Competence to Consent and Willingness to Participate in Behavioral Trials Among a Mixed HIV Serostatus Sample of Young Gay and Bisexual Men Who Use Stimulants: A Mixed-Methods Study

Introduction Despite elevated need, young gay and bisexual men (YGBM) who use stimulants are underrepresented in research. Consent processes are essential for human subjects’ protection, yet shortcomings in consent practices and their role in willingness to participate in research have been underexplored.Methods Between July 2024 and January 2025, we enrolled 115 YGBM who use stimulants and are at risk for HIV transmission/acquisition in an online survey assessing willingness to participate and competence to consent to participation in a hypothetical risk reduction trial. We used a mixed-methods approach to examine factors associated with willingness to participate in the hypothetical trial and consent competence and identify motivations to trial participations and shortcomings in competence to consent.Results Participants’ mean age was 21.83 years and 53.1% identified as white. Most participants (76.8%) expressed willingness to participate in the hypothetical trial, driven by personal interest in research, altruism, and compensation. Barriers to participation included scheduling challenges and study risks, including confidentiality concerns. Willingness to participate was higher among younger individuals and those experiencing recent food insecurity (p < 0.05). Participants expressed inadequate comprehension of the experimental design of the trial and therapeutic misconception (i.e., the belief that the trial was primarily designed to benefit their health). Competence to consent was positively associated with health literacy and negatively associated with sensation seeking.Discussion When designing recruitment and retention strategies, researchers should help YGBM identify and navigate potential barriers to participation. Future studies should explore informed consent interventions that enhance participants’ understanding of trial information.