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Counseling Protocol for Rapid HIV Testing Sessions hepatitis

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Counseling Protocol for Rapid HIV Testing Sessions hepatitis

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									          Confidential HIV Counseling & Testing Protocol




A. Introduction                                                 2

B. Education & Informed Consent                                 7

C. Documentation & Reporting                                    9

D. HIV Testing Options                                          10

E. HIV Counseling                                               13

F. Providing Test Results                                       19

G. Referrals                                                    22

H. Quality Assurance                                            26

I. Laboratory and HIV Testing Procedures                        26

J. Privacy Law and Confidentiality of HIV Related Information   34




                            Revised November 2005
                                Confidential HIV Counseling & Testing Protocol


                                                        A. Introduction


           HIV integration in Family Planning

―Any two services can be considered integrated when they are offered at the same
facility during the same operating hours, and the provider of one service actively
encourages clients to consider using the other service during that visit. According to
this definition, integrated services may or may not be offered in the same physical
location within the facility and may or may not be offered by the same service
provider1.‖

The purpose of this protocol is to delineate the expectations for community health
centers funded by (organization name) to integrate on-site HIV counseling and testing in
their delivery of family planning services.

           Family planning clients

A family planning visit is one in which a female or male of any age receives face to face
family planning counseling, alone or in conjunction with related services.

If a client only wishes to access HIV testing, they must meet the criteria for a family
planning visit. The visit may have occurred in the past and there is not a time frame on
which they are considered a family planning client.

If there are any questions about the definition of a family planning client, please speak
to the Clinical Program Manager.

An FPER should be submitted for all family planning visits as defined above,
regardless of the reimbursement source for that visit.

When an FPER is submitted for a family planning visit, the medical record and FPER
must provide documentation of family planning counseling as defined above.
Medical record documentation must correspond with what is coded on the FPER, as
stated in the (organization name) Policies, Procedures, Protocols and Recommended
Guidelines Manual.


1
 JSI Research & Training Institute, Inc. Region I Title X, Integrating HIV Prevention and Family Planning Services: Organizational Self-
Assessment Manual, 2004



                                                                                                                                           2
       HIV Counselors

The ultimate goal of the project is to make HIV counseling and testing a routine part of
family planning/ reproductive health care and increase the number of people who
know their HIV status. It is crucial that HIV counselors are knowledgeable, culturally
sensitive/ competent, nonjudgmental and create a HIV counseling session that is
confidential and interactive. This approach directed at the client’s personal risk and the
situations in which risk occurs is effective in establishing rapport and trust while
increasing the benefits of the counseling session.

To provide quality HIV counseling and testing to clients, counselors must:
    protect the confidentiality of client information,
    obtain informed consent before testing, and
    provide effective counseling services and appropriate referrals.

It is expected that all HIV counseling and testing staff attend required trainings. Any
exceptions/substitutions to these training requirements must be approved by
appropriate (organization name) staff.

Basic Family Planning (including certification)
A seven-session training offered three times each year. Certification requires attendance
at all sessions, a certification examination following the training (requiring a 90% or
higher score), and on-site observation of counseling session conducted by Training
Specialist following completion of Basic Family Planning. Contact (organization name) at
(###) ###-##### for more information.

Ongoing Certification
To maintain family planning certification, counselors must attend a minimum of 4
continuing education trainings per year, including mandatory trainings and optional
trainings. Counselors must also be monitored/observed, on-site, twice a year by the
Training Specialist. At these sessions, the counselor will be given feedback on
counseling skills and content of family planning sessions. Contact (organization name) at
(###) ###-##### for more information.

Fundamentals of HIV, Hepatitis and STD’s, MDPH
This one-day training provides participants with basic and updated information about
HIV, other STDs and Hepatitis. This includes risk factors, modes of transmission, signs
and symptoms, testing/screening options, treatment overview, basic prevention and
the relationship between HIV, other STDs and Hepatitis. Updated information on
mother-to-child transmission and prevention, nonoxynol-9 and Reality (female)
condoms is also covered. This is a prerequisite to the HIV counseling and testing core
standards training.



                                                                                          3
HIV Counseling and Testing Core Standards and Practice, MA Department of Public
Health (MDPH)
This two-day training provides participants with information about the HIV/AIDS
Bureau goals, expectations and requirements regarding the delivery of HIV counseling
and testing services. This includes informed consent, testing options, pre- and post-test
protocols and scripts, specimen collection, data requirements, and core counseling
skills. Prerequisite: Fundamentals of HIV, Hepatitis and STDs

Behavioral Basic Risk Assessment and Risk Reduction Core Standards and Practice,
MDPH
This two-day training provides participants with information and an opportunity to
enhance skills in conducting a behavioral risk assessment within a harm reduction
framework. This includes the goals, process and core components of a behavioral risk
assessment, an introduction to a brief behavioral and health risk assessment tool, how
to develop risk reduction plans, and a demonstration of the active referral process for
HIV, other STDs, Hepatitis, substance abuse and mental health. Prerequisite:
Fundamentals of HIV, Hepatitis and STDs

Positive Prevention, MDPH
This two-day training provides participants with a working understanding of a positive
prevention framework including core components, interventions, and practical
applications across HIV service systems. Participants learn about the impact of stigma,
disclosure issues, substance use, and other co-factors that impact on risk and overall
health of people living with HIV/AIDS. Participants practice assessing behavioral and
health risk and developing individual risk reduction plans and messages. There is an
opportunity to develop individual and agency action plans. Prerequisite: Fundamentals
of HIV, Hepatitis and STDs, Behavioral Risk Assessment and Risk Reduction (Highly
Recommended)

(Organization name) _Skill Building
This one day training focuses on the ―ABC’s of HIV Prevention‖ approach to HIV
counseling, a requirement of the HIV integration funding. We will explore risk
assessment, addressing the multiple needs of clients, and targeting prevention messages
using the ABC’s. Participants will have an opportunity to examine situations they have
encountered and gain additional tools to implementing the ABC’s approach.

HIV Counselor Certification
The (organization name) HIV Counseling and Testing Project Coordinator will observe
pre-test and post-test counseling sessions with the client’s permission. It is also
recommended that on-site supervisors of the counselors periodically observe pre and
post test sessions. There are three levels of HIV testing certification; Basic, OMT and
Rapid. Basic certification is granted after one pre and one post test counseling session is
observed. This certification does not include any laboratory competencies. OMT


                                                                                            4
certification includes one pre and one post test counseling for OMT testing and includes
laboratory competencies. Rapid certification includes two counseling sessions observed
and laboratory competencies. Upon satisfactory completion, the counselor will be
certified at the level observed. All counselors should be certified within three months
after successful completion of the MDPH HIV Counseling and Testing training. To
maintain certifications, all counselors are required to attend Common Visions:
Statewide HIV Conference, sponsored by MDPH and one additional continuing
education training, specific to HIV, each year.

OSHA training
All staff should participate in an OSHA training offered by your respective facility,
which includes a section on blood borne pathogens and universal precautions. All staff
should have expertise in universal precautions and they must be practiced at all times
when collecting specimens and performing HIV testing. All infectious medical waste
must be disposed of in a properly marked biohazard container. Any spills should be
cleaned using OSHA guidelines. Please speak with your immediate supervisor to
ensure this requirement is met.

As a result of the required trainings, HIV counselors will be knowledgeable about:

      Transmission and prevention of HIV,
      Assessing risk for HIV,
      Prevention measures, risk reduction/avoidance, and negotiating risk
       reduction/avoidance plans, including ABC’s counseling,
      Signs and symptoms associated with HIV infections, pros and cons of HIV
       testing and the types of tests available,
      Anonymous and confidential testing including the advantages and
       disadvantages of each,
      The significance of HIV seropositivity, seronegativity and indeterminate test
       results,
      Community resources and appropriate referral agencies,
      Available counseling and testing options in MA, including sites that offer
       anonymous testing.

HIV counselors should have a basic understanding of:

      State and federal regulations that govern HIV services, including confidentiality,
       disclosure and reporting requirements,
      The sensitivity and specificity of each method of testing.

All HIV/ FPCs must be co-trained and certified by (organization name) as a family
planning counselor, and trained in HIV Counseling & Testing according to MDPH
standards. MDPH standards for HIV C&T include successful completion of the



                                                                                        5
following trainings: Fundamentals of HIV, Hepatitis and STDs; HIV Counseling &
Testing Core Standards and Practice; Behavioral Risk Assessment & Risk Reduction
Planning; and Positive Prevention. HIV Counselor Certification for the purposes of this
program is obtained through (organization name).

HIV counselors must meet the following qualifications before providing HIV testing:
   Successful completion of the (organization name) Basic Family Planning Training,
      including certification,
   Completion of the following MDPH Trainings: Fundamentals of HIV, Hepatitis
      and STD’s, HIV Counseling & Testing Core Standards and Practice.

It is recommended that HIV counselors complete MDPH Behavioral Risk Assessment
and Risk Reduction Planning within the first three months of performing HIV testing.

