JMIR Publications

ABSTRACT

Background:

Pre-exposure prophylaxis (PrEP) substantially reduces risk of HIV infection. Tele-health interventions could improve PrEP initiation and adherence for high incidence groups such as Black sexual minority men (BSMM). However, BSMM remain underrepresented in clinical trials and culturally responsive ways to improve PrEP tele-health trial participation among BSMM is needed.

Objective:

To fill this gap, this study identified ethical and culturally responsive study activities to improve PrEP tele-health clinical trials participation among BSMM.

Methods:

Data come from seven virtual, synchronous focus groups among 28 BSMM ages 18-34 were conducted from April to August 2020 to identify culturally responsive research activities to improve PrEP clinical trial research participation. Focus groups included a brief survey followed distributed online via Qualtrics™ followed by a virtual, synchronous focus group conducted via Zoom lasting between 50 and 75 minutes. Focus groups were stratified by age (18-24 vs 25-34) and outlined the components of an example PrEP tele-health randomized controlled trial and probed on domains of the study design- research motivations, study funding, recruitment activities, informed consent, randomization, follow-up, and end of the study activities. Participants were asked targeted questions regarding the ethics and trustworthiness of the study and ways that researchers could gain their trust in the PrEP tele-health trial along the protocol.

Results:

Focus groups resulted in 2 groups of 18-24 year olds and 5 groups of 25-35 year olds. The average age of participants was 27.2 years (SD 4.4). Ten (38.4) reported a bachelor’s degree was their highest education completed; 21% reported some graduate degree or higher. Most reported working full-time (57.1%) and being single or not in a committed relationship (75%). Most (85.7) reported using at least one drug before sex in the 6 months prior to study. Everyone reported ever hearing about PrEP and 35% were current PrEP users. Overall, focus groups yielded themes related to how researcher intentions, study funding, recruitment activities, informed consent details, randomization, and study team interactions during and after during the study impact trust and participation.

Conclusions:

Medical/research mistrust persists among BSMM. Given the salience of medical mistrust, future studies should test the relative impact of implementing findings on research participation in a PrEP tele-health clinical trial.