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HIV Testing

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					  HIV Testing

   Antonio Urbina, MD
  Paul Galatowitsch, PhD




    St. Vincent’s LPS
New York/New Jersey AETC
       HIV in the U.S.



 Since 1999, HIV infections have
remained steady at 40-45,000/year
                       HIV in the US
     • Lifetime cost of treating HIV Infected
                      Persons


                        • $619,000




Schacter, et al 2006
           HIV in the US


 By end of 2003, 1-1.2 million persons
     estimated to be living with HIV

~1/4 or 252-312,000 persons unaware of their
 infection
                                        12% of US
                                        population




CDC HIV/AIDS Surveillance Report 2003
                   HIV in US
• During 1993-2004, 39% of persons who
  tested positive for HIV developed AIDS in
  <1 year after test result
  – Persons who tested late were more likely to
    be black or Hispanic and been exposed
    through heterosexual contact
     • 87% received their first positive HIV test at an
       acute or referral medical care setting
     • 65% were tested because of an illness
                Late Diagnosis of HIV Increases
                Risk of Death from AIDS by Two
                             Thirds
                                  20%
                                                 17.7%
% dead from HIV-related causes
 3.5 years after AIDS diagnosis




                                  15%
                                                                                11.2%
                                  10%


                                  5%


                                  0%
                                        AIDS Diagnosed Concurrently   AIDS Diagnosed After HIV (Not
                                                   w/HIV                      Concurrently)

DOHMH HIV Surveillance & Epidemiology, 2005
Attitudes Toward HIV Testing in the US
              HIV in New York City
1. Number of PLWHA: 96,645. Male = 67,340; Female 29,305
2. Estimated number of undiagnosed HIV infections: 11,338 - 45,914*

About 1 in 70 New Yorkers is infected with HIV, but the proportion of people
  in different groups who are infected varies widely:

•   1 in 40 African Americans.
•   1 in 25 men living in Manhattan.
•   1 in 12 black men age 40-49 years.
•   1 in 10 men who have sex with men.
•   1 in 8 injection drug users.
•   1 in 5 black men age 40-49 in Manhattan.
•   1 in 4 men who have sex with men in Chelsea.


    NYC DOH 2006
HIV in NYC, Cont.
             Today in NYC…
12 people will be diagnosed with AIDS
  • 9 will be black or Hispanic
  • 3 will be women
3 people will first learn they are HIV-positive
 when they are already sick from AIDS
4 people will die from AIDS
  • 3 will be black or Hispanic
Key Dates in History of HIV Testing
•    1981: First AIDS case reported
•    1984: Human immunodeficiency Virus (HIV) identified
•    1985: First test for HIV licensed (ELISA)
•    1987: First Western Blot blood test kit
•    1992: First rapid test
•    1993: CDC releases updated guideline on HIV testing
•    1994: First oral fluid test
•    1995: viral load testing available
•    1996: First home and urine tests
•    2002: First rapid test using finger prick
•    2003: Rapid finger prick test granted CLIA waiver
•    2004: First rapid oral fluid test (also granted CLIA waiver)
•    2006: CDC releases new U.S. guidelines recommending routine HIV
     screening of all adults in health care settings.*
    *Kaiser Family Foundation HIV/AIDS Policy Fact Sheet, June 2006. www.kff.org
                   Definitions
• Informed consent for HIV testing: A process of
  communication between patient and provider
  through which an informed patient can choose
  whether to undergo HIV testing or decline to do
  so
  – Elements of informed consent typically include
    providing oral or written information regarding HIV,
    the risks and benefits of testing, the implications of
    HIV test results, how test results will be
    communicated, and the opportunity to ask questions.
               Definitions
• HIV prevention (pre-test) counseling: An
  interactive process of assessing risk,
  recognizing specific behaviors that
  increase the risk for acquiring or
  transmitting HIV, and developing a plan to
  take specific steps to reduce risks
DEFINING OPT-IN AND OPT-OUT
1. Opt-in HIV testing. Requires HCW to provide
   counseling and a separate written informed
   consent, which patients must sign before being
   permitted to have an HIV test.
2. Opt-out HIV testing. Patients are informed
   either orally or via general medical consent
   that HIV testing will be included as part of the
   routine blood tests. Patients can decline the
   HIV test (opt-out). Assent is inferred unless the
   patient declines testing
 2006 CDC Recommendations
• Intended for the following healthcare
  settings:
  – ED, urgent care clinics, inpatient services,
    substance abuse treatment clinics, public
    health clinics, correctional facilities and
    primary care setting
• Excludes organizations performing HIV
  testing in non-clinical settings
  – CBOs, outreach settings, mobile vans
Comparison of NYS Law with CDC
      Recommendations

