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

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

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

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

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

Stopped, Ongoing and Planned TDF PREP Trials Location Group Sponsor Results Status Cambodia high-risk women NIH & FHI 2007 stopped Nigeria high-risk women FHI 2007 stopped Cameroon high-risk women FHI 2007 stopped Ghana high-risk women FHI 2007 ongoing Malawi high-risk men FHI 2007 stopped Botswana young adults CDC 2007 ongoing Thailand IDUs CDC 2007 ongoing USA MSM CDC 2007 ongoing Peru MSM NIH 2008 planned

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

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

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