TY  - JOUR
AU  - Mackey, Tim
AU  - Cuomo, Raphael E
AU  - Xu, Qing
AU  - McMann, Tiana J
AU  - Li, Zhuoran
AU  - Cai, Mingxiang
AU  - Wenzel, Christine
AU  - Yang, Joshua S
PY  - 2025
DA  - 2025/4/11
TI  - Approach to Design and Evaluate Digital Tools to Enhance Young Adult Participation in Clinical Trials: Co-Design and Controlled Intercept Study
JO  - J Med Internet Res
SP  - e70852
VL  - 27
KW  - health
KW  - clinical trials
KW  - COVID-19
KW  - digital health
KW  - coronavirus disease
AB  - 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<.01) and website (Δ=0.93, P<.01) compared to those exposed to a Facebook ad (Δ=0.21) but not a digital flyer (Δ=0.58). Furthermore, those exposed to the mobile app (x̅=5.76, P=.04) and electronic flier (x̅=5.72, P=.04), but not the website (x̅=5.55), exhibited significantly higher postexposure interest in learning about clinical trials when compared to participants exposed to the Facebook (Meta) ad (x̅=5.06). Participants in the intercept study were more likely to consider joining a clinical trial after seeing a mobile app (Δ=0.74, P<.01) or website (Δ=0.93, P<.001) compared to a Facebook ad (Δ=0.21), but the digital flyer (Δ=0.58) did not show a significant difference. In addition, those who saw the mobile app (x̅=5.76, P=.04) or the digital flyer (x̅=5.72, P=.04) showed more interest in learning about clinical trials than those who saw the Facebook ad (x̅=5.06), though the website (x̅= 5.55) did not significantly impact interest. Conclusions: Mobile apps and web pages co-designed with young diverse adults may represent effective digital tools to advance shared goals of encouraging inclusive clinical trials. 
SN  - 1438-8871
UR  - https://www.jmir.org/2025/1/e70852
UR  - https://doi.org/10.2196/70852
DO  - 10.2196/70852
ID  - info:doi/10.2196/70852
ER  -