1. 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

3. Epidemiology of HIV/AIDS in the US AIDS incidence by yearBy risk group Valdiserri R, et al. 10 th CROI, Boston 2003, #4; Data from the CDC MSM Heterosexual IDU MSM/IDU Year of diagnosis Number of cases 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 80,000 95969798990001

4. It’s not the what, but rather the how.

5. 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

6. 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

7. 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

8. 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

9. Principles of Bioethics Justice Beneficence Autonomy

10. We all have an HIV status… Do you know yours?

11. Written vs Verbal Consent Definitive documentation with written consent Preserves the true meaning of consenting process Less prone to subtle coercion

12. 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

16. “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

18. 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

19. The Flu Shot Vaccine information sheet Consent form?

20. 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

21. 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

22. 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

24. An HIV-positive Diagnosis Stressful Presented insensitively adds to the trauma First do no harm Requires additional information be relayed immediately Mandates of linkage to care may deter provider offices and emergency departments from testing

25. 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.

26. Do patients have a right not to know their HIV status? Public health – the greater good? Decreased transmission Early treatment Avoid hospitalization Telling people what’s good for them

27. 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

28. 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

29. 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

30. Thank you!