Partnering for prevention services

1. Partnering for prevention services Kathleen M. MacQueen, PhD, MPH UNAIDS International Consultation Creating Effective Partnerships for HIV Prevention Trials Geneva, 20-21 June 2005

2. There is a crack in everything, That’s how the light gets in. Leonard Cohen

3. Learning from the Cameroon TDF experience • Strategy at study start-up (June 2004) • Concerns & responses (Feb-Mar 2005) • Current status (June 2005) • Looking toward the future

4. Strategy at start-upCounselors • Experienced HIV VCT counselors hired as study counselors • Originally trained in VCT by the Society for Women and AIDS in Africa (SWAA) or MERO • Counselors observed conducting counseling to ensure they were competent

5. Strategy at start-upCondom use • Male condoms provided free • FHI staff provided training to ALL staff on • Condom use • Correct condom use demonstrations • The need to encourage condom use at each monthly visit

6. Strategy at start-upInformed consent • Informed consent • “We do not know if TDF can prevent you from getting HIV. That is why we are conducting the study.” • “We know that the pills without TDF do not protect against HIV infection.” • Informed consent process • Probe for comprehension after each section • Comprehension questions at end of form review • If any question was not answered correctly, that section of the form was reviewed again • If the counselor did not think the participant understood the contents of the consent form, she was not to enroll the participant • Independent witnesses contracted through MERO to observe IC with illiterate participants • IC process took about 1 hour

7. Strategy at start-upMonthly follow-up • HIV pre- and post-test counseling • Risk-reduction counseling on safe sexual practices • Male condoms provided (as many as women asked for) • Participants counseled that • Tenofovir has not been proven to prevent HIV • They may receive placebo, which contains none of the active ingredient in tenofovir

8. Emergent Concerns • Perceived conflict of interest in having study staff provide prevention counseling • Absence of female condoms as part of prevention package • Counselor-to-participant ratio criticized as inadequate • Some women may not have fully understood the experimental nature of the trial & the need for on-going behavioral risk reduction

9. Concerns: Government response • February 3, 2005: Ministère de la Santé Publique du Cameroun suspended trial to address these & other concerns • Distribution of drug & placebo stopped • Official commission established to review trial procedures • Following review, Ministère recommended • Addition of female condoms to prevention package • Use of collaborative contracts with NGOs to strengthen counseling & on-going informed consent

10. Concerns: FHI Response • March 2005: Contracts signed with SUNAIDS and MERO to provide independent participant advocates • Participate in & assure that VCT counseling is understood • Implement risk reduction counseling • Demonstrate correct use of male & female condoms & encourage their use • Provide clear explanations of study-specific issues to participants & community members • Participate in regular meetings with TDF staff • Provide regular reports to the TDF Project & the Ministère • Assist with health care referrals (HIV & other) to contracted centers

11. Current status • Study suspension remains in effect • No drug distribution for >4 months • Since suspension began, every woman has received monthly follow-up care: • voluntary HIV testing • counseling on HIV risk reduction • Male condoms • medical care for symptomatic sexually transmitted infections • safety tests for liver and kidney function • Female condoms are not distributed due to global supply shortages

12. Looking toward the future • Participant advocates for HIV prevention do not appear to have been used in any other HIV prevention trial • Innovative approach • Quantitative measures of risk behavior will be difficult to interpret • Unable to disentangle suspension effects from changes in counseling • In-depth interviews and/or focus groups with participants, contractors, study staff to include questions about experience with prevention services • Social/behavioral research conducted by IRESCO with separate FHI funding

13. Looking toward the future • Perception, opinion, and anecdotal reports point toward concerns • Innovative approaches to providing prevention services in trials are warranted • But they should also be systematically evaluated • Empirical evidence should be the foundation of best practices for prevention services in prevention trials