positive                                               x       x      x
      (2 shots)
                                      All infants, children, and adolescents should be
                                      vaccinated as scheduled. See Recommended
                                      Immunization Schedule for Persons Aged 0–6
                                      Years—UNITED STATES • 2007,
                                      Recommended Immunization Schedule for
      Hepatitis B vaccination         Persons Aged 7–18 Years, Catch-up
12    completed or in process         Immunization Schedule for Persons Aged 4                            x       x       x      x
      (3 shots)                       Months–18 Years Who Start Late or Who Are
                                      More Than 1 Month Behind,
                                      (http://www.cdc.gov/vaccines/recs/schedules/downloads/chil
                                      d/2007/child-schedule-color-print.pdf)
                                      For adults, see AETC Hepatitis A, B & C
                                      Screening Tool
                                      (http://www.aidsetc.org/pdf/workgroups/pcare/pcwg-heptools.pdf)
                                      NA if a patient was admitted to clinic less than
      Influenza vaccine in the        one year ago. May vary somewhat due to the
12                                                                                                        x       x       x      x
      past 12 months                  distribution of the vaccine.

      PPD in the past 12              NA if a patient was admitted to clinic less than
      months (or chest x-ray          one year ago. Previous history of a positive
12                                                                                                                x       x      x
      or cough & symptom              PPD requires all future evaluations to include
      eval)                           annual TB symptom assessment or chest X-ray.
      Varicella vaccine at 1
12    year if CD4 > 25% (two                                                                              x       x
      dose series)




Florida/Caribbean AETC Chart Review                                                                                                     H-7
#     Item Text                      Instructions:                                              Infant   Child   Adol   Adult
      MMR at 12-15 mos (2
12    shots, 1-2 months apart)                                                                    x       x
      if CD4 > 15%
      Pneumococcal vaccine
12                                                                                                x
      at age 2
                                     See Recommended Adult Immunization
                                     Schedule, by Vaccine and Medical and Other
      Pneumococcal vaccine 2         Indications, UNITED STATES,OCTOBER
12                                                                                                        x       x       x
      shots, 5-6 years apart         2006–SEPTEMBER 2007,
                                     (http://www.cdc.gov/vaccines/recs/schedules/downloads/ad
                                     ult/06-07/adult-schedule-11x17.pdf)
      Meningococcal vaccine
12    at 11 yr - 12 yr or at entry                                                                        x       x
      to college
      Complete initial history
13    and physical                                                                                x       x       x       x
      examination
13    Symptom-targeted exam                                                                       x       x       x       x
      Height and weight at
13                                                                                                x       x       x
      each clinic visit
      If significant weight loss
13    or weight gain for age,                                                                     x       x       x
      nutritional consult
      If in low height percentile
13    for age, diff diagnosis                                                                     x       x       x
      considered
      Head circumference at
13                                                                                                x       x
      each visit
      If in low HC percentiles,
13    developmental delay or                                                                      x       x
      neurological exam
                                     The problem list must be complete and up to
13    Problem list utilized                                                                       x       x       x       x
                                     date with start and stop dates to score yes.
                                     Score yes only if all current drugs are listed in
      Organized and complete         one place.
13                                                                                                x       x       x       x
      medication list present

                                     Score yes only if both dosage and frequency
      Dosage and frequency
13                                   are documented. NA if patient has no                         x       x       x       x
      documented
                                     prescribed or over-the-counter medications.
      Start and stop dates           NA if patient has no prescribed or over-the-
13                                                                                                x       x       x       x
      documented                     counter medications.
      Drug allergies clearly
13                                                                                                x       x       x       x
      noted
                                     This can be in the initial visit or anywhere in the
      Documentation of all           chart. If there is documentation that the patient
13                                                                                                        x       x       x
      past ARV                       was asked but could not provide the
                                     information, score yes.
      Missed appointments
13                                                                                                x       x       x       x
      addressed
      Consultation reports in
13                                                                                                x       x       x       x
      record


H-8                                                                                             Florida/Caribbean AETC Chart Review
                                                      Chart Review Guidelines


 #    Item Text                       Instructions:                                     Infant   Child   Adol   Adult
      Developmental
      milestones documented,
13                                                                                        x
      referred if abnormal
      (refer if abnormal)
      Advance directives in
13                                                                                                x       x      x
      chart or discussed
      Evidence of anticipatory
13    guidance to                                                                                 x       x
      parents/caregivers
      Developmental
13    assessment (refer if                                                                        x
      abnormal)
      Records from previous
13                                                                                        x       x       x      x
      provider
      Oral exam in the past 12        Evaluations must have occurred at least once in
13                                                                                                x       x      x
      months                          past 12 months.
                                      Chest exam means cardio or pulmonary exam.
      Chest exam in the past
13                                    Evaluations must have occurred at least once in             x       x      x
      12 months
                                      past 12 months.
      Abdomen exam in the             Evaluations must have occurred at least once in
13                                                                                                x       x      x
      past 12 months                  past 12 months.
      Genito-rectal exam in the       Evaluations must have occurred at least once in
13                                                                                                x       x      x
      past 12 months                  past 12 months.
      Lymph node exam in the          Evaluations must have occurred at least once in
13                                                                                                x       x      x
      past 12 months                  past 12 months.
                                      Evaluations must have occurred at least once in
                                      past 12 months. Indication of assessment of
      Neurological exam in the
13                                    reflexes or cranial nerves or sensory exam or               x       x      x
      past 12 months
                                      neuro box checked on form.

      Skin exam in the past 12        Evaluations must have occurred at least once in
13                                                                                                x       x      x
      months                          past 12 months.
      Weight assessed                 Occasional omissions are acceptable but at
13                                                                                                               x
      routinely                       least twice per year.
                                      Unintentional weight loss of > 10% of body
13    Weight loss addressed           weight. Addressed = nutrition referral or                                  x
                                      documentation of counseling.
      Evidence of AZT
14                                                                                        x
      chemoprophylaxis
14    pre-partum                                                                          x
14    intra-partum                                                                        x
14    post-partum                                                                         x
14    continued 6 weeks                                                                   x
      dose given according to
14                                                                                        x
      weight
      evidence of tolerance
14                                                                                        x
      assessed
      mother/caregiver
14                                                                                        x
      instructed
      PCP prophylaxis
14                                                                                        x
      initiated at 6 weeks




Florida/Caribbean AETC Chart Review                                                                                     H-9
#      Item Text                  Instructions:                                                    Infant   Child   Adol   Adult
       Discontinued if HIV DNA
14     PCR negative at 4                                                                             x
       months
       Mother instructed about
14                                                                                                   x
       breastfeeding
       Perinatal infections
14                                                                                                   x
       documented
15     ARV within the last year   This item is not scored.                                                   x       x       x
                                  See CHILD: Table 6. Indications for Initiation of
                                  Antiretroviral Therapy in Children Infected with
                                  Human Immunodeficiency Virus, Guidelines for
                                  the Use of Antiretroviral Agents in Pediatric HIV
                                  Infection October 26, 2006
                                  (http://aidsinfo.nih.gov/contentfiles/PediatricGuid
                                  elines.pdf). ADOLESCENT & ADULT: Table 5.
       ARV initiated according
15                                Indications for Initiating Antiretroviral Therapy                          x       x       x
       to DHHS Guidelines
                                  for the Chronically HIV-1 Infected Patient.
                                  Guidelines for the Use of Antiretroviral Agents in
                                  HIV-1-Infected Adults and Adolescents October
                                  10, 2006
                                  (http://aidsinfo.nih.gov/contentfiles/AdultandAdol
                                  escentGL.pdf) Score NA if patient was started
                                  on ARV by previous provider.
                                  Any regimen will be considered consistent with
                                  the Guidelines (score yes) if not specifically
                                  identified as "not recommended" See CHILD:
                                  Table 8. Antiretroviral Regimens or Components
                                  that Should Not Be Offered for Treatment of
                                  Human Immunodeficiency Virus Infection in
                                  Children, Guidelines for the Use of Antiretroviral
       ARV regimen consistent     Agents in Pediatric HIV Infection October 26,
15     with current DHHS          2006                                                                       x       x       x
       Guidelines                 (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf)
                                  ADOLESCENT/ ADULTS: Table 8. Antiretroviral
                                  Regimens or Components That Should Not Be
                                  Offered At Any Time. Guidelines for the Use of
                                  Antiretroviral Agents in HIV-1-Infected Adults
                                  and Adolescents October 10, 2006
                                  (http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.p
                                  df) If exception criterion is met, score yes.




H-10                                                                                               Florida/Caribbean AETC Chart Review
                                                       Chart Review Guidelines


 #    Item Text                       Instructions:                                                     Infant   Child   Adol   Adult
                                      Item addresses all drug incompatibilities. See
                                      CHILD: Table 7. Recommended Antiretroviral
                                      Regimens for Initial Therapy for Human
                                      Immunodeficiency Virus Infection in Children,
                                      Table 15. Treatment Options Following Failure
                                      of Initial Antiretroviral Regimen, Table 16. Novel
                                      Strategies to Consider for Treatment-
                                      Experienced Children with Few Available Active
                                      Treatment Options , Guidelines for the Use of
                                      Antiretroviral Agents in Pediatric HIV Infection
                                      October 26, 2006,
      All medications correctly       (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf).
15                                    ADOLESCENT & ADULT: Table 6a.                                               x       x      x
      dosed and combined
                                      Antiretroviral Components Recommended for
                                      Treatment of HIV-1 Infection in Treatment Naïve
                                      Patients, Table 6b. Antiretroviral Components
                                      That Are Acceptable as Initial Antiretroviral
                                      Components but Are Inferior to Preferred or
                                      Alternative Components, Table 7. Antiretroviral
                                      Components Not Recommended as Initial
                                      Therapy , Guidelines for the Use of Antiretroviral
                                      Agents in HIV-1-Infected Adults and
                                      Adolescents October 10, 2006
                                      (http://aidsinfo.nih.gov/contentfiles/
                                      AdultandAdolescentGL.pdf
      Were medications
15                                                                                                                x       x      x
      adjusted for
                                      Many antiretroviral medications (e.g., abacavir,
                                      emtricitabine, lamivudine, tenofovir, and some
                                      PIs) are administered to children at higher
                                      weight- or surface area based doses than would
                                      be predicted by direct scaling of adult doses,
                                      based upon reported pharmacokinetic data
                                      indicating higher drug oral clearance in children.
                                      Continued use of these pediatric weight- or
15    surface area or weight          surface area-based doses as a child grows                                   x       x
                                      during adolescence can result in medication
                                      doses that are higher than the usual adult
                                      doses. Data suggesting optimal doses for every
                                      antiretroviral medication for adolescents are not
                                      available. Guidelines for the Use of Antiretroviral
                                      Agents in Pediatric HIV Infection October 26,
                                      2006
                                      (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf)
15    renal impairment                                                                                            x       x      x
15    hepatic impairment                                                                                          x       x      x




Florida/Caribbean AETC Chart Review                                                                                                  H-11
#      Item Text                  Instructions:                                                    Infant   Child   Adol   Adult
                                  Dosages of medications for HIV infection and
                                  opportunistic infections traditionally have been
                                  prescribed according to Tanner staging of
                                  puberty rather than strictly on the basis of age.
                                  Using this method, adolescents in early puberty
                                  (Tanner Stages I and II) are administered doses
                                  using pediatric schedules, whereas those in late
                                  puberty (i.e., Tanner Stage V) are administered
15     Tanner staging             doses using adult schedules. However, Tanner                               x       x
                                  stage and age are not necessarily directly
                                  predictive of drug pharmacokinetics. In addition,
                                  puberty may be delayed in perinatally HIV
                                  infected children, adding to discrepancies
                                  between Tanner stage-based dosing and age-
                                  based dosing. Guidelines for the Use of
                                  Antiretroviral Agents in Pediatric HIV Infection
                                  October 26, 2006
                                  (http://aidsinfo.nih.gov/contentfiles/PediatricGuidelines.pdf)
15     Weight                                                                                                                x
                                  Increase = > _ log change from previous test.
       Increasing viral load      Addressed = repeat test or consider non-
15                                                                                                           x       x       x
       addressed                  adherence, recent vaccinations or illnesses, or
                                  change medications.
       Decreasing CD4             If documented that patient was non-adherent,
15                                                                                                           x       x       x
       addressed                  score NA
       Adverse effects to
15                                                                                                           x       x       x
       treatment documented
       If VL NOT < limit of
15     detection at 5-6 months,                                                                              x       x       x
       addressed
                                  See HIV-Infected Women of Reproductive Age
                                  and Pregnant Women
                                   • When initiating antiretroviral therapy for
                                  women of reproductive age, the indications for
                                  initiation of therapy and the goals of treatment
                                  are the same as for other adults and
                                  adolescents (AI).
                                  • Efavirenz (Sustiva®) should be avoided for the
                                  woman who desires to become pregnant or who
                                  does not use effective and consistent
                                  contraception (AIII)
       Child bearing status       • For the woman who is pregnant, an additional
15     considered in ARV          goal of therapy is prevention of mother-to-child                                   x       x
       selection                  transmission (PMTCT), with a goal of viral sup-
                                  pression to <1,000 copies/mL to reduce risk of
                                  transmission of HIV to fetus and newborn (AI).
                                  • Selection of an antiretroviral combination
                                  should take into account known safety, efficacy,
                                  and pharmacokinetic data of each agent during
                                  pregnancy (AIII).
                                  • Clinicians should consult the most current PHS
                                  guidelines when designing a regimen for a
                                  pregnant patient (AIII).
                                  (continued)


H-12                                                                                               Florida/Caribbean AETC Chart Review
                                                      Chart Review Guidelines


 #    Item Text                       Instructions:                                            Infant   Child   Adol   Adult
                                      Various PIs and NNRTIs are known to interact
                                      with oral contraceptives, resulting in possible
                                      decreases in ethinyl estradiol or increases in
                                      estradiol or norethindrone levels. These
                                      changes may decrease the effectiveness of the
                                      oral contraceptives or potentially increase risk of
                                      estrogenor progestin-related side effects.
                                      Providers should be aware of these drug
                                      interactions and an alternative or additional
                                      contraceptive method should be considered.
                                      Amprenavir (and probably fosamprenavir) not
                                      only increases blood levels of both estrogen and
                                      progestin components, but oral contraceptives
                                      decrease amprenavir levels as well; these drugs
                                      should not be co-administered. There is minimal
                                      information about drug interactions with use of
                                      newer hormonal contraceptive methods (e.g.,
                                      patch, vaginal ring). Counseling should be
                                      provided on an ongoing basis. Women who
                                      express a desire to become pregnant should be
                                      referred for pre-conception counseling and care,
                                      including discussion of special considerations
                                      with antiretroviral therapy use during pregnancy.
                                      Guidelines for the Use of Antiretroviral Agents in
                                      HIV-1-Infected Adults and Adolescents October
                                      10, 2006 (http://aidsinfo.nih.gov/contentfiles/
                                      AdultandAdolescentGL.pdf)
                                      See Table 2. Preclinical and Clinical Data
                                      Relevant to the Use of Antiretrovirals in
                                      Pregnancy and Table 3. Antiretroviral Drug Use
                                      in Pregnant HIV-Infected Women:
                                      Pharmacokinetic and Toxicity Data in Human
      If patient pregnant, and        Pregnancy and Recommendations for Use in
15                                    Pregnancy, Public Health Service Task Force                                x      x
      VL > 1,000:
                                      Recommendations for Use of Antiretroviral
                                      Drugs in Pregnant HIV-1-Infected Women for
                                      Maternal Health and Interventions to Reduce
                                      Perinatal HIV-1 Transmission in the United
                                      States October 12, 2006
                                      (http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf)
      Attempts to start or
15                                                                                                               x      x
      change regimen
                                      See Table 2. Preclinical and Clinical Data
                                      Relevant to the Use of Antiretrovirals in
                                      Pregnancy and Table 3. Antiretroviral Drug Use
                                      in Pregnant HIV-Infected Women:
                                      Pharmacokinetic and Toxicity Data in Human
      ARV consistent with             Pregnancy and Recommendations for Use in
15    DHHS Guidelines for             Pregnancy, Public Health Service Task Force                                x      x
      pregnancy                       Recommendations for Use of Antiretroviral
                                      Drugs in Pregnant HIV-1-Infected Women for
                                      Maternal Health and Interventions to Reduce
                                      Perinatal HIV-1 Transmission in the United
                                      States October 12, 2006
                                      (http://aidsinfo.nih.gov/ContentFiles/PerinatalGL.pdf)




Florida/Caribbean AETC Chart Review                                                                                         H-13
#      Item Text                      Instructions:                                               Infant   Child   Adol   Adult
                                      See TABLE 11. Prophylaxis to prevent first
                                      episode of opportunistic disease among infants
                                      and children infected with human
       PCP prophylaxis                immunodeficiency virus and TABLE 12.
       according to U.S. Public       Prophylaxis to prevent recurrence of
       Health Service and the         opportunistic disease, after chemotherapy for
16                                    acute disease, among HIV-infected infants and                         x
       Infectious Diseases
       Society of America             children, Guidelines for the Prevention of
       Guidelines                     Opportunistic Infections Among HIV-Infected
                                      Persons – 2002 Recommendations of the U.S.
                                      Public Health Service and the Infectious
                                      Diseases Society of America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
                                      See TABLE 11. Prophylaxis to prevent first
                                      episode of opportunistic disease among infants
                                      and children infected with human
       MAC prophylaxis                immunodeficiency virus and TABLE 12.
       according to U.S. Public       Prophylaxis to prevent recurrence of
       Health Service and the         opportunistic disease, after chemotherapy for
16                                    acute disease, among HIV-infected infants and                         x
       Infectious Diseases
       Society of America             children, Guidelines for the Prevention of
       Guidelines                     Opportunistic Infections Among HIV-Infected
                                      Persons – 2002 Recommendations of the U.S.
                                      Public Health Service and the Infectious
                                      Diseases Society of America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
       Ophthalmologic exam if
16                                                                                                          x
       CD 4 < 50
       CMV prophylaxis if
16                                                                                                          x
       retinitis or prior infection
       Prophylaxis for severe or
16     frequent recurrences of                                                                              x
       herpes simplex
                                      See TABLE 11. Prophylaxis to prevent first
                                      episode of opportunistic disease among infants
                                      and children infected with human
       Toxo prophylaxis               immunodeficiency virus and TABLE 12.
       according to U.S. Public       Prophylaxis to prevent recurrence of
       Health Service and the         opportunistic disease, after chemotherapy for
16                                    acute disease, among HIV-infected infants and                         x
       Infectious Diseases
       Society of America             children, Guidelines for the Prevention of
       Guidelines                     Opportunistic Infections Among HIV-Infected
                                      Persons – 2002 Recommendations of the U.S.
                                      Public Health Service and the Infectious
                                      Diseases Society of America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
       TB prophylaxis if              See Table 3. Doses of antituberculosis drugs for
       PPD+/exposed according         adults and children, June 20, 2003, Treatment
       to American Thoracic           of Tuberculosis, American Thoracic Society,
16     Society, CDC, and              CDC, and Infectious Diseases Society of                               x
       Infectious Diseases            America,
       Society of America             (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5211a1.htm
       Guidelines                     #tab6)




H-14                                                                                              Florida/Caribbean AETC Chart Review
                                                      Chart Review Guidelines


