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

ABSTRACT

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.

KEYWORDS:

• Decisional capacity
• youth
• HIV
• consent
• assent
• intervention

Acknowledgment

We would like to thank Julianna Capobianco, Alexandra Cario, Anica Colon, HunterDrake, Sarah Gardy, Elham Azamian Jazi, Alicia Marion, Tara Ochoa, Coleman O’Toole, Wendy Rote, Joshua Stanz, and Bernard Washington for their contributions to this manuscript.

DISCLOSURE STATEMENT

No potential conflict of interest was reported by the author(s).

DATA AVAILABILITY STATEMENT

Data will be made available upon request.

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10508422.2024.2358323.

Additional information

Funding

This work was supported by the University of South Florida Nexus Initiative (UNI) Award.