Background:
The Pre-Exposure Prophylaxis (PrEP) Trials Working Group was established in September 2008 with funding from the Bill and Melinda Gates Foundation under the aegis of the Forum for Collaborative HIV research. Its establishment followed discussions held by various PrEP trial investigators concerning the need and desire for a neutral forum in which PrEP trial investigators and sponsors could convene for the purpose of sharing information, coordinating current and future research activities, plan for dissemination of trial results, and collaboratively discussing implications of trial results for future HIV prevention research and programmatic activities. Therefore, the PrEP Working Group was established in order to facilitate the synergistic collaboration between researchers engaged in conducting PrEP efficacy trials as a means for HIV prevention. After subsequent discussions with trial investigators and sponsors, The Forum convened the first meeting of the group on September 7, 2008, in Cape Town, South Africa. Each PrEP clinical trial team was invited to send representatives to the meeting; representatives from the organizations sponsoring the PrEP trials were also invited to attend.
Objectives:
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The objectives of the PrEP Trials Working Group are as follows:
- To create a forum in which groups actively involved (or about to be involved) in PrEP safety, efficacy and/or effectiveness trials may share information, experiences and early results in a setting of confidentiality, openness, and trust;
- To create opportunities for groups undertaking PrEP trials to share and potentially standardize measurement tools, trial procedures, etc. so that results can be meaningfully compared across trials;.
- To brainstorm solutions to the complex problems facing the conduct of PrEP trials, such as estimating HIV incidence before a trial site is selected, sharing trial sites, and developing simpler methodologies for estimating product effectiveness in smaller trials;;
- To share "lessons learned" from completed or ongoing PrEP trials in order to enhance or inform the conduct of ongoing or future PrEP trials;
- To learn from researchers undertaking effectiveness trials of other prevention technologies with the aim of enhancing the optimal conduct of PrEP trials;
- To facilitate communications with and between data safety and monitoring teams;
- To facilitate information exchange and effective communication between researchers, sponsors, and members of advocacy and target user communities.
Status:
- First Meeting: September 2, 2008, Capetown, South Africa
- Second Meeting: February 7, 2008, Boston, MA
- Third Meeting: July 17-18, 2009, Capetown, South Africa