 #    Item Text                       Instructions:                                               Infant   Child   Adol   Adult
                                      See TABLE 1. Prophylaxis to prevent first
                                      episode of opportunistic disease among adults
                                      and adolescents infected with human
      If CD4 < 200, or <14%           immunodeficiency virus (HIV) Guidelines for the
16    was patient on PCP              Prevention of Opportunistic Infections Among                                  x      x
      prophylaxis                     HIV-Infected Persons – 2002
                                      Recommendations of the U.S. Public Health
                                      Service and the Infectious Diseases Society of
                                      America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
                                      See TABLE 13. Criteria for starting,
                                      discontinuing, and restarting opportunistic
      If CD4 increased above          infection prophylaxis for adults with human
      200 and >14%, is PCP            immunodeficiency virus infection, Guidelines for
      prophylaxis continued           the Prevention of Opportunistic Infections
16                                                                                                                  x      x
      for 3-6 months and then         Among HIV-Infected Persons – 2002
      discontinued if CD4             Recommendations of the U.S. Public Health
      remains >200 and >14%           Service and the Infectious Diseases Society of
                                      America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
                                      See TABLE 1. Prophylaxis to prevent first
                                      episode of opportunistic disease among adults
                                      and adolescents infected with human
      If CD4 < 100, and pt is         immunodeficiency virus (HIV) Guidelines for the
16    toxo IgG pos, patient on        Prevention of Opportunistic Infections Among                                  x      x
      toxo prophylaxis                HIV-Infected Persons–2002 Recommendations
                                      of the U.S. Public Health Service and the
                                      Infectious Diseases Society of America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
                                      See TABLE 13. Criteria for starting,
                                      discontinuing, and restarting opportunistic
      If CD4 increased above          infection prophylaxis for adults with human
      100, is toxo prophylaxis        immunodeficiency virus infection, Guidelines for
16    continued for 3-6 months        the Prevention of Opportunistic Infections                                    x      x
      and then discontinued if        Among HIV-Infected Persons–2002 Recom-
      CD4 remains > 100               mendations of the U.S. Public Health Service
                                      and the Infectious Diseases Society of America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
                                      See TABLE 1. Prophylaxis to prevent first
                                      episode of opportunistic disease among adults
                                      and adolescents infected with human
      If CD4 < 50, was patient        immunodeficiency virus (HIV) Guidelines for the
16                                    Prevention of Opportunistic Infections Among                                  x      x
      on MAC prophylaxis
                                      HIV-Infected Persons–2002 Recommendations
                                      of the U.S. Public Health Service and the
                                      Infectious Diseases Society of America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
                                      See TABLE 13. Criteria for starting,
                                      discontinuing, and restarting opportunistic
      If CD4 increased above          infection prophylaxis for adults with human
      100, is MAC prophylaxis         immunodeficiency virus infection, Guidelines for
16    continued for 3-6 months        the Prevention of Opportunistic Infections                                    x      x
      and then discontinued if        Among HIV-Infected Persons – 2002
      CD4 remains > 100               Recommendations of the U.S. Public Health
                                      Service and the Infectious Diseases Society of
                                      America
                                      (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)


Florida/Caribbean AETC Chart Review                                                                                            H-15
#      Item Text                   Instructions:                                               Infant   Child   Adol   Adult
                                   (http://aidsinfo.nih.gov/contentfiles/OIpreventionGL.pdf)
       If CD4 <50, was eye         Score yes whether eye exam was performed in
16                                                                                                               x       x
       exam performed              clinic or referred.
                                   A Pap test should be obtained twice in the first
                                   year after diagnosis of HIV infection and, if the
                                   results are normal, every 12 months thereafter.
       Pap smear in the past 12
17                                 When establishing care, if no records available,                              x       x
       months (female)
                                   PAP should be done at baseline & 6 months
                                   later. NA if woman has had uterus removed.
                                   NA if man.
       Anal cytology in the past
17     12 months (male &           Recommended                                                                   x       x
       female)
                                   Beginning at age 50, both men and women at
                                   average risk for developing colorectal cancer
                                   should follow one of these five testing
                                   schedules: • yearly fecal occult blood test
                                   (FOBT)* or fecal immunochemical test (FIT) •
                                   flexible sigmoidoscopy every 5 years • yearly
       Colon cancer screening      FOBT* or FIT plus flexible sigmoidoscopy every
17                                                                                                                       x
       referral, (50+ years old)   5 years** • double-contrast barium enema every
                                   5 years • colonoscopy every 10 years • *For
                                   FOBT, the take-home multiple sample method
                                   should be used. • **The combination of yearly
                                   FOBT or FIT plus flexible sigmoidoscopy every
                                   5 years is preferred over either of these options
                                   alone.
                                   Abnormalities addressed = Repeat Pap ordered
17     Abnormalities addressed                                                                                           x
                                   or referral for colposcopy.
       Age appropriate             Initial mammogram between ages of 35 and 40.
17     mammograms, (female,        Subsequent mammograms every 1 to 2 years                                              x
       age 40)                     after age 40.
17     Abnormalities addressed     Follow-up test or referral.                                                           x
       PSA, (male, 50+ years
17                                                                                                                       x
       old)
                                   If checked boxes on forms or written mention in
       Education or
17                                 progress note at least once in past 12 months,                        x       x       x
       Counseling: Nutrition
                                   score yes.
       Education or                If checked boxes on forms or written mention in
17     Counseling: Dental          progress note at least once in past 12 months,                        x       x       x
       health                      score yes.
                                   If checked boxes on forms or written mention in
       Education or
                                   progress note at least once in past 12 months,
       Counseling:
17                                 score yes. Includes clinic visits and medications.                            x       x
       Medication/treatment
                                   However, If not currently on medications, score
       adherence
                                   NA
                                   If IDU, both drugs and sex must be included in
       Education or
                                   prevention. If checked boxes on forms or written
17     Counseling: Prevention                                                                                    x       x
                                   mention in progress note at least once in past
       (sex/drugs)
                                   12 months, score yes.




H-16                                                                                           Florida/Caribbean AETC Chart Review
                                                      Chart Review Guidelines


 #    Item Text                       Instructions:                                        Infant   Child   Adol   Adult
                                      If documented that patient is not sexually active,
                                      score NA. Score NA if post-menopausal woman
      Education or
                                      or person who denies any heterosexual sex. If
17    Counseling: Birth                                                                                      x      x
                                      checked boxes on forms or written mention in
      control
                                      progress note at least once in past 12 months,
                                      score yes.
      Education or                    All three must be yes to score yes. If checked
17    Counseling: Drugs,              boxes on forms or written mention in progress                  x       x      x
      alcohol, tobacco                note at least once in past 12 months, score yes.
      Education or                    If checked boxes on forms or written mention in
17    Counseling: Mental              progress note at least once in past 12 months,                 x       x      x
      health                          score yes.
                                      If checked boxes on forms or written mention in
      Education or
17                                    progress note at least once in past 12 months,                         x      x
      Counseling: Exercise
                                      score yes.




Florida/Caribbean AETC Chart Review                                                                                     H-17
TABLE 1. Prophylaxis to Prevent First Episode of Opportunistic Disease in Adults and
Adolescents Infected with Human Immunodeficiency Virus

                                                                           Preventive Regimens

Pathogen                                         Indication                First Choice              Alternatives


I. Strongly recommended as standard of care
Pneumocystis carinii1                           CD4+ count <200/µL       Trimethoprim-           Dapsone, 50 mg po
                                                or oropharyngeal         sulfamethoxazole        b.i.d. or 100 mg po
                                                candidiasis              (TMP-SMZ), 1 DS po      q.d. (BI); dapsone, 50
                                                                         q.d. (AI)               mg po q.d. plus
                                                                                                 pyrimethamine,
                                                                         TMP-SMZ, 1 SS po        50 mg po q.w. plus
                                                                         q.d. (AI)               leucovorin 25 mg po
                                                                                                 q.w. (BI); dapsone
                                                                                                 200 mg po plus
                                                                                                 pyrimethamine,
                                                                                                 75 mg po plus
                                                                                                 leucovorin, 25 mg po
                                                                                                 q.w. (BI); aerosolized
                                                                                                 pentamidine, 300 mg
                                                                                                 q.month via
                                                                                                 Respirgard II(TM)
                                                                                                 nebulizer (BI);
                                                                                                 atovaquone, 1500 mg
                                                                                                 po q.d. (BI); TMP-
                                                                                                 SMZ, 1 DS po
                                                                                                 t.i.w. (BI)

Mycobacterium
tuberculosis
  Isoniazid-sensitive2                          TST reaction ≥5 mm       Isoniazid, 300 mg po    Rifampin, 600 mg
                                                or prior positive TST    plus pyridoxine,        po q.d. (BIII) x 4 mo
                                                result without           50 mg po q.d. x 9 mo    or rifabuin 300 mg
                                                treatment or contact     (AII) or isoniazid,     po q.d. (CIII) x 4
                                                with case of active      900 mg po plus          mo
                                                tuberculosis             pyridoxine, 100 mg po
                                                regardless of TST        b.i.w. x 9 mo (BII)     Pyrazinamide, 15-20
                                                result (BIII)                                    mg/kg po q.d. x 2
                                                                                                 mo plus either
                                                                                                 rifampin, 600 mg po
                                                                                                 q.d. (BI) x 2 mo or
                                                                                                 rifabutin, 300 mg po
                                                                                                 q.d. (CIII) x 2 mo


 Isoniazid-resistant                            Same as above; high      Rifampin 600 mg po      Pyrazinamide
                                                probability of           (AIII) or rifabutin,    15-20 mg/kg po q.d.
                                                exposure to isoniazid-   300 mg po (BIII) q.d.   plus either rifampin,
                                                resistant tuberculosis   x 4 mo                  600 mg po (BI) or
                                                                                                 rifabutin, 300 mg po
                                                                                                 (CIII) q.d. x 2 mo

 Multidrug-(isoniazid and rifampin) resistant   Same as above; high      Choice of drugs         ------
                                                probability of           requires consultation
                                                exposure to multidrug-   with public health
                                                resistant tuberculosis   authorities. Depends
                                                                         on susceptibility of
                                                                         isolate from source
                                                                         patient



                                                                                                                          38



                                                              1
TABLE 1. Prophylaxis to Prevent First Episode of Opportunistic Disease in Adults and
Adolescents Infected with Human Immunodeficiency Virus (continued)

                                                                     Preventive Regimens

Pathogen                                   Indication                First Choice               Alternatives


Toxoplasma gondii3                        IgG antibody to            TMP-SMZ, 1 DS po           TMP-SMZ, 1 SS po
                                          Toxoplasma and             q.d. (AII)                 q.d. (BIII): dapsone,
                                          CD4+ count <100/µL                                    50 mg po q.d. plus
                                                                                                pyrimethamine,
                                                                                                50 mg po q.w. plus
                                                                                                leucovorin, 25 mg po
                                                                                                q.w. (BI); dapsone, 200
                                                                                                mg po plus
                                                                                                pyrimethamineˆ, 75 mg
                                                                                                po plus leucovorin, 25 mg
                                                                                                po q w (BI); atovaquone,
                                                                                                1500 mg po q.d. with
                                                                                                or without
                                                                                                pyrimethamine,
                                                                                                25 mg po q.d. plus
                                                                                                leucovorin, 10 mg po q.d.
                                                                                                (CIII)

Mycobacterium                              CD4+ count <50/µL         Azithromycin,             Rifabutin, 300 mg po
avium complex4                                                       1,200 mg po q.w., (AI)    q.d. (BI);
                                                                     or clarithromycin,4       azithromycin,
                                                                     500 mg po b.i.d. (AI)     1,200 mg po q.w. plus
                                                                                               rifabutin, 300 mg po
                                                                                               q.d. (CI)

Varicella zoster virus                     Significant exposure      Varicella zoster
(VZV)                                      to chickenpox or          immune globulin
                                           shingles for patients     (VZIG), 5 vials
                                           who have no history       (1.25 mL each) im,
                                           of either condition or,   administered ≤96 h
                                           if available, negative    after exposure, ideally
                                           antibody to VZV           within 48 h (AIII)

II. Generally Recommended

Streptococcus                              CD4+ count > 200/µL       23 valent poly-          None
pneumoniae5                                                          saccharide
                                                                     vaccine, 0.5 mL im [BII]


Hepatitis B virus6,7                       All susceptible           Hepatitis B vaccine:      None
                                           (anti-HBc-negative)       3 doses (BII)
                                           patients




                                                                                                                       39



                                                        2
TABLE 1. Prophylaxis to Prevent First Episode of Opportunistic Disease in Adults and
Adolescents Infected with Human Immunodeficiency Virus - continued

                                                                                        Preventive Regimens

Pathogen                                                   Indication                   First Choice                  Alternatives

Influenza virus6,8                                         All patients (annually,      Inactivated               Oseltamivir, 75 mg
                                                           before influenza             trivalent influenza virus po q.d. (influenza A or B)
                                                           season)                      vaccine: one annual dose (CIII); rimantadine, 100 mg
                                                                                        (0.5 mL) im (BIII)        po b.i.d. (CIII), or
                                                                                                                  amantadine, 100 mg
                                                                                                                  po b.i.d. (CIII)
                                                                                                                  (influenza A only)


Hepatitis A virus6,7                                       All susceptible            Hepatitis A vaccine:            None
                                                           (anti-HAV-negative)        two doses (BIII)
                                                           patients at increased
                                                           risk for HAV infection
                                                           (e.g., illicit drug users,
                                                           men who have sex with
                                                           men, hemophiliacs) or
                                                           with chronic liver disease,
                                                           including chronic hepatitis
                                                           B or hepatitis C

III. Evidence for Efficacy but Not Routinely Indicated

Bacteria                                                   Neutropenia                  Granulocyte-                  None
                                                                                        colony-stimulating
                                                                                        factor (G-CSF),
                                                                                        5-10 µg/kg sc q.d. x
                                                                                        2-4 w or granulocyte-
                                                                                        macrophage
                                                                                        colony-stimulating
                                                                                        factor (GM-CSF),
                                                                                        250 µg/m2 sc iv
                                                                                        x 2-4 w (CII)

Cryptococcus                                               CD4+ count <50/µL            Fluconazole,                   Itraconazole capsule,
neoformans                                                                              100-200 mg po q.d.             200 mg po q.d. (CIII)
                                                                                        (CI)

Histoplasma                                                CD4+ count <100/µL,           Itraconazole capsule,         None
Capsulatum9                                                endemic geographic            200 mg po q.d.(CI)
                                                           area

Cytomegalovirus                                            CD4+ count <50/µL            Oral ganciclovir, 1g           None
(CMV)10                                                    and CMV antibody             po t.i.d. (CI)
                                                           positivity


NOTES: Information included in these guidelines might not represent Food and Drug Administration (FDA) approval or approved labeling for the
particular products or indications in question. Specifically, the terms "safe" and "effective" might not be synonymous with the FDA-defined legal
standards for product approval. The Respirgard IITM nebulizer is manufactured by Marquest, Englewood, Colorado. Letters and Roman numerals in
parentheses after regimens indicate the strength of the recommendation and the quality of evidence supporting it (see page 7).
ABBREVIATIONS: Anti-HBc = antibody to hepatitis B core antigen; b.i.w.= twice a week; DS = double-strength tablet; HAART = highly active
antiretroviral therapy; HAV = hepatitis A virus; HIV = human immunodeficiency virus; im = intramuscular; iv = intravenous; po = by mouth; q.d. =
daily; q.m. = monthly; q.w. = weekly; SS= single-strength tablet; t.i.w. = three times a week; TMP-SMZ = trimethoprim-sulfamethoxazole; sc =
subcutaneous; and TST = tuberculin skin test.
1
  Prophylaxis should also be considered for persons with a CD4+ percentage of <14%, for persons with a history of an AIDS-defining illness, and
possibly for those with CD4+ counts >200 but <250 cells/µL. TMP-SMZ also reduces the frequency of toxoplasmosis and some bacterial infections.
Patients receiving dapsone should be tested for glucose-6 phosphate dehydrogenase deficiency. A dosage of 50 mg q.d. is probably less effective than

                                                                                                                                                  40
                                                                        3
100 mg q.d. The efficacy of parenteral pentamidine (e.g., 4 mg/kg/month) is uncertain. Fansidar (sulfadoxine-pyrimethamine) is rarely used because of
severe hypersensitivity reactions. Patients who are being administered therapy for toxoplasmosis with
sulfadiazine-pyrimethamine are protected against Pneumocystis carinii pneumonia and do not need additional prophylaxis against PCP.
2
  Directly observed therapy is recommended for isoniazid, e.g., 900 mg b.i.w.; isoniazid regimens should include pyridoxine to prevent peripheral
neuropathy. If rifampin or rifabutin are administered concurrently with protease inhibitors or non-nucleoside reverse transcriptase inhibitors,
careful consideration should be given to potential pharmacokinetic interactions (54). See discussion of rifamycin interactions in paragraph 11
in section on Tuberculosis. There have been reports of fatal and severe liver injury associated with the treatment of latent TB infection in
HIV-uninfected persons treated with the 2 month regimen of daily rifampin and pyrazinamide; therefore it may be prudent to use regimens
that do not contain pyrazinamide in HIV-infected persons whose completion of treatment can be assured (CDC. Update: Fatal and Severe
Liver Injuries Associated with Rifampin and Pyrazinamide for Latent Tuberculosis Infection and Revisions in American Thoracic
Society/CDC Recommendations, United States 2001 MMWR 50 (No. 34), Aug 31, 2001). Exposure to multidrug-resistant tuberculosis might
require prophylaxis with two drugs; consult public health authorities. Possible regimens include pyrazinamide plus either ethambutol or a
fluoroquinolone.
3
  Protection against toxoplasmosis is provided by TMP-SMZ, dapsone plus pyrimethamine, and possibly by atovaquone. Atovaquone may be used with
or without pyrimethamine. Pyrimethamine alone probably provides little, if any, protection.
4
  See paragraph 9, in section on “Disseminated Infection with Mycobacterium avium complex” and references 53-54 for discussion of drug
interactions.
*During pregnancy, azithromycin is preferred over clarithromycin because of the teratogenicity in animals of clarithromycin.
5
  Vaccination may be offered to persons who have a CD4+ T-lymphocyte count <200 cells/µL, although the efficacy is likely to be diminished.
Revaccination 5 years after the first dose or sooner if the initial immunization was given when the CD4+ count was <200 cells/µL and the CD4+ count
has increased to >200 cells/µL on HAART is considered optional. Some authorities are concerned that immunizations might stimulate the replication
of HIV.
6
  Although data demonstrating clinical benefit of these vaccines in HIV-infected persons are not available, it is logical to assume that those
patients who develop antibody responses will derive some protection. Some authorities are concerned that immunizations might stimulate HIV
replication, although for influenza vaccination, a large observational study of HIV-infected persons in clinical care showed no adverse effect of this
vaccine, including multiple doses, on patient survival (J. Ward, CDC, personal communication). Also, this concern may be less relevant in the
setting of HAART. However, because of the theoretical concern that increases in HIV plasma RNA following vaccination during pregnancy
might increase the risk of perinatal transmission of HIV, providers may wish to defer vaccination for such patients until after HAART is
initiated.
7
  Hepatitis B vaccine has been recommended for all children and adolescents and for all adults with risk factors for hepatitis B virus (HBV).
For persons requiring vaccination against both hepatitis A and hepatitis B, a combination vaccine is now available. For additional
information regarding vaccination against hepatitis A and B, see CDC. Hepatitis B virus: a comprehensive strategy for eliminating
transmission in the United States through universal childhood vaccination. Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR 1991;40 (No RR13).
8
  Oseltamivir is appropriate during outbreaks of either influenza A or influenza B. Rimantadine or amantadine are appropriate during
outbreaks of influenza A (although neither rimantadine nor amantadine is recommended during pregnancy). Dosage reduction for antiviral
chemoprophylaxis against influenza might be indicated for decreased renal or hepatic function, and for persons with seizure disorders.
Physicians should consult the drug package inserts and the annual CDC influenza guidelines for more specific information about adverse
effects and dosage adjustments. For additional information about vaccination, antiviral chemoprophylaxis and therapy against influenza, see:
CDC. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR
2001;50(No. RR-4).
9
  In a few unusual occupational or other circumstances, prophylaxis should be considered; consult a specialist.
10
   Acyclovir is not protective against CMV. Valacyclovir is not recommended because of an unexplained trend toward increased mortality observed in
persons with AIDS who were being administered this drug for prevention of CMV disease.