New York State Law                   CDC Recommendations
1.   Requires pre-test counseling    1. Recommend opt-out
     (can be streamlined)               screening (Notify patient that
                                        testing will be performed.
2.   Requires post-test counseling      Patient can decline)


3.   Requires separate written and   2. Recommend eliminating pre-
                                        test counseling.
     signed informed consent
                                     3. Recommend eliminating
                                        separate written and signed
                                        informed consent forms
                                        (General informed consent is
                                        sufficient to cover HIV testing)
  Texas General Consent Law
Sec. 81.106. General Consent.
(a) A person who has signed a general
  consent form for the performance of
  medical tests is not required to also sign a
  specific consent form relating to medical
  tests to determine HIV infection that will be
  performed on the person during the time in
  which the general consent form is in effect.
  Example of Current General Medical
              Consent
Consent for Medical Treatment
I, the patient named or parent or guardian of the named
    patient, hereby authorize and request SVCMC to provide
    such medical care and administer such diagnostic,
    radiological and/or therapeutic procedures and treatments,
    including, but not limited to, the administration of
    pharmaceutical products, routine blood and urine tests,
    injections and intravenous medications or therapeutic
    solutions as in the judgment of the physicians in
    attendance are deemed necessary and advisable. These
    include all diagnostic tests and procedures, including, but
    not limited to the diagnostic x-ray, pharmaceutical
    products or medications, and drawing of blood and other
    miscellaneous related tests and procedures as may be
    warranted by my (the Patient’s) condition. . .
 Example of Revised Medical Consent
   that includes Opt-out HIV testing
Consent for Medical Treatment
I, the patient named or parent or guardian of the named
    patient, hereby authorize and request SVCMC to provide
    such medical care and administer such diagnostic,
    radiological and/or therapeutic procedures and
    treatments, including, but not limited to, the administration
    of pharmaceutical products, routine blood and urine tests,
    which include HIV screening, injections and intravenous
    medications or therapeutic solutions as in the judgment of
    the physicians in attendance are deemed necessary and
    advisable. These include all diagnostic tests and
    procedures, including, but not limited to the diagnostic x-
    ray, pharmaceutical products or medications, and drawing
    of blood and other miscellaneous related tests and
    procedures as may be warranted by my (the Patient’s)
    condition. . . I understand that I must inform hospital staff
    should I wish to decline any tests and treatments.
  Should New York State Law Requiring Pre-Test
  Counseling And Separate Informed Consent Be
        Changed From Opt-in To Opt-out
    Arguments for retaining Opt-in HIV Testing
1. Provides greater berth for patients to reflect on
   consequences of a potential HIV+ result
  a) HIV+ result can cause trauma
  b) Stigma for persons testing HIV+ remains high
  c) Breach of confidentiality of one’s HIV diagnosis can
     result in discrimination?
2. Persons who receive pre-test counseling will
   reduce HIV risk behaviors?
3. Could opt-out testing drive people from care?
Should New York State Law Requiring Pre-Test
Counseling And Separate Informed Consent Be
      Changed From Opt-in To Opt-out
       Argument for changing Law
1. More people will be diagnosed earlier
  a) Earlier diagnosis yields better prognosis
     a) Fewer hospitalizations
     b) Better quality of life
  b) Earlier diagnosis yields fewer secondary HIV
     transmissions.
2. Could opt-out testing draw more people to
   care?
    Knowledge of HIV Infection and
             Behavior
After people become aware they are
  HIV positive, the prevalence of high
  risk sexual behavior is reduced
  substantially

