Approach to Design and Evaluate Digital Tools to Enhance Young Adult Participation in Clinical Trials: Co-Design and Controlled Intercept Study

Abstract

Background: Certain populations are underrepresented in clinical trials, limiting the generalizability of new treatments and their efficacy and uptake in these populations. It is essential to identify and understand effective strategies for enrolling young adults in clinical trials, as they represent a vital and key demographic for future clinical trial participation. Objective: This study aimed to develop, test, and evaluate digital tools designed to encourage the participation of young adults in the clinical trial process. An interdisciplinary approach, incorporating social listening, qualitative focus groups, and co-design workshops, was used to achieve this goal. Methods: Digital tools were designed and evaluated using a 4-phase approach that included: (1) social listening to characterize lived experiences with COVID-19 trials as self-reported by online users, (2) qualitative focus groups with young adults to explore specific lived attitudes and experiences related to COVID-19 clinical research hesitancy and engagement, (3) a series of cocreation and co-design workshops to build digital tools aimed at encouraging clinical trial participation, and (4) a controlled intercept study to assess the usability and specific outcome measures of the co-designed digital tools among young adults. Results: A significantly higher change in the likelihood of participating in a clinical trial post exposure was observed among study participants when exposed to prototypes of a mobile app (Δ=0.74 on a 10-point scale, P