This primer was developed to help advocates understand the mechanism of the US Food and Drug Administration’s external advisory committee. It was specifically developed in preparation for the US FDA review of Truvada for use as PrEP in 2012. It offers a guide to the workings of the external advisory committee (a set of outside experts who make recommendations) and ways for civil society to participate in the process.
FDA’s Advisory Committee Review of Daily Oral Truvada as PrEP to Reduce the Risk of HIV Infection: An advocate’s primer for public participation
Anticipo de los Resultados de Ensayos de PrEP: Una poderosa herramienta nueva para la prevención del VIH podría estar cerca. ¿Estamos preparados para ella?
A 2008 document providing background information on pre-exposure prophylaxis (PrEP) and discussing efficacy trials that were then planned and ongoing. It discusses the research agenda and key advocacy priorities to move PrEP research forward.
Trials of Intermittent Dosing of Pre-Exposure Prophylaxis (PrEP): Summary from an AVAC think tank
Four-page summary of 2008 meeting on possibilities for intermittent PrEP research.
Anticipating the Results of PrEP Trials: A powerful new HIV prevention tool may be on the horizon. Are we prepared?
A 2008 document providing background information on pre-exposure prophylaxis (PrEP) and discussing efficacy trials that were then planned and ongoing. It discusses the research agenda and key advocacy priorities to move PrEP research forward.
PrEP Financing in the US: Summary from an AVAC think tank
A six-page summary of an AVAC-convened think tank exploring possibilities of financing for PrEP in the United States.
A Cascade of Hope and Questions: Anticipating results of ARV-based HIV prevention trials
A report designed to help advocates understand results of the 2010 CAPRISA 004 trial and how they related to the research agenda for ARV-based prevention strategies.
Understanding the Results of CAPRISA 004
A 2010 document discussing the results of the CAPRISA 004 microbicide gel trial. It explores the implications of the data and outlines the next steps in evaluating tenofovir gel.
PrEP: A new option for women for safer loving
A brochure designed for women who want information on whether PrEP is the right prevention option for them.
Adherence in HIV Prevention Research: A primer for HIV prevention advocates
A two-page resource providing simple explanations of how adherence is defined and measured in biomedical HIV prevention trials, with a focus on PrEP and microbicides.
Intermittent PrEP (iPrEP) Research Agenda: Summary of an amfAR/AVAC think tank
A six-page summary of a meeting convened by amfAR and AVAC involving leaders from research and research sponsor agencies. The meeting reviewed the status of biomedical, behavioral and animal research relevant to intermittent PrEP, identifed gaps and priorities for moving forward.