Additional training for rapid testing may be available. Please speak with the
(organization name) HIV C&T Project Coordinator for additional training needs.

Project Meetings
Project meetings are required for all HIV/ FPCs. It is a mandatory requirement of this
project that all funded FPCs will attend the meetings. All meetings will have both a
programmatic and training component. The frequency, time and dates of the meetings
will be determined by the HIV C&T Project Coordinator.

Absences will only be excused in the event of illness or extenuating circumstances and
the Project Coordinator must be notified prior to the meeting.




                                                                                         6
                                 B. Education and Informed Consent

           Confidential and Anonymous Testing

HIV testing may be ―confidential‖ or ―anonymous.‖ The (organization name) counseling
and testing program does not provide anonymous testing. Clients should be presented
with both HIV testing options during visits, so that if they choose to test anonymously
they can be appropriately referred.

Anonymous testing can benefit the health of individual persons and the public by
prompting earlier entry into care. Persons who may not otherwise be tested might seek
anonymous testing and learn their HIV status. When a patient has an anonymous HIV
test, he/she is given a number and no one asks for or knows his/her name. Clients
should be informed that anonymous testing is not linked to their name. Therefore, if the
does not return for the result, the provider will not be able to contact the client with the
results.

Each site should have a list of all sites that offer anonymous HIV testing in the Boston
area. This list should be easily accessible during all visits for clients who opt for
anonymous HIV testing.

The (organization name) counseling and testing project only provides confidential
testing. Confidential testing promotes returning for test results and linkage for follow
up counseling and referral for needed services.2

Confidential HIV testing allows the counselor to have the client name as well as some
contact information, should the counselor need to reach the client. The test results
should be put in the client’s medical record. Like all medical information, HIV test
results are confidential and can not be released without the client’s written permission.

The results of the HIV test will be stored in the medical record. As with medical
information, test results are strictly confidential. The results will only be disclosed with
the client signature on a Medical Release of Information to a third party. The Medical
Release of Information requires an additional signature for the release of information
related to HIV.


           Informed Consent and Confidentiality

As written in the (organization name) Counseling and Education Guidelines (Section III),
informed consent signifies the voluntary participation of a knowledgeable, informed

2
    CDC Revised Guidelines for HIV Counseling, Testing & Referral. MMWR, November 9, 201/Vol.50/ No.RR-19



                                                                                                            7
client who acknowledges their understanding of the information provided. The consent
forms must be written in a language understood by the client or translated and
witnessed by an interpreter. The consent forms must be reviewed in detail with client,
and the client’s understanding of the information contained in the consent should be
addressed through open-ended questions. All client questions should be answered
prior to the consent being signed. The consent must be witnessed, signed and dated by
the clinician or counselor who has counseled the client, and additionally by the
interpreter if the client requires interpreting services.

An informed consent documenting the client’s voluntary consent to receive services
must be signed by the client prior to his or her receiving HIV antibody testing. The
client must be informed that he or she has a right to withhold or withdraw his or her
consent to HIV testing at any time prior to the time of the test, and that this will not
prejudice his or her future care or result in loss of other benefits to which the client
might otherwise be entitled.

Written informed consent specific to HIV antibody testing (Section II) must be signed
before the test is provided. The HIV consent form should be completed each time a test
is conducted.

To provide informed consent for HIV testing, the client must receive information on the
testing procedure (including benefits and risks, safety, effectiveness), transmission, risk
assessment, risk reduction/ avoidance, and the meaning of test results. Informed
consent means that a client has been made aware of the nature, benefits, risks and HIV
testing options prior to testing and that the client s can make a voluntary,
knowledgeable decision to test or to forgo testing. In this context, it is recognized that a
client must understand:
    - the purpose and nature of an HIV antibody test, including how samples will be
       collected,
    - the type of information which is revealed by an HIV antibody test.

In order to give informed consent a client must have the capacity to make an informed
decision to take a test. A person is considered competent if she/he has the ability to
understand in general terms what an HIV test is and the ability to make a reasoned
choice to have an HIV test. Client understanding of the information given during the
HIV testing session should be addressed through open-ended questions. All questions
should be answered about HIV testing prior to the consent being signed. The consent
must be witnessed, signed and dated by the clinician or counselor who has counseled
the client, and additionally by the interpreter if the client requires interpreting services.
The signed consent should be kept in the client’s medical record.

As with family planning, minors (clients under age 18) can give their own consent for
HIV testing. When minor clients give her/his own consent for family planning or HIV


                                                                                                8
services, the record of those services is confidential and cannot be released without the
minor’s consent.

However, minors must be informed that there are certain limitations to confidentiality
including if the minor discloses abuse or neglect, or is suspected of being abused or
neglected, or is she/he discloses intent to harm her/him self or someone else. Any
questions or concerns regarding the safety of a minor client must be discussed with a
supervisor that same day to determine if a report should be filed under the state child
abuse and neglect reporting requirements.

In addition, minors must be asked if there is a family member she/he could involve in
their decision to seek family planning or HIV services (family involvement), and
counseled around methods to resist sexual coercion.




                         C. Documentation and Reporting

Each site is responsible for documentation in the medical record when a client seeks
HIV testing. Documentation includes services rendered, including HIV testing, test
results, informed consent, counseling, and completing the FPER.

For each client who receives HIV counseling and testing, the Confidential HIV Counseling and
Testing (Section II) form must be completed and attached to a copy of the Family Planning
Encounter Record (FPER). The original FPER for this visit is included with all other family
planning visit FPERs submitted monthly to (organization name).

Sites should also complete a Monthly Report (Section II) to be sent with the testing data.
This form should include all relevant trainings attended by HIV counselors in the
reporting month, and it should be used as a communication tool with (organization
name). Any concerns, barriers, successes or guidance needs should be noted in the
comments section.

All monthly reporting forms (Confidential C &T Forms with a copy of the FPER
attached, and Monthly Report) should be put in a separate envelope from other FPERs
and returned by courier to (organization name) at the monthly FPER
collection/contraceptive drop-off on the 4th Friday of the month. The envelope should
read ―Attention C & T Project‖. For all HIV C&T visits, an FPER should be completed
and sent to (organization name) for family planning data with all other family planning
visit FPERs.




                                                                                               9
                                                    D. Testing options

            Window period

HIV testing detects HIV antibodies. Antibodies are proteins produced by the immune
system to fight a specific germ. HIV antibodies can be found in the blood and oral
mucosal fluid of individuals who have been infected with HIV.

When testing for HIV antibodies, the time between the time a person was last at
risk for contracting HIV and the time that he/she gets a test done is commonly
referred to as the "window period".

According to MDPH, it takes six weeks for the body to produce enough
antibodies for a standard HIV antibody test to be accurate.

According to the CDC, ―The tests commonly used to detect HIV infection are actually
looking for antibodies produced by an individual’s immune system when they are
exposed to HIV. Most people will develop detectable antibodies within two to eight
weeks (the average is 25 days). Ninety seven percent will develop antibodies in the first
three months following the time of their infection. In very rare cases, it can take up to
six months to develop antibodies to HIV3.‖

Using both MDPH and CDC definitions, (organization name) encourages clients to get
tested 6 weeks following possible exposure while making clients aware that antibodies
may take up to three months to develop. Clients should be encouraged to repeat the test
based on the time of the exposure. A client should never be refused testing, even if the
exposure is within the window period. Offer the test and strongly encourage the client
to return for follow up testing, making it extremely clear that the test does not include
the risks that occurred within the window period.

If people are continually at risk (active intravenous drug users, for example), they
may want to get tested even if six weeks have not passed since their last
risk. During this "window period" the client will not test positive for HIV even if
she/he are infected. If the test result is negative, the client who is at continual risk
should be encouraged to test again.

            Bodily Fluids

There are four bodily fluids that contain a high concentration of HIV and all have
been link to HIV transmission. These fluids include blood, semen, vaginal fluids
and breast milk. When explaining HIV transmission, ensure clients understand

3
    CDC, Accessed online at http://www.cdc.gov/hiv/pubs/faq/faq9.htm on May 22, 2005



                                                                                       10
the bodily fluids that transmit HIV. Counselors should use language that is
familiar to the client, sensitive and culturally and age appropriate.

       HIV Antibody Testing

Antibody test results for HIV are accurate more than 99.5% of the time. The first test
done on a standard blood or OMT test is called an "EIA" or "ELISA" test. If this test is
negative for HIV antibodies, the test result is reported as negative. If the ELISA test
result is positive, it is confirmed by another test called a ―Western Blot‖ before it is
reported as positive.

Two special cases can lead to false results:

Children born to HIV-positive mothers may have false positive test results for several
months because mothers pass infection-fighting antibodies to their newborn children.
Even if the children are not infected with HIV, they have HIV antibodies and will test
positive. Other tests must be used, such as a viral load test that looks specifically for
HIV itself and not the antibodies.