                                                                                                                                                   41
                                                                       4
TABLE 2. Prophylaxis to Prevent Recurrence of Opportunistic Disease in Adults (after chemotherapy for acute
disease) in Adults and Adolescents Infected with Human Immunodeficiency Virus

                                                                         Preventive Regimens

Pathogen                          Indication              First Choice              Alternatives

Recommended as standard of care

Pneumocystis carinii              Prior P. carinii        Trimethoprim-                            Dapsone, 50 mg po
                                  pneumonia               sulfamethoxazole                         b.i.d. or 100 mg po
                                                          (TMP-SMZ), 1 DS po                       q.d. (BI); dapsone,
                                                          q.d. (AI);                               50 mg po q.d. plus
                                                                                                   pyrimethamine,
                                                          TMP-SMZ 1 SS po                          50 mg po q.w. plus
                                                          q.d. (AI)                                leucovorin, 25 mg po
                                                                                                   q.w. (BI); dapsone,
                                                                                                   200 mg po plus
                                                                                                   pyrimethamine, 75 mg
                                                                                                   po plus leucovorin, 25
                                                                                                   mg po q.w. (BI);
                                                                                                   aerosolized
                                                                                                   pentamidine,
                                                                                                   300 mg q.m. via
                                                                                                   Respirgard IITM
                                                                                                   nebulizer (BI);
                                                                                                   atovaquone, 1500 mg
                                                                                                   po q.d. (BI); TMP-
                                                                                                   SMZ, 1 DS po t.i.w.
                                                                                                   (CI)

Toxoplasma gondii1                Prior toxoplasmic       Sulfadiazine, 500-1,000                  Clindamycin, 300-450
                                  encephalitis            mg po q.i.d. plus                        mg po q 6-8 h plus
                                                          pyrimethamine,                           pyrimethamine, 25-50
                                                          25-50 mg po q.d. plus                    mg po q.d. plus,
                                                          leucovorin, 10-25 mg                     leucovorin 10-25 mg
                                                          po q.d. (AI)                             po q.d. (BI);
                                                                                                   atovaquone 750 mg po
                                                                                                   q 6-12 h with
                                                                                                   or without
                                                                                                   pyrimethamine, 25 mg
                                                                                                   po q.d. plus
                                                                                                   leucovorin, 10
                                                                                                   mg po, q.d. (CIII)

Mycobacterium                     Documented              Clarithromycin,2 500 mg                  Azithromycin, 500 mg
avium complex2                    disseminated            po b.i.d. (AI) plus                      po q.d. (AII) plus
                                  disease                 ethambutol, 15 mg/kg po                  ethambutol, 15 mg/kg
                                                          q.d. (AII); with or without              po q.d.(AII); with
                                                          rifabutin, 300 mg po q.d. (CI)           or without rifabutin,
                                                                                                   300 mg po q.d. (CI)

Cytomegalovirus                   Prior end-organ         Ganciclovir, 5-6 mg/kg/day iv            Cidofovir, 5 mg/kg iv
                                  disease                 5-7 days/wk or 1,000 mg                  q.o.w. with probenecid
                                                          po t.i.d. (AI); or foscarnet,            2 grams po 3 hours
                                                          90-120 mg/kg iv q.d. (AI);               before the dose
                                                          or (for retinitis) ganciclovir           followed by 1 gram po
                                                          sustained-release implant                2 hours after the dose,
                                                          q 6-9 months plus                        and 1 gram po 8 hours
                                                          ganciclovir, 1.0-1.5 g po                after the dose (total of
                                                          t.i.d. (AI);                             4 grams) (AI).
                                                                                                   Fomivirsen 1 vial (330
                                                                                                   µg) injected into the
                                                                                                   vitreous, then repeated
                                                                                                   every 2-4 wks (AI);
                                                                                                   valganciclovir 900 mg po
                                                                                                   q.d. (BI)

                                                                                                                            42
                                                      5
TABLE 2. Prophylaxis to Prevent Recurrence of Opportunistic Disease in Adults (after chemo-therapy for acute
disease) in Adults and Adolescents Infected with Human Immunodeficiency Virus (continued)


                                                                                        Preventive Regimens

Pathogen                                   Indication                    First Choice                 Alternatives

Cryptococcus                               Documented                    Fluconazole, 200 mg po                      Amphotericin B,
neoformans                                 disease                       q.d. (AI)                                   0.6-1.0 mg/kg iv
                                                                                                                     q.w.-t.i.w. (AI);
                                                                                                                     itraconazole, 200 mg
                                                                                                                     capsule po q.d. (BI)

Histoplasma                                Documented                    Itraconazole capsule,                       Amphotericin B,
capsulatum                                 disease                       200 mg po b.i.d. (AI)                       1.0 mg/kg iv q.w. (AI)

Coccidioides                               Documented                    Fluconazole, 400 mg po                      Amphotericin B,
immitis                                    disease                       q.d. (AII)                                  1.0 mg/kg iv q.w. (AI);
                                                                                                                     itraconazole, 200 mg
                                                                                                                     capsule po b.i.d. (AII)

Salmonella species,                        Bacteremia                    Ciprofloxacin, 500 mg po                    Antibiotic
(non-typhi)3                                                             b.i.d. for several months                   chemoprophylaxis
                                                                         (BII)                                       with another active
                                                                                                                     agent (CIII)

II. Recommended only if subsequent episodes are frequent or severe

Herpes simplex virus                       Frequent/severe               Acyclovir, 200 mg po t.i.d                  Valacyclovir, 500 mg
                                           recurrences                   or 400 mg po b.i.d.(AI)                     po b.i.d. (CIII)

                                                                         Famciclovir 250 mg po
                                                                         b.i.d. (AI)

Candida                                    Frequent/severe               Fluconazole 100-200 mg                      Itraconazole solution,
(oropharyngeal or                          recurrences                   po q.d. (CI)                                200 mg po q.d. (CI);
vaginal)

Candida (esophageal)                       Frequent/severe               Fluconazole 100-200 mg                      Itraconazole solution,
                                           recurrences                   po q.d. (BI)                                200 mg po q.d. (BI);



NOTES: Information included in these guidelines might not represent Food and Drug Administration (FDA) approval or approved labeling for
the particular products or indications in question. Specifically, the terms "safe" and "effective" might not be synonymous with the FDA-defined
legal standards for product approval. The Respirgard II(TM) nebulizer is manufactured by Marquest, Englewood, Colorado. Letters and Roman
numerals in parentheses after regimens indicate the strength of the recommendation and the quality of evidence supporting it (see page 7).
ABBREVIATIONS: b.i.d. = twice a day; DS = double-strength tablet; po = by mouth; q.d. = daily; q.m. = monthly; q.w. = weekly; q.o.w. =
every other week; SS = single-strength tablet; t.i.d. = three times a day; t.i.w. = three times a week; and TMP-SMZ = trimethoprim-
sulfamethoxazole.
1
  Pyrimethamine-sulfadiazine confers protection against PCP as well as toxoplasmosis; clindamycin-pyrimethamine does not offer protection against
PCP.
2
  Many multiple-drug regimens are poorly tolerated. Drug interactions (e.g., those seen with clarithromycin and rifabutin) can be problematic;
rifabutin has been associated with uveitis, especially when administered at daily doses of >300 mg or concurrently with fluconazole or
clarithromycin. See discussion of rifamycin interactions in paragraph 9 in section on Tuberculosis (54). During pregnancy, azithromycin is
recommended instead of clarithromycin because clarithromycin is teratogenic in animals.
3
  Efficacy for eradication of Salmonella has been demonstrated only for ciprofloxacin.




                                                                                                                                               43
                                                                     6
                                                                                                                                          October 10, 2006




Table 5. 	 Indications for Initiating Antiretroviral Therapy for the Chronically HIV-1 Infected
           Patient

       The optimal time to initiate therapy is unknown among persons with asymptomatic disease and CD4+ T cell
       count of >200 cells/mm3. This table provides general guidance rather than absolute recommendations for an
       individual patient. All decisions regarding initiating therapy should be made on the basis of prognosis as
       determined by the CD4+ T cell count and level of plasma HIV RNA indicated in table 4, the potential benefits
       and risks of therapy, and the willingness of the patient to accept therapy.


      Clinical Category             CD4+ Cell Count               Plasma HIV RNA                            Recommendation

     AIDS-defining illness
     or severe symptoms*                 Any value                     Any value                                     Treat
     (AI)

     Asymptomatic** (AI)                CD4+ T cells
                                                                       Any value                                     Treat
                                         < 200/mm3

     Asymptomatic (BII)                 CD4+ T cells                                             Treatment should be offered
                                       > 200/mm3 but                                             following full discussion of pros
                                                                       Any value
                                         < 350/mm3                                               and cons with each patient (See
                                                                                                 text.)

     Asymptomatic (CII)                 CD4+ T cells                    > 100,000                Most clinicians recommend
                                         > 350/mm3                                               deferring therapy, but some
                                                                                                 clinicians will treat (See text.)



     Asymptomatic (DII)                 CD4+ T cells                    < 100,000                Defer therapy
                                         > 350/mm3


*
     AIDS-defining illness per Centers for Disease Control, 1993. Severe symptoms include unexplained fever or diarrhea > 2-4 weeks,
     oral candidiasis, or > 10% unexplained weight loss.
**
     Clinical benefit has been demonstrated in controlled trials only for patients with CD4+ T cells < 200/mm³, however, the majority of
     clinicians would offer therapy at a CD4+ T cell threshold < 350/mm³. A collaborative analysis of data from 13 cohort studies from
     Europe and North America found that lower CD4 count, higher HIV viral load, injection drug use, and age over 50 were all predictors
     of progression to AIDS or death in antiretroviral-naïve patients beginning combination antiretroviral therapy. These data indicate that
     the prognosis is better for patients who initiate therapy at > 200 cells/mm3, but risk after initiation of therapy does not vary
     considerably at > 200 cells/mm3 (For additional information, see “When to Treat - Indications for Antiretroviral Therapy”)




                                                                                                                                                 Page 46
                                                                 Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                             October 10, 2006


  Table 7. Antiretroviral Components Not Recommended as Initial Therapy

Antiretroviral drugs or components      Reasons for not recommending as initial therapy
(in alphabetical order)

Darunavir (ritonavir-boosted) (DIII)    • Lack of data in treatment-naïve patients

Delavirdine (DII)                       • Inferior virologic efficacy
                                        • Inconvenient (three times daily) dosing
Didanosine + tenofovir (DII)            • High rate of early virologic failure
                                        • Rapid selection of resistant mutations
                                        • Potential for immunologic non-response/CD4+ decline
Enfuvirtide (DIII as initial regimen)   • No clinical trial experience in treatment-naïve patients
                                        • Requires twice-daily subcutaneous injections

Indinavir (unboosted) (DIII)            • Inconvenient dosing (three times daily with meal restrictions)
                                        • Fluid Requirement
Indinavir (ritonavir-boosted) (DII)     • High incidence of nephrolithiasis

Ritonavir as sole PI (DIII)             • High pill burden
                                        • Gastrointestinal intolerance

Saquinavir (unboosted) (DII)            • High pill burden
                                        • Inferior virologic efficacy
Tipranavir (ritonavir-boosted) (DIII)   • Lack of data in treatment-naïve patients


Zalcitabine + zidovudine (DII)          • Inferior virologic efficacy
                                        • Higher rate of adverse effects than other dual-NRTI alternatives




                                                                                                                                    Page 49
                                                    Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                                                       October 10, 2006


     Table 8. Antiretroviral Regimens or Components That Should Not Be Offered At Any Time
                                                                               Rationale                                                 Exception
    Antiretroviral Regimens Not Recommended
    Monotherapy with NRTI or NNRTI (EII)                   • Rapid development of resistance                        • Pregnant women with pretreatment HIV
                                                           • Inferior antiretroviral activity when compared           RNA <1,000 copies/mL using ZDV
                                                             with combination with three or more                      monotherapy for prevention of perinatal
                                                             antiretrovirals                                          HIV transmission, not for HIV treatment
                                                                                                                      for the mother*; however, combination
                                                                                                                      therapy is generally preferred.
    Dual-NRTI regimens (EII)                               • Rapid development of resistance
                                                           • Inferior antiretroviral activity when compared
                                                             with combination with three or more
                                                             antiretrovirals
    Triple-NRTI regimens (EII) except for                  • High rate of early virologic non-response seen         • Abacavir/zidovudine/lamivudine (CII);
    abacavir/zidovudine/lamivudine                           when triple NRTI combinations including                  and possibly tenofovir +
    or possibly tenofovir +                                  ABC/TDF/3TC or TDF/ddI/3TC were used as                  zidovudine/lamivudine (DII)
    zidovudine/lamivudine                                    initial regimen in treatment-naïve patients
                                                           • Other 3-NRTI regimens have not been evaluated
    Antiretroviral Components Not Recommended As Part of Antiretroviral Regimen
    Amprenavir oral solution (EIII) in:                    • Oral liquid contains large amount of the               • No exception
    • pregnant women; children <4 yr old;                    excipient propylene glycol, which may be toxic
     patients with renal or hepatic failure; and             in the patients at risk
     patients on metronidazole or disulfiram
    Amprenavir + fosamprenavir (EII)                       • Amprenavir is the active antiviral for both            • No exception
                                                            drugs, combined use have no benefit and may
                                                            increase toxicities
    Amprenavir oral solution + ritonavir oral              • The large amount of propylene glycol used as a         • No exception
    solution (EIII)                                          vehicle in amprenavir oral solution may compete
                                                             with ethanol (the vehicle in oral ritonavir
                                                             solution) for the same metabolic pathway for
                                                             elimination. This may lead to accumulation of
                                                             either one of the vehicles.
    Atazanavir + indinavir (EIII)                          • Potential additive hyperbilirubinemia                  • No exception
    Didanosine + stavudine (EIII)                          • High incidence of toxicities – peripheral              • When no other antiretroviral options are
                                                             neuropathy, pancreatitis, and hyperlactatemia            available and potential benefits outweigh
                                                           • Reports of serious, even fatal, cases of lactic          the risks* (DIII)
                                                             acidosis with hepatic steatosis with or without
                                                             pancreatitis in pregnant women*
    Didanosine + zalcitabine (EIII)                        • Additive peripheral neuropathy                         • No exception
    Efavirenz in first trimester of pregnancy              • Teratogenic in nonhuman primates                       • When no other antiretroviral options are
    or in women with significant child­                                                                               available and potential benefits outweigh
    bearing potential* (EIII)                                                                                         the risks* (DIII)
    Emtricitabine + lamivudine (EIII)                      • Similar resistance profile                             • No exception
                                                           • No potential benefit
    Lamivudine + Zalcitabine (EIII)                        • In vitro antagonism                                    • No exception
    Nevirapine initiation in treatment-naïve               Higher incidence of symptomatic (including               Only if the benefit clearly outweighs the risk
    women with CD4 >250 cells/mm3 or in                    serious and even fatal) hepatic events in these
    treatment-naïve men with CD4 >400                      patient groups
    cells/mm3 (DI)
    Saquinavir as single protease inhibitor                • Poor oral bioavailability (4%)                         • No exception
    (EIII)                                                 • Inferior antiretroviral activity when compared
                                                             with other protease inhibitors
    Stavudine + zalcitabine (EIII)                         • Additive peripheral neuropathy                         • No exception
    Stavudine + zidovudine (EII)                           • Antagonistic effect on HIV-1                           • No exception
•    When constructing an antiretroviral regimen for an HIV-infected pregnant woman, please consult “Public Health Service Task Force Recommendations for the
     Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United
     States” in http://www.aidsinfo.nih.gov/guidelines/.
                                                                                                                                                              Page 50
                                                                              Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                                                                     October 10, 2006


      Table 20. Drugs That Should Not Be Used With PI or NNRTI Antiretrovirals
Drug Category#        Calcium    Cardiac          Lipid         Anti-            Anti­         Gastro-      Neuro-     Psychotropic   Ergot Alkaloids        Herbs          Other
                      channel                     Lowering      Mycobacterial‡   histamine∂    intestinal   leptic                    (vasoconstrictor)
                      blocker                     Agents                                       drugs∂
Protease Inhibitors
                      bepridil   (none)           simvastatin   rifampin         astemizole    cisapride    pimozide   midazolam∑     dihydroergotamine      St. John’s     Delavirdine
Amprenavir*                                       lovastatin    rifapentine      terfenadine                           triazolam      (D.H.E. 45)            wort           fluticasone
and                                                                                                                                   ergotamine† (various
                                                                                                                                                                            oral
Fosamprenavir                                                                                                                         forms) ergonovine                     contraceptives
                                                                                                                                      methylergonovine
                      bepridil   (none)           simvastatin   rifampin         astemizole    cisapride    pimozide   midazolam∑     dihydroergotamine      St. John’s     fluticasone
                                                  lovastatin    rifapentine      terfenadine                           triazolam      (D.H.E. 45)            wort           indinavir
Atazanavir                                                                                     proton                                 ergotamine† (various
                                                                                               pump                                                                         irinotecan
                                                                                                                                      forms) ergonovine
                                                                                               inhibitors                             methylergonovine
                                                  simvastatin   rifampin         astemizole    cisapride    pimozide   midazolam∑     dihydroergotamine      St. John’s     carbamazepine
                      (none)     (none)           lovastatin    rifapentine      terfenadine                           triazolam      (D.H.E. 45)            wort           phenobarbital
                                                                                                                                      ergotamine† (various                  phenytoin
Darunavir
                                                                                                                                      forms)
                                                                                                                                      ergonovine
                                                                                                                                      methylergonovine                      fluticasone⊗
                      (none)     amiodarone       simvastatin   rifampin         astemizole    cisapride    pimozide   midazolam∑     dihydroergotamine      St. John’s     Atazanavir
                                                  lovastatin    rifapentine      terfenadine                           triazolam      (D.H.E. 45)            wort
Indinavir                                                                                                                             ergotamine† (various
                                                                                                                                      forms) ergonovine
                                                                                                                                      methylergonovine
                      (none)     flecainide       simvastatin   rifampin∫        astemizole    cisapride    pimozide   midazolam∑     dihydroergotamine      St. John’s     fluticasone⊗
                                 propafenone      lovastatin    rifapentine      terfenadine                           triazolam      (D.H.E. 45)            wort
Lopinavir +
                                                                                                                                      ergotamine† (various
Ritonavir
                                                                                                                                      forms) ergonovine
                                                                                                                                      methylergonovine
                      (none)     (none)           simvastatin   rifampin         astemizole    cisapride    pimozide   midazolam∑     dihydroergotamine      St. John’s
                                                  lovastatin    rifapentine      terfenadine                           triazolam      (D.H.E. 45)            wort
Nelfinavir                                                                                                                            ergotamine† (various
                                                                                                                                      forms) ergonovine
                                                                                                                                      methylergonovine
                      bepridil   amiodarone       simvastatin   rifapentine      astemizole    cisapride    pimozide   midazolam∑     dihydroergotamine      St. John’s     voriconazole
                                 flecainide       lovastatin                     terfenadine                           triazolam      (D.H.E. 45)            wort           (with RTV >
Ritonavir                                                                                                                             ergotamine† (various                  400mg bid)
                                 propafenone
                                                                                                                                      forms) ergonovine                     fluticasone⊗
                                 quinidine                                                                                            methylergonovine
                                                                                                                                                                            alfuzosin
                      (none)     (none)           simvastatin   rifampin         astemizole    cisapride    pimozide   midazolam ∑    dihydroergotamine      St. John’s     fluticasone
                                                  lovastatin    rifabutin∆       terfenadine                           triazolam      (D.H.E. 45)            wort
Saquinavir                                                                                                                            ergotamine† (various   garlic
                                                                rifapentine
                                                                                                                                      forms) ergonovine      supplements
                                                                                                                                      methylergonovine
                      bepridil   amiodarone       simvastatin   rifampin         astemizole    cisapride    pimozide   midazolam ∑    dihydroergotamine      St. John’s     fluticasone⊗
Tipranavir                       flecainide       lovastatin    rifapentine      terfenadine                           triazolam      (D.H.E. 45)            wort
                                                                                                                                      ergotamine† (various
                                 propafenone
                                                                                                                                      forms) ergonovine
                                 quinidine                                                                                            methylergonovine
Non-nucleoside Reverse Transcriptase Inhibitors
                      (none)     (none)           simvastatin   rifampin         astemizole    cisapride    (none)     alprazolam     dihydroergotamine      St. John’s     amprenavir
Delavirdine                                       lovastatin    rifapentine‡     terfenadine   H2                      midazolam∑     (D.H.E. 45)            wort           fosamprenavir
                                                                                               blockers                               ergotamine† (various
                                                                rifabutin                                              triazolam                                            carbamazepine
                                                                                               proton                                 forms) ergonovine                     phenobarbital
                                                                                               pump                                   methylergonovine                      phenytoin
                                                                                               inhibitors
                      (none)     (none)           (none)        rifapentine‡     astemizole    cisapride    (none)     midazolam∑     dihydroergotamine      St. John’s     voriconazole
                                                                                 terfenadine                           triazolam      (D.H.E. 45)            wort
Efavirenz                                                                                                                             ergotamine† (various
                                                                                                                                      forms) ergonovine
                                                                                                                                      methylergonovine
                      (none)     (none)           (none)        rifampin         (none)        (none)       (none)     (none)         (none)                 St. John’s
Nevirapine
                                                                rifapentine‡                                                                                 wort
 #	  Certain listed drugs are contraindicated based on theoretical considerations. Thus, drugs with narrow therapeutic indices and suspected metabolic involvement with P450–3A,
     2D6, or unknown pathways are included in this table. Actual interactions may or may not occur among patients.
 ‡   HIV patients treated with rifapentine have a higher rate of TB relapse than those treated with other rifamycin-based regimens; an alternative agent is recommended. 

