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Sunita Kishor, Ph.D. The 2nd Global HIV/AIDS Surveillance Meeting Bangkok, March 2-5, 2009

Ethical Issues Related to Population-Based Surveys with HIV Testing The Demographic and Health Surveys (DHS) Experience. Sunita Kishor, Ph.D. The 2nd Global HIV/AIDS Surveillance Meeting Bangkok, March 2-5, 2009.

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Sunita Kishor, Ph.D. The 2nd Global HIV/AIDS Surveillance Meeting Bangkok, March 2-5, 2009

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  1. Ethical Issues Related to Population-Based Surveys with HIV Testing The Demographic and Health Surveys (DHS) Experience Sunita Kishor, Ph.D. The 2nd Global HIV/AIDS Surveillance Meeting Bangkok, March 2-5, 2009

  2. The Demographic and Health Surveys (DHS) project has been funded by USAID and implemented by Macro International since 1984. • Nationally representative surveys; average sample size is around 10,000 women and men age 15-49. • Primary objective is to help countries collect and use data to develop, monitor, and evaluate health, population, and nutrition programs. Overview of the MEASURE DHS Project

  3. Biological and Physiological Measurements in DHS • Since 2001, HIV testing has been included in 38 surveys • Since 1986, height and weight measurements have been included in most surveys to assess nutritional status • Since 1995, hemoglobin testing has been included in 50+ surveys to estimate prevalence of anemia • Since 1996, other biomarkers have been included in a few surveys to meet country needs including: Syphilis Chlamydia Herpes Simplex Virus 2 Hepatitis B Hepatitis C Vitamin A Deficiency Diabetes Measles Tetanus Toxoid Malaria Lead Lipids (Chol, LDL, HDl, TG)

  4. Since 2001, HIV testing has been included in 38 surveys implemented in 32 countries.

  5. Objectives of HIV Testing in the DHS HIV testing in the DHS is for surveillance, not for a medical trial or for research study. • The objective is to provide: • prevalence estimates, and • information on the characteristics of the epidemic • in order to help governments develop strategic and evidence-based responses to HIV/AIDS.

  6. DHS Standard HIV Testing Protocol: Key Elements • Informed, voluntary interview and informed, voluntary, anonymous HIV testing • Respondents informed during consent process that they will not receive their HIV test results • Respondents referred to nearest facility for free VCT services and provided educational material • Dried blood spots collected on filter paper from a finger prick for testing in central laboratory • No name on the filter paper: only a bar code • Before blood is tested for HIV: • Questionnaire parts destroyed • Original identifiers ‘scrambled’ in data file

  7. Is the DHS protocol ethically reviewed? • Questionnaires and protocols reviewed and approved annually by the Macro Institutional Review Board. Any variations to the protocol must go through another review • Macro IRB is registered with the Office of Human Subjects Protection; granted Federal Wide Assurance • Protocols also reviewed by host-country ethics boards. • If any CDC funds involved, protocol may also be reviewed by CDC Atlanta

  8. DHS Standard Anonymous HIV Testing Protocol: Key Principles • Participation is informed and voluntary • No potential for coercion since • survey test results not returned, and • vouchers typically given even if test refused • Test results are absolutely confidential • No risk of inadvertent disclosure • Anonymity minimizes refusal • Additional costs limited Disadvantage: To know status, respondent has to go to a VCT center which may be far away

  9. Changes and Improvements to the DHS Standard Protocol • In order to improve access to VCT and knowledge of HIV status, different approaches have been used in various surveys: • Newly established fixed sites (Mali 2001) • Existing sites equipped and/or updated (Ethiopia 2005, Uganda 2004/05) • Outreach VCT sites established for short durations at fixed locations (Uganda 2004/05, DRC 2007) • Reimbursement for travel cost (Malawi 2004, Cambodia 2005) • Mobile VCT following the teams during fieldwork (Kenya 2003)

  10. Other Potential Approaches • Mobile VCT: Team visits each cluster after the survey interviewers leave; sets up a fixed VCT site for one week; also provides home-based VCT, on request. VCT available to everyone in the community. • Results delivered to respondent at the time of the interview: RDTs done, and trained counselors give results to respondents immediately in the home.

  11. Other Potential Approaches • HIV test results sent to nearby clinic: respondent goes to nearby clinic to get test results about 8 weeks after the survey (testing done in central laboratory)

  12. All approaches raise ethical issues…

  13. Conclusions • In every country the survey should contribute to HIV counseling and testing, not on its own, but as part of the country’s effort to scale up the response to HIV. • Surveys are done in very different settings. What is possible in one country may not be possible in another country. • Protocols should not be so complex that good services cannot be ensured. • There is no one perfect system for all countries: need to be flexible in meeting country needs

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