As mentioned above, people who were recently infected may test negative if they get
tested too soon after being infected with HIV.

At the present time, there are three options for HIV antibody testing (Section IV). It is
important to give clients both the positive and negative aspects of each testing option.


       Blood Testing (Serum, Venipuncture)

The standard testing method, and the most common HIV test for the past 20 years has
been a needle blood draw. A needle is inserted into a vein, blood is withdrawn and the
specimen is sent to a laboratory. Results are usually returned within two weeks.

Positive Aspects                                 Negative Aspects
Accuracy of test                                 Invasive
Opportunity to implement risk                    Increased stress or anxiety during 2-
reduction/ avoidance plan during                 week waiting period
waiting period
If positive, opportunity to enter into
treatment




                                                                                            11
       OraSure Testing (Oral Mucosal Transudate)

The OMT test is a mouth swab (OraSure) that tests cells from inside the cheek. This test
can detect HIV antibodies in mouth fluid (not the same as saliva) through a scraping
from inside the cheek.

Positive Aspects                                Negative Aspects
No blood draw, less invasive                    Tastes ―salty‖
Opportunity to implement risk                   Increased stress or anxiety during 2-
reduction/ avoidance plan during                week waiting period
waiting period
If positive, opportunity to enter into
treatment


       Rapid Testing

Approved by the FDA, Rapid tests require a finger stick to obtain a small blood sample.
Clients will have a preliminary result in 20 minutes.

Positive Aspects                                Negative Aspects
Preliminary result in 20 minutes                If positive, confirmatory test required
If positive, opportunity to enter into          Final result takes up to 2 weeks
treatment                                       Increased stress or anxiety


       Reporting HIV+ Cases to the State

Individuals who participate in confidential HIV counseling & testing do not have their
names reported to the state. In the event that she/he tests positive for HIV, it is the
physician’s responsibility to report the HIV diagnosis to the state. HIV cases are
reported to the state using a unique identifier that is not linked to the name of the
individual who is HIV+.

AIDS cases are names-reported in all US states and territories. AIDS was declared a
disease dangerous to the public health by regulation (105 CMR 300) under the authority
of Massachusetts General Law, Ch. 111, s. 6. Physicians, other health care providers and
health care facilities are required to report AIDS cases. In Massachusetts, AIDS has been
reportable since 1983.




                                                                                          12
                                                  E. HIV Counseling

Staff providing family planning counseling at (organization name) sites are required to
adhere to the (organization name) Counseling and Education Guidelines and HIV Risk
Assessment and Sexual History Guidelines (Section III) and also contained in the
(Organization name) _Policies, Procedures, Protocols and Recommended Guidelines
Manual.

Research suggests ―Many people prefer being tested as part of a routine check-up,
instead of by public health sites. However, testing in private venues does not offer
anonymity, and patients who get tested as part of routine medical care may not receive
adequate counseling or referrals.4‖ Therefore, it is extremely important when
integrating HIV testing into family planning that clients receive information that is
unbiased, accurate and appropriate to age, knowledge level and culturally and
linguistically appropriate.

          Basic Communication and Counseling Skills

Family Planning Counselors learn basic communication and counseling skills in the
Basic Family Planning training (Section IV). To promote high quality counseling,
family planning counselors should5

1. Demonstrate professionalism: Display self confidence, competence, dependability,
preparation, integrity, and appropriate seriousness. Convincingly convey a
commitment to confidentiality. Appear non-judgmental and objective about behavior
and lifestyle. As appropriate, professionalism may also include: Wearing a name tag,
selecting a private area, ensuring no interruptions, ensuring no physical barriers,
reviewing record, calling the client by full name, greeting client and introducing self.
2. Establish rapport: Display respect, empathy, sincerity, and politeness. Seek out and
deal with clients’ concerns.
3. Affirm/support client: Take advantage of opportunities to affirm, such as, ―I’m glad
you asked that. You know a lot about HIV.‖
4. Address significant problems: Help client to express concerns without making
assumptions about needs; explore clients’ issues further, provide information, make
referrals, and notes on chart when issues/problems arise.
5. Use open-ended questions: Avoid the use of ―why‖ questions.
6. Give information simply and as needed: Communicate at client’s level; avoid technical
terms, jargon, etc. Demonstrate accurate and up-to-date information. Offer to

4
  Source: http://www.caps.ucsf.edu/C&T.html#8, accessed 4/3/05 Secondary Source: Haidet P, Stone DA, Taylor WC, et al. When risk is low:
primary care physicians' counseling about HIV prevention. Patient Education and Counseling. 2002;46:21-29.
5
  JSI Research and Training Institute, Supporting Quality HIV Risk Assessment: A Guide for Reproductive Health Managers and Supervisors,
2002; 43



                                                                                                                                     13
investigate unanswered questions. Avoid overwhelming client with information, focus
on main points, and offer information that is specific to individual client’s needs and
situation.
7. Paraphrase and reflect feelings: When appropriate, restate client’s words to demonstrate
and clarify understanding. Use active listening to validate and check out feelings.
8. Attend non-verbally: Use appropriate body language; respectful, open gestures and
facial expressions. Non-verbal communication mirrors verbal communication.
9. Use silence appropriately: Pause, relax, and do not rush the client.
10. Demonstrate comfort in openly discussing sexuality issues: Body language and other
communication skills do not alter when sexuality is discussed; is open and non-
judgmental in communicating across diverse sexual behaviors and values.

Section

          HIV Risk Assessment Counseling

HIV counseling requires an interactive counseling model, which involves face-to-face
sessions with a counselor. Pre-test counseling encourages clients to identify,
understand, and acknowledge the behaviors and circumstances that put them at
increased risk for HIV. The session should explore identified risks, previous attempts to
reduce risk and challenges of these efforts. The counselor’s role is to help the client
consider ways to reduce risk and help identify the mechanisms to do so. If appropriate,
the counselor should ask the client to commit to one explicit step to reduce risk.

The skills required for quality HIV risk assessment include basic communication and
counseling skills, but also include additional skills that promote in depth conversation
and more comprehensive discussion around HIV risk.

HIV counselors should6:
1. Normalize the risk assessment process with client: State the rationale for risk assessment.
2. Give client permission to not answer questions: Let the client know that the more she/ he
is able to share, the better the provider will be able to meet her/ his needs.
3. Help client assess her level of risk: Ask open-ended questions to elicit client’s self-
awareness of risk-taking behavior.
4. Confront, if necessary: Respectfully challenge client’s self-perception of risk, if evidence
of risky behavior is apparent. Use a supportive tone when confronting client who
expresses contradictory desires (―I don’t want to get infected, but I’m not going to use
condoms!‖) or whose medical history conflicts with self-perception (client insists she is
not at risk; has been treated for STI.)




6
 JSI Research and Training Institute, Supporting Quality HIV Risk Assessment: A Guide for Reproductive Health Managers and Supervisors,
2002; 43



                                                                                                                                    14
5. Address all topic areas of risk assessment: Ask about current and recent past sexual
behaviors, HIV/STI risk, substance use history, pregnancy intentions, and domestic
violence/sexual abuse.
6. Offer risk reduction/ avoidance information: Provide (organization name) counseling and
other pertinent prevention information.
7. Provide appropriate referrals: Offer accurate, up-to-date information on who, where,
what, and how, considering specific client needs.
8. Offer referral assistance: Facilitate a connection with referral agency, encourage
feedback, and set a follow-up appointment as needed.

For HIV counseling & testing, there are specific goals for the pre-test counseling session.
A HIV pre-test counseling session is more extensive than the HIV prevention
counseling conducted during a regular family planning session with either the family
planning counselor (FPC) or the medical provider. In other words, the FPC or medical
provider who initially sees a client will take a sexual history, assess risk and target more
intensive interventions for the client. The client is then either seen by or referred to the
Family Planning/ HIV Counselor for a more comprehensive risk assessment,
prevention messages, risk reduction/ avoidance plans, and appropriate referrals.

HIV pre-test counseling sessions should be focused on HIV risk reduction and 1) be
tailored to the individual needs of the client, 2) include an in depth, client-centered risk
assessment and 3) result in a client-centered plan for the client to reduce (with a goal of
risk avoidance) the risk for HIV infection/ transmission. This counseling is an
individualized, client-centered dialogue with the client which includes a discussion of
personal risk for HIV/STD’s, and the necessary risk reduction options to be
implemented by the client.

As part of the client-centered risk assessment, counselors should be flexible in the
prevention approach and counseling process. Counselors should be prepared to discuss
a variety of risk factors for HIV and provide prevention options that are tailored to the
needs of the client. Counseling should be focused on the needs of the client and
provide skill building opportunities as necessary.

       Elements of HIV Pre-test Counseling

The components of pre-test counseling include the following:

Introduction: Introduce yourself to the client including your role as an HIV counselor.
Outline the session, the length of time of the session, explain confidentiality, and the
wait time for the result. Explain the nature of data collection and provide the client with
the option of ―passing‖. Also explain to the client that the more accurate information
you have, the better able you are to assess their risk. Assure the client that it is safe
space, as it is confidential and clearly state what confidentiality means.