 Δ Rifabutin may be used with saquinavir only if it is combined with ritonavir. 

 ∫   In one small study, higher doses of RTV (additional 300mg BID) or a double dose of LPV/RTV offset rifampin-inducing activity of LPV. Of note, 28% of subjects 

     discontinued because of increases in LFTs. The safety of this combination is still under evaluation. Further studies are needed.
 Σ Midazolam can be used with caution as a single dose and given in a monitored situation for procedural sedation.
 †   This is likely a class effect. 

 ∂   Astemizole and terfenadine are not marketed in the U.S. The manufacturer of cisapride has a limited-access protocol for patients meeting specific clinical eligibility criteria.

 *	 Each mL of amprenavir oral solution has 46 IU vitamin E. Patients should be cautioned to avoid supplemental doses of vitamin E. Multivitamin products containing minimal
     amounts of vitamin E are acceptable.
 ⊗	 Concomitant use of fluticasone and ritonavir results in significantly reduced serum cortisol concentrations. Coadministration of fluticasone and ritonavir or any ritonavir­
     boosted PI regimen is not recommended unless potential benefit outweighs risk of systemic corticosteroid side effects. Fluticasone should be used with caution and
     alternatives considered if given with an unboosted PI regimen.
 Suggested Alternatives:
     Cerivastatin (no longer marketed in the United States), simvastatin, lovastatin: Pravastatin and fluvastatin have the least potential for drug-drug interactions (except for
     pravastatin with darunavir/ritonavir, see Table 21a); atorvastatin should be used with caution, using the lowest possible starting dose and monitor closely; no pharmacokinetic
     data or safety data are available for coadministration of rosuvastatin with the antiretroviral agents.
     Rifabutin: clarithromycin, azithromycin (MAI prophylaxis); clarithromycin, azithromycin, ethambutol (MAI treatment)
     Astemizole, terfenadine (no longer marketed in the United States): desloratadine, loratadine, fexofenadine, cetirizine
     Midazolam, triazolam: temazepam, lorazepam

                                                                                                                                                                      Page 80
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Table 21a: page 1 of 4
 Table 21a. Drug Interactions Among Antiretrovirals and Other Drugs: Protease Inhibitors (PIs)
                    Drug Interactions Requiring Dose Modifications or Cautious Use
Drugs Affected             Atazanavir (ATV)                           Fosamprenavir (fAPV)
ANTIFUNGALS
                                                                                                              No data, but potential for bi-directional inhibition between itraconazole and PIs,
                            No data, but potential for bi-directional inhibition between itraconazole and
Itraconazole                PIs, monitor for toxicities.
                                                                                                              monitor for toxicities.
                                                                                                              Dose: Dose adjustment for patients receiving > 400mg/day may be needed.
                                                                                                              No data, but presumably similar interaction as seen with APV with an increase in
                            Unboosted: No dosage adjustment necessary.                                        both APV and ketoconazole levels (APV Ï 31%; ketoconazole Ï 44%).
Ketoconazole                RTV boosted: See RTV recommendations.                                             Dose: Consider ketoconazole dose reduction if dose is > 400mg/day.
                                                                                                              If fAPV/r: Use with caution; do not exceed 200mg ketoconazole daily.
                            RTV boosted: No data, but potential for bi-directional inhibition between         No data, but potential for bi-directional inhibition between voriconazole and PIs;
Voriconazole                voriconazole and PIs exists; monitor for toxicities.                              monitor for toxicities. See RTV recommendations if boosted with RTV.
                            See RTV recommendations if boosted with RTV.
ANTI-MYCOBACTERIALS
                            Levels: clarithromycin AUC Ï 94% and may cause QTc prolongation.                  Presumably similar interaction and recommendation as APV. Levels: APV AUC
Clarithromycin              Clarithromycin active metabolite concentrations are significantly reduced.
                                                                                                              Ï 18%. No change in clarithromycin AUC. No dose adjustment.
                            Dose: Ð clarithromycin dose by 50%. Consider alternative therapy.
                                                                                                              Rifabutin 150mg QOD + fAPV 700/100mg BID, rifabutin unchanged. No data on
                                                                                                              fAPV level.
                            Levels: Rifabutin AUC Ï 2.5-fold
Rifabutin                                                                                                     Dose: No change in fAPV dose; decrease rifabutin to 150mg QD or 300mg
                            Dose: Ð rifabutin dose to 150mg QOD or 3x/week¢
                                                                                                              3x/week¢.
                                                                                                              If RTV-boosted fAPV, reduce rifabutin dose to 150mg QOD or 3x/week¢.
                                                                                                              A substantial decrease in APV AUC (≈ Ð 82%) is expected based on the interaction
Rifampin                    Should not be coadministered.                                                     with APV.
                                                                                                              Should not be co-administered.

HORMONAL CONTRACEPTIVES
                                                                                                              An increase in ethinyl estradiol and norethindrone levels occurred with APV, and
                            Levels: Ethinyl estradiol AUC Ï 48%, norethindrone AUC Ï 110%
                                                                                                              APV levels Ð 20%.
                            Dose: use lowest effective dose or alternative methods.
                                                                                                              Do not co-administer; alternative methods of contraception are recommended.
LIPID–LOWERING AGENTS
                            Atorvastatin levels have potential for large increase. Use lowest possible        Atorvastatin AUC Ï 150% - use lowest possible starting dose of atorvastatin
Atorvastatin                starting dose of atorvastatin with careful monitoring.                            with careful monitoring.
Pravastatin                                                      No data.                                                                            No data.
Simvastatin                 Levels: Potential for large increase in statin levels. Avoid concomitant use.
                                                                                                              Levels: Potential for large increase in statin levels. Avoid concomitant use
Lovastatin
ANTICONVULSANTS
Carbamazepine               Unknown, but may decrease ATV levels substantially.
                                                                                                              Unknown, but may decrease APV levels substantially. Monitor anticonvulsant levels
Phenobarbital                                                                                                 and virologic response, or consider alternative anticonvulsant. Consider monitoring
                            Monitor anticonvulsant level and virologic response. Consider using alternative   APV levels and boosting with RTV if necessary.
Phenytoin                   anticonvulsant or monitoring ATV level and boosting with RTV if necessary.

                                                                                                              With APV, R-methadone levels Ð 13%, and APV Cmin Ð 25%. The interaction with
METHADONE                   No change in methadone or ATV levels.                                             fAPV is presumed to be similar.
                                                                                                              Monitor and titrate methadone if needed.

ERECTILE DYSFUNCTION AGENTS
                            Sildenafil levels have potential for increase. Start with reduced dose of 25 mg   Sildenafil AUC Ï 2- to 11-fold with APV. Use cautiously. Start with reduced dose of
Sildenafil                  every 48 hours and monitor for adverse effects.                                   25 mg every 48 hours and monitor for adverse effects.
                            Concomitant administration will result in substantial increase in tadalafil AUC   No data, but concomitant administration will result in substantial increase in tadalafil
Tadalafil                   and half-life (normal=17.5h). Start with a 5 mg dose, and do not exceed a         AUC and half-life (normal = 17.5 h).
                            single dose of 10mg every 72 hours.                                               Start with a 5 mg dose, and do not exceed a single dose of 10mg every 72 hours.
                            No data, but vardenafil AUC may be substantially increased.                       No data, but vardenafil AUC may be substantially increased.
Vardenafil                  Start with a 2.5 mg dose and do not exceed a single 2.5 mg dose in 24 hours.      Start with a 2.5 mg dose and do not exceed a single 2.5 mg dose in 24 hours. Do not
                            Do not exceed 2.5 mg in 72 hours if administered with RTV.                        exceed 2.5 mg in 72 hours if administered with RTV.
                            Diltiazem: AUC Ï 125%, Ð diltiazem dose by 50%; ECG monitoring is                 H2 Blockers: Coadministration of ranitidine with fAPV decreases (Ð) APV AUC
MISCELLANEOUS               recommended.                                                                      30%; Cmin unchanged. Separate administration if coadministration is necessary.
                            Other calcium channel blockers: caution is warranted; dose titration should be    Monitor closely for desired virologic response. Consider boosting with RTV.
                            considered; ECG monitoring is recommended.                                        Proton-Pump Inhibitors: No effect of esomeprazole 20mg on APV AUC, Cmax, or
                            Irinotecan: ATV inhibits UGT and may interfere with irinotecan metabolism;        Cmin, regardless of whether fAPV was given with or without ritonavir.
                            avoid concomitant use.
                            H2-receptor antagonists: reduced ATV concentrations with simultaneous
                            administration; in treatment-naïve, give ATV at least 10 hrs after or 2 hrs
                            before H2-receptor antagonist, or use ATV/r 300/100mg; in treatment-
                            experienced, boost ATV and administer separately.
                            Proton-Pump Inhibitors: Coadministration with these agents may significantly
                            decrease ATV solubility. Do not co-administer.
                            Antacids and buffered medications: Reduced ATV concentrations are expected
                            with simultaneous administration; give ATV 2 hrs before or 1 hr after these
                            medications.
¢
    Rifabutin: At least 3x/week is recommended if CD4 cell count is <100/mm3
                                                                                                                                                                         Page 81
                                                                                         Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                                                                                               October 10, 2006

     Table 21a: page 2 of 4
Table 21a. Drug Interactions Among Antiretrovirals and Other Drugs: PIs
                  Drug Interactions Requiring Dose Modifications or Cautious Use
Drugs        Darunavir + Ritonavir         Indinavir (IDV)          Lopinavir + Ritonavir (LPV/r)
Affected         (DRV/RTV)†
ANTIFUNGALS
                          Level: No data.                                          Level: IDV 600mg Q8H given with itraconazole            Levels: Itraconazole Ï when administered with LPV/r.
                          Dose: Use with caution; do not exceed 200mg              200mg bid: AUC similar to IDV 800mg Q8H.                Dose: Itraconazole – consider not exceeding 200mg/day, or monitor
Itraconazole              itraconazole daily.                                      Dose: IDV 600mg Q8H; Itraconazole: Do not               level and toxicity.
                                                                                   exceed 200mg bid.
                          Levels: DRV AUC Ï 42%. Azole AUC Ï 3-fold.               Levels: IDV Ï 68%. Dose: IDV 600mg Q8H.                 Levels: LPV AUC Ð 13%. Azole Ï 3-fold.
Ketoconazole              Dose: Use with caution; do not exceed 200mg                                                                      Dose: Use with caution; do not exceed 200mg ketoconazole daily.
                          ketoconazole qd.
                          Levels: No data with DRV/r. Voriconazole AUC             Levels: No significant changes in AUC of azole or       Voriconazole AUC Ð 39% with RTV 100mg BID; Coadministration is
                          Ð 39% with RTV 100mg BID; co-administration              IDV (healthy subjects). See RTV                         not recommended unless the benefit outweighs the risk.
Voriconazole              not recommended unless benefit outweighs risk.           recommendations if boosted with RTV.
                                                                                   Dose: Standard.

ANTI-MYCOBACTERIALS
                          Levels: Clarithromycin AUC Ï 57%. DRV:No                 Levels: Clarithromycin Ï 53%.No dose                    Levels: Ï Clarithromycin AUC 77%.
Clarithro­                significant effect.                                      adjustment.                                             Dose: Adjust clarithromycin dose for moderate and severe renal
                                                                                                                                           impairment.
mycin                     Dose: Adjust clarithromycin dose for moderate &
                          severe renal impairment.
                          Levels: No data                                          Levels: IDV Ð 32%. Rifabutin Ï 2X.                      Levels: Rifabutin AUC Ï 3-fold. 25-O-desacetyl metabolite Ï 47.5­
                          Dose: Decrease rifabutin to 150mg QOD.                   Dose: Ð rif to 150mg/d or 300mg 3x/week.¢ IDV           fold.
Rifabutin                                                                          1,000mg Q8H.If RTV boosted, rif 150mg QOD or            Dose: Decrease rifabutin dose to 150mg QOD or 3x/week¢; LPV/r:
                                                                                   3x/week¢ continue current dose of boosted IDV.          Standard.
                          Levels: No data, but a significant decrease in DRV       Levels: IDV (unboosted) Ð 89%; IDV (boosted)            Levels: LPV AUC Ð 75%.*
Rifampin                  concs is expected. Should not be coadministered.         Ð 87%; Should not be coadministered.                    Should not be coadministered.

HORMONAL CONTRACEPTIVES
                          Levels: Potential forÐ ethinyl estradiol from RTV.       Levels: Norethindrone Ï 26%.       Ethinylestradiol     Levels: ethinyl estradiol Ð 42%.
                          Use alternative or additional method with DRV/r.         Ï 24%.No dose adjustment.                               Use alternative or additional method.

LIPID–LOWERING AGENTS
                          Statin exposure from 10mg qd with DRV/r gives            Levels: Potential for increase in atorvastatin          Atorvastatin AUC Ï 5.88-fold. Use lowest possible starting dose of
Atorvastatin              similar exposure to 40mg qd alone. Use lowest            levels.Use lowest possible starting dose of             atorvastatin with careful monitoring.
                          possible statin starting dose w/careful monitoring.      atorvastatin with careful monitoring.
                          Levels: Mean Ï in statin AUC was 81% with
                          DRV/r. However, statin AUC increased by up to                                                                    Pravastatin AUC Ï 33%; no dosage adjustment necessary.
Pravastatin               5-fold in some subjects. Start at lowest dose and
                                                                                                         No Data.
                          titrate up, monitor for toxicities.
                          Levels: Potential for large increase in statin levels.   Levels:Potential for large increase in statin levels.   Levels: Potential for large increase in statin levels.
Simvastatin               Avoid concomitant use.                                   Avoid concomitant use.                                  Avoid concomitant use.
Lovastatin
ANTICONVULSANTS
Carbamazepine             Co-administration is expected to result in               Carbamazepine markedly Ð IDV AUC. Consider              Many possible interactions: carbamazepine: Ï levels when co­
                          significant decrease in DRV concentrations. Avoid        alternative anticonvulsant, RTV boosting, and/or        administered with RTV. Use with caution. Monitor anticonvulsant
Phenobarbital             concomitant use.                                         monitoring IDV level.                                   levels. Phenytoin: Ð levels of LPV, RTV, and of phenytoin when given
 Phenytoin                                                                                                                                 together. Avoid concomitant use or monitor LPV level.
                                                                                                                                           Methadone AUC Ð 53%. Opiate withdrawal may occur. Monitor and
Methadone                 Levels: No data with DRV/r. However, RTV is a            No change in methadone levels.
                                                                                                                                           titrate dose if needed. May require Ï methadone dose.
                          known inducer of methadone metabolism. Monitor
                          closely; increase methadone as clinically indicated.

ERECTILE DYSFUNCTCION AGENTS
                          Sildenafil AUC from a 25 mg single dose given w/         Sildenafil AUC Ï 3-fold. Use cautiously. Start          Sildenafil AUC Ï 11-fold in combination with RTV. Do not exceed 25
Sildenafil                DRV/r was similar to 100mg given alone. Do not           with reduced dose of 25 mg every 48 hours and           mg every 48 hours.
                          exceed 25 mg q48h; monitor for adverse effects.          monitor for adverse effects.
                          No data, but concomitant administration is               Concomitant administration will result in               Tadalafil AUC Ï 124% when co-administered with RTV. Do not
                          expected to result in substantial increase in            substantial increase in tadalafil AUC & half life       exceed a single dose of 10mg every 72 hours.
Tadalafil                 tadalafil AUC and half-life (normal = 17.5h). Do         (normal=17.5h). Start with 5 mg dose; do not
                          not exceed a single dose of 10mg in 72h.                 exceed a single dose of 10mg q72h.
                          No data, but a substantial increase in vardenafil        Vardenafil AUC Ï 16-fold. IDV (unboosted)               No data, but vardenafil AUC may be substantially increased.
                          AUC is expected. Do not exceed a single dose of          AUC Ð 30%. Dose: Consider sildenafil instead of         Do not exceed a single 2.5 mg dose in 72 hours.
Vardenafil                2.5 mg in 72 hours.                                      vardenafil if IDV unboosted. Do not exceed
                                                                                   vardenafil 2.5 mg in 72h if administered w/RTV.
                          Paroxetine and Sertraline AUC's Ð 39% and 49%,           Grapefruit juice Ð IDV levels by 26%. Vitamin C         LPV/r levels unchanged when tablets are given with omeprazole or
Miscellaneous             respectively. Patients initiated on DRV/r should be      >1 gram/day Ð IDV AUC by 14% and Cmin by                ranitidine.
                          monitored closely for antidepressent response.           32%.Amlodipine: Amlodipine AUC Ï 90% when
                          Carefully titrate SSRI dose based on clincal             co-administered with IDV/RTV. No change in
                          assessment. DRV levels unchanged when DRV/r              IDV/RTV levels. Monitor closely.
                          is administered with omeprazole or ranitidine.
†
    Darunavir interaction studies were conducted with RTV 100mg bid and mostly with darunavir doses of 300-400mg BID instead of the FDA approved dose of DRV 600mg BID
¢
    Rifabutin: At least 3x/week is recommended if CD4 cell count is <100/mm3.
* 	 In one small study, higher doses of RTV (an additional 300mg BID) or a double dose of LPV/RTV offset rifampin-inducing activity of LPV. Of note, 28% of subjects discontinued treatment because
    of increases in LFTs. The safety of this combination is still under evaluation. Further studies are needed.

