Pablo K. Valente, Celia B. Fisher, Katie B. Biello, Matthew J. Mimiaga, Giselle O'Connor, Nicoletta Pellegrino, Amelia Knopf, B. B. Brown
PURPOSE: Standard consent practices in HIV research often do not facilitate truly competent informed consent. We examined a brief audiovisual intervention to enhance competence to consent to participate in a hypothetical trial aimed at promoting sexual health and reducing stimulant use among young gay and bisexual men who use stimulants. METHODS: Between June 2024 and January 2025, we enrolled 115 young gay and bisexual men aged 16-24 years who were at risk for HIV transmission or acquisition and reported recent stimulant use. Participants were randomized to standard consent (i.e., written informed consent form) or an audiovisual intervention (i.e., standard consent plus an animated video). We evaluated differences in overall competence to consent and in each competence domain (understanding, appreciation, and reasoning). Secondary outcomes included willingness to participate in the hypothetical trial, satisfaction with the consent, and acceptability of video-enhanced consent. RESULTS: Participants' mean age was 21.8 years (standard deviation = 1.7), and approximately half (53%) identified as White; the remaining were racial/ethnic minorities. Fifty-three participants (46%) were randomized to standard consent practices and 62 (54%) to the audiovisual intervention. Participants in the audiovisual intervention had higher overall competence to consent (p = .02), understanding (p = .04), and appreciation scores (p = .04). There were no differences in reasoning scores or in willingness to participate. Participants in the audiovisual group also reported greater satisfaction with the consent. Acceptability of video-enhanced consent was high across groups. DISCUSSION: Audiovisual consent interventions may be valuable tools to improve competence to consent for HIV and substance use behavioral trials, particularly by enhancing understanding and appreciation of study information.