                                                                                          15
Identify client concern and knowledge of HIV/ ADS: Explore what brought the client
in for testing and what information they know about HIV/ AIDS. This section should
cover how HIV transmitted, correct misconceptions and address client concerns.

Client self-perceived risk: Explore the behaviors that can put the client at risk for HIV
and provide the client with an understanding of risk as a continuum from high risk to
no risk. The counselor should explore how the client made other changes in past
situations and discuss things to reduce levels of risk, thus decreasing the likelihood of
HIV transmission. Counselors should acknowledge and provide positive reinforcement
for positive actions already made by the client and actions to reduce risk, which
includes the client’s decision to access HIV services.

Development of a Risk Reduction Plan: Negotiate a concrete, achievable behavior-
change step that will reduce HIV risk. Help the client identify a reasonable yet
challenging change that could be used to reduce risk for HIV (this includes practicing
safer sex with partners, mutual monogamy, avoid sharing needles or bleaching works
before sharing, etc). Counselors should offer several options to the client and assist
them in choosing a method to reduce their risk that is appropriate to the client’s
concern. The action should be concrete and specific and include an identified back up
plan.

Identification of Support and Barriers: Help the client identify strengths and needs,
particularly if their test result is positive. Assess for domestic violence issues.
Assessment should include: barriers to the risk reduction plan, patterns of behavior in
coping with stressful situations, expected reaction if result is positive, social support
networks, including who is aware of the client testing today, and plans for coping with
the waiting period.

Testing: The counselor should assess the client’s readiness to test, including the
advantages and disadvantages of testing. The counselor should review with the client
and explain the various options for testing (blood, OMT and Rapid testing), the
meaning of the possible test results and the window period for having a reliable test
result. The counselor should also explain to the client that MDPH requires that all
positive test results are reported using a unique identifier (without client’s name).

Referrals: Client referrals should be given as necessitated by the risk assessment.

Closure and follow up: The counselor should make an appointment for the client to
return for their results (if necessary) and emphasize the need for the client to call and
reschedule if they are unable to keep the appointment. Knowledge of HIV status is a
critical HIV prevention strategy and essential for early entry into care. As such,
providers should stress to clients the importance of receiving test results and


                                                                                            16
establishing a plan to do so. The client should be urged to call the counselor between
appointments if he/she needs support during the waiting period. At the pre-test visit,
providers will establish a confidential means of contacting clients who do not return for
results as scheduled.

       ABCs of HIV Prevention

As part of the funding requirements, education regarding HIV prevention in family
planning clinics should incorporate the ―ABC‖ message. That is, for unmarried
individuals and adolescents, the message is ―abstinence‖. For individuals who are in
committed relationships or are married, the message is ―be faithful‖. For individuals
who do not fit in either category and engage in behavior that places them at risk for
HIV, the message is ―condom use.‖

Since 1993, the Center for Disease Control (CDC) has recommended client centered
counseling for HIV prevention, including testing. Moreover, client-centered approaches
have long been seen as the heart of effective family planning counseling. Therefore, the
ABCs should be seen as a way to organize, rather than to replace, client-centered
counseling sessions focused on HIV prevention.

Client centered HIV counseling using the ABCs includes risk assessment to determine
the specific clinical and counseling needs of the client, education on abstinence,
postponing sexual involvement, and developing healthy, non-exploitive relationships
for adolescents and others not currently involved in committed relationships (―A‖);
partner communication skills to address issues such as faithfulness, sexual history,
STD/HIV testing, and condom use (―B‖); and for those engaging in risky behavior,
condom use and counseling/testing services available within the delegate and service
delivery sites (―C‖). Family planning counselors role-play situations to allow clients an
opportunity to practice these skills in a safe, comfortable atmosphere. Clients are also
encouraged to include partners in educational sessions to involve them in HIV/STD
prevention decision-making.

The use of counseling activities can make HIV education/counseling with the ABCs
more interactive and therefore more effective. A useful activity for talking about either
A, B, or C—or all three—involves discussing what a person needs to know, have, and be
able to do if they are to abstain, be faithful, or use condoms effectively. For starters, a
person must be able to define what abstinence or faithfulness means to them and share
that understanding with a partner. Moreover, a person must be able to negotiate with a
partner for any of these strategies to work effectively, so this activity leads discussions
of communication within relationships; issues of partner cooperation, respect and safety
within a relationship; and sexual coercion. Similarly, discussion of what it takes to
effectively practice abstinence, faithfulness, or condom use often leads to important




                                                                                        17
discussions of substance use, and how alcohol or drugs can affect one’s efforts to
prevent HIV.

       Additional Considerations

Pregnant Women

Many pregnant women (an estimated 70 – 95%) will accept HIV testing. Many women
will accept testing because they believe, accurately so, that knowing their HIV status
will benefit both the mother and the infant. The CDC recommends voluntary
counseling and testing offered routinely to all pregnant women as early in pregnancy as
possible.

There are two occasions in which a pregnant woman is considered a family planning
client: during a pregnancy testing counseling visit and at 28 weeks. If a woman comes
in for pregnancy testing, and the test result is positive, and the woman opts to test for
HIV at this same visit during which she receives options counseling if desired, it can be
captured under this project. Similarly, if a woman who is pregnant comes in at 28 weeks
or at another time during the third trimester for an overview of post-partum family
planning options, and chooses to test for HIV at that visit, it again can be captured
under this project. The general rule is that if a woman is in prenatal care, she cannot test
for HIV under this project because she is not considered a family planning client

In the event that a woman tests positive for HIV during pregnancy, she should be
referred to a specialty provider who has experience and knowledge with antiretroviral
medication treatment to decrease perinatal HIV transmission.

Persons seeking repeat HIV testing

In addition to prevention counseling sessions aimed at personal risk reduction, it may
be useful to reevaluate the risk plan. This includes a detailed discussion on the risk plan
and the steps previously established. Discuss with the client what the barriers were to
implementing the steps and encourage the client to determine new, achievable steps.

Persons who use drugs

For injecting drug users, personalized, interactive prevention counseling with goal
setting is useful in reducing drug using behaviors. It is also extremely important to
discuss sexual risk and the circumstances around such risk (i.e. are they engaging in
sexual risk while under the influence). Various programs (methadone maintenance
programs, other drug treatment programs, outreach programs and needle exchange
programs) should also be recommended to clients as well.



                                                                                         18
Sexual assault

In the context of sexual assault, follow the procedure of the facility, which includes
sexual assault-related clinical assessment and counseling support, HIV testing and post-
exposure prophylaxis. Consult the clinical supervisor for the current sexual assault
protocol used at each site.


                              F. Providing Test Results

No test results are given over the phone. Providers should stress the importance of
returning to receive test results and establish a plan to do so including scheduling an
appointment to return for results before the client leaves the day of testing. It is
particularly important for the people who test positive to receive their results. These
clients will benefit from early entry into care. At the pre-test visit, providers will
establish a confidential means of contacting clients who do not return for results as
scheduled.

The components of post test counseling include the following:

Reintroduction and assessing client’s readiness to receive the result: The counselor
should do a quick check in with the client.

Provide the HIV test result: The result should be given with the use of jargon and/or
technical terms. Ensure that the client understands the need for retesting should there
be any recent or ongoing risk behaviors. The counselor may need to allow time for the
client to take in the result.

Discussion of the meaning of the result: The counselor should explain the exact
meaning of the result and ensure the client understands the meaning of the result.

Discussion of the client’s feelings about the result: The counselor should try to
normalize the client’s feelings. The counselor should avoid giving HIV 101 and/or
information that is not pertinent to the client. If negative, reinforce the risk reduction
plan discussed in the pre-test counseling session.

If positive, assess support: For clients with a reactive Rapid test result, a confirmatory
test should be offered and done at this time, if possible. For all positive results (OMT,
blood or reactive rapid), clients should be encouraged to create a 24 hour plan, or at the
very least what they plan to do when they leave the clinic. The counselor should help
the client develop a plan for contacting a support person. The counselor may offer
themselves as a support person. Counselors should also assess the client’s suicide risk
and provide immediate mental health evaluation, if necessary.


                                                                                             19
Discuss possible consequences of disclosure: Discuss with the client the possibility of
disclosure to significant other(s) and consequences of such disclosure. Offer the client
the option of accessing Partner Notification (please refer to section G).

 Referrals: Provide clients with appropriate referrals. Referring back to the pre-test
counseling session, counselors should follow up with services previously offered or
suggested. For clients who are HIV positive, the client should be encouraged to make
an appointment with a medical provider. The counselor should make every attempt to
facilitate the appointment with the client. In addition, if the client agrees, he/she should
be linked to case management services, metal health services and other support services
as requested.

