Implementing Good Participatory Practice (GPP) in HVTN505 - The HIV Vaccine Trials Network (HVTN) Experience

AIDS Research and Human RetrovirusesVol. 30, No. S1 Good Participatory Practices and Community InvolvementFree AccessImplementing Good Participatory Practice (GPP) in HVTN505 - The HIV Vaccine Trials Network (HVTN) ExperienceGail B. Broder, James P. Maynard, Shelly T. Karuna, Chuka Anude, Magda E. Sobieszczyk, Scott M. Hammer, and HVTN 505 Protocol Team of the NIAID-funded HIV Vaccine Trials NetworkGail B. BroderFred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA, United StatesHIV Vaccine Trials Network, Community Engagement Unit, Seattle, WA, United StatesSearch for more papers by this author, James P. MaynardFred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA, United StatesHIV Vaccine Trials Network, Communications and Community Engagement Units, Seattle, WA, United StatesSearch for more papers by this author, Shelly T. KarunaFred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, Seattle, WA, United StatesHIV Vaccine Trials Network, Clinical Development Unit, Seattle, WA, United StatesSearch for more papers by this author, Chuka AnudeDAIDS/NIAID/NIH, Vaccine Clinical Research Program, Bethesda, MD, United StatesSearch for more papers by this author, Magda E. SobieszczykColumbia University College of Physicians and Surgeons, Division of Infectious Diseases, Department of Medicine, New York, NY, United StatesSearch for more papers by this author, Scott M. HammerColumbia University College of Physicians and Surgeons, Division of Infectious Diseases, Department of Medicine, New York, NY, United StatesSearch for more papers by this author, and HVTN 505 Protocol Team of the NIAID-funded HIV Vaccine Trials NetworkSearch for more papers by this authorPublished Online:30 Oct 2014https://doi.org/10.1089/aid.2014.5198.abstractAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail P07.02Background: HVTN has valued community involvement in its operations since it began, and continued this practice with HVTN505, a Phase 2B trial in MSM and transwomen. During HVTN505 implementation, results from the iPrEx trial and subsequent FDA approval of Truvada® for pre-exposure prophylaxis (PrEP) led the HVTN to consider changes to HIV prevention services offered to participants (ppts). Several community consultations informed our actions that addressed the GPP principles of transparency and the standard of HIV prevention.Methods: Community members were part of the protocol team from the outset, contributing to study design, informed consent materials, engagement and recruitment efforts, and communications planning. Post-iPrEx, HVTN505 ppts were surveyed about their intent to use PrEP. Consultations were held with Global Community Advisory Board members representing all network sites and with a wider group of community stakeholders to discuss the iPrEx results and standards of HIV prevention. Community input was sought on the advisability of providing PrEP for trial ppts interested in using it, and on the mechanisms of that provision. Post-FDA approval, a second consultation was held regarding implementation of such a plan.Results: Stakeholders felt strongly that ppts should be educated about PrEP and counseled about how to access it. The study was amended and incorporated the potential for 20% uptake in PrEP use among ppts. As discussions in the field continue about the changing standard of HIV prevention, HVTN is working to make Truvada® available free of charge to interested HVTN505 ppts. This evolving discussion will continue to inform future trial designs.Conclusions: The HVTN embraces the GPP guidelines and continues its efforts to fully implement them. Involving the community at all levels is key in the HVTN's structure and all of its trials. HVTN505 provided a unique opportunity to engage the community at a time when the conversation about HIV prevention was evolving particularly rapidly.FiguresReferencesRelatedDetailsCited byTesting the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial7 April 2015 | Clinical Trials, Vol. 12, No. 4 Volume 30Issue S1Oct 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Gail B. Broder, James P. Maynard, Shelly T. Karuna, Chuka Anude, Magda E. Sobieszczyk, Scott M. Hammer, and HVTN 505 Protocol Team of the NIAID-funded HIV Vaccine Trials Network.Implementing Good Participatory Practice (GPP) in HVTN505 - The HIV Vaccine Trials Network (HVTN) Experience.AIDS Research and Human Retroviruses.Oct 2014.A105-A106.http://doi.org/10.1089/aid.2014.5198.abstractPublished in Volume: 30 Issue S1: October 30, 2014PDF download