Co-creation of digital tools to enhance young adult minority participation in COVID-19 trials

项目摘要/摘要 增加青年、种族和少数民族对新冠肺炎临床试验的参与是至关重要的 减少新冠肺炎疫苗接种和治疗负担方面的健康差距的组成部分。然而， 若干障碍阻碍种族/少数族裔参与审判，包括与以下方面有关的结构性障碍 缺乏财政资源，交通和交通问题，以及群体特定问题，如对 医学/研究团体或对医学实验的关注。尽管广泛的研究已经 侧重于解决少数群体和代表性不足的社区在临床研究中参与度低的问题， 满足21世纪创建包容性临床试验的目标，这些试验代表着快速变化和 美国日益多样化的患者群体仍然是一个巨大的挑战。建议数 项目新颖，通过直接解决复杂的交叉性，填补了关键的研究和创新空白 使用几种跨学科的调查方法对新冠肺炎临床试验和健康公平进行研究。的目标是 拟议的项目是利用涉及大数据、机器学习、数据科学和 社区驱动的定性研究，以开发和评估鼓励少数族裔年轻人的数字工具 参与临床试验过程。通过对ClinicalTrials.gov的数据挖掘和地理空间分析， 对美国哪些社区在获得COVID方面代表性不足的洞察- 将开发19项临床试验(目标1)，同时将使用大数据和机器学习方法 在社交媒体上描述用户自我报告的与新冠肺炎相关的知识、态度和生活经历 平台(目标2)。将利用焦点小组讨论来深入探索具体的合理性， 与少数民族青年参与新冠肺炎临床研究相关的文化规范和历史影响 成人(目标3)。从这多个来源收集的数据将作为一项议定书的基础，以确定、共同和 创建并联合设计一个数字健康工具，以鼓励年轻的成年少数民族参与临床试验 通过共同设计会议和与少数族裔青年举行的试点测试，为少数族裔青年提供培训(目标4)。 将通过在以下人群中进行受控前后研究来评估数字健康工具的有效性 一所被指定为少数民族服务机构的大学的年轻成年大学生群体(目标5)。 拟议的项目将产生一个数字健康工具，旨在增加年轻人对COVID的参与- 19项临床试验。

PROJECT SUMMARY/ABSTRACT Increasing young adult racial and ethnic minorities’ participation in COVID-19 clinical trials is an essential component of reducing health disparities in the uptake of COVID-19 vaccinations and treatment burden. Yet, several obstacles hinder racial/ethnic minority participation in trials, including structural barriers associated with lack of financial resources, access and transportation issues, and group-specific issues such as mistrust of the medical/research community or concerns about medical experimentation. Although extensive research has focused on addressing the low participation of minority and underrepresented communities in clinical research, meeting 21st century goals of creating inclusive clinical trials that are representative of rapidly changing and increasingly diverse patient demographics in the United States remains a significant challenge. The proposed project is novel and fills a critical research and innovation gap by directly addressing the complex intersectionality of COVID-19 clinical trials and health equity using several interdisciplinary methods of inquiry. The objective of the proposed project is to utilize novel approaches involving big data, machine learning, data science, and community-driven qualitative research to develop and evaluate a digital tool to encourage young minority adults to participate in the clinical trial process. Through data mining and geospatial analysis of ClinicalTrials.gov, insights into which communities in the United States are underrepresented in the context of access to COVID- 19 clinical trials will be developed (Aim 1), while big data and machine learning approaches will be used to characterize user self-reported knowledge, attitudes, and lived experiences related to COVID-19 on social media platforms (Aim 2). Focus group discussions will be used to engage in deep exploration of specific rationalities, cultural norms, and historical influences related to COVID-19 clinical research engagement with minority young adults (Aim 3). Data collected from these multiple sources will serve as the basis of a protocol to ideate, co- create, and jointly design a digital health tool to encourage clinical trial participation among young adult minority populations through co-design sessions and pilot testing held with racial/ethnic minority young adults (Aim 4). The efficacy of the digital health tool will be evaluated by conducting a controlled before-and-after study among a population of young adult college students at a university designated as a Minority Serving Institution (Aim 5). The proposed project will result in a digital health tool designed to increase young adult participation in COVID- 19 clinical trials.