If negative, review the risk reduction plan: Discuss the plan developed during the pre
test counseling session and review progress and barriers. The counselor should
reinforce and support the client’s efforts to reduce their risk for HIV. If needed, the risk
reduction plan may be modified. Ask the client for commitment to continue with the
plan as developed and/or changed. If appropriate, the client should be offered the
option to retest based on recent exposure.

Proof of Status: Occasionally, clients may request a copy of their HIV test result. The
counselor must explain the reliability of the test result based on the length of time
between the possible exposure and performance of the test. Please complete the
appropriate test result form (Section II).

       Delivering HIV Test Results

All results should be delivered in person.

During the post test session, providers should use explicit language when providing
results. The discussion should include the implications of the result, and the importance
of re-testing for high risk individuals. Providers should consider the timing of the last
potential exposure and the presence or likelihood of ongoing risk behavior to determine
an appropriate recommendation for follow up testing.

Counseling/support for all results should include:
      Allow the client time to absorb the meaning of the test result.
      Explore client’s understanding of result.
      Assess how client is coping with result.
      Identify and discuss the client’s concerns. Answer client questions.

Providers should be prepared to:
    provide prevention referrals/ resources based on ongoing assessment,


                                                                                          20
      Discuss and develop risk reduction plan for sexual and drug use activities.

Key points when explaining the meaning of HIV test results:
       The test screens for HIV antibodies (an immune system response to HIV
         infection), not the virus itself.
       Emphasize need to practice safe sex and needle use behavior to avoid
         transmitting the virus.

Negative Test Results

Providers should:
    Explain the meaning of the result clearly and simply; a negative test indicates the
      absence of antibodies to HIV,
    Explain the limitations of a negative test; infection after exposure to HIV in the
      past 6 weeks cannot be determined by the test

Positive Test Results

Providers should:
    Explain the meaning of the result clearly and simply; a positive test indicates the
      presence of antibodies to HIV, infectious nature of the disease and prevention
      measures to reduce transmission,
    Acknowledge the challenges of dealing with a positive result.
    Positive results do not indicate an AIDS diagnosis or a ―death sentence.‖
    Medical care is available to monitor health of immune system and limit harmful
      activity of HIV in the body. Refer to HIV specialty care or ID specialists,
    Assess for risk of suicide and homicide given positive test result.
    Refer to mental health services,
    Suggest Partner Notification (please refer to section G) and provide referrals, if
      requested.
    Re-assess and discuss support options for coping with positive result.
    Assist client to establish a support plan for the next twenty-four hours.

Rapid Test reactive results
   a) Reveal and identify test results clearly and simply for the client.
   b) Review meaning of the results.
       Positive results are preliminary and require confirmatory testing.
       The test screens for HIV antibodies (an immune system response to HIV
         infection), not the virus itself.
       In the context of a high risk client’s risk history, positive results mean the
         client is likely to be infected; however, results are preliminary.




                                                                                         21
          
          Emphasize need for confirmatory testing in order to rule out chance of false
          positive result.
         Emphasize need to practice safe sex and needle use behavior to avoid
          transmitting the virus.
         Even when results are confirmed positive, the result does not indicate an
          AIDS diagnosis or a ―death sentence.‖
         If results are confirmed positive, medical care is available to monitor health of
          immune system and limit harmful activity of HIV in the body.
     c) Counseling/support
         Allow the client time to absorb the meaning of the test result.
         Explore client’s understanding of preliminary result.
         Assess how client is coping with preliminary result.
         Identify and discuss the client’s concerns. Answer client questions.
         Acknowledge the challenges of dealing with a preliminary, reactive result.
         Assess for risk of suicide and homicide given preliminary test results.
         Re-assess and discuss support options for coping with preliminary result.
         Assist client to establish a support plan for the next twenty-four hours.
         Assist client to establish a support plan for the time until confirmation test
          result appointment.


Indeterminate Test Results

         Explain the meaning of the result clearly and simply,
         Refer client to medical provider to rule out known causes of cross-reactive non-
          specific antibodies (autoimmune disease, lymphoma, liver disease etc),
         Arrange for follow-up testing if the last known risk behavior was within the
          window period.


                                                          G. Referrals

Conducting risk assessments during pre-test counseling allows the provider to evaluate
the clients need, identify the cost and benefits of seeking different services and make a
referral.7 In making a referral, it is important the client’s needs are met and the referral
is responsive to identified needs and appropriate to culture, language, gender, sexual
orientation, age, and developmental level.

Examples of these services include:
      Quality medical care including medical evaluation, care, and treatment

7
 Garrity, Joan et al. Comprehensive HIV Risk Assessment: Building Skills in Sexual and Substance Use History Taking: A Provider Training
Manual. JSI Research and Training Institute, Inc. October 2002.



                                                                                                                                       22
         Prevention case management
         Drug or alcohol prevention and treatment programs including syringe
          exchange programs
         Legal Services
         Mental Health Services (including Emergency Mental Health) and
         Housing and employment services
         Intimate partner violence services

Each facility should have a list of community resources to meet the needs of the clients.
This list should include, but not limited to, the list provided above.

Once a referral is made (and documented in the medical record), it is important that
providers support client follow through. Address all personal concerns and resources
(transportation, child care, etc.), clearly explain the service being referred, and if
requested, provide direct referral assistance (e.g. setting up the appointment, etc.).

Provider should also follow up with clients through the invitation of feedback on the
referral, or contacting the referred provider (with appropriate consent). Referral follow
up should be documented in the medical record.

      HIV Partner Notification (PN)

When a family planning client tests positive for HIV antibodies, the family planning
counselors must discuss partner notification as part of the counseling session. HIV
counselors should be familiar with the state PN program, be able to explain the
program to clients and know how to access the program.

PN provides a ―Disease Intervention Specialist‖ (DIS) to locate and inform a partner of
the exposure without revealing the source of the information. This is provided on an
individual and personalized basis. As a prevention tool, PN can help fine-tune and
target the messages for those at greatest risk.

Previously known as ―contact tracing‖, PN aims to reach people who have been
exposed to HIV disease, and provide an appropriate intervention. For PN, the client
identifies past or current sexual or needle-sharing partner and chooses:

   1. to notify his/her partner(s) directly,
   2. to work with PN who will notify his/her partner(s)

Elements of PN:
    PN is always voluntary,
    DIS employee do not need to know the clients name,
    PN is always delivered in person, face-to-face, in privacy


                                                                                         23
      Partners are notified of possible exposure, not that they are infected,
      The source of the information is never revealed or acknowledged, only that the
       person naming them was a contact during the last 10 years,
      No records are kept of HIV infected persons using PN.

Advantages of PN for the HIV-infected person:
   Safety - many HIV-infected people, particularly women, fear the possibility of
     emotional or physical abuse. PN provides a safe way to reach partners and
     minimize risk of harm to the infected person.
   Selective notification - an infected person who fears for his/her safety from a
     particular partner need not name that person, but there may be other partners
     who could be named without the same concern for safety.
   Empowerment - the HIV-infected person is taking an active role in their own
     care and in the care of those important to them.

Advantages of HIV- PN for partners:
   Partners are informed of risks of which they may not be aware.
   HIV-PN provides personalized education to those at highest risk of infection, i.e.,
     partners of HIV-infected people, with advice on how to continue expressing their
     sexuality while reducing future risks of exposure and infection.
   Partners are informed of risks to which they may be exposing other partners.
   Partners are offered counseling/medical care/social services to help determine
     whether they're infected and to help cope with such news - thus, HIV-PN is a
     gateway to services for those at highest risk of infection.

Protecting the infected person:
    The DIS interviewer does not need to know the infected person's name; the
       person notifying the partner(s) may not be the one who interviewed the infected
       person, so there's little chance of inadvertently providing any identifying clues.
    Pronouns (he, she) regarding the infected person are avoided.
    Partners are directed away from dwelling on "Who named me?" and focus
       instead on learning about HIV and the need to deal with the possibility of being
       infected.
    Partners are informed only that the person naming them was a contact during
       the past 10 years.

PN notification services are offered through anyone who works with HIV-infected
people, e.g., clinicians, counselors, social workers, etc. The provider can call the STD
Prevention Division whenever their client decides to use the service and can arrange a
meeting between the client and the DIS representative. By working through the
provider, the client's identity is not divulged and the DIS representative will have the
provider's assurance that the person requesting PN services is actually HIV-infected.
This protects against false notifications perpetrated against other people.


                                                                                        24
Call the Greater Boston Division of STD Prevention at (617) 983-6940 to receive further
information or visit http://www.mass.gov/dph/cdc/std/services/hivpn.htm.


       Managing the Referral Process

It is important, in discussing and providing referrals, that counselors document the
referral made and follow up with the client at their next visit. The following are
guidelines to help manage referrals.

Assess client referral needs: In discussing referrals with clients, counselors should
identify factors that are 1) likely to influence the client’s ability to adopt or sustain
behaviors to reduce risk for HIV and 2) promote health and/or disease progression.
This should include the client’s willingness and ability to accept and complete a referral.
Referrals that match the client’s self-identified priority needs are more likely to be
successful and completed.

