HIV Testing

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HIV Testing

• Antonio Urbina, MD
• Paul Galatowitsch, PhD

St. Vincents LPS New York/New Jersey AETC
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HIV in the U.S.

• Since 1999, HIV infections have remained steady
  at 40-45,000/year

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HIV in the US

• Lifetime cost of treating HIV Infected Persons
• 619,000

Schacter, et al 2006
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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

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12 of US population
CDC HIV/AIDS Surveillance Report 2003
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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

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Late Diagnosis of HIV Increases Risk of Death
from AIDS by Two Thirds
DOHMH HIV Surveillance Epidemiology, 2005
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Attitudes Toward HIV Testing in the US
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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
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HIV in NYC, Cont.
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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

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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
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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.

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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

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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

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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

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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)

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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.

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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. . .
  

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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.

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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?

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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?

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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
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Arguments for changing to Opt Out
testingRoutine Opt Out HIV Testing Texas STD
Clinics, 1996-97
Opt In Opt Out change
Tested 14,927 (78) 23,020 (97) 54
HIV Positive 168 268 59
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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
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Is the stigma of an HIV/AIDS diagnosis less of a
concern today than it was years past?

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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
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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
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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.

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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

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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 ??

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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.

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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 ??

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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.
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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.

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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

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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.

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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
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HIV Testing Then and Now
2006
1985
BENEFIT
RISK
BENEFIT
RISK
?
Risks and benefits not clear benefits slightly
outweigh risks
Benefits clearly outweigh risks