The draft second edition of The Good Participatory Practice (GPP) Guidelines for Biomedical HIV Prevention Trials were released at the International AIDS Conference in Vienna by AVAC. The GPP Guidelines aim to provide trial funders, sponsors, and implementers with systematic guidance on how to effectively work with a range of stakeholders as they design and conduct biomedical HIV prevention trials.
The guidelines were developed by AVAC and UNAIDS in consultation with a broad range of global stakeholders who have provided perspectives since the first edition was published in 2007. AVAC and UNAIDS are now seeking feedback on the draft second edition from those with interest and expertise in HIV prevention research until 31 October, after which the final second edition will be published.
Clinical trials are guided by Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other guidelines and regulations that cover scientific and general ethical conduct, but global guidelines had not existed for community engagement before the first publication of GPP.
"Recent breakthroughs, including positive results from the CAPRISA 004 microbicide trial, have reenergized prevention research, and around the world, thousands of research participants and hundreds of researchers and trial site staff are working together find new HIV prevention options. Thousands more will be needed as we work to find new solutions to ending the AIDS epidemic," said Mitchell Warren, executive director of AVAC.
"The GPP Guidelines were developed to fill an important gap in the conduct of biomedical HIV prevention research and to help research teams, trial sponsors, trial funders, communities, advocates, and other stakeholders plan, implement, and evaluate community engagement in trials, reduce unnecessary conflict and ensure that research is meaningful to both communities and trial implementers," Warren added.
"AVAC and UNAIDS is pleased to release this new version of the GPP guidelines at the conference at which the groundbreaking results of the CAPRISA tenofovir microbicide gel trial have been presented, recalling that it was the stopping of antiretroviral pre-exposure prophylaxis trials in 2004 that first inspired the development of the GPP guidelines," said Dr. Catherine Hankins, UNAIDS' chief scientific adviser.
The GPP guidelines include: Guiding Principles of GPP that serve as the foundation of the relationship between trial funders, sponsors, implementers, and other stakeholders; GPP Standards that trial funders, sponsors, and implementers should follow when designing, preparing for, conducting, and concluding a biomedical HIV prevention trial.
The GPP Guidelines are available online at: www.avac.org/gppdocuments or www.unaids.org.