ethical dimensions in hiv testing for surveillance

1. Ethical dimensions in HIV testing for surveillance Theresa Diaz Surveillance Team Surveillance and Infrastructure Development Branch Global AIDS Program

2. Presentation Review HIV surveillance systems that require laboratory support General ethical issues related to these surveillance systems Ethical issues unique to laboratory component of these surveillance systems

3. HIV/AIDS Surveillance requiring laboratory support Sentinel HIV surveillance in ANC clinics Left-over blood taken for routine health care Unlinked anonymous testing No test results returned, women unaware of testing Sentinel HIV surveillance in high risk groups Persons consented for HIV testing Sometimes those tests not returned Referral for free VCT when test results not returned Population-based HIV surveys Household surveys Persons consented for HIV testing Usually those tests not returned Usually referral for free VCT

4. HIV/AIDS Surveillance requiring laboratory support ARV drug resistance surveillance Propose to use specimens already collected for surveillance Persons unaware of testing or findings HIV surveillance for recent infections Propose to use specimens already collected for surveillance Persons unaware of testing or findings

5. Strengths of UAT Minimizes self-selection bias for HIV testing � increases data validity Can be carried out where counseling and care/treatment services are not (easily) available UAT does not preclude testing by informed consent � e.g. ante-natal clinics offering PMTCT and function as surveillance sites

6. General ethical issues: HIV sentinel surveillance in ANC clinics Women are not consented for testing Women are not provided HIV test results 1994 AZT found effective in preventing transmission of HIV from mother to infant; missed opportunity to prevent HIV transmission

7. History of UAT HIV surveys in the United States CDC family of surveys � (1987 � 1999) UAT HIV testing in STI patients, drug treatment centers, prisoners, military, job corps, hospitals, university students, child-bearing women Above surveys, except for child-bearing women survey, ended for reasons concerning scientific value National survey of child-bearing women Newborns were tested for HIV (heel prick) � used anonymous approach, women were not informed of HIV test result 1994 AZT found to prevent transmission In the face of inquiries by members of Congress and the media the survey was stopped

8. Background ethical issues UAT for HIV In 1998 an ethical consultation on UAT for HIV surveillance was held at CDC Recommendation that HIV test result did not have to be provided to participants if: No extra blood drawn for HIV test Community was aware of survey True anonymity � identifiers irreversibly stripped Local access to counseling and testing should be available Data used to benefit community UAT testing HIV surveillance is endorsed in resource constrained countries: WHO/AFRO Technical network emphasizes that questions related to ethics of UAT are misdirected, as the major ethical problem is lack of services.

9. General ethical issues: Population based surveys, high risk group HIV surveillance Although persons are aware they will be HIV tested those test results not often returned Returning test results Can confidentiality be maintained? Potential harm � violence against partner Potential benefit � knowledge of HIV status Provision of referral for free VCT Is it accessible? Will persons go get tested?

10. General ethical issues: ARV drug resistance surveillance, recent infections Added on to existing surveillance systems so persons unaware of results ARV drug resistance Is there benefit to individual patient if physician aware of findings? Is community awareness sufficient? Recent infections What benefit, if any, of individual knowledge of result? Scientifically individual results may not be valid (meant for population interpretation)

11. Ethical issues related to laboratory component of HIV surveillance: Potential problems Poor quality HIV testing Inaccurately recording results Mislabeling specimens Not following de-linking procedures for anonymous testing Not maintaining confidentiality for linked testing

12. Ethical issues related to laboratory component of HIV surveillance: Potential consequences Over or underestimation of magnitude Public health actions that would have otherwise not been taken Notifying persons of wrong test results Releasing the identity of HIV infected persons (resulting in stigma etc)

13. Summary Often HIV surveillance systems do not return test results, thus encouraging persons to get HIV tested is important Anonymity or confidentiality must be maintained by laboratory personnel Poor quality HIV testing for surveillance poises multiple ethical issues

14. Steps forward Make sure laboratory personnel are aware of general ethical issues related to surveillance systems Provide adequate training for HIV testing including recording results, labeling specimens, de-linking, and maintaining confidentiality Provide ongoing quality assurance Community-based consent