Multimedia consent to improve decisional capacity among youth living with HIV: findings from a randomized controlled pilot trial

This pilot randomized controlled trial explored the feasibility, acceptability, and potential utility of an intervention to improve the decisional capacity (DC) for research consent/assent among youth living with HIV (YLWH). We randomly assigned 30 YLWH aged 13-24 to a control (paper-based) or intervention (multimedia) consent/assent condition. Using a between- and within-subjects design, participants completed a demographic questionnaire and measures of DC, acceptability/feasibility, and voluntary self-consent perceptions after undergoing a hypothetical consent/assent process for a biomedical HIV study. Findings suggest participants found the intervention feasible and acceptable. Participants in the intervention condition scored higher on a DC measure; however, scores did not meet the predetermined cutoff score for adequate DC in either group. The potential implications of these findings for research with youth, including YLWH, are discussed.