Identifying Ethical and Culturally Responsive Research Activities to Build Trust and Improve Participation of Black Sexual Minority Men in Pre-Exposure Prophylaxis Telehealth Clinical Trials: Qualitative Study (Preprint)

Abstract

Telehealth interventions could improve pre-exposure prophylaxis (PrEP) initiation and adherence in high HIV incidence groups such as young Black sexual minority men (BSMM). However, young BSMM remain distrustful of and underrepresented in clinical trials. Therefore, ethical and culturally responsive ways are needed to build trust and improve their participation in PrEP telehealth clinical trials.

To bridge this gap, this study identified ethical and culturally responsive activities to build trust and improve participation of young BSMM in PrEP telehealth clinical trials.

We obtained data from 7 virtual, synchronous focus groups that were conducted from April to August 2020 and consisted of 28 BSMM aged 18-34 years. Focus groups included a brief survey distributed online via Qualtrics followed by a virtual, synchronous focus group conducted via Zoom that lasted between 50 and 75 minutes. Focus groups were stratified by age (18- to 24-year-old participants and 25- to 34-year-old participants), outlined the components of an example PrEP telehealth randomized controlled trial, and included questions on domains of the study design—research motivations, study funding, recruitment activities, informed consent details, randomization, follow-up, and end of study activities. Participants were asked targeted questions regarding the ethics and trustworthiness of the study and ways in which researchers could gain their trust through the protocol used in the PrEP telehealth clinical trial.

The focus groups included 2 groups of 18- to 24-year-old participants and 5 groups of 25- to 34-year-old participants. The mean age of participants was 27.2 years (SD 4.4 years). Of the 28 participants, 10 (36%) reported a bachelor’s degree to be their highest completed education level and 6 (21%) reported some graduate degree or higher to be their highest completed education level. Most participants (16/28, 57%) reported that they worked full-time and that they were single or not in a committed relationship (21/28, 75%). Most participants (24/28, 86%) reported that they used at least one drug before sex in the 6 months prior to the study. All participants reported that they heard about PrEP and 36% (10/28) were current PrEP users. Overall, the focus groups yielded themes related to the impact of researcher intentions, study funding, recruitment activities, informed consent details, randomization, and study team interactions during and after the study on trust and participation in the clinical trial.

Medical and research mistrust persists among BSMM. This study identified several ethical and culturally responsive activities to build trust and improve participation of young BSMM in PrEP telehealth clinical trials. Future studies should assess the relative impact of implementing these findings on research participation in a PrEP telehealth clinical trial.