PD01.01
Background: Sub-optimal product use in previous HIV prevention trials highlights the need for strategies to foster participant adherence to protocol requirements. Early in ASPIRE, participant engagement activities were implemented across all 15 study sites to enhance participant commitment within the prevention trial setting.
Methods: Monthly tracking tools, site presentations and assessment visit summaries were reviewed to describe engagement activities, lessons learned and staff feedback. Proportion of ASPIRE participants engaged is reported from event attendance logs. Participant feedback is taken from staff debriefing reports of qualitative interviews.
Results: Across ASPIRE sites, 76% of enrolled participants attended at least one of 199 staff-facilitated events held between 3/13-4/14. Events fell into 6 broad categories: milestone/retention events, social events, group education, male involvement events, couples workshops and holiday events. Support was fostered through peer educators, motivational speakers and shared experiences. Discussion topics included ring experiences, contraceptive options, adherence, impact of HIV, trial disclosure and community rumors. Social activities included movies, games and employment/life skills training. Lessons learned include designing events to be flexible and participant-centered, ensuring a mix of attendees, while maintaining participant confidentiality and comfort in group settings. Staff reported increased rapport with participants and improved team morale. Preliminary data from 28 participant interviews suggest that participants perceive engagement events as having a positive impact on personal commitment to trial and product use, as well as improved staff relations.
Conclusions: Meaningful participant engagement is essential to HIV prevention trials with long follow-up and ongoing product use. Monitoring of participant engagement activities in ASPIRE will help inform design of future participant engagement and product support strategies in prevention trials.