“PROUD to have been involved”: an evaluation of participant and community involvement in the PROUD HIV prevention trial

Abstract

Background: The PROUD trial, a HIV prevention trial in men who have sex with men and trans women, set out to involve community representatives and trial participants in several ways. PROUD also aimed to evaluate participant involvement, to learn lessons and make recommendations for future clinical trials. Methods: Two structured surveys, one of participant and community representatives involved in the PROUD study, and the other of researchers from the PROUD team, were carried out in 2017. The results from the surveys were reviewed quantitatively and qualitatively, and themes emerging from the data identified and synthesised. Results: Survey invitations were sent to 88 involved participants, 11 community representatives and 10 researchers. The overall response rate was 55% (60/109). Overall, participants were younger than community representatives, and the majority were from Greater London. As expected, participants were predominantly involved in participant involvement meetings and community representatives in management committees. Participants and community representatives cited different motivations for getting involved in PROUD. Overall, participants were positive about their involvement; only two participants rated their experience unfavourably. Community representatives were also broadly positive. Most participants and all community representatives felt their involvement made a difference to the trial, themselves and / or the organisations they represented. However, some participant answers reflected the impact of participation in the trial rather than involvement in PPI activities. Researchers felt that PPI had positive impact across the entire trial cycle. Half felt they would have liked there to have been more PPI activity in PROUD. Researchers noted some challenges and recommendations for the future, including need for adequate funding, more engagement in PPI by all researchers, the need for PPI expertise to facilitate involvement activities and training and mentoring in PPI. Conclusions: Involving clinical trial participants and wider community representatives as active partners in PPI is feasible and valuable in trials. Researchers are encouraged to consider and appropriately resource participant involvement and prospectively evaluate all PPI within their trials.

Patient and public involvement in mobile health-based research for hay fever: a qualitative study of patient and public involvement implementation process

“…While the PPI interactive evaluation form used for this study was sourced from an expert team on PPI research and referred previous studies [35][36][37] and PPI evaluation formats [38,39], its validity and reliability has not yet been confirmed. Globally, publications on the impacts of PPI on research quality have nearly tripled, increasing at an unprecedented rate [13,48].…”

“…The questionnaire used for the interactive evaluation was created by PPI experts of the team (KFujisawa and KM) based on previous studies [35][36][37] and PPI evaluation formats [38,39], which comprised 10 multiplechoice and two free-answer questions (Additional file 1: S1 and S2. Specific items of the multiple-choice portion of the interactive evaluation were tailored as appropriate, and a 3-5-point Likert scale was used for evaluation (Table 2).…”

Brief Report: Representations and Willingness of People Living With HIV in Switzerland to Participate in HIV Cure Trials: The Case of Gene-Modified Cell Therapies

“…25 Such an approach, integrated in the UNAIDS/AVAC Good Participatory Practice guidelines, 26 has been successfully implemented in HIV preventive research and PrEP-related clinical trials and has been found to be beneficial to both researchers and PLWH involved. [27][28][29] Similar initiatives should be conducted for GMCT research.…”

Patient and Public Involvement in HIV research: a mapping review and development of an online evidence map

“…We further excluded 25 studies for the following reasons: only conference abstract available (n = 11), study examines PPI on a theoretical level without providing guidance (n = 9), not about HIV (n = 2), not about HIV research only HIV service provision (n = 3). The remaining twelve studies were extracted in detail [17][18][19][20][21][22][23][24][25][26][27][28].…”