Post on 23-Jan-2016
description
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