                                                                                                                                                                                Page 82
                                                                                                Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
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     Table 21a: page 3 of 4
Table 21a. Drug Interactions Among Antiretrovirals and Other Drugs: PIs
                  Drug Interactions Requiring Dose Modifications or Cautious Use
Drugs Affected          Nelfinavir (NFV)                            Ritonavir* (RTV)
ANTIFUNGALS
                                                                                                             No data, but potential for bi-directional inhibition between itraconazole and RTV;
                                  No data, but potential for bi-directional inhibition                       monitor for toxicities.
Itraconazole                      between itraconazole and PIs; monitor for toxicities.                      Dose: Dose adjustment for patients receiving > 400mg itraconazole may be needed,
                                                                                                             or consider monitoring itraconazole level.
                                  No dose adjustment necessary.                                              Levels: ketoconazole Ï 3X.
Ketoconazole                                                                                                 Dose: Use with caution; do not exceed 200mg ketoconazole daily.
                                  No data, but potential for bi-directional inhibition                       Levels: voriconazole AUC Ð 82% when co-administered with 400mg BID of RTV,
                                                                                                             and concomitant therapy of voriconazole with RTV 400mg BID or higher is
Voriconazole                      between voriconazole and PIs exists; monitor for
                                                                                                             contraindicated. Voriconazole AUC Ð 39% with RTV 100mg BID; administration of
                                  toxicities.
                                                                                                             voriconazole and RTV 100mg is not recommended unless benefit outweighs risk.
ANTI-MYCOBACTERIALS
                                                                                                             Levels: Clarithromycin Ï 77%.
Clarithromycin                                                  No data.                                     Dose: Adjust clarithromycin dose for moderate and severe renal impairment.
                                  Levels: NFV Ð 32% if 750mg Q8H dose given; no change if                    Levels: Rifabutin Ï 4X.
                                  1,250mg Q12H dose used. Rifabutin Ï 2X.                                    Dose: Ð rifabutin to 150mg QOD or dose 3x/week.¢
Rifabutin                         Dose: Ð rifabutin to 150mg QD or 300mg 3x/wk. ¢ NFV                        RTV: Maintain current dose.
                                  1,250mg BID.

                                  Levels: NFV Ð 82%.                                                         Levels: RTV Ð 35%. Increased liver toxicity possible. Coadministration may lead to
Rifampin                                                                                                     loss of virologic response if RTV sole PI. Alternative antimycobacterial agents, such
                                  Should not be coadministered.                                              as rifabutin, should be considered. Should not be coadministered.
HORMONAL CONTRACEPTIVES
                                  Levels: Norethindrone Ð 18%. Ethinyl estradiol Ð 47%.                      Levels: Ethinyl estradiol Ð 40%.
                                  Use alternative or additional method.                                      Use alternative or additional method.

LIPID–LOWERING AGENTS
                                  Atorvastatin AUC Ï 74%. Use lowest possible starting                       Levels: 450% Ï when administered with SQV/RTV combination. Use lowest
Atorvastatin                      dose of atorvastatin with careful monitoring.                              possible starting dose of atorvastatin with careful monitoring.

                                                                No data.                                     Levels: 50% Ð when administered with SQV/RTV combination.
Pravastatin                                                                                                  Dose: Pravastatin dosage adjustment based on lipid response.

Simvastatin                       Simvastatin AUC Ï 505%. Potential for large increase in
                                  lovastatin AUC. Avoid concomitant use.                                     Levels: Potential for large increase in statin levels. Avoid concomitant use.
Lovastatin
ANTICONVULSANTS
Carbamazepine                     Unknown, but may decrease NFV levels substantially.
                                                                                                             Carbamazepine: Ï serum levels when co-administered with RTV.
Phenobarbital                     Monitor anticonvulsant levels and virologic response.
                                                                                                             Use with caution. Monitor anticonvulsant levels.
Phenytoin                         Consider alternative anticonvulsant or NFV levels.
                                  NFV may decrease methadone levels, but opiate                              Methadone Ð 37%. Monitor and titrate dose if needed.
METHADONE                         withdrawal rarely occurs. Monitor and titrate dose if
                                  needed. May require Ï methadone dose.                                      May require Ï methadone dose.

ERECTILE DYSFUNCTION AGENTS
                                  Sildenafil AUC Ï 2- to 11-fold. Use cautiously. Start with
                                                                                                             Sildenafil AUC Ï 11-fold. Use cautiously. Start with reduced dose of 25 mg every 48
Sildenafil                        reduced dose of 25 mg every 48 hours; monitor for adverse
                                                                                                             hours and monitor for adverse effects.
                                  effects.
                                  Concomitant administration will result in substantial
                                  increase in tadalafil AUC and half-life (normal = 17.5 h).                 Tadalafil AUC Ï 124%. Start with a 5 mg dose, and do not exceed a single dose of
Tadalafil                         Start with a 5 mg dose, and do not exceed a single dose of                 10mg every 72 hours.
                                  10mg every 72 hours.
                                  No data, but vardenafil AUC may be substantially
                                                                                                             Vardenafil AUC Ï 49 fold. RTV AUC Ð 20%.
                                  increased. Start with a 2.5 mg dose and do not exceed a
Vardenafil                        single 2.5 mg dose in 24 hours. Do not exceed 2.5 mg in
                                                                                                             Dose: Vafdenafil: Start with a 2.5 mg dose and do not exceed a single 2.5 mg dose in
                                                                                                             72 hours. RTV: Maintain current dose.
                                  72 hours if administered with RTV.
                                                                                                             Many possible interactions.
                                                                                                             Desipramine Ï 145%; reduce dose.
                                                                                                             Trazodone AUC Ï 2.4-fold when given with RTV 200mg BID. Use lowest dose of
                                                                                                             trazodone and monitor for CNS and CV adverse effects.
MISCELLANEOUS
                                                                                                             Theophylline Ð 47%; monitor theophylline levels.
                                                                                                             RTV 100mg BID significantly increases systemic exposure of inhaled (oral or nasal)
                                                                                                             fluticasone and may predispose patients to systemic corticosteroid effects.
                                                                                                             Coadministration not recommended unless benefit of fluticasone outweighs the risk.
*
     Drugs for which plasma concentrations may be decreased by coadministration with ritonavir: anticoagulants (warfarin), anticonvulsants (phenytoin, divaproex, lamotrigine), antiparasitics (atovaquone).
¢
    Rifabutin: At least 3x/week is recommended if CD4 cell count is <100/mm3.
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     Table 21a: page 4 of 4
  Table 21a. Drug Interactions Among Antiretrovirals and Other Drugs: PIs
                    Drug Interactions Requiring Dose Modifications or Cautious Use
Drugs Affected            Saquinavir† (SQV)                    Tipranavir + Ritonavir (TPV/RTV)
ANTIFUNGALS
                              Bi-directional interaction between itraconazole & SQV has been
                              observed.
                                                                                                                       No data. Use with caution; do not exceed 200mg itraconazole daily.
 Itraconazole                 Dose: Not established, but decreased itraconazole dosage may be
                              warranted. Consider therapeutic drug monitoring for both SQV (if
                              unboosted) and itraconazole.
                              Levels: SQV Ï 3X.                                                                        No data. Use with caution; do not exceed 200mg ketoconazole daily.
 Ketoconazole                 Dose: No dosage adjustment necessary.
                                                                                                                       Potential for bi-directional inhibition between voriconazole and PIs exists.
                              No data, but potential for bi-directional inhibition between voriconazole                Voriconazole AUC Ð 39% with RTV 100mg BID; interaction between TPV and
 Voriconazole                 and PIs, monitor for toxicities                                                          voriconazole unknown. Coadministration is not recommended unless the benefit
                                                                                                                       outweighs the risk.
ANTI-MYCOBACTERIALS
                                                                                                                       Levels: TPV Ï 66%, Clarithromycin Ï 19%, 14-hydroxy-clarithromycin
                              Levels: Clarithromycin Ï 45%. SQV Ï 177%.                                                metabolite Ð 97%.
 Clarithromycin               Dose: No dose adjustment.                                                                Dose: No adjustment for patients with normal renal function; reduce
                                                                                                                       clarithromycin dose by 50% for CrCl 30-60 mL/min; reduce clarithromycin dose
                                                                                                                       by 75% for CrCl <30 mL/min.
                              Levels: SQV Ð 84%.
                              Marked elevation of transaminases was seen in a pharmacokinetic study,
 Rifampin                                                                                                              No data; should not be coadministered.
                              where healthy volunteers received a combination of rifampin 600mg QD
                              + RTV/SQV 100/1,000mg BID. This combination should not be used.
                              Levels: SQV Ð 40%.                                                                       Levels: Rifabutin AUC Ï 2.9-fold. 25-O-desacetyl metabolite Ï 20.7-fold.
 Rifabutin                    Contraindicated unless SQV/RTV.                                                          Dose: Decrease rifabutin dose to 150mg QOD or 3x/week. ¢ Single-dose study,
                              Dose: Rifabutin 150mg qod or 3x/week.¢                                                   thus the effect of multiple doses of rifabutin on TPV/r PK was not assessed.
HORMONAL CONTRACEPTIVES
                                                                                                                       Levels: Ethinyl estradiol Cmax and AUC Ð ~ 50%.a Use alternative or additional
                                                                    No data.                                           method. Women on estrogen may have increased risk of non-serious rash. Used as
                                                                                                                       hormone replacement therapy, monitor clinically for signs of estrogen deficiency.
LIPID–LOWERING AGENTS
                              Levels: 450% Ï when administered with SQV/RTV combination. Use                           Levels: atorvastatin AUC Ï 9-fold.
 Atorvastatin                 lowest possible starting dose of atorvastatin with careful monitoring.                   Dose: Use lowest possible starting dose of atorvastatin with careful monitoring.
                              Levels: 50% Ð when administered with SQV/RTV combination. No dose
 Pravastatin                  adjustment needed.                                                                                                             No data.
                              Dose: Pravastatin dosage adjustment based on lipid response.
 Simvastatin                  Levels: Potential for large increase in statin levels. Avoid concomitant
                                                                                                                        Potential for large increase in statin levels. Avoid concomitant use.
 Lovastatin                   use.

ANTICONVULSANTS
 Carbamazepine                Unknown, but may markedly Ð SQV levels. Consider alternative
                                                                                                                       No data. Consider alternative anticonvulsant. Monitor anticonvulsant levels and
 Phenobarbital                anticonvulsant. Monitor anticonvulsant levels and consider monitoring
                                                                                                                       consider obtaining TPV level.
 Phenytoin                    SQV level.
                              Methadone AUC Ð 20% when co-administered with SQV/RTV
                              400/400mg BID.                                                                           No data. Dosage of methadone may need to be increased when co-administered
METHADONE                     Dose: No adjustment for this PI regimen, but monitor and titrate to                      with TPV/r.
                              methadone response as necessary.

ERECTILE DYSFUNCTION AGENTS
 Sildenafil                   Sildenafil AUC Ï 2-fold. Use a 25 mg starting dose of sildenafil.                        No data. Starting dose should not exceed 25 mg sildenafil within 48 hours.
                              Concomitant administration will result in substantial increase in tadalafil
 Tadalafil                    AUC and half-life (normal = 17.5 h). Start with a 5 mg dose, and do not                  No data. Starting dose should not exceed 10mg tadalafil every 72 hours.
                              exceed a single dose of 10mg every 72 hours.
                              No data, but vardenafil AUC may be substantially increased. Start with a
 Vardenafil                   2.5 mg dose and do not exceed a single 2.5 mg dose in 24 hours. Do not                   No data. Starting dose should not exceed 2.5 mg vardenafil every 72 hours.
                              exceed a single 2.5 mg dose in 72 hours if administered with RTV.
                                                                                                                       Abacavir Ð 35-44%.a Appropriate doses for the combination of ABC and TPV/r
                                                                                                                       have not been established.
                                                                                                                       Zidovudine Ð 31-43%. Appropriate doses for the combination of ZDV and TPV/r
                              Grapefruit juice Ï SQV levels.                                                           have not been established.
MISCELLANEOUS                                                                                                          Loperamide Ð 51%.a TPV Cmin Ð 26% with loperamide.
                              Dexamethasone Ð SQV levels.                                                              Antacids Ð TPV ~30%, TPV should be administered 2 hrs before or 1 hr after
                                                                                                                       these medications.
                                                                                                                       Fluconazole: Doses > 200mg/day are not recommended to be given with TPV.
                                                                                                                       TPV capsules contain alcohol. Avoid use of disulfiram and metronidazole.
 a
     Study conducted with TPV/r dose(s) other than FDA-approved dose of 500/200mg BID.
 †
     Some drug interaction studies were conducted with Invirase® soft gel capsule. May not necessarily apply to use with Fortovase.

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                                                                                                                                                                    October 10, 2006


  Table 21b. Drug Interactions Among Antiretrovirals and Other Drugs: NNRTIs
                                     Drug Interactions Requiring Dose Modifications or Cautious Use
Drugs Affected                           Delavirdine (DLV)              Efavirenz (EFV)             Nevirapine (NVP)
ANTIFUNGALS
                                                                                                                                            Levels: NVP: Cmax, AUC, and Cmin Ï
                                No clinically significant changes in DLV or fluconazole         No clinically significant changes in EFV    100%. Fluconazole: No change.Risk of
Fluconazole                     concentrations.                                                 or fluconazole concentrations.              hepatotoxicity may Ï with this combination.
                                                                                                                                            If co-administered, monitor NVP toxicity.
                                DLV: Cmin Ï 50%. Ketoconazole: No data.                                                                     Levels: Keto Ð 63%. NVP Ï 15%-30%.
Ketoconazole                    Dose: Standard.
                                                                                                                No data.
                                                                                                                                            Dose: Not recommended.
                                                                                                Levels: EFV Ï 44%. Voriconazole Ð           Metabolism of voriconazole may be induced
                                Metabolism of voriconazole may be inhibited by DLV.
                                                                                                77%.                                        by NVP. Voriconazole may inhibit NNRTI
Voriconazole                    Voriconazole may inhibit NNRTI metabolism. Frequently
                                                                                                                                            metabolism. Carefully monitor for NNRTI
                                monitor for NNRTI toxicity and antifungal outcome.              This combination is not recommended.
                                                                                                                                            toxicity and antifungal outcome.
ANTI-MYCOBACTERIALS
                                Levels: Clarithromycin Ï 100%. DLV Ï 44%.                       Levels: Clarithromycin Ð 39%. Monitor       Levels: NVP Ï 26%. Clarithromycin Ð 30%.
Clarithromycin                                                                                  for efficacy or use alternative agent.      Monitor for efficacy or use alternative agent
                                Adjust dosage for renal failure.
                                Levels: DLV Ð 80%. Rifabutin Ï 100%.                            Levels: EFV unchanged. Rif Ð 35%.
                                                                                                                                            Levels: NVP Ð 16%.
Rifabutin                                                                                       Dose: Ï rifabutin dose to 450-600mg
                                Not recommended.                                                QD or 600mg 3x/week.* EFV: Standard.        No dose adjustment.*
                                                                                                                                            Levels: NVP Ð 20%-58%. Virologic
                                                                                                Levels: EFV Ð 25%.
                                                                                                                                            consequences are uncertain; the potential for
                                Levels: DLV Ð 96%.                                              Dose: Maintain EFV dose at 600mg QD
Rifampin                        Contraindicated.                                                in patients weighing <50 kg or consider
                                                                                                                                            additive hepatotoxicity exists. Combination is
                                                                                                                                            not recommended; if used, coadministration
                                                                                                Ï EFV to 800mg QD.
                                                                                                                                            should be done with careful monitoring.
HORMONAL CONTRACEPTIVES
                                Levels of ethinyl estradiol may increase. Clinical              Levels: Ethinyl estradiol Ï 37%. No
                                significance is unknown.                                                                                    Levels: Ethinyl estradiol Ð approx 20%. Use
                                                                                                data on other component. Use alternative
                                                                                                                                            alternative or additional methods.
                                                                                                or additional methods.
LIPID–LOWERING AGENTS
                                                                                                Levels: Atorvastatin AUC Ð43%; EFV
                                                                                                unchanged.
                                Potential for inhibition of atorvastatin metabolism. Use
Atorvastatin                    lowest possible dose and monitor for toxicity.
                                                                                                Dose: Adjust atorvastatin dose according                       No data.
                                                                                                to lipid responses, not to exceed the
                                                                                                maximum recommended dose.

Pravastatin                                               No data.                                              No data.                                       No data.
                                                                                                Levels: Simvastatin AUC Ð by 58%;
Simvastatin                                                                                     EFV unchanged.
                                Levels: Potential for large increase in statin levels. Avoid
                                                                                                Dose: Adjust simvastatin dose according                        No data.
Lovastatin                      concomitant use.
                                                                                                to lipid responses, not to exceed the
                                                                                                maximum recommended dose.
ANTICONVULSANTS
Carbamazepine                                                                                   Use with caution. CBZ and EFV AUCs
                                                                                                Ð 27% and 36%, respectively, when
Phenobarbital                   Levels: DLV Cmin Ð 90% when co-administered with
                                                                                                combined. One case report showed low
Phenytoin                       phenytoin, phenobarbital, or carbamazepine.
                                                                                                EFV concs with phenytoin. Monitor
                                Contraindicated.
                                                                                                anticonvulsant and EFV levels. If
                                                                                                possible, use alternative anticonvulsant.
                                                                                                                                            Levels: NVP unchanged. Methadone Ð
                                                                                                Levels: Methadone Ð 60%.
                                Levels: DLV unchanged; no data on methadone levels but                                                      significantly. Opiate withdrawal common
                                                                                                Opiate withdrawal common; increased
METHADONE                       potential for increased levels. Monitor for methadone                                                       when this combination is used; increased
                                                                                                methadone dose often necessary. Titrate
                                toxicity; may require a dose reduction.                                                                     methadone dose often necessary. Titrate
                                                                                                methadone dose to effect.
                                                                                                                                            methadone dose to effect.
                                May increase levels of dapsone, warfarin, and quinidine.
MISCELLANEOUS                   Sildenafil: Potential for increased concentrations and
                                adverse effects. Use cautiously. Start with reduced dose of
                                25 mg every 48 hours and monitor for adverse effects.
                                Vardenafil: No data, but vardenafil AUC may be
                                                                                                Monitor warfarin when used
                                substantially increased.Start with a 2.5 mg dose and do not
                                                                                                concomitantly.                                                 No data.
                                exceed a single 2.5 mg dose in 24 hours.
                                Tadalafil: No data, but concomitant administration will
                                likely result in substantial increase in tadalafil AUC and
                                half-life (normal = 17.5 h). Start with a 5 mg dose and do
                                not exceed a single dose of 10mg every 72 hours.
                                 Coadministration of fluoxetine increases DLV Cmin 50%.
   *
       These recommendations apply to regimens that do not include PIs, which can substantially increase rifabutin levels.