Plan the referral: Referrals should be responsive to the client’s needs and appropriate to
their culture, language, gender, sexual orientation, age and developmental level. In
consultation with the client, counselors should assess and address any factors that make
completing the referral difficult (such as lack of transportation, childcare, work
schedule etc.). If services are easily accessible, clients are more likely to complete the
referral.

Help the client access the referral: Clients should receive information necessary to
successfully access the referral (contact name, location, hours etc.). Counselors should
offer to assist the referral by facilitating the referrals (making the call for the client or
allowing the use of the phone to schedule the appointment). Clients must give consent
before identifying information necessary to complete the referral is shared.

Document referral and follow up: Counselors should document if a referral was given.
At the next appointment, the counselor should ask if the referral was completed and
determine the client’s level of satisfaction. If the client was not satisfied, provide
additional options for referral. It is important to receive feedback on the referrals given
so that counselors are better able to meet the needs of clients.




                                                                                            25
                                 H. Quality Assurance

(Organization name) conducts reviews of services rendered, including counseling
and education services, at the contracted delivery sites to monitor these requirements.

Quality assurance is defined as ―planned, step-by-step activities that let one know that
testing is being carried out correctly, results are accurate, and mistakes are found and
corrected to avoid adverse outcomes‖ (CDC, QA Guidelines for Testing using the
OraQuick rapid HIV-1 Antibody Test). Quality control is a part of quality assurance
and refers to the techniques or tasks that are in place to identify and correct problems
that may occur.

Each site should identify a person that is responsible for implementing the QA program
as well as the procedure should a problem be identified.

To facilitate quality assurance, (organization name) will provide guidance for sites
around training requirements. (Organization name) will also implement ongoing project
meetings (see page 6) intended to provide support to staff, share resources and
expertise, and provide a forum for raising any concerns, issues or successes.

It is each site’s responsibility to ensure that each HIV test is performed correctly and for
rapid testing, that external controls and temperature logs are monitored.

As part of (organization name) ongoing QA, the site coordinator is responsible to
communicate identified problems and the corrective action to the HIV Counseling and
Testing Coordinator. The HIV Counseling & Testing Coordinator is available to offer
assistance and support in implementing testing at each of the sites and as such, should
be used a resource to ensure the HIV testing is carried out successfully.

(Organization name) will also conduct reviews to ensure that all requirements are met
and QA programs are in place.

                   I. Laboratory and HIV Testing Procedures

       (Lab name) Laboratories

(Organization name) has contracted with (lab name) Laboratories for HIV blood testing.
There is no cost to the health centers to perform HIV blood testing under the C&T
Project.

(Lab name) Requisitions


                                                                                          26
Requisitions should be completed by the HIV/FPC as follows:
    In the upper left hand corner, please check the box that states ―Bill account.‖
    The client’s medical record and date of birth should be completed. No other
      identifying information should go on the requisition.
    The date of the test should be indicated.
    Even if the individual has health insurance, do not check the insurance box.
    All requisitions need to be signed by a physician.
    Please indicate the type of test you are requesting. HIV-2 test requests must be
      based on the screening tool.
A sample requisition form is attached. To order additional requisitions, please call
(XXX) XXX-XXX ext. XXX.

Laboratory information
(Lab name) provides supplies (tubes, needles, specimen collection bags, etc). To order
supplies, please call (XXX) XXX-XXXX ext. XXX

All specimens should be sent to (lab name) using the (organization name) requisition
form. Specimens should be placed in a bag with the requisition form. No other samples
should be in the bag with the specimen being tested for HIV. Please note: this applies to
clients performing multiple tests and health centers that use (lab name) for other tests.
The requisition indicates the billing method. No other specimens can be sent to (lab
name). There is only HIV testing. Specimens are stable refrigerated for 2 weeks.
(Organization name) requires that they are picked up within 5 days of collection.

(Lab name) has a courier service. Initially sites should be calling (lab name) for specimen
pick up and once the frequency of blood tests are determined, regular pick up times can
be scheduled. For specimen pick up, please call (XXX) XXX-XXXX.

Test Results
The test results will be returned to the site in approximately 3 days, depending on the
time of day the specimen is picked up. A positive test takes longer because additional
tests need to be performed. For C&T, please inform clients the results will take
approximately 2 week(s).



       Laboratory Procedures for HIV testing Specimens

Blood and OMT specimens are sent to a lab for the HIV testing using the ELISA test and
a Western Blot test to confirm an initially positive rapid test result. There is an average
wait of 1-2 weeks between sample collection and the test results.




                                                                                          27
There are currently three types of HIV antibody testing offered. These options include
blood testing, OMT (Oral Mucosal Transudate) testing and Rapid Testing. Below is the
procedure for administering each type of testing.

      Blood Testing (Serum, Venipuncture)

This option is probably the most invasive of the procedures offered. Clients choosing
this option must sign the consent form and indicate the specific test requested.

Equipment needed:
Exam gloves                           Tourniquet               Lab specimen bag
Needle holder                         Eye goggles              Sharps disposal unit
Vacutainer needle (20-22 gauge)       Alcohol wipe             Lab slip
Vacutainer tube(s)                    2 X 2 gauze              Pen

Staff persons performing the test must wear exam gloves. Use of eye goggles is highly
recommended and should be available at clinics. The following steps should be adhered
to when performing an HIV blood test.

   1. Evaluate the history of syncope with phlebotomy. If present, have client lie down
       for procedure.
   2. Place tourniquet above site to be used; palpate for vein.
   3. Wipe off area to be used with alcohol wipe.
   4. Using sterile technique, insert needle into vein, bevel upward until puncture of
       wall is made.
   5. Push vacutainer into needle and wait for flow of blood to stop.
   6. When phlebotomy is complete, release tourniquet. Withdraw vacutainer from
       needle.
   7. Withdraw needle from vein.
   8. Place pressure on vein used with gauze pad and apply band-aid.
   9. Discard needle in hazardous waste disposal unit. Do not discard needle holder
       (barrel).
   10. Label sample with client’s bar code number and mail to lab with submission
       form.
   11. Centrifuge specimen as indicated.
   12. Refrigerate specimen only if it is not mailed the same day, however all specimens
       should be mailed that same day if at all possible.

Care should be taken to avoid ―needle stick‖ of the staff person performing phlebotomy
with a contaminated needle. If this occurs, please refer to your agency protocol for
occupational hazards.




                                                                                        28
      OMT Testing

OMT testing is a less invasive testing method, thus eliminating fear associated with
needles. The OMT is client controlled and provides greater safety to the health care
provider. In addition the tests can be performed by minimally trained staff or non-
medical staff. Clients choosing this method must be given the ―OraSure Subject
Information‖ pamphlet prior to testing, and must sign the consent form and indicate
testing option requested.

Equipment needed:
Exam gloves                     OraSure test kit                  Pen
Bio-hazard disposal unit        Timer

Staff persons performing the test must wear exam gloves. The following steps should be
adhered to when performing an HIV testing using the OMT.

   1. Open the OraSure package containing the collection pad and specimen vial.
       Orient the package so that the pad is ―down‖ and the ―stick‖ end is up.
   2. With the thumb and index finger of each hand, simultaneously and
       symmetrically peel apart (down) the two sides of the packaging far enough to
       allow for easy removal of the collection pad.
   3. Without touching the contents, present the stick of the device to the client and
       instruct him/her to pull it out of the packaging sleeve.
   4. Instruct the client to place the collection pad inside his/her mouth (pad oriented
       down) between the lower cheek and gum and gently rub the pad and forth along
       the gum line until the pad is moist.
   5. Begin timing for 2 minutes.
   6. Instruct the client to leave the pad stationary against the lower gum for a
       minimum of two minutes and maximum of five minutes.
   7. Remove the specimen vial from the package and record the test subject
       identification number and date of collection on the specimen vial.
   8. Open the vial in an upright position (with the cap, pointed tip pointed down) by
       gently rocking the cap back and forth to avoid spilling the contents.
   9. Give the opened vial to the client, being careful not to spill the contents.
   10. At the end of two minutes, instruct the client to remove the pad from his/her
       mouth and insert the pad into the blue liquid in the specimen vial and to push
       the pad all the way to the bottom of the vial.
   11. Instruct the client to break the nylon stick by snapping it against the side of the
       vial and in a direction away from the counselor and/or other personnel. (The
       stick is scored to facilitate breakage.) Discard in bio-hazard container.
   12. Take the vial from the client and replace the cap, ensuring it is tight. The cap will
       ―snap‖ into place when secure.



                                                                                          29
   13. Protect the specimen from impact, direct sunlight and temperature exceeding 98
       degrees F.
   14. Mail the specimen as soon as possible.