Reduction in Unprotected Anal or
 Vaginal Intercourse with HIV
                                         68%
 negative partners: HIV pos Aware
 vs HIV pos Unaware
Marks G, et al JAIDS, 2005;39:446
         Arguments for changing to Opt Out testing

     Routine Opt Out HIV Testing Texas STD Clinics, 1996-97

               Opt In           Opt Out          % change



Tested         14,927           23,020           +54
               (78%)            (97%)


HIV            168              268              +59
Positive
  Arguments for Opt Out Screening,
                cont.
• Prenatal HIV testing for           • Meta-analysis of 27
  pregnant women:                      studies of HIV-CT
     – RCT of 4 counseling
       models with opt in consent:

          • 35% accepted testing     • Participants who tested
          • Some women felt            HIV negative and
            accepting an HIV test      received pre-test
            indicated high risk        counseling did not
            behavior
                                       change their risk
                                       behaviors
• When testing was offered
  as Opt Out:
     – 88 % accepted testing
     – Reported significantly less
       anxiety about testing

1. Simpson W, et al, BMJ June 1999        Weinhardt et al, 1999, Am J Public Health
Is the stigma of an HIV/AIDS diagnosis less
 of a concern today than it was years past?
  The Americans w/Disabilities Act
• . . . Persons with HIV disease, both symptomatic
  and asymptomatic, have physical impairments
  that substantially limit one or more major life
  activities and are, therefore, protected by the
  law. Persons who are discriminated against
  because they are regarded as being HIV-
  positive are also protected. For example, a
  person who was fired on the basis of a rumor
  that he had AIDS, even if he did not, would be
  protected by the law.

      http://www.usdoj.gov/crt/ada/pubs/hivqanda.txt
Legal Protections for Persons w/ HIV
Persons With AIDS or HIV - New York State offers
  protection of rights and benefits to employees with
  Acquired Immune Deficiency Syndrome (AIDS), as with
  any other disability or illness. Employees who have AIDS
  or who are Human Immunodeficiency Virus (HIV)-
  positive have the right to continue their normal duties as
  long as they are able. Employees with AIDS or HIV have
  the right to confidentiality regarding their conditions. New
  York State law guarantees confidentiality of HIV test
  results. Unauthorized disclosure of such results is
  subject to legal penalties. Similarly, disclosure of an
  employee's medical condition to unauthorized individuals
  is considered an invasion of privacy.

     http://www.goer.state.ny.us/orientation/policies.html
   Is NYC capable of managing the logistical requirements needed
              to implement routine, Opt In HIV testing?


Challenges:
1.   Clinical settings must devise policies mandating staff to offer HIV
     testing routinely to all patients.
   a) All facilities must then train, coordinate multiple departments,
         monitor and evaluate the effectiveness of the their HIV
         counseling and testing efforts
2.   Economic: facilities must pay staff to develop, and oversee
     algorithms and protocols
3.   HCPs must expand their roles to include separate informed
     consent procedures for routine HIV counseling and testing. Will
     HCPs remember to do so? Will they become busy with other
     patients and forgo offering testing? Will HCPs engage in personal
     risk assessment and decide to offer testing on that basis? Etc.
Our experience at St. Vincent’s
 – 60% of our interns and residents reported
   forgetting to offer the test.

 – 46% reported doing their own risk
   assessment as the reason for not offering
   routine HIV testing

 –   48% reported that they were too busy with
     other patient’s care to offer HIV testing
  Is NYC capable of managing the logistical requirements needed
             to implement routine, Opt In HIV testing?


4. Facilities management must monitor
   compliance and remediate non-
   compliance
5. COST: ??
     Is NYC capable of managing the logistical requirements needed
               to implement routine, Opt Out HIV testing?