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     Table 21c. Drug Interactions Among Antiretrovirals and Other Drugs: NRTIs
                                Drug Interactions Requiring Dose Modifications or Cautious Use
                                    Didanosine (ddI)                      Stavudine                    Tenofovir (TDF)                      Zidovudine (ZDV)
    Drugs Affected
                                                                            (d4T)
                                                                                                ATV 400mg + TDF 300mg ­
                                                                                                Levels: ATV AUC Ð 25% and Cmin
                                                                                                Ð 40%. TDF AUC Ï 24%. Avoid
                                                                                                concomitant use without RTV.
                              Levels: Simultaneous EC ddI +
                                                                                                ATV + RTV 300/100mg QD + TDF
                              ATV (with food): Ð AUC of ddI                                                                              ZDV: No change in AUC but
                                                                                                300mg QD ­
                              34%. ATV no change. Administer                                                                             30% Ð in Cmin.
Atazanavir (ATV)              separately; ATV should be taken
                                                                       No data.                 Levels: ATV AUC Ð 25% and Cmin
                              with food and ddI-EC on an empty                                  Ð23%; ATV Cmin higher with RTV           Significance unknown.
                              stomach.                                                          than without . TDF AUC Ï 30%;
                                                                                                monitor for toxicities.
                                                                                                Dose: ATV + RTV 300/100mg QD
                                                                                                co-administered with TDF 300mg
                                                                                                QD.
                              Buffered ddI + ganciclovir (GCV):
                              ddI AUC Ï 50%-111%; GCV
                              AUC Ð 21% when ddI                                                                                         Ganciclovir + ZDV: No
Cidofovir,                    administered 2 hours prior to oral                                Serum concentration of these drugs       significant changes in levels for
                              GCV; no change in IV GCV                                          and/or tenofovir may be increased.       either drug.
Ganciclovir,                                                           No data.
                              concentrations.                                                                                            Potential increase in
Valganciclovir                                                                                  Monitor for dose-related toxicities.
                              Appropriate doses for the                                                                                  hematologic toxicities.
                              combination of ddI and GCV have
                              not been established.
                                                                                                Levels: Tenofovir AUC Ï 22%,
                                                                                                Cmax Ï 24% and Cmin Ï 37%.
Darunavir (DRV)                     No data                            No data.
                                                                                                Clinical significance unknown;
                                                                                                                                         No data.
                                                                                                monitor for tenofovir toxicity.
                                                                       Peripheral               Levels: ddI EC AUC Ï by 48-60%,
                                                                       neuropathy, lactic       Cmax Ï by 48-64%
                                                                       acidosis, and
                                                                                                For patients >60 kg, 250mg/day of ddI
                                                                       pancreatitis seen with
                                                                                                EC is recommended; for patients <60
Didanosine                                    •                        this combination;                                                 No significant interactions.
                                                                                                kg, 200mg EC ddI is recommended;
                                                                       should be avoided
                                                                                                the ddI doses apply to patients with
                                                                       unless potential
                                                                                                creatinine clearanace >60 mL/min.
                                                                       benefit far outweighs
                                                                       potential risks.         Monitor for ddI-associated toxicities.


                              EC ddI can be taken together with        No significant PK        Levels: IDV Cmax Ï 14%.
Indinavir (IDV)               IDV.                                     interaction.
                                                                                                                                         No significant PK interaction.
                                                                                                Dose: Standard.


                                                                                                LPV/r 400/100mg AUC Ð 15%; TDF
Lopinavir/ritonavir           No data.                                 No data.                 AUC Ï 34%; clinical significance of      No data.
(LPV/r)                                                                                         interaction is unknown; monitor for
                                                                                                tenofovir toxicities.
                                                                       Levels: d4T Ð 27%;
                                                                       methadone
                              Levels: EC ddI unchanged.                unchanged.                                                        ZDV AUC Ï 43%. Monitor for
Methadone                                                                                       No change in methadone or TDF levels.
                                                                                                                                         ZDV-related adverse effects.
                              Dose: No change EC ddI.
                                                                       Dose: No dose
                                                                       adjustment.
                               Coadministration not                                                                                      Ribavirin inhibits
                              recommended. Ribavirin increases                                                                           phosphorylation of ZDV; this
                                                                                                Level: Ribavirin unchanged; no data
Ribavirin                     the intracellular levels of the active   No data.
                                                                                                on TDF level.
                                                                                                                                         combination should be avoided
                              metabolite of ddI and may cause                                                                            if possible, or closely monitor
                              serious toxicities.                                                                                        virologic response.
                              Levels: EC ddI Ð 10%.a TPV                                                                                 Levels: ZDV AUC and Cmax
                              Cmin Ð 34% with EC ddI.a                                          TPV AUC and Cmin Ð 9%-18% and            Ð 31%-42% and 46%-51%,
Tipranavir/                                                            No significant PK
                                                                                                12%-21%, respectively a; clinical        respectively.a Appropriate doses
ritonavir                     Dose: EC ddI and TPV/r should be         interaction.
                                                                                                significance is unknown.                 for the combination of ZDV and
                              separated by at least 2 hours.                                                                             TPV/r have not been established.
a
    Study conducted with TPV/r dose(s) other than FDA-approved dose of 500/200mg BID.

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Table 15: page 1 of 2

Table 15. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
   Antiretrovirals                 Daily Dose              Dosing in Renal Insufficiency                    Dosing in Hepatic Impairment
 Nucleoside Reverse Transcriptase Inhibitors – Note:                Use of fixed-dose combination NRTI (+/- NNRTI) of: Atripla, Combivir,
 Trizivir, Epzicom – not recommended in patients with CrCl <50 mL/min; use of Truvada – not recommended in patients with CrCl <30 mL/min

 Abacavir* (Ziagen®)        300mg PO BID                     No need for dosage adjustment                       No dosage recommendation
                        ®
 Didanosine (Videx )        > 60 kg                                         Dose
                            400mg PO qd                CrCl (mL/min) >60 kg       <60 kg
                                                       30-59          200mg       125 mg                         No dosage recommendation
                                                       10-29          125 mg       100mg
                                                       < 10           125 mg       75 mg
                            < 60 kg                    CAPD or HD patients: use same dose as
                            250mg qd                   CrCl < 10 ml/min
 Emtricitabine              200mg oral capsule PO qd   CrCl       capsule       solution
 (Emtriva®)                 or                         30-49     200mg q48h     120mg q24h
                            240mg (24mL) oral          15-29     200mg q72h      80mg q24h                       No dosage recommendation
                            solution PO qd             <15       200mg q96h      60mg q24h
                                                       or HD*
 Lamivudine*                300mg PO qd or 150mg       CrCl (mL/min)        Dose
 (Epivir®)                  PO BID                     30-49     150mg qd
                                                       15-29     150mg x 1, then 100mg qd                        No dosage recommendation
                                                       5-14      150mg x 1, then 50mg qd
                                                       <5        50mg x 1, then 25 mg qd
                                                       or HD*
 Stavudine (Zerit®)         > 60 kg                                         Dose
                            40mg PO BID                CrCl (mL/min) >60 kg       <60 kg
                                                       26-50       20mg q12h 15 mg q12h                          No dosage recommendation
                                                       10-25       20mg q24h 15 mg q24h
                            < 60 kg                    or HD*
                            30mg PO BID
 Tenofovir (Viread®)        300mg PO qd                CrCl (mL/min)           Dose
                                                       30-49              300mg q48h
                                                       10-29              300mg twice weekly                     No dosage recommendation
                                                       ESRD                300mg q7d
                                                       or HD*
 Tenofovir +                1 tablet PO qd             CrCl (mL/min)           Dose
 Emtricitabine                                         30-49                1 tablet q48h                        No dosage recommendation
 (Truvada®)                                            < 30                not recommended
 Zalcitabine (Hivid®)       0.75 mg PO TID             CrCl (mL/min)           Dose
                                                       10-40              0.75 mg BID
                                                       < 10               0.75 mg qd                             No dosage recommendation
                                                       No data on hemodialysis
 Zidovudine*                300mg PO BID               “Severe” renal impairment or HD –                         No dosage recommendation
 (Retrovir®)                                           100mg TID
 Non- Nucleoside Reverse Transcriptase Inhibitors
 Delavirdine                400mg PO TID               No dosage adjustment necessary                   No recommendation; use with caution in
 (Rescriptor®)                                                                                          patients with hepatic impairment
 Efavirenz (Sustiva®)       600mg PO qd                No dosage adjustment necessary                   No recommendation; use with caution in
 Efavirenz/tenofovir/       One tablet PO qd           Atripla™ - not recommended if CrCl <50           patients with hepatic impairment
 emtricitabine                                         ml/min
 (Atripla™)
 Nevirapine                 200mg PO BID               No dosage adjustment necessary                   No data available; avoid use in patients with
 (Viramune®)                                                                                            moderate to severe hepatic impairment
      *
  HD = dose after dialysis on dialysis days
  HD = hemodialysis
  CAPD = chronic ambulatory peritoneal dialysis
  ESRD = End Stage Renal Disease
                                                                                                                                                   Page 68
                                                                   Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                                                    October 10, 2006

 Table 15: page 2 of 2
Table 15. Antiretroviral Dosing Recommendations in Patients with Renal or Hepatic Insufficiency
      Antiretrovirals                    Daily Dose                 Dosing in Renal Insufficiency                     Dosing in Hepatic Impairment
  Protease Inhibitors
  Amprenavir                    1,400mg PO BID                   Not recommended in patients with               Not recommended in patients with hepatitic
  (Agenerase®) Oral                                              renal failure                                  failure
  Solution
  Atazanavir (Reyataz®)         400mg PO qd                         No dosage adjustment necessary              Child-Pugh Class Dose
                                                                                                                     7-9               300mg qd
                                                                                                                     >9                not recommended
  Darunavir (Prezista™,         (DRV 600mg + RTV                    No dosage adjustment necessary              No dosage recommendation; use with caution
  DRV)                          100mg) PO BID                                                                   in patients with hepatic impairment
  Fosamprenavir                 1,400mg PO BID                      No dosage adjustment necessary              Child-Pugh Score Dose
  (Lexiva®)                                                                                                          5-8             700mg BID
                                                                                                                     9-12           not recommended
                                                                                                                ritonavir boosting should not be used in
                                                                                                                patients with hepatic impairment
  Indinavir (Crixivan®)         800mg PO q8h                        No dosage adjustment necessary              Mild to moderate hepatic insufficiency
                                                                                                                because of cirrhosis: 600mg q8h
  Lopinavir/ritonavir           400/100mg PO BID or                 No dosage adjustment necessary              No dosage recommendation; use with caution
  (Kaletra®)                    800/200mg PO QD (QD                                                             in patients with hepatic impairment
                                only for txt-naïve pats)
  Nelfinavir (Viracept®)        1,250mg PO BID                      No dosage adjustment necessary              No dosage recommendation; use with caution
                                                                                                                in patients with hepatic impairment
  Ritonavir (Norvir®)           600mg PO BID                        No dosage adjustment necessary              No dosage adjustment in mild hepatic
                                                                                                                impairment; no data for moderate to severe
                                                                                                                impairment, use with caution
  Saquinavir soft gel cap       1,200mg TID                         No dosage adjustment necessary              No dosage recommendation; use with caution
  (Fortovase®)                                                                                                  in patients with hepatic impairment
  Tipranavir (Aptivus®)         500mg PO BID with                   No dosage adjustment necessary              No dosage recommendation; use with caution
                                ritonavir 200mg PO BID                                                          in patients with hepatic impairment;
                                                                                                                TPV/RTV is contraindicated in pts with
                                                                                                                moderate to severe (Child-Pugh Class B & C)
                                                                                                                hepatic insufficiency
  Entry Inhibitors
  Enfuvirtide (Fuzeon®)         90mg SQ q12h                        No dosage adjustment necessary                        No dosage recommendation

 Creatinine Clearance calculation:
 Male: (140-age in yr) x weight (kg)     Female: (140-age in yr) x weight (kg) x 0.85
              72 x S.Cr.                     72 x S.Cr.
 Child-Pugh Score
             Component                                                                  Score Given
                                                1                                2                                               3
                    *
  Encephalopathy                       None                   Grade 1-2                                   Grade 3-4
  Ascites                              None                   Mild or controlled by diuretics             Moderate or refractory despite diuretics
  Albumin                              > 3.5 g/dl             2.8 to 3.5 g/dl                             < 2.8 g/dl
  Total Bilirubin                      < 2 mg/dL              2 to 3 mg/dL                                > 3 mg/dL
                                       (< 34 μ mol/L)         (34 μ mol/L to 50 μ mol/L)                  (> 50 μ mol/L)
  OR
  Modified Total Bilirubin**           < 4 mg/dL              4-7 mg/dL                                   > 7 mg/dL
  Prothrombin time                     <4                     4-6                                         >6
  (sec prolonged) OR
  INR                                  < 1.7                  1.7-2.3                                     > 2.3
         *
            NB: Encephalopathy Grades - Grade 1: Mild confusion, anxiety, restlessness, fine tremor, slowed coordination
                                              Grade 2: Drowsiness, disorientation, asterixis
                                              Grade 3: Somnolent but rousable, marked confusion, incomprehensible speech, incontinence, hyperventilation
                                              Grade 4: Coma, decerebrate posturing, flaccidity
         **
            Modified Total Bilirubin used to score patients who have Gilbert’s Syndrome or who are taking indinavir
         Child-Pugh Classification - Child-Pugh Class A = score 5-6; Class B = score 7-9; Class C = score > 9
                                                                                                                                                           Page 69
                                                                           Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                                                October 10, 2006

Table 29. page 1 of 3
Table 29. 	 Antiretroviral Drug Use in Pregnant HIV-Infected Women: Pharmacokinetic and
            Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy
                   (See also “Safety and Toxicity of Individual Antiretroviral Drugs in Pregnancy” for additional toxicity data. Table adopted from
                   “Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce
                   Perinatal HIV-1 Transmission in the United States”. Please see this document for detailed guidelines on treatment options.)

 Antiretroviral         Pharmacokinetics in             Concerns in Pregnancy                  Rationale for Recommended Use in Pregnancy
     Drug                   Pregnancy
 NRTIs/                                             See text for discussion of potential      NRTIs are recommended for use as part of combination
 NtRTIs                                             maternal and infant mitochondrial         regimens, usually including two NRTIs with either an
                                                    toxicity.                                 NNRTI or one or more PIs. Use of single or dual NRTIs
                                                                                              alone is not recommended for treatment of HIV infection
                                                                                              (AZT alone may be considered for prophylaxis of
                                                                                              perinatal transmission in pregnant women with HIV
                                                                                              RNA <1,000 copies/mL).
 Recommended agents
 Zidovudine*            Pharmacokinetics not        No evidence of human                      Preferred NRTI for use in combination antiretroviral
                        significantly altered in    teratogenicity [325]. Well-tolerated,     regimens in pregnancy based on efficacy studies and
                        pregnancy; no dosage        short-term safety demonstrated for        extensive experience; should be included in regimen
                        change indicated [324].     mother and infant.                        unless significant toxicity or stavudine use.
 Lamivudine*            Pharmacokinetics not        No evidence of human                      Because of extensive experience with lamivudine in
                        significantly altered in    teratogenicity [325]. Well-tolerated,     pregnancy in combination with zidovudine, lamivudine
                        pregnancy; no dosage        short-term safety demonstrated for        plus zidovudine is the recommended dual NRTI
                        change indicated [326].     mother and infant.                        backbone for pregnant women.
 Alternate agents
 Didanosine             Pharmacokinetics not        Cases of lactic acidosis, some fatal,     Alternate NRTI for dual nucleoside backbone of
                        significantly altered in    have been reported in pregnant            combination regimens. Didanosine should be used with
                        pregnancy; no dosage        women receiving didanosine and            stavudine only if no other alternatives are available.
                        change indicated [327].     stavudine together [328-330]
 Emtricitabine†         No studies in human         No studies in human pregnancy.            Alternate NRTI for dual nucleoside backbone of
                        pregnancy.                                                            combination regimens.
 Stavudine              Pharmacokinetics not        No evidence of human                      Alternate NRTI for dual nucleoside backbone of
                        significantly altered in    teratogenicity [325]. Cases of lactic     combination regimens. Stavudine should be used with
                        pregnancy; no change        acidosis, some fatal, have been           didanosine only if no other alternatives are available. Do
                        in dose indicated [331].    reported in pregnant women                not use with zidovudine because of potential for
                                                    receiving didanosine and stavudine        antagonism.
                                                    together [328-330].
 Abacavir*              Pharmacokinetics are        Hypersensitivity reactions occur in       Alternate NRTI for dual nucleoside backbone of
                        not significantly altered   ~5-8% of non-pregnant persons; a          combination regimens. See footnote regarding use in
                        in pregnancy; no            much smaller percentage are fatal         triple NRTI regimen.#
                        change in dose              and are usually associated with
                        indicated.                  rechallenge. Rate in pregnancy
                                                    unknown. Patient should be
                                                    educated regarding symptoms of
                                                    hypersensitivity reaction.
 Insufficient data to recommend use
 Tenofovir†             No studies in human         Studies in monkeys show decreased         Because of lack of data on use in human pregnancy and
                        pregnancy. Phase I          fetal growth and reduction in fetal       concern regarding potential fetal bone effects, tenofovir
                        study in late pregnancy     bone porosity within two months of        should be used as a component of a maternal
                        in progress.                starting maternal therapy [332].          combination regimen only after careful consideration of
                                                    Clinical studies in humans                alternatives.
                                                    (particularly children) show bone
                                                    demineralization with chronic use;
                                                    clinical significance unknown [206,
                                                    333].
 Not recommended
 Zalcitabine   No studies in human                  Rodent studies indicate potential for     Given lack of data and concerns regarding teratogenicity
                        pregnancy.                  teratogenicity and developmental          in animals, not recommended for use in human
                                                    toxicity (See Table 28).                  pregnancy unless alternatives are not available.


                                                                                                                                                       Page 95
                                                                       Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                                                      October 10, 2006

 Table 29: page 2 of 3
 Table 29. 	 Antiretroviral Drug Use in Pregnant HIV-Infected Women: Pharmacokinetic and
             Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy
Antiretroviral                  Pharmacokinetics                          Concerns in Pregnancy                        Rationale for Recommended Use in
    Drug                          in Pregnancy                                                                                     Pregnancy
NNRTIs
Recommended agents
Nevirapine               Pharmacokinetics not significantly      No evidence of human teratogenicity [325].       Nevirapine should be initiated in pregnant women
                         altered in pregnancy; no change in      Increased risk of symptomatic, often rash-       with CD4+ counts > 250 cells/mm3 only if benefit
                         dose indicated [334].                   associated, and potentially fatal liver          clearly outweighs risk, because of the increased risk
                                                                 toxicity among women with CD4+ counts >          of potentially life-threatening hepatotoxicity in
                                                                 250/mm3 when first initiating therapy [97,       women with high CD4+ counts. Women who enter
                                                                 166]; unclear if pregnancy increases risk.       pregnancy on nevirapine regimens & are tolerating
                                                                                                                  them well may continue therapy, regardless of CD4+
                                                                                                                  count.
Not recommended
Efavirenz †              No studies in human pregnancy. 	        FDA Pregnancy Class D; significant               Use of efavirenz should be avoided in the first
                                                                 malformations (anencephaly, anophthalmia,        trimester, and women of childbearing potential
                                                                 cleft palate) were observed in 3 (15%) of 20     must be counseled regarding risks and avoidance of
                                                                 infants born to cynomolgus monkeys               pregnancy. Because of the known failure rates of
                                                                 receiving efavirenz during the first trimester   contraception, alternate regimens should be strongly
                                                                 at a dose giving plasma levels comparable        considered in women of child bearing potential. Use
                                                                 to systemic human therapeutic exposure;          after the second trimester of pregnancy can be
                                                                 there are three case reports of neural tube      considered if other alternatives are not available and
                                                                 defects in humans after first trimester          if adequate contraception can be assured
                                                                 exposure [95, 325, 335]; relative risk           postpartum.
                                                                 unclear.
Delavirdine              No studies in human pregnancy. 	        Rodent studies indicate potential for            Given lack of data and concerns regarding
                                                                 carcinogenicity and teratogenicity (See          teratogenicity in animals, not recommended for use in
                                                                 Table 28).                                       human pregnancy unless alternatives are not available
Protease 	                                                       Hyperglycemia, new onset or exacerbation
                                                                 of diabetes mellitus, and diabetic
inhibitors 	                                                     ketoacidosis reported with PI use; unclear if
                                                                 pregnancy increases risk. Conflicting data
                                                                 regarding preterm delivery in women
                                                                 receiving PIs (See text).
Recommended agents
Lopinavir/               Pharmacokinetic studies of standard	    No evidence of human teratogenicity. Well­         The capsule formulation is no longer available.
ritonavir 	              dose of lopinavir/ ritonavir capsules   tolerated, short-term safety demonstrated in       Pharmacokinetic studies of the new tablet
                         (3 capsules twice daily) during 3rd     phase I/II studies.                                formulation are underway, but there are
                         trimester indicated levels were                                                            currently insufficient data to make a definitive
                         significantly lower than during                                                            recommendation regarding dosing in pregnancy.
                         postpartum period and in non­                                                              Some experts would administer standard dosing
                         pregnant adults; an increased dose                                                         (2 tablets twice daily) throughout pregnancy and
                         of 4 capsules of lopinavir/ritonavir                                                       monitor virologic response and lopinavir drug
                         twice daily starting in the 3rd                                                            levels, if available. Other experts, extrapolating
                         trimester resulted in adequate                                                             from the capsule formulation pharmacokinetic
                         lopinavir exposure; by 2 weeks                                                             data, would increase the dose of the tablet
                         postpartum, standard dosing was                                                            formulation during the 3rd trimester (from 2
                         again appropriate. Pharmacokinetic                                                         tablets to 3 tablets twice daily), returning to
                         studies of the new                                                                         standard dosing postpartum . Once daily
                         lopinavir/ritonavir tablet                                                                 lopinavir/ritonavir dosing is not recommended
                         formulation are underway, but data                                                         during pregnancy because there are no data to
                         are not yet available.                                                                     address whether drug levels are adequate with
                                                                                                                    such administration.
Nelfinavir 	             Adequate drug levels are achieved       No evidence of human teratogenicity [325].         Given pharmacokinetic data and extensive
                         in pregnant women with nelfinavir       Well-tolerated, short-term safety demonstrated     experience with use in pregnancy compared with
                         1250mg, given twice daily [117].        for mother and infant. Nelfinavir dosing at        other PIs, preferred PI for combination regimens in
                                                                 750mg three times daily produced variable and      pregnant women, particularly if HAART is being
                                                                 generally low levels in pregnant women.            given solely for perinatal prophylaxis. In clinical
                                                                                                                    trials of initial therapy in non-pregnant adults,
                                                                                                                    nelfinavir-based regimens had a lower rate of viral
                                                                                                                    response compared with lopinavir/ritonavir or
                                                                                                                    efavirenz-based regimens, but similar viral
                                                                                                                    response compared with atazanavir or nevirapine­
                                                                                                                    based regimens [106, 107, 111, 125].

