1. INTERNATIONAL AIDS SOCIETY Stakeholder consultation to address issues related to tenofovir prophylactic research SUMMARY MEETING UPDATE, MAY 2005, SEATTLE, USA Yasmin Halima, IAS Senior Consultant July 2005, Rio de Janeiro

3. Stakeholder Consultation Draft Report
Controversies surrounding tenofovir trials starkly illustrate the costs involved when trial sponsors, researchers, communities, and activists fail to work in collaboration.
Stakeholder Consultation Draft Report

4. IAS convened stakeholder consultation Bill and Melinda Gates Foundation US National Institutes of Health US Centers for Disease Control and Prevention Meeting organised to address issues raised by community - community engagement - informed consent - prevention counselling and availability of prevention tools - provision of treatment and care including for those who seroconvert Over 50 international stakeholders gathered including - host country ministries of health - investigators - local and international community advocates and activists - bioethicists - study sponsors - Gilead

5. Foster meaningful dialogue between key stakeholders
Purpose of meeting
Foster meaningful dialogue between key stakeholders
Identify ethical and operational challenges that obstruct research and work towards resolution of these challenges
Identify strategies for problem management, including reporting emerging challenges

6. willingness to work together to resolve issues
opportunity for intensive country-specific working groups
many challenges can be seen as practical problems rather than ethical controversies

7. Stopped, Ongoing and Planned TDF PREP Trials
Location Group Sponsor Results Status
Cambodia high-risk women NIH & FHI stopped
Nigeria high-risk women FHI stopped
Cameroon high-risk women FHI stopped
Ghana high-risk women FHI ongoing
Malawi high-risk men FHI stopped
Botswana young adults CDC ongoing
Thailand IDUs CDC ongoing
USA MSM CDC ongoing
Peru MSM NIH planned

8. Country-specific strategies and recommendations
Botswana
development of educational resources to improve research and
treatment literacy of communities and potential trial participants;
development of National Prevention Guidelines on civil society
engagement
Cameroon
provision of PMTCT services for trial enrolees infected during trial;
treatment for Hepatitis B and C coinfection and HIV if needed
Thailand
safeguarding trial participant’s safety, in particular IDUs and CSWs

9. full consultation report international taskforce
Meeting recommendations and outcomes
rapid summary report
full consultation report
international taskforce

10. Researcher, Stakeholder Meeting, Seattle
“This meeting has been healing in a lot of ways. There was a great divide. We didn’t do everything right in these trials. Sometimes that’s really important to say.”
Researcher, Stakeholder Meeting, Seattle