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
% dead from HIV-related causes
3.5 years after AIDS diagnosis
20%
17.7%
15%
11.2%
10%
5%
0%
AIDS Diagnosed Concurrently
w/HIV
DOHMH HIV Surveillance & Epidemiology, 2005
AIDS Diagnosed After HIV (Not
Concurrently)
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:
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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
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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
(can be streamlined)
2.
Requires post-test counseling
1. Recommend opt-out
screening (Notify patient that
testing will be performed.
Patient can decline)
3.
Requires separate written and
signed informed consent
2. Recommend eliminating pretest counseling.
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 xray, 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
negative partners: HIV pos Aware
vs HIV pos Unaware
Marks G, et al JAIDS, 2005;39:446
68%
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
(78%)
23,020
(97%)
+54
HIV
Positive
168
268
+59
Arguments for Opt Out Screening,
cont.
• Prenatal HIV testing for
pregnant women:
• Meta-analysis of 27
studies of HIV-CT
– 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:
• Participants who tested
HIV negative and
received pre-test
counseling did not
change their risk
behaviors
– 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 HIVpositive 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 noncompliance
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?
A.
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)
B.
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.
C.
Hospitals and clinics will gain as their
reimbursement rates from private and public
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.
A.
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.
B.
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.
C.
Tax revenue. ADAP and Medicaid will be strained
and require more money to sustain existing
standards of HIV care.
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
Public
Hearings
NYS Health
Commissioner
HIV Testing – Then and Now
1985
R
I
S
K
?
B
E
N
E
F
I
T
Risks and benefits not clear;
benefits slightly outweigh risks
2006
R
I
S
K
B
E
N
E
F
I
T
Benefits clearly
outweigh risks