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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 ... – PowerPoint PPT presentation

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Title: HIV Testing


1
HIV Testing
  • Antonio Urbina, MD
  • Paul Galatowitsch, PhD

St. Vincents LPS New York/New Jersey AETC
2
HIV in the U.S.
  • Since 1999, HIV infections have remained steady
    at 40-45,000/year

3
HIV in the US
  • Lifetime cost of treating HIV Infected Persons
  • 619,000

Schacter, et al 2006
4
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

5
12 of US population
CDC HIV/AIDS Surveillance Report 2003
6
HIV in US
  • During 1993-2004, 39 of persons who tested
    positive for HIV developed AIDS in lt1 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

7
Late Diagnosis of HIV Increases Risk of Death
from AIDS by Two Thirds
DOHMH HIV Surveillance Epidemiology, 2005
8
(No Transcript)
9
Attitudes Toward HIV Testing in the US
10
(No Transcript)
11
HIV in New York City
  • Number of PLWHA 96,645. Male 67,340 Female
    29,305
  • 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
12
HIV in NYC, Cont.
13
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

14
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
15
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.

16
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

17
DEFINING OPT-IN AND OPT-OUT
  • 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.
  • 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

18
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

19
Comparison of NYS Law with CDC Recommendations
  • New York State Law
  • Requires pre-test counseling (can be streamlined)
  • Requires post-test counseling
  • Requires separate written and signed informed
    consent
  • CDC Recommendations
  • Recommend opt-out screening (Notify patient that
    testing will be performed. Patient can decline)
  • Recommend eliminating pre-test counseling.
  • Recommend eliminating separate written and signed
    informed consent forms (General informed consent
    is sufficient to cover HIV testing)

20
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.

21
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 Patients) condition. . .

22
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 Patients) condition. . . I understand that
    I must inform hospital staff should I wish to
    decline any tests and treatments.

23
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
  • Provides greater berth for patients to reflect on
    consequences of a potential HIV result
  • HIV result can cause trauma
  • Stigma for persons testing HIV remains high
  • Breach of confidentiality of ones HIV diagnosis
    can result in discrimination?
  • Persons who receive pre-test counseling will
    reduce HIV risk behaviors?
  • Could opt-out testing drive people from care?

24
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
  • More people will be diagnosed earlier
  • Earlier diagnosis yields better prognosis
  • Fewer hospitalizations
  • Better quality of life
  • Earlier diagnosis yields fewer secondary HIV
    transmissions.
  • Could opt-out testing draw more people to care?

25
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 negative partners HIV pos
    Aware vs HIV pos Unaware

68
Marks G, et al JAIDS, 200539446
26
Arguments for changing to Opt Out
testingRoutine Opt Out HIV Testing Texas STD
Clinics, 1996-97
27
Arguments for Opt Out Screening, cont.
  • Prenatal HIV testing for pregnant women
  • RCT of 4 counseling models with opt in consent
  • 35 accepted testing
  • Some women felt accepting an HIV test indicated
    high risk behavior
  • When testing was offered as Opt Out
  • 88 accepted testing
  • Reported significantly less anxiety about testing
  • Meta-analysis of 27 studies of HIV-CT
  • Participants who tested HIV negative and
    received pre-test counseling did not change their
    risk behaviors

Weinhardt et al, 1999, Am J Public Health
1. Simpson W, et al, BMJ June 1999
28
Is the stigma of an HIV/AIDS diagnosis less of a
concern today than it was years past?

29
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
30
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.h
tml
31
Is NYC capable of managing the logistical
requirements needed to implement routine, Opt
In HIV testing?
  • Challenges
  • Clinical settings must devise policies mandating
    staff to offer HIV testing routinely to all
    patients.
  • All facilities must then train, coordinate
    multiple departments, monitor and evaluate the
    effectiveness of the their HIV counseling and
    testing efforts
  • Economic facilities must pay staff to develop,
    and oversee algorithms and protocols
  • 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.

32
Our experience at St. Vincents
  • 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
    patients care to offer HIV testing

33
Is NYC capable of managing the logistical
requirements needed to implement routine, Opt
In HIV testing?
  • Facilities management must monitor compliance and
    remediate non-compliance
  • 5. COST ??

34
Is NYC capable of managing the logistical
requirements needed to implement routine, Opt
Out HIV testing?
  • Challenges
  • Clinical settings must incorporate HIV testing
    into general medical consent.
  • HIV screening must be added to routine blood
    tests
  • Facilities must establish protocols for linking
    patients testing HIV to care.
  • Economic facilities must pay staff to develop,
    and oversee the incorporation of routine HIV
    screening into general medical consent.
  • 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.

35
Is NYC capable of managing the logistical
requirements needed to implement routine, Opt
Out HIV testing?, cont.
  • Facilities must monitor compliance and remediate
    non-compliance
  • COSTS ??

36
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 gt30 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.
37
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
  • Clinical and social service settings will
    incorporate newly diagnosed persons into their
    service portfolios.
  • State and Federal resources will adjust to meet
    the increased need.

38
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
  • Clinical and social service settings will NOT
    incorporate increased HIV case loads into their
    service portfolios
  • Or will reduce HIV services for all to
    accommodate new cases
  • State and Federal resources will NOT adjust to
    meet the increased need for additional resources

39
Who stands to gain or lose from an Opt-Out HIV
testing policy?
  • GAINERS
  • Persons with undiagnosed HIV will experience life
    saving gains as many will be diagnosed before
    their immune systems are badly damaged and
    difficult to salvage This will substantially
    prolong the length and quality of their lives
    (estimated at 11,338-45,914)
  • HIV negative sexual partners of people with
    undiagnosed HIV infection. As more people are
    diagnosed with HIV under Opt-Out, newly
    identified HIV people can take steps to protect
    their HIV negative partners.
  • Hospitals and clinics will gain as their
    reimbursement rates from private and public
    insurance will increase as they identify more
    patients with HIV disease.
  • HIV/AIDS NGOs will expand to accommodate higher
    case loads.
  • Pharmaceutical companies will realize greater
    profits as demand for ARV drugs and other HIV
    related therapies increase.
  • NON-GAINERS
  • Health settings that receive funding for
    separate HIV/AIDS counseling and testing programs
    will likely see a decrease or elimination of
    funding once all health care providers begin to
    routinely perform HIV testing.
  • Private insurance companies will have to pay more
    in health claims as patients identified earlier
    will survive longer. The average life- time cost
    of treating HIV is now 619,000. Average life
    expectancy from time of diagnosis is 24 years.
  • Tax revenue. ADAP and Medicaid will be strained
    and require more money to sustain existing
    standards of HIV care.

40
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 Committee
Senate Health Committee
NYS Health Commissioner
Public Hearings
41
HIV Testing Then and Now
2006
1985
BENEFIT
RISK
BENEFIT
RISK
?
Risks and benefits not clear benefits slightly
outweigh risks
Benefits clearly outweigh risks
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