OA19.05
Background: The Good Participatory Practice (GPP) Guidelines and Tools for Biomedical HIV Prevention Trials aim to ensure effective stakeholder engagement throughout trials. GPP Guidelines (2nd edition) have been published, but experience with translation from principles to practice is limited. We evaluated the formal implementation of 16 GPP principles within the FACTS 001 trial, a phase III licensure trial of tenofovir 1% gel conducted across 9 sites in South Africa.
Methods: Prior to trial initiation, staff and community advisory boards (CABs) at all sites received GPP training. Sites subsequently produced comprehensive GPP plans; these were reviewed and updated quarterly, and sites reported monthly on the implementation of the plans. We evaluated 44 GPP plans and 129 monthly reports produced by sites between January 2012 and July 2013 to determine the extent to which the GPP principles were applied and found effective.
Results: FACTS sites effectively applied all of the GPP principles relevant to sites before and during implementation of the trial. This was achieved through support from a full-time GPP manager based in the CORE team, formal incorporation of GPP procedures into the Manual of Procedures, extensive staff and CAB trainings, and regular review of site materials. While plans were not always implemented as designed, sites developed site-specific strategies and used new tools to meet specific needs. Challenges included staff turn-over at sites, and the need for repeat training in GPP planning and reporting. Balancing the requirement for multiple tools to monitor GPP formally, without making monitoring burdensome, was a key lesson learned.
Conclusions: The GPP guidelines provided a framework for the development of effective stakeholder engagement in the FACTS trial. Site-specific GPP plans provide useful over-arching guidance and strategies needed for rapid response situations.
