Opt-in HIV Testing:Counterpoint

Douglas G. Fish, MD

Asst. Professor of Medicine

Head, Division of HIV Medicine

Albany Medical College, Albany, NY

November 15, 2006

Epidemiology of HIV/AIDS in the US

AIDS incidence by year By risk group

Valdiserri R, et al. 10th CROI, Boston 2003, #4; Data from the CDC

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

94 95 96 97 98 99 00 01

Year

Nu

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of

HIV

dia

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es

MSM

Heterosexual

IDU

MSM/IDU

Year of diagnosis

Nu

mb

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f ca

ses

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

95 96 97 98 99 00 01

It’s not the what,

but rather the how.

What are the goals?

Diagnose people with HIV Diagnose HIV earlier

39% with AIDS within 1 year of HIV diagnosis in 2004*

Diagnose people with their consent Maintain confidentiality

*CDC, HIV/AIDS Surveillance Report, Vol. 16, 2005

What are the barriers to this goal? Lack of perceived risk 61% Their doctor never recommended it They worry about confidentiality They don’t know where to get tested They don’t like needles or giving blood They’re afraid they will test positive

2006 Kaiser Family Foundation Survey of Americans on HIV/AIDS

The Written Consent

How much of a barrier is it, really? Allows for an exchange of information Patients’ questions answered Revised consent form is quick

good information can be given to the patient

Objectively documents the interaction

Provider Barriers to Testing

Perception of limited risk Fitting HIV testing in at all Consenting process Fear of a positive result, and having to

deal with it Tracking patients to get them into care

Principles of Bioethics

Justice

Beneficence

Autonomy

We all have an HIV status…

Do you know yours?

Written vs Verbal Consent

Definitive documentation with written consent

Preserves the true meaning of consenting process

Less prone to subtle coercion

Informed Consent vs Assent

Opt-out assent: “The patient will be notified that the test will be performed, and consent is inferred unless the patient declines.”

Informed consent: Explanation of the risks, benefits and alternatives to testing, and some attempt to ensure that these are understood

“I thought I had already been tested?” Among those reporting having been

tested for HIV/AIDS, 23% thought that HIV testing was done as part of a routine exam

A third thought that blood drawn at a doctor’s office was automatically tested for HIV “I must be fine.”

Kaiser Family Foundation Survey of Americans on HIV/AIDS, 2004

HIV Testing in Pregnancy

Huge success in decrease of mother-to-child HIV transmission

95% of mothers agree to testing

New York State led the way

Yet done with current, informed consenting process

The Flu Shot

Vaccine information sheet

Consent form?

Cholesterol check or PSA? HIV ELISA is a screening test

Some who screen positive won’t have it

A significant number who screen positive will

Unless using the rapid test, the diagnostic test (Western blot) is done reflexively

Prostate Cancer or AIDS

Life-altering diagnosis

One can’t ever be fully prepared, but shouldn’t we try?

The individual before me is my patient Duty to inform, respect autonomy &

protect Doesn’t have to be at the expense of the

public health

HIV: Exceptional or Not?

Still significant stigma to HIV diagnosis

Ramifications for insurance, health care, job and societal/cultural acceptance

Potential destigmatization of testing does nothing to mitigate stigma for those who test positive

An HIV-positive Diagnosis

Stressful Presented insensitively adds to the

traumaFirst do no harm

Requires additional information be relayed immediately

Mandates of linkage to care may deter provider offices and emergency departments from testing

Are we engaging the PWA community?

Don‘t they have something to teach us?

They have been through this.

Have we asked them?

We should engage the infected/affected community in this discussion.

Do patients have a right not to know their HIV status?

Public health – the greater good?Decreased transmissionEarly treatmentAvoid hospitalization

Telling people what’s good for them

Potential Unintended Consequences False sense of security if negative?

The burden of disproving the false positives

Could routine, opt-out testing drive people from care?

People not in care at all

More alike than different

HIV testing should be broadened Earlier HIV diagnosis yields better

prognosis We have better therapies Access is available in New York Routine HIV testing appears cost-

effective

Opt-How? Opt-ion… Prenatal testing was the pilot Broaden HIV testing, absolutely Educational campaign to health care

providers Any provider can consent

Educational campaign to patients Know your status

Maintain written, informed consent

Thank you!