Mackey Tim, Cuomo Raphael E, Xu Qing, McMann Tiana J, Li Zhuoran, Cai Mingxiang, Wenzel Christine, Yang Joshua S
Global Health Program, Department of Anthropology, University of California San Diego, La Jolla, CA, United States.
Global Health Policy and Data Institute, San Diego, CA, United States.
J Med Internet Res. 2025 Apr 11;27:e70852. doi: 10.2196/70852.
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.
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.
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.
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.
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.
某些人群在临床试验中的代表性不足，这限制了新疗法的可推广性及其在这些人群中的疗效和应用。识别并理解让年轻人参与临床试验的有效策略至关重要，因为他们是未来临床试验参与的重要关键人群。
本研究旨在开发、测试和评估旨在鼓励年轻人参与临床试验过程的数字工具。采用了一种跨学科方法，包括社会倾听、定性焦点小组和协同设计工作坊来实现这一目标。
使用四阶段方法设计和评估数字工具，包括：（1）社会倾听，以描述在线用户自我报告的新冠病毒试验的生活经历；（2）与年轻人进行定性焦点小组讨论，以探索与新冠病毒临床研究犹豫和参与相关的特定生活态度和经历；（3）一系列共创和协同设计工作坊，以构建旨在鼓励参与临床试验的数字工具；（4）一项对照拦截研究，以评估协同设计的数字工具在年轻人中的可用性和特定结果指标。
与接触脸书广告（Δ=0.21）但未接触数字传单（Δ=0.58）的参与者相比，研究参与者在接触移动应用程序原型（10分制下Δ=0.74，P<.01）和网站（Δ=0.93，P<.01）后，参与临床试验的可能性有显著更高的变化。此外，与接触脸书（Meta）广告（x̅=5.06）的参与者相比，接触移动应用程序（x̅=5.76，P=.04）和电子传单（x̅=5.72，P=.04）但未接触网站（x̅=5.55）的参与者在接触后对了解临床试验表现出显著更高的兴趣。拦截研究中的参与者在看到移动应用程序（Δ=0.74，P<.01）或网站（Δ=0.93，P<.001）后比看到脸书广告（Δ=0.21）更有可能考虑参加临床试验，但数字传单（Δ=0.58）没有显示出显著差异。此外，看到移动应用程序（x̅=5.76，P=.04）或数字传单（x̅=5.7二，P=.04）的人比看到脸书广告（x̅=5.06）的人对了解临床试验表现出更多兴趣，尽管网站（x̅=5.55）对兴趣没有显著影响。
与不同的年轻成年人共同设计的移动应用程序和网页可能是推进鼓励包容性临床试验共同目标的有效数字工具。
