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

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 FoundationUS National Institutes of HealthUS 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

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 andtreatment literacy of communities and potential trial participants;development of National Prevention Guidelines on civil societyengagement

Cameroonprovision of PMTCT services for trial enrolees infected during trial; treatment for Hepatitis B and C coinfection and HIV if needed

Thailandsafeguarding trial participant’s safety, in particular IDUs and CSWs

Meeting recommendations and outcomes

rapid summary report

full consultation report

international taskforce

“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