       Rapid Testing

The Rapid HIV-1 Antibody test is the first HIV point of care (testing and result is
available during session) test approved by the US Federal and Drug Administration
(FDA). Rapid testing is minimally invasive, requiring a finger stick, and results are
available in 20- 30 minutes.

Equipment needed:
Rapid Testing Antibody Test Device and Developer Solution
Reusable test stand          Bio-hazard container                  Clean, disposal workspace
Latex or vinyl gloves        Specimen collection                   cover
Timer or watch               loop                                  Subject information
Sterile gauze pads           Sterile lancet                        pamphlet
Band- aids                   Antiseptic wipe

Temperature Required:
Storage area: 35 O -80 O F
Testing area: 59O - 80 O F

Controls:
If a new test kit lot is being used, or if the temperature of the testing area (59O - 80 O F)
or storage areas (35 O -80 O F) falls outside of the recommended guidelines, kit controls
should be run prior to testing. Test kits should be allowed to come to room temperature
before use.

Prior to testing, clients should be given the ―Subject Information‖ pamphlet.

Staff persons performing the test must wear exam gloves. The following steps should be
adhered to when performing an HIV Rapid test.
   1. Put on your gloves and open the two chambers of the Divided Pouch by tearing
       at the notches on the top of each side of the Pouch. To prevent contamination,
       leave the Test Device in the Pouch until you are ready to use it.
   2. Remove the Developer Solution Vial from the Pouch. Hold the vial firmly in your
       hand and carefully remove the cap by gently rocking the cap back and forth
       while pulling it off. Set the cap on the workspace cover. Slide the vial into the top
       of one of the slots in the test stand. DO NOT force the vial into the stand fro the
       front of the slot as slashing may occur. Make sure the vial is pushed all the way
       to the bottom of the slot.



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   3. Collection of the Finger stick Whole Blood. Using an antiseptic wipe, clean the
      finger of the person being tested. Allow the finger to dry or wipe dry with a
      sterile gauze pad. Using a sterile lancet, puncture the skin just off the center of
      the finger pad. Hold the finger downward. Apply gentle pressure beside the
      point of the puncture. Avoid squeezing the finger to make it bleed. Wipe away
      this first drop of blood with a sterile gauze pad. Allow a new drop of blood to
      form. Pick up an unused Specimen Collection Loop by the thick ―handle‖ end.
      Put the ―rounded‖ end of the loop on the drop of blood. Make sure that the loop
      is completely filled with blood.
   4. Mix. Immediately insert the blood-filled end of the loop all the way into the vial.
      Use the loop to stir the blood sample in the Developer Solution. Remove the used
      loop from the solution. Throw the used loop away in a biohazard waste
      container. Check the solution to make sure that it appears pink. This means that
      the blood was correctly mixed into the solution. If the solution is not pink,
      discard all of the test materials in a biohazard container. Start the test over using
      a new pouch and a new blood sample.
   5. Test. Remove the Test Device from the pouch. DO NOT touch the flat pad. Check
      to see if an absorbent packet is included with the device. If there is not an
      absorbent packet, discard the device and obtain a new pouch for testing. Inset
      the flat pad of the device all the way into the vial containing the blood sample.
      Make sure that the flat pad touched the bottom of the vial. The Result Window
      on the device should be facing towards you. Start timing the test. DO NOT
      remove the device from the vial while the test is running. Pink fluid will
      gradually disappear as the test develops. Read the results after 20 minutes, but
      no more that 40 minutes in a fully lighted area.
   6. Reading Results. A test is non-reactive if a reddish-purple line appears next to
      the triangle labeled ―C‖ and NO line appears next to the triangle labeled ―T‖. A
      non-reactive test means that HIV-1 antibodies we not detected in the specimen.
      A test is reactive if a reddish-purple line appears next to the triangle labeled ―C‖
      AND a reddish-purple line appears next to the triangle labeled ―T‖. One of these
      lines may be darker than the other. The test is reactive is any reddish-purple line
      appears next to the two triangles, no matter how faint. A reactive test means that
      HIV-1 antibodies have been detected in the specimen.
   7. A reactive result on a rapid HIV test requires a second test; Preliminary reactive
      rapid test results are confirmed using either blood or OMT testing sent to the lab.


A test is invalid if NO reddish-purple line appears next to the triangle labeled ―C‖ or a
red background in the result window makes it difficult to read the result after 20
minutes or if any of the lines are NOT inside the ―C‖ or ―T‖ triangle areas. An invalid
test means there was a problem running the test, either related to the specimen or the
device. An invalid result cannot be interpreted.



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CLIA Waiver

As the first point of care test approved by the FDA, the rapid test is also the first test to
be waived under the Clinical Laboratory Improvement Amendment (CLIA) regulations.
Each site should apply for a CLIA waiver through MDPH. Both federal and state
requirements must be met in order to obtain a CLIA waiver (Section II). The
(organization name) HIV Counseling & Testing Project Coordinator is available to assist
sites in obtaining a CLIA waiver, if necessary.


       Additional Considerations for Rapid Testing

Sites should be familiar with the MDPH Rapid HIV Counseling & Testing protocol
(Section III).

Support and Referrals

      HIV Rapid Testing should not be conducted on Fridays, unless access to support
       services is available throughout the weekend.
      It is also important to have several staff and/or appropriate support services in
       place when performing Rapid Testing. For example, in the event of a preliminary
       positive, a client may be in need of professional mental health support. If this is
       not available at the health center, it is important that you have a referral in place,
       with an established agreement, for an individual (and phone number) who can
       provide immediate support.

Controls

      One staff person at each site should be designated to run external kit controls by
       testing each test kit lot. External controls should be run on each test kit lot of 25.
       This individual should also be responsible for ensuing the appropriate storage
       and room temperatures are maintained (refer to QA section).


Storage of Test Kits

      If where tests kits are stored goes beyond the acceptable temperature range, it
       may affect the performance of the test. This may cause the test to indicate
       inaccurate results.
      If kits are stored refrigerated they must be warmed to room temperature before
       using, to ensure the test kit is performing properly. Forgetting to warm test kits
       to room temperature could cause inaccurate results.




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Temperature of Testing Area

      If room temperature where the test is performed goes beyond the acceptable
       temperature range, it may affect the performance of the test. This may cause the
       test to indicate inaccurate results.


Specimen Collection

      Only fingerstick whole blood can be used with this testing device – other
       specimen types have not been validated by the manufacturer.
      Specimen collection loop must be filled completely or there may not be enough
       specimen to give a valid result. Incorrect specimen collection could cause
       inaccurate results.
      Developer solution should be pink after the specimen has been added or there
       may not be sufficient specimen to give a valid result. In sufficient specimen
       could cause inaccurate results.


Test Kit Components

      Test devices/developer solutions – must be from the same kit; interchanging lots
       numbers may give invalid results.
      Absorbent packet must be present in pouch containing the test device to insure
       that test device has not been adversely affected by excess moisture.
      Do not touch the flat pad on the test device – may contaminate the pad and
       interfere with test performance. Interference in test performance may cause
       inaccurate results.
      Do not cover the two holes in the back of the test device with labels or other
       materials – this could impair the fluid flow and cause an invalid result.
      Never reuse test components – they are made to be used only once. A test
       conducted with reused kit components could cause inaccurate results.


Reading the Test

      Adequate lighting must be available to read the test - faint lines may be missed if
       lighting is poor. This could cause misreading of results.
      Reading the test before 20 minutes or after 60 minutes could give invalid test
       results. Accurate timing of the test is critical for accurate results.
      Control line missing means test is invalid – fluid may have not migrated
       adequately through the test device. Missing an invalid test and reading results
       could cause inaccurate results.



                                                                                        33
      All lines must be within triangle area of ―C‖ or ―T‖ or test is invalid.
      Red background on test and control area means test is invalid.
      If external controls do not give expected results the test kits may not be
       functioning properly. In such a case, do not report patient results. Results could
       be invalid.


       J. Privacy Law and Confidentiality of HIV- Related Information

The information below pertains to Massachusetts state law and was provided by GLAD (Gay &
Lesbian Advocates & Defenders) Equal Justice under Law (www.glad.org).


The Massachusetts HIV Testing Statute

Massachusetts General Law Chapter 111, Section 70F provides that a physician, health
care provider, or health care facility may not without first obtaining a person’s written
informed consent:

   - Test a person for HIV;
   - Reveal to third-parties that a person took an HIV test; or
   - Disclose to third-parties the results of a person’s HIV test.

It is important to keep in mind that this law only prohibits the disclosure of HIV status
by health care providers. See Confidentiality and Privacy Beyond the Health Care Context
below for privacy protections in other contexts.

Consent to an HIV Test Must Be Written, Not Oral, and Must Be HIV-Specific, Not
General

Written informed consent means that a person must sign a specific release authorizing
the health care provider to test for HIV.