Challenges
1.  Clinical settings must incorporate HIV testing into general medical
    consent.
   a) HIV screening must be added to routine blood tests
   b) Facilities must establish protocols for linking patients testing
        HIV+ to care.
2.  Economic: facilities must pay staff to develop, and oversee the
    incorporation of routine HIV screening into general medical
    consent.
   a) Efficiency gains: providers need not remember to offer HIV
        testing, being busy with other patients will not preclude the
        facility from offering HIV screening, Offers of HIV screening
        will not depend on ad hoc risk assessments.
  Is NYC capable of managing the logistical requirements needed
         to implement routine, Opt Out HIV testing?, cont.


1. Facilities must monitor compliance and
   remediate non-compliance

COSTS: ??
      What is the probable impact of universal
          testing on the spread of HIV?
 • Universal testing may decrease new HIV
   transmissions (HIV incidence).

       – Transmission is 3.5x higher among persons
         who are unaware of their infection.
         Translation: New sexually transmitted HIV
         infections could be reduced by >30% each
         year


Marks G, et al. Estimated sexual transmission of HIV from persons aware and unaware that they are
infected with the virus in the USA. AIDS 2005.
 If the HIV law is changed to Opt-Out, what will the
impact be on the delivery of services for those who
                      test HIV+?

POSTIVE CONTINGENCIES:
1. Clinical and social service settings will
   incorporate newly diagnosed persons
   into their service portfolios.

2. State and Federal resources will adjust
   to meet the increased need.
 If the HIV law is changed to Opt-Out, what will the
impact be on the delivery of services for those who
                   test HIV+?, cont
NEGATIVE CONTINGENCIES
1. Clinical and social service settings will
   NOT incorporate increased HIV case
   loads into their service portfolios
  a) Or will reduce HIV services for all to
     accommodate new cases
2. State and Federal resources will NOT
   adjust to meet the increased need for
   additional resources
 Who stands to gain or lose from an
   Opt-Out HIV testing policy?
                       GAINERS                                                NON-GAINERS
A.   Persons with undiagnosed HIV will experience       A.   Health settings that receive funding for separate
     life saving gains as many will be diagnosed             HIV/AIDS counseling and testing programs will
     before their immune systems are badly damaged           likely see a decrease or elimination of funding once
     and difficult to salvage This will substantially        all health care providers begin to routinely perform
     prolong the length and quality of their lives           HIV testing.
     (estimated at 11,338-45,914)
                                                        B.   Private insurance companies will have to pay more
B.   HIV negative sexual partners of people with             in health claims as patients identified earlier will
     undiagnosed HIV infection. As more people are           survive longer. The average life- time cost of
     diagnosed with HIV under Opt-Out, newly                 treating HIV is now $619,000. Average life
     identified HIV+ people can take steps to protect        expectancy from time of diagnosis is 24 years.
     their HIV negative partners.
                                                        C.   Tax revenue. ADAP and Medicaid will be strained
C.   Hospitals and clinics will gain as their                and require more money to sustain existing
     reimbursement rates from private and public             standards of HIV care.
     insurance will increase as they identify more
     patients with HIV disease.

D.   HIV/AIDS NGOs will expand to accommodate
     higher case loads.

E.   Pharmaceutical companies will realize greater
     profits as demand for ARV drugs and other HIV
     related therapies increase.
Who are the primary decision makers in the health policy process
               and how do they exert leadership?

                       Back channel
                      discussions w/
                      interest groups



         NYC Commissioner of Health proposes change in
               HIV counseling and testing law to




   Assembly Health      Senate Health        NYS Health
     Committee           Committee          Commissioner



                           Public
                          Hearings
     HIV Testing – Then and Now
           1985         B                  2006
                        E          R
                        N          I                      B
    R                   E          S                      E
    I                   F          K                      N
    S                   I                                 E
    K         ?         T                                 F
                                                          I
                                                          T
 Risks and benefits not clear;         Benefits clearly
benefits slightly outweigh risks       outweigh risks

				
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