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

CDC HIV/AIDS Surveillance Report 2003

12% of US population

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

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Attitudes Toward HIV Testing in the US

HIV in New York City1. Number of PLWHA: 96,645. Male = 67,340; Female 29,3052. 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 1. Requires pre-test counseling

(can be streamlined)

2. Requires post-test counseling

3. Requires separate written and

signed informed consent

CDC Recommendations1. Recommend opt-out

screening (Notify patient that testing will be performed. Patient can decline)

2. Recommend eliminating pre-test 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 TreatmentI, 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 TreatmentI, 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 Testing1. 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 highc) 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 earliera) 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:– 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

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?

Challenges1. 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 CONTINGENCIES1. 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?

GAINERSA. 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.

NON-GAINERSA. 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.

Assembly Health Committee

Senate Health Committee

NYS Health Commissioner

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

Public Hearings

Back channel discussions w/ interest groups

Who are the primary decision makers in the health policy process and how do they exert leadership?

HIV Testing – Then and Now

1985 2006

RISK

RISK

BENEFIT

BENEFIT

Risks and benefits not clear;benefits slightly outweigh risks

Benefits clearlyoutweigh risks

?