                                                                                                                                                             Page 96
                                                                             Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                                                       October 10, 2006

Table 29: page 3 of 3
Table 29. Antiretroviral Drug Use in Pregnant HIV-Infected Women: Pharmacokinetic and Toxicity
          Data in Human Pregnancy and Recommendations for Use in Pregnancy
 Antiretroviral              Pharmacokinetics in                        Concerns in Pregnancy                         Rationale for Recommended Use in
     Drug                        Pregnancy                                                                                        Pregnancy
 Alternate agents
 Indinavir              Two studies including 18 women           Theoretical concern re: increased indirect          Alternate PI to consider if unable to use
                        receiving indinavir 800mg three          bilirubin levels, which may exacerbate              nelfinavir or saquinavir-SGC/ritonavir, but
                        times daily showed markedly lower        physiologic hyperbilirubinemia in the neonate,      would need to give indinavir as ritonavir-boosted
                        levels during pregnancy compared         but minimal placental passage. Use of               regimen. Optimal dosing for the combination of
                        with postpartum, although                unboosted indinavir during pregnancy is not         indinavir/ritonavir in pregnancy is unknown.
                        suppression of HIV RNA was seen          recommended.
                        [336, 337].
 Ritonavir              Phase I/II study in pregnancy            Limited experience at full dose in human            Given low levels in pregnant women when used
                        showed lower levels during               pregnancy; has been used as low- dose               alone, recommended for use in combination with
                        pregnancy compared with                  ritonavir boosting with other PIs.                  second PI as low-dose ritonavir “boost” to
                        postpartum [338].                                                                            increase levels of second PI.
 Saquinavir-hard        Pharmacokinetic studies of               Well-tolerated, short-term safety demonstrated      Saquinavir-SGC are no longer available. There
 gel capsule            saquinavir-soft gel capsules (SGC)       for mother and infant for both saquinavir-SGC       are only limited pharmacokinetic data on
 [HGC]                  indicated that inadequate drug levels    and -HGC in combination with low-dose               saquinavir-HGC in pregnancy. Ritonavir­
 (Invirase®)/           were observed in pregnant women          ritonavir.                                          boosted saquinavir-HGC is an alternative PI for
 ritonavir              given 1,200 mg of saquinavir-SGC as                                                          combination regimens in pregnancy, and is an
                        a sole PI three times daily [339], but                                                       alternative initial antiretroviral recommendation
                        adequate levels were achieved when                                                           for non-pregnant adults.
                        800 mg saquinavir-SGC boosted with
                        ritonavir 100 mg was given twice
                        daily [340]. However, saquinavir-
                        SGC are no longer produced.
                        Limited pharmacokinetic data on
                        saquinavir-hard gel capsule (HGC)
                        suggest that 1,000 mg saquinavir-
                        HGC/100 mg ritonavir given twice
                        daily will achieve adequate
                        saquinavir drug levels in pregnant
                        women.
 Insufficient data to recommend use
 Amprenavir             No studies in human pregnancy.           Oral solution contraindicated in pregnant           Safety and pharmacokinetics in pregnancy data
                                                                 women because of high levels of propylene           are insufficient to recommend use of capsules
                                                                 glycol, which may not be adequately                 during pregnancy.
                                                                 metabolized during pregnancy.
 Atazanavir             No studies in human pregnancy.           Theoretical concern re: increased indirect          Safety and pharmacokinetics in pregnancy data
                                                                 bilirubin levels, which may exacerbate              are insufficient to recommend use during
                                                                 physiologic hyperbilirubinemia in the neonate,      pregnancy.
                                                                 although transplacental passage of other PIs
                                                                 has been low.
 Darunavir              No studies in human pregnancy.           No experience in human pregnancy.                   Safety and pharmacokinetics in pregnancy data are
                                                                                                                     insufficient to recommend use during pregnancy.
 Fosamprenavir          No studies in human pregnancy.           No experience in human pregnancy.                   Safety and pharmacokinetics in pregnancy data are
                                                                                                                     insufficient to recommend use during pregnancy.
 Tipranavir             No studies in human pregnancy.           No experience in human pregnancy.                   Safety and pharmacokinetics in pregnancy data are
                                                                                                                     insufficient to recommend use during pregnancy.
 Fusion Inhibitors
 Insufficient data to recommend use
 Enfuvirtide            No studies in human pregnancy.           No experience in human pregnancy.                Safety and pharmacokinetics in pregnancy data are
                                                                                                                  insufficient to recommend use during pregnancy.
  NRTI = nucleoside reverse transcriptase inhibitor; NtRTI = nucleotide reverse transcriptase inhibitor; NNRTI = non-nucleoside reverse transcriptase inhibitor;
      PI = protease inhibitor; SGC = soft gel capsule; HGC = hard gel capsule.
  * 	 Zidovudine and lamivudine are included as a fixed-dose combination in Combivir®; zidovudine, lamivudine, and abacavir are included as a fixed-dose
      combination in Trizivir®.
  † 	 Emtricitabine and tenofovir are included as a fixed-dose combination in Truvada®; emtricitabine, tenofovir, and efavirenz are included as a fixed-dose
      combination in Atripla™.
  # 	 Triple NRTI regimens including abacavir have been less potent virologically compared with PI-based HAART regimens. Triple NRTI regimens should be
      used only when an NNRTI- or PI-based HAART regimen cannot be used (e.g., because of significant drug interactions). A study evaluating use of
      zidovudine/lamivudine/abacavir among pregnant women with HIV RNA < 55,000 copies/mL as a class-sparing regimen is in development.

                                                                                                                                                             Page 97
                                                                             Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
                                                                                                                    Chart Review Scoring Guidelines

                                                The overall scoring rule is that scores are calculated as yes/ yes + no. This is calculated for the total and the sections (Labs, ARV
                                                 Therapy, OI Prophylaxis, Vaccines & PPD, Health Maintenance/Education).
                                                Prevention for Positives (P for P) is also scored, which include the prevention items in Health Maintenance/Education plus the STD
                                                 labs.
                                                The initial visit score includes all the baseline labs.
                                                The hepatitis score includes all the hepatitis screens and hepatitis vaccines.
                                                Consider creating sub-scores for any collection of items that address what will be included in the training. Or after the fact, identify
                                                 the topics that were trained on and select those items to get a score.
                                                Compare changes on those items to changes on other items to see if overall improvement was related to training provided or to general
                                                 improvement.




Florida/Caribbean AETC Chart Review
                                                                                                                                                                      Scoring Category                                                           Include in Report
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                                                                                                                                              PPD
                                                                                                                                                                        ARV
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                                                                                                                                                                                                                                                     Child
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                                                  Topic
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                                                                                                                                                                      therapy
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                                                                                                                                                        Charting &
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                                                                                                                                           Vaccines &
                                                                                                                                                                                                                  morbidities




                                      Header                     1       Date of Chart Review                                                           Maint./Educ                                                                         YES      YES     YES    YES
                                      Header                     2       Reviewer                                                                                                                                                           YES      YES     YES    YES
                                      Header                     3       Clinic                                                                                                                                                             YES      YES     YES    YES
                                      Header                     4       Subject Number                                                                                                                                                     YES      YES     YES    YES
                                      Header                     5       Age                                                                                                                                                                YES      YES     YES    YES
                                      Header                     6       Sex                                                                                                                                                                YES      YES     YES    YES
                                      Header                     7       Race/Ethnicity                                                                                                                                                     YES      YES     YES    YES
                                      Header                     8       Hispanic/Latino or Spanish Origin?                                                                                                                                 YES      YES     YES    YES
                                      Header                     9       Provider                                                                                                                                                           YES      YES     YES    YES
                                      Labs                       1       Three HIV DNA-PCR (at ages:< 48 hrs; 1-2 mos; 3-6 mos)     X                                                                                                       YES
                                      Labs                       2       ELISA and Western Blot at 12 - 18 mos                      X                                                                                                       YES
                                      Labs                       3       If positive, repeat test                                   X                                                                                                       YES
                                      Labs                       4       Patient classification by 18 mos                           X                                                                                                       YES
                                      Labs                       5       seroreverted                                               X                                                                                                       YES
                                                                         CBC/diff/platelets at birth, 2 weeks and 6 weeks if on
                                      Labs                       7                                                                  X                                                                                                       YES
                                                                         prophylactic AZT
                                      Labs                       8         Abnormalities addressed                                  X                                                                                                       YES
                                      Labs                       9       Urine CMV at birth                                         X                                                                                                       YES
                                      Labs                     10        Proof of positivity in chart                               X                                                                                                                YES
                                      Labs                     11        Patient classification (select one)                        X                                                                                                                YES




I-1
                                      Labs                     12        Pediatric classification correct and correctly revised     X                                                                                                                YES
                                                                                                                                                                      Scoring Category                                                           Include in Report




I-2
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                                                                                                                                                        Charting &
                                                                                                                                                        Monitoring


                                                                                                                                           Vaccines &
                                                                                                                                                                                                                  morbidities




                                                                                                                                                        Maint./Educ
                                      Viral Load               1       Every 3-4 months                                             X                                                                                                                YES     YES    YES
                                      Viral Load               2       Within 2-8 weeks of ARV change                               X                                                                                                                YES     YES    YES
                                      Viral Load               3       Most recent viral load                                       X                                                                                                                YES     YES    YES
                                      CD4 count                1       Every 3-4 months                                             X                                                                                                                YES     YES    YES
                                      CD4 count                2       Most recent CD4                                              X                                                                                                                YES     YES    YES
                                      CD4 count                3       CD4% every 3-4 months                                        X                                                                                                                YES
                                      CD4 count                4       Most recent CD4%                                             X                                                                                                                YES
                                      Resistance testing       1       Prior to initiating or changing therapy                      X                                                                                                                YES     YES    YES
                                                                       If VL > 1000 && < 1 log drop after 8 weeks following
                                      Resistance testing       2                                                                    X                                                                                                                YES     YES    YES
                                                                       initiation or change, and non-adherence excluded.
                                                                       Was patient appropriate for resistance test per VL && drug
                                      Resistance testing       3                                                                    X                                                                                                                YES     YES    YES
                                                                       pressure
                                      CBC/diff/platelets       1       After initiating or changing therapy                         X                                                                    X                                           YES     YES    YES
                                      CBC/diff/platelets       2       q 3-4 months if on ART                                       X                                                                    X                                           YES     YES    YES
                                      CBC/diff/platelets       3       Abnormalities addressed                                      X                                                                    X                                           YES     YES    YES
                                      CMP                      1       At baseline                                                  X                                                                    X                                           YES     YES    YES
                                      CMP                      2       q 3-4 months if on ART                                       X                                                                    X                                           YES     YES    YES
                                      CMP                      3       Abnormalities addressed                                      X                                                                    X                                           YES     YES    YES
                                      CMP                      4       If Glucose elevated, was HgbA1c or 2 hr. GTT done?           X                                                                                X                                       YES    YES
                                      CMP                      5       Amylase and lipase at baseline and q 3-4 mos if on ART       X                                                                                                                YES
                                      Lipid profile            1       HDL/LDL/triglycerides pre ART                                X                                                                    X           X                                       YES    YES
                                      Lipid profile            2       HDL/LDL/triglycerides q 3-4 mos if on ART                    X                                                                    X           X                                       YES    YES
                                      Lipid profile            3       Fasting status documented for lipid assessment               X                                                                    X           X                                       YES    YES
                                                                       If cholesterol/triglycerides elevated were NCEP guidelines
                                      Lipid profile            4                                                                    X                                                                    X           X                                       YES    YES
                                                                       followed
                                      Hepatitis                1       Hepatitis A total antibody (HAVAb) or IgG                    X                                                                                                                        YES    YES
                                                                       Hepatitis A total antibody (HAVAb) or IgG if infected with
                                      Hepatitis                2                                                                    X                                                                                                                YES
                                                                       Hep B or Hep C
                                      Hepatitis                3       Hepatitis B surface antigen (HBsAg)                          X                                                                                X                               YES     YES    YES
                                      Hepatitis                4         if positive, Hep B VL tested                               X                                                                                X                               YES     YES    YES
                                      Hepatitis                5       Hepatitis B surface antibody (HBsAb)                         X                                                                                X                               YES     YES    YES
                                      Hepatitis                6       Hepatitis B core antibody (HBcAb) total or IgG               X                                                                                X                               YES     YES    YES
                                      Hepatitis                7       Hepatitis C antibody (HCVAb)                                 X                                                                                X                               YES     YES    YES
                                      Hepatitis                8         if positive, Hep C VL tested                               X                                                                                X                               YES     YES    YES
                                      Hepatitis                9         if VL positive, genotype determined                        X                                                                                X                               YES     YES    YES




Florida/Caribbean AETC Chart Review
                                                                                                                                                                     Scoring Category                                                           Include in Report




                                                                                                                                                                                                                    Co-




                                                                                                                                             PPD
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                                                                                                                                                       Charting &
                                                                                                                                                       Monitoring


                                                                                                                                          Vaccines &
                                                                                                                                                                                                                 morbidities




                                                                                                                                                       Maint./Educ
                                      Hepatitis            10         if positive, treatment plan in record                        X                                                                                X                               YES     YES    YES
                                                                        if negative and active IDU, (HCV Ab) repeated in the
                                      Hepatitis            11                                                                      X                                                                                X                                       YES    YES
                                                                    past 12 months
                                                                    If unexplained chronic LFT elevation, were Hep C viral
                                      Hepatitis            12                                                                      X                                                                                X                                       YES    YES
                                                                    loads checked
                                      Other Labs            1       G6PD (if AA or middle-eastern)                                 X                                                                    X                                           YES     YES    YES
                                      Other Labs            2       Toxo IgG                                                       X                                                                                                                        YES    YES




Florida/Caribbean AETC Chart Review
                                      Other Labs            3          If negative, repeated when CD4 < 100                        X                                                                                                                        YES    YES
                                      Other Labs            4       CMV IgG (optional)                                             X                                                                                                                               YES
                                      Other Labs            5       CMV IgG                                                        X                                                                                                                YES     YES
                                      Other Labs            6       Labs ordered within 4 weeks prior to scheduled office visit    X                                                                                                                        YES    YES
                                      Other Labs            7       Baseline Syphilis screening (RPR, VDRL)                        X                                                        X                                                               YES    YES
                                      Other Labs            8         If positive, treated or evidence of past treatment           X                                                        X                                                               YES    YES
                                                                    Syphilis screening in the past 12 months or documentation
                                      Other Labs            9       that patient is not sexually active (optional, based on        X                                                        X                                                               YES    YES
                                                                    regional prevalence)
                                                                    Chlamydia screening in the past 12 months or
                                      Other Labs           10       documentation that patient is not sexually active (optional,   X                                                        X                                                               YES    YES
                                                                    based on regional prevalence)
                                                                    Gonorrhea screening in the past 12 months or
                                      Other Labs           11       documentation that patient is not sexually active (optional,   X                                                        X                                                               YES    YES
                                                                    based on regional prevalence)
                                      Maternal records      1       Maternal toxo serology in record                                                                                                                            X          YES      YES
                                      Maternal records      3       Maternal syphilis in record                                                                                                                                 X          YES      YES
                                      Maternal records      4         If positive, obtained RPR and treated as needed                                                                                                           X          YES      YES
                                      Maternal records      5       Maternal GC/chlamydia in record                                                                                                                             X          YES      YES
                                      Maternal records      6       Maternal CMV serology in record                                                                                                                             X          YES      YES
                                      Maternal records      8       Maternal HBsAg in record                                                                                                                                    X          YES      YES
                                      Maternal records      9         If positive, immune globulin                                                                                                                              X          YES      YES
                                      Maternal records     10       Maternal HCV Ab                                                                                                                                             X          YES      YES
                                                                      If positive, Hep C PCR on infant at birth, 6 weeks, and 6
                                      Maternal records     11                                                                                                                                                                   X          YES      YES
                                                                    mos
                                      Maternal records     12         If PCR positive, genotype determined                                                                                                                      X          YES      YES
                                      Maternal records     13         If PCR positive, Hep C viral load test                                                                                                                    X          YES      YES
                                      Maternal records     14       Mother's viral load at delivery                                                                                                                             X          YES
                                      Maternal records     15       Mother's ARV history                                                                                                                                        X          YES
                                      Maternal records     16       Method of delivery                                                                                                                                          X          YES




I-3
                                      Maternal records     17       If Cesarean section done, indication stated                                                                                                                 X          YES
                                                                                                                                                                   Scoring Category                                                           Include in Report




I-4
                                                                                                                                                                                                                  Co-




                                                                                                                                           PPD
                                                                                                                                                                     ARV
                                                                                                                                                                                                                                                          Adol




                                                                                                                                 Labs
                                                                                                                                                                                                                                                  Child
                                                                                                                                                                                                                                                                 Adult




                                                   Topic
                                                                                                                                                                                                                                         Infant




                                                           Item #
                                                                                                                                                       Health
                                                                                                                                                                                         P for P



                                                                                                                                                                   therapy
                                                                                                                                                                                                    Adverse
                                                                                                                                                                                                                             Records
                                                                                                                                                                                                                             Maternal
                                                                                                                                                                                                                             Exposed
                                                                                                                                                                                                                             infant Tx




                                                                                                   Item Text
                                                                                                                                                                                                   reactions




                                                                                                                                                                             OI Prophy




                                                                                                                                                     Charting &
                                                                                                                                                     Monitoring


