Ethical Issues of Unlinked Anonymous Testing of Left Over Blood for HIV in Antenatal Clinics

1. Ethical Issues of Unlinked Anonymous Testing of Left Over Blood for HIV in Antenatal Clinics Theresa Diaz, MD, MPH CDC GAP

2. Presentation • What is unlinked anonymous testing (UAT)? • Antenatal Clinic (ANC) sentinel surveillance • International History • Data use • U.S. history • Previous ethical reviews

3. Unlinked Anonymous HIV Testing • Anonymous: No one knows who the patient is (staff can not link individual to test result). • Unlinked: Bond between chart (or personal identifying information) and specimen is broken. # 3-5-4

4. Procedures UAT in ANC Clinics • Conducted in clinics where left-over blood or other fluids (originally taken for other reasons, such as syphilis testing) can be tested for HIV surveillance purposes • Coded specimen • All personal identifiers removed • Therefore persons are not consented • No results returned # 3-5-5

5. Why UAT for HIV Surveillance • Participation bias reduced and therefore accuracy improved. • Logistically feasible and practical • Anonymity is maintained. • Does not interrupt or impede access to other clinic services

6. International History of UAT HIV Sentinel Surveillance • WHO guidelines 1989 recommended UAT in sentinel populations, especially pregnant women attending antenatal clinics. • Felt to be representative of general population • WHO Second Generation Surveillance Guidelines 2000, use UAT ANC to follow trends in generalized epidemics • WHO Guidelines 2003: HIV Surveillance in Pregnant Women and Other Populations, recommended UAT ANC in generalized epidemics

7. Positive Aspects of UAT ANC HIV Surveillance data • These data had been the backbone of projections and estimates for all countries in sub-Saharan Africa. • These estimates provided critical information that resulted in increases in USG funds for Global AIDS efforts. • These data are now the main source of information to monitor trends • These data have and can be used to evaluate PMTCT programs

8. Negative Aspects of UAT ANC HIV Surveillance data • Individual woman are not informed of their HIV status • Can be missed opportunity to provide prophylaxis, treatment and prevent infection

9. U.S. History of UAT(Survey of Child Bearing Woman) • Blood samples collected in an anonymous unlinked fashion from new born children using left over blood samples from congenital disease screening. • Treatment became in available in mid 1990s • In 1995, CDC made political decision to stop support of UAT surveys in U.S. • HIV testing and treatment for pregnant women is widely available in the U.S.

10. CDC Ethical Review of Anonymous Unlinked Serosurveys for HIV in International Settings, June 1998. • Okay to not return HIV test results if: • No extra blood drawn for HIV test • Community awareness (no individual consent needed) • True anonymity – identifiers irreversibly stripped • Local access to counseling and testing should be available • Data used to benefit community

11. WHO/AFRO technical network on HIV/AIDS and STI Surveillance, Oct. 2001 • UAT surveillance is to measure HIV prevalence and monitor trends. Attack on UAT as unethical is therefore misdirected, the actual ethical problem is lack of services. • PMTCT and VCT data are not good enough for epidemiologic surveillance. • UAT for surveillance should run parallel to VCT. • UAT should be maintained and improved until there is as adequate coverage of VCT providing high quality data showing no disparity from the data currently provided by UAT.

12. CDC/GAP consult of HIV Serosurveillance, Feb 2002 • Each country must provide ethical clearance and must periodically review serosurveillance. • U.S. standards are not always appropriate. • WHO and CDC should ensure general agreement. • As conditions change – e.g. treatment becomes available – UAT serosurveillance may be reconsidered.

13. Unlinked Anonymous HIV Surveillance in Antenatal Clinics in GAP Countries - 08/2003 • Assessments should be conducted to determine the utility of PMTCT data for surveillance in the general population after an appropriate period of scale-up of PMTCT programs • Focus on scaling up programs and offering VCT to population as part of a national strategy of prevention and care, instead of focusing on returning individual test results in the context of surveillance • May be appropriate to stop doing UAT in ANC when other data sources become reliable for indicating HIV prevalence

14. WHO Ethical Considerations for Surveillance 2004 “Unlinked anonymous surveillance may be imperative for establishing the need for and the provision of testing and counseling programs. Not knowing the levels of infection in either the general population or subgroups at potentially high risk may result in inadequate planning for the HIV epidemic and may preclude effective advocacy for the necessary preventive and clinical services. The possibility of such advocacy provides the basis for an exception to the requirement that unlinked surveillance be undertaken only if access to voluntary testing and counseling is available.”

15. WHO/AFRO Technical Network on HIV/AIDS and STI Surveillance 2006 meeting • All UAT surveillance sites should offer PMTCT services. • PMTCT services should be introduced in ANC clinics in a manner that does not negatively impact UAT surveillance. • All UAT surveillance sites should record on the surveillance form routinely collected variables from the PMTCT program • Countries should assess the feasibility of using PMTCT data for surveillance by: • Comparing HIV prevalence from PMTCT to HIV prevalence from UAT. • Examining the effect of participation bias • Comparing HIV testing algorithms and QA. • A national expert committee should review findings from these assessments and decide if the results indicate proposing replacement of UAT surveillance with PMTCT program data..

16. USG Ethical consultation UAT without informed consent - 2008 • UAT for HIV can be ethically justified in some countries but (perhaps increasingly) not in others. The ethical justification depends on facts and circumstances that can change, and must be reviewed periodically to determine whether they no longer warrant testing without providing results to the individuals tested.

17. Declaration of Helsinki “Individual autonomy should be respected; the endeavour should provide benefits, if not to individuals, to the population, and no harm should be done.”

18. Issues for Panel to Consider • Are there countries or places in which it is appropriate to perform UAT HIV surveillance within ANC clinics? • If PMTCT is widely available in a county should UAT HIV surveillance in ANC clinics still be conducted?