Remedy for Violation of HIV Testing Statute

A health care provider or facility which tests for HIV or discloses an HIV test result
without written informed consent violates M.G.L. c. 93A, which protects consumers
from unfair and deceptive trade practices. This statute permits the recovery of
compensatory damages for harm such as emotional distress, the recovery of attorneys’
fees and, under certain circumstances, multiple damages -- damages up to three times
the amount of a person’s actual damages. A physician may also be liable for medical
malpractice or battery.




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The Meaning of Informed Consent

A competent adult has the right to decide whether he or she wishes to undergo any
medical treatment or testing. Without informed consent, the provision of medical
treatment is considered to be a ―battery,‖ a legal claim based upon nonconsensual
physical contact with or intrusion upon a person’s body.

In the context of medical treatment, informed consent means that a physician or health
care provider must make the client aware of the nature, benefits, risks, and alternatives
to treatment such that the client can make a voluntary, knowledgeable choice to accept
or forego treatment. The health care provider does not have to inform the client of
every possible risk, but only the significant risks which a reasonable person in the
client’s situation would want to know in order to decide whether to accept or forego
treatment.

In the context of HIV testing, it is sufficient that a client understand:

      the general purpose and nature of an HIV antibody test including that the client
       will give a blood/ OMT sample which will be tested for the presence of HIV
       antibodies.
      the type of information which is revealed by an HIV antibody test.

―Competency‖ to Consent

In order to give informed consent, an individual must have the minimum mental
capacity to make an informed decision to take an HIV test. Competency is a threshold
level of understanding about the nature and consequences of a decision one has to
make and does not require a sophisticated level of intelligence or knowledge about HIV
or AIDS. There is no single legal criterion for competence. Mental illness or retardation
does not itself make a person incompetent to take an HIV test.

A person is competent to provide informed consent for an HIV test if he or she has:

      the ability to understand in general terms what an HIV test is.
      the ability to make a reasoned choice to have an HIV test.

If you have doubts about a person’s competence to provide informed consent for an
HIV test, you may want to ask the person:

      Do you understand you have to give a blood sample which will be tested for
       antibodies for HIV?
      Do you understand what HIV is and what the purpose of an HIV test is?
      Why do you want to take an HIV test?



                                                                                        35
Consent By Minors

Under Massachusetts law, minors (persons under the age of 18) are generally
considered to lack the legal capacity to consent to medical treatment. However, given
the importance of making HIV testing available to adolescents, there are two sources of
law which authorize a minor to consent to medical treatment or testing, such as an HIV
test, without the consent of a parent or legal guardian. Massachusetts General Law
Chapter 112, Section 12F

This statute provides that a minor may give consent to medical or dental care if he or
she is:

      married, widowed or divorced.
      a parent of a child.
      a member of the armed forces.
      pregnant or believes herself to be pregnant.
      living separate and apart from his parents or legal guardian and is managing his
       own financial affairs.
      ―reasonably believes himself to be suffering from or to have come in contact with
       any disease defined as dangerous to the public health [by the Department of
       Public Health] pursuant to chapter 111.‖ The list of such diseases includes HIV.
       The minor may only consent to care relating to the diagnosis or treatment of that
       disease.

Medical or dental records and other information about a minor who consents to
treatment are confidential for that treatment and may not be released except with the
consent of the minor or upon a judicial order. The statute, however, creates an
exception to the confidentiality of a minor’s medical information when the physician or
dentist ―reasonably believes‖ that the minor’s condition is ―so serious that his life or
limb is endangered.‖ In this case, the physician or dentist must notify the parents or
legal guardian of the minor’s condition.

Medical Record Release

A general release to a health care provider authorizing the disclosure of medical records
and information is insufficient to authorize a health care provider to release information
about HIV testing. Under Chapter 111, Section 70F, the release must specifically
authorize the disclosure of HIV test results and must state the purpose for which the
information is being requested.

Medical record documentation containing information pertaining to HIV counseling
and testing or HIV status may only be released if the client gives specific permission to




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release HIV related information. Each facility must have a Medical Release of
Information that requires a second signature for the release of HIV related information.

      Confidentiality and Privacy Beyond the Health Care Context

The Statutory Right to Privacy in Massachusetts

Massachusetts General Law Chapter 214, Section 1B provides: A person shall have a
right against unreasonable, substantial or serious interference with his privacy.

How Do Courts Determine Whether There Has Been a Violation of c. 214, § 1B?

As an initial matter, in order to be protected by this law, a person must have a ―privacy
right‖ in particular information. Courts have ruled that a person has a privacy right in
HIV infection status because: (1) HIV is personal medical information; and (2) HIV is
associated with significant social stigma and discrimination. Simply having a ―privacy
right‖ in certain personal information, however, does not mean that every disclosure is
a violation of the law.

In analyzing whether there has been a violation of the statute, courts will determine
whether there is any legitimate countervailing reason for the disclosure. If there is a
legitimate countervailing reason, the Court will ultimately find a privacy violation
where the nature and substantiality of the disclosure outweigh the legitimate reason put
forth by the defendant. In other words, a court will balance privacy rights versus other
reasons that a defendant articulates as to why a disclosure was necessary in spite of the
infringement upon privacy.

For example, if an employee reveals his or her HIV status to a supervisor, the
supervisor may only reveal that information to others for a necessary business reason.
It may be considered a legitimate business reason to discuss the employee’s HIV status
with other management personnel in connection with making adjustments to a person’s
job duties as a reasonable accommodation. It would not, however, be a legitimate
business reason to tell the employee’s co-workers or non-essential management
personnel.

If a day care center or school revealed the identity of a child or student with AIDS to
parents or other students, there is a good argument that such conduct violates chapter
214, Section 1B. There is no legitimate interest in disclosing the child’s HIV status,
especially since the risk of transmission to others is minuscule.

The Constitutional Right to Privacy

Many Courts have found that a person has a constitutional privacy right to the
nondisclosure of HIV status. Courts have based this right on the Due Process Clause of


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the U.S. Constitution which creates a ―privacy interest‖ in avoiding disclosure of certain
types of personal, intimate information.

The constitutional right to privacy can only be asserted when the person disclosing the
information is a state or government actor – e.g., police, prison officials, doctors at a
state hospital.

Similar to the Massachusetts privacy statute (c. 214, § 1B), courts will balance the nature
of the intrusion into a person’s privacy against the weight to be given the government’s
legitimate reason for a policy or practice which results in the disclosure.

Warning Third Parties of Harm From Clients

A counselor or physician may learn that a client is engaging in unsafe sex or other risky
behavior without having disclosed his or her HIV-positive status to a partner. Many
people have asked whether there is a legal basis to breach client or patient
confidentiality under these circumstances. It is the AIDS Law Project’s view that there
is no clear justification for such a breach of confidentiality under Massachusetts law.
Providers and consumers alike, however, should be aware that the case law in this area
is still developing and remains unresolved. For a legal opinion on how to handle a
specific situation, consult with your supervisor and the health center lawyer.

Massachusetts law has various provisions which permit health care providers, under
certain limited circumstances, to warn third parties of potential harm from a patient.

Physicians

In Alberts v. Devine, a 1985 Massachusetts Supreme Judicial Court Opinion, the Court
stated that physicians owe patients a legal duty not to disclose confidential patient
medical information without the patient’s consent, ―except to meet a serious danger to
the patient or others.‖ The Court did not, and has not since then, articulated the
meaning and scope of the words ―serious danger.‖

Licensed Mental Health Professionals

Massachusetts has a statute which permits licensed social workers and licensed mental
health professionals to warn third-parties under certain limited circumstances.

M.G.L. c. 112, Section 135A, provides that a social worker may, but is not legally
mandated to, disclose confidential communications if:

          the client has communicated an explicit threat to kill or inflict serious bodily
           injury upon a reasonably identified victim or victims with the apparent intent
           and ability to carry out the threat.


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          the client has a history of physical violence which is known to the social worker
           and the social worker has a reasonable basis to believe a client will kill or inflict
           serious bodily injury on a reasonably identifiable victim.

The statute provides that ―any duty to warn or protect‖ is discharged if the social
worker: a) communicates the threat to the identified victim; b) notifies law enforcement
agency; or c) arranges for the client to be hospitalized voluntarily or involuntarily.

There are virtually identical statutes for licensed psychologists (chapter 112, section
129A); and licensed mental health professionals (chapter 123, section 36B).

     Based on current Massachusetts law, there is not a clear legal justification to breach
     the confidentiality of a client’s HIV status. As set out in the first section of this
     outline, Massachusetts has a specific statute prohibiting the involuntary disclosure
     of HIV status by a health care provider. No court has ever interpreted the
     relationship between the HIV confidentiality statute and other general provisions
     permitting disclosure of patient information under limited circumstances by
     doctors or mental health providers. Therefore, providers who involuntarily
     disclose a client’s HIV status risk liability for invasion of privacy. However, it is
     very important to understand that the law is still evolving in this area and it is
     possible that in the future a court will decide that physicians, social workers,
     therapists or counselors may have an obligation to warn third-parties of potential
     exposure to HIV.




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