                                                                                                                                        Vaccines &
                                                                                                                                                                                                               morbidities




                                                                                                                                                     Maint./Educ
                                      Vaccines and PPD      1       DTaP according to age and schedule                                     X                                                                                             YES      YES     YES
                                      Vaccines and PPD      2       IPV according to age and schedule                                      X                                                                                             YES      YES     YES
                                      Vaccines and PPD      3       HIB according to age and schedule                                      X                                                                                             YES      YES     YES
                                      Vaccines and PPD      4       Prevnar according to age and schedule                                  X                                                                                             YES      YES     YES
                                      Vaccines and PPD      5       Hepatitis A vaccination completed or in process (2 shots)              X                                                                                                      YES     YES    YES
                                      Vaccines and PPD      6       Hepatitis B vaccination completed or in process (3 shots)              X                                                                      X                      YES      YES     YES    YES
                                      Vaccines and PPD      7       Influenza vaccine in the past 12 months                                X                                                                                             YES      YES     YES    YES
                                                                    PPD in the past 12 months (or chest x-ray or cough &&
                                      Vaccines and PPD      8                                                                              X                                                                                                      YES     YES    YES
                                                                    symptom eval)
                                      Vaccines and PPD      9       Varicella vaccine at 1 year if CD4 > 25% (two dose series)             X                                                                                             YES      YES
                                                                    MMR at 12-15 mos (2 shots, 1-2 months apart) if CD4 >
                                      Vaccines and PPD     10                                                                              X                                                                                             YES      YES
                                                                    15%
                                      Vaccines and PPD     11       Pneumococcal vaccine at age 2                                          X                                                                                             YES
                                      Vaccines and PPD     12       Pneumoccocal vaccine 2 shots, 5-6 years apart                          X                                                                                                      YES     YES    YES
                                                                    Meningococcal vaccine at 11 yr - 12 yr or at entry to
                                      Vaccines and PPD     13                                                                              X                                                                                                      YES     YES
                                                                    college
                                      Charting/
                                                            1       Complete initial history and physical examination                                 X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            2       Symptom-targeted exam                                                             X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            3       Height and weight at each clinic visit                                            X                                                                                  YES      YES     YES
                                      Monitoring
                                      Charting/                       If significant weight loss or weight gain for age,
                                                            4                                                                                         X                                                                                  YES      YES     YES
                                      Monitoring                    nutritional consult
                                      Charting/                       If in low height percentile for age, diff diagnosis
                                                            5                                                                                         X                                                                                  YES      YES     YES
                                      Monitoring                    considered
                                      Charting/
                                                            6       Head circumference at each visit                                                  X                                                                                  YES      YES
                                      Monitoring
                                      Charting/                       If in low HC percentiles, developmental delay or
                                                            7                                                                                         X                                                                                  YES      YES
                                      Monitoring                    neurological exam
                                      Charting/
                                                            8       Problem list utilized                                                             X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            9       Organized and complete medication list present                                    X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                           10         Dosage and frequency documented                                                 X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                           11         Start and stop dates documented                                                 X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                           12       Drug allergies clearly noted                                                      X                                               X                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                           13       Documentation of all past ARV                                                     X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/




Florida/Caribbean AETC Chart Review
                                                           14       Missed appointments addressed                                                     X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                                                                                                                                                 Scoring Category                                                           Include in Report




                                                                                                                                                                                                                Co-




                                                                                                                                         PPD
                                                                                                                                                                   ARV
                                                                                                                                                                                                                                                        Adol




                                                                                                                               Labs
                                                                                                                                                                                                                                                Child
                                                                                                                                                                                                                                                               Adult




                                                 Topic
                                                                                                                                                                                                                                       Infant




                                                            Item #
                                                                                                                                                     Health
                                                                                                                                                                                       P for P



                                                                                                                                                                 therapy
                                                                                                                                                                                                  Adverse
                                                                                                                                                                                                                           Records
                                                                                                                                                                                                                           Maternal
                                                                                                                                                                                                                           Exposed
                                                                                                                                                                                                                           infant Tx




                                                                                                 Item Text
                                                                                                                                                                                                 reactions




                                                                                                                                                                           OI Prophy




                                                                                                                                                   Charting &
                                                                                                                                                   Monitoring


                                                                                                                                      Vaccines &
                                                                                                                                                                                                             morbidities




                                                                                                                                                   Maint./Educ
                                      Charting/
                                                            15       Consultation reports in record                                                 X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/                      Developmental milestones documented, referred if
                                                            16                                                                                      X                                                                                  YES
                                      Monitoring                     abnormal
                                      Charting/
                                                            17       Advance directives in chart or discussed                                       X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            18       Evidence of anticipatory guidance to parents/caregivers                        X                                                                                           YES     YES
                                      Monitoring
                                      Charting/
                                                            19       Developmental Assessment (refer if abnormal)                                   X                                                                                           YES




Florida/Caribbean AETC Chart Review
                                      Monitoring
                                      Charting/
                                                            20       Records from previous provider                                                 X                                                                                  YES      YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            21       Oral exam in the past 12 months                                                X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            22       Chest exam in the past 12 months                                               X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            23       Abdomen exam in the past 12 months                                             X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            24       Genito-rectal exam in the past 12 months                                       X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            25       Lymph Node exam in the past 12 months                                          X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            26       Neurologic exam in the past 12 months                                          X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            27       Skin exam in the past 12 months                                                X                                                                                           YES     YES    YES
                                      Monitoring
                                      Charting/
                                                            28       Weight assessed routinely                                                      X                                                                                                          YES
                                      Monitoring
                                      Charting/
                                                            29        Weight loss addressed                                                         X                                                                                                          YES
                                      Monitoring
                                      Care of the exposed
                                                             1       Evidence of AZT chemoprophylaxis                                                                                                                            X     YES
                                      neonate
                                      Care of the exposed
                                                             2         pre-partum                                                                                                                                                X     YES
                                      neonate
                                      Care of the exposed
                                                             3         intra-partum                                                                                                                                              X     YES
                                      neonate
                                      Care of the exposed
                                                             4         post-partum                                                                                                                                               X     YES
                                      neonate
                                      Care of the exposed
                                                             5         continued 6 weeks                                                                                                                                         X     YES
                                      neonate
                                      Care of the exposed
                                                             6         dose given according to weight                                                                                                                            X     YES
                                      neonate
                                      Care of the exposed
                                                             7         evidence of tolerance assessed                                                                                                                            X     YES
                                      neonate
                                      Care of the exposed
                                                             8         mother/caregiver instructed                                                                                                                               X     YES
                                      neonate
                                      Care of the exposed
                                                             9       PCP prophylaxis initiated at 6 weeks                                                                                                                        X     YES
                                      neonate




I-5
                                                                                                                                                                      Scoring Category                                                           Include in Report




I-6
                                                                                                                                                                                                                     Co-




                                                                                                                                              PPD
                                                                                                                                                                        ARV
                                                                                                                                                                                                                                                             Adol




                                                                                                                                    Labs
                                                                                                                                                                                                                                                     Child
                                                                                                                                                                                                                                                                    Adult




                                                  Topic
                                                                                                                                                                                                                                            Infant




                                                                Item #
                                                                                                                                                          Health
                                                                                                                                                                                            P for P



                                                                                                                                                                      therapy
                                                                                                                                                                                                       Adverse
                                                                                                                                                                                                                                Records
                                                                                                                                                                                                                                Maternal
                                                                                                                                                                                                                                Exposed
                                                                                                                                                                                                                                infant Tx




                                                                                                       Item Text
                                                                                                                                                                                                      reactions




                                                                                                                                                                                OI Prophy




                                                                                                                                                        Charting &
                                                                                                                                                        Monitoring


                                                                                                                                           Vaccines &
                                                                                                                                                                                                                  morbidities




                                                                                                                                                        Maint./Educ
                                      Care of the exposed                  Discontinued if HIV DNA by PCR negative after 4
                                                                10                                                                                                                                                                    X     YES
                                      neonate                            months
                                      Care of the exposed
                                                                11       Mother instructed about breastfeeding                                                                                                                        X     YES
                                      neonate
                                      Care of the exposed
                                                                12       Perinatal infections documented                                                                                                                              X     YES
                                      neonate
                                      ARV Therapy                1       ARV within the last year                                                                                                                                                    YES     YES    YES
                                      ARV Therapy                2       ARV initiated according to DHHS Guidelines                                                     X                                                                            YES     YES    YES
                                      ARV Therapy                3       ARV regimen consistent with current DHHS Guidelines                                            X                                                                            YES     YES    YES
                                      ARV Therapy                4       All medications correctly dosed and combined                                                   X                                X                                           YES     YES    YES
                                      ARV Therapy                5       Were medications adjusted for                                                                  X                                                                            YES     YES    YES
                                      ARV Therapy                6         surface area or weight                                                                       X                                                                            YES     YES
                                      ARV Therapy                7         renal impairment                                                                             X                                X           X                               YES     YES    YES
                                      ARV Therapy                8         hepatic impairment                                                                           X                                X           X                               YES     YES    YES
                                      ARV Therapy                9         Tanner staging                                                                               X                                                                            YES     YES
                                      ARV Therapy               10         weight                                                                                       X                                X                                                          YES
                                      ARV Therapy               11       Increasing viral load addressed                                                                X                                                                            YES     YES    YES
                                      ARV Therapy               12       Decreasing CD4 addressed                                                                       X                                                                            YES     YES    YES
                                      ARV Therapy               13       Adverse effects to treatment documented                                                        X                                X                                           YES     YES    YES
                                      ARV Therapy               14       If VL NOT < limit of detection at 5-6 months, addressed                                        X                                                                            YES     YES    YES
                                      ARV Therapy               15       Child bearing status considered in ARV selection                                               X                                                                                    YES    YES
                                      ARV Therapy               16       If patient pregnant, and VL > 1,000:                                                           X                                                                                    YES    YES
                                      ARV Therapy               17         Attempts to start or change regimen                                                          X                                                                                    YES    YES
                                      ARV Therapy               18         ARV consistent with Guidelines for pregnancy                                                 X                                                                                    YES    YES
                                      Opportunistic Infection
                                                                 1       PCP prophylaxis according to Guidelines                                                                 X                                   X                               YES
                                      Prophylaxis
                                      Opportunistic Infection
                                                                 2       MAC prophylaxis according to Guidelines                                                                 X                                   X                               YES
                                      Prophylaxis
                                      Opportunistic Infection
                                                                 3       Ophthalmologic exam if CD4 < 50                                                                         X                                   X                               YES
                                      Prophylaxis
                                      Opportunistic Infection
                                                                 4       CMV prophylaxis if retinitis or prior infection                                                         X                                   X                               YES
                                      Prophylaxis
                                      Opportunistic Infection            Prophylaxis for severe or frequent recurrences of herpes
                                                                 5                                                                                                               X                                   X                               YES
                                      Prophylaxis                        simplex
                                      Opportunistic Infection
                                                                 6       Toxo prophylaxis according to Guidelines                                                                X                                   X                               YES
                                      Prophylaxis
                                      Opportunistic Infection
                                                                 7       TB prophylaxis according to Guidelines                                                                  X                                   X                               YES
                                      Prophylaxis
                                      Opportunistic Infection
                                                                 8       If CD4 < 200, or <14% was patient on PCP prophylaxis                                                    X                                   X                                       YES    YES




Florida/Caribbean AETC Chart Review
                                      Prophylaxis
                                                                                                                                                                       Scoring Category                                                           Include in Report




                                                                                                                                                                                                                      Co-




                                                                                                                                               PPD
                                                                                                                                                                         ARV
                                                                                                                                                                                                                                                              Adol




                                                                                                                                     Labs
                                                                                                                                                                                                                                                      Child
                                                                                                                                                                                                                                                                     Adult




                                                  Topic
                                                                                                                                                                                                                                             Infant




                                                                Item #
                                                                                                                                                           Health
                                                                                                                                                                                             P for P



                                                                                                                                                                       therapy
                                                                                                                                                                                                        Adverse
                                                                                                                                                                                                                                 Records
                                                                                                                                                                                                                                 Maternal
                                                                                                                                                                                                                                 Exposed
                                                                                                                                                                                                                                 infant Tx




                                                                                                      Item Text
                                                                                                                                                                                                       reactions




                                                                                                                                                                                 OI Prophy




                                                                                                                                                         Charting &
                                                                                                                                                         Monitoring


                                                                                                                                            Vaccines &
                                                                                                                                                                                                                   morbidities




                                                                                                                                                         Maint./Educ
                                      Opportunistic Infection            If CD4 increased above 200, is PCP prophylaxis continued
                                      Prophylaxis                9       for 3-6 months and then discontinued if CD4 remains >                                                    X                                   X                                       YES    YES
                                                                         100
                                      Opportunistic Infection            If CD4 < 100, and pt is toxo IgG pos, patient on toxo
                                                                10                                                                                                                X                                   X                                       YES    YES
                                      Prophylaxis                        prophylaxis
                                                                         If CD4 increased above 100, is toxo prophylaxis continued
                                      Opportunistic Infection
                                                                11       for 3-6 months and then discontinued if CD4 remains >                                                    X                                   X                                       YES    YES
                                      Prophylaxis
                                                                         100
                                      Opportunistic Infection
                                                                12       If CD4 < 50, was patient on MAC prophylaxis                                                              X                                   X                                       YES    YES




Florida/Caribbean AETC Chart Review
                                      Prophylaxis
                                                                         If CD4 increased above 100, is MAC prophylaxis
                                      Opportunistic Infection
                                                                13       continued for 3-6 months and then discontinued if CD4                                                    X                                   X                                       YES    YES
                                      Prophylaxis
                                                                         remains > 100
                                      Opportunistic Infection
                                                                14       If CD4 <50, was eye exam performed                                                                       X                                   X                                       YES    YES
                                      Prophylaxis
                                      Health
                                                                 1       Pap smear in the past 12 months (female)                                               X                                                     X                                       YES    YES
                                      Maintenance/Education
                                      Health
                                                                 2       Anal cytology                                                                          X                                                     X                                       YES    YES
                                      Maintenance/Education
                                      Health
                                                                 3       Colon cancer screening referral, (50+ years old)                                       X                                                                                                    YES
                                      Maintenance/Education
                                      Health
                                                                 4          Abnormalities addressed                                                             X                                                                                                    YES
                                      Maintenance/Education
                                      Health
                                                                 5       Age appropriate mammograms, (female, age 40)                                           X                                                                                                    YES
                                      Maintenance/Education
                                      Health
                                                                 6          Abnormalities addressed                                                             X                                                                                                    YES
                                      Maintenance/Education
                                      Health
                                                                 7       PSA, (male, 50+ years old)                                                             X                                                                                                    YES
                                      Maintenance/Education
                                      Health
                                                                 8       Education or Counseling: Nutrition                                                     X                                                                                     YES     YES    YES
                                      Maintenance/Education
                                      Health
                                                                 9       Education or Counseling: Dental health                                                 X                                                                                     YES     YES    YES
                                      Maintenance/Education
                                      Health
                                                                10       Education or Counseling: Medication/treatment adherence                                X                                                                                             YES    YES
                                      Maintenance/Education
                                      Health
                                                                11       Education or Counseling: Prevention (sex/drugs)                                        X                             X                                                               YES    YES
                                      Maintenance/Education
                                      Health
                                                                12       Education or Counseling: Birth control                                                 X                                                                                             YES    YES
                                      Maintenance/Education
                                      Health
                                                                13       Education or Counseling: Drugs, alcohol, tobacco                                       X                                                                                     YES     YES    YES
                                      Maintenance/Education
                                      Health
                                                                14       Education or Counseling: Mental health                                                 X                                                                                     YES     YES    YES
                                      Maintenance/Education
                                      Health
                                                                15       Education or Counseling: Exercise                                                      X                                                                                             YES    YES
                                      Maintenance/Education




I-7
                         Chart Review – Interview One (Baseline)


Name of Clinic
Date of review
Date report mailed
Date of call
Interview Conducted by
Clinic staff person interviewed

1. What is your primary role in this clinic?
     Clinician                      Administrator


For questions 2–6, 1 = low value and 5 = high value

2. What has been the value of this review overall?


3. What was the value of the case conference?


4. What was the value of the feedback session after the review?


5. What was the value of the written report?


6. How helpful were the tools and materials?


7. What changes do you expect to make as a result of this review?


8. What changes would you recommend in the review process?



Other Comments:




Florida/Caribbean AETC Facility Assessment                          J-1
                        Chart Review – Interview Two (Follow-up)


Name of Clinic
Date of review
Date report mailed
Date of call
Interview Conducted by
Clinic staff person interviewed

1. What is your primary role in this clinic?
     Clinician                      Administrator


2. What changes have been made as a result of this project?




3. What aspects of the projects worked well for you?




4. What changes would you recommend in the review process?




5. Would you recommend the chart review project to other clinics?




Florida/Caribbean AETC Facility Assessment                          K-1
                              Report of Scores at Baseline & Follow-up

This template can be used to prepare a report of findings from the chart review process.

1.   Introduction
      Thanks
      Include: “A sample of (#) patient charts was reviewed on (date). Charts were selected using random and
         non-random processes. This small sample is not sufficient to serve as a quality assurance audit. Rather, it
         provides us with useful information about patterns of clinical care and documentation that assist us in
         developing and proposing a plan of continued training and technical assistance that we believe would be
         beneficial to your HIV Program.”
      Some positive statement(s) about the clinic, staff, etc.

2.   Summary of Positive Findings
      Paragraph

3.   Summary of Mixed Findings (defined as topics with inconsistent findings or category of activities that can’t
     be split into all positive or not positive)
      Paragraph

4.   Summary of Findings which need to be addressed
      Paragraph

         Topics to be covered in paragraphs 2, 3 and 4:
         Physical Examination
         Problem List
         Medication Record
         Advance Directive/Living Will/Health Care Surrogate
         Labs (initial and monitoring) Vaccines
         Primary Care
         Age-appropriate Screenings
         Health Maintenance/Education
         Patients Lost to Care
         CDC Advancing HIV Prevention Initiative
         ARV Therapy (initiation, appropriateness, monitoring)
         Resistance Testing
         OI Prophylaxis

5.   Recommendations: Go back through what you have written above and make a list of any deviations from
     standards. Organize that list into groups which could be the focus of a training or technical assistance
     intervention. You will likely have more than one training. Then propose the interventions outlining all proposed
     training sessions/TAs. Include what we intend to teach and who should be present for the training or technical
     assistance offered and how long it should take. The interventions should be listed in a bulleted format, one
     bullet for each topic grouping identified above.

6.   Contact information for follow-up, scheduling, etc. Include the statement: “As part of the AETC’s internal
     quality improvement plan someone from the AETC will be calling you within a few weeks to discuss the chart
     review process. We appreciate your feedback.”

7.   Closing and signature of Team Leader. Include the statement: “On behalf of the chart review team of (list all
     members) we are grateful to the all the staff members for their cooperation and hospitality during the review
     process and we hope our comments are helpful.”




Florida/Caribbean AETC Chart Review                                                                               L-1
Notes
Notes
                                                    This guide was produced as part of the
                                                     Collaborative Pilot Evaluation Project.
                                                             For more information, contact:
                                                          AETC National Evaluation Center
                                                               AIDS Policy Research Center
                                                         Center for AIDS Prevention Studies
                                                     University of California, San Francisco
                                                                50 Beale Street, Suite 1300
                                                                   San Francisco, CA 94105
                                                                            (415) 597-9285
                                                                     www.ucsf.edu/aetcnec

This guide is supported by grant #U69HA02501 from the Health Resources and Services Administration’s
HIV/AIDS Bureau (HRSA/HAB). The publication’s contents are solely the responsibility of the authors and
                                           do not necessarily represent the official view of HRSA/HAB.

				
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