COMmunity Mistrust and Institutional Trustworthiness to advance health EQuity research (COMMIT-EQ)

项目概要/摘要 该提案回应了FDA促进种族和少数民族参与的愿望， COVID-19/COVID-19变体临床试验和/或有助于告知持续的 FDA批准的产品（治疗、诊断和 疫苗）或EUA/EUA扩展产品用于治疗、预防或 COVID-19诊断（RFA-FD-22-003）。我们有资格与FDA合作 由于我们数十年的健康差异和健康公平研究， 与临床试验和社区研究中代表性不足相关的因素- 学术伙伴关系。在COVID-19大流行期间，不一致和交付不佳 主要科学家和决策者的交流，以及持续的卫生不平等 在非洲裔美国人社区，特别是巴尔的摩， 使不信任感永久化，从而降低参与临床护理的意愿， research.为了解决这些根本原因，学术和其他研究机构以及卫生 护理系统必须改变他们的透镜，从一个只关注改变行为， 服务不足和弱势群体。在COVID-19临床试验中推进健康公平是 极具挑战性，但当活动由社区指导时， 研究障碍/因素以及与历史上 代表性不足的社区。通过我们的社区研究（CEnR） 与非裔美国人教会、社区药房和社区咨询机构建立伙伴关系 董事会，我们拟议的研究将共同开发一个以公平为重点的实用战略工具包， 用于促进在临床试验方案制定中纳入公平性的规划的资源 和执行 通过与社区和社区药房合作伙伴的合作，我们的目标是： 目标1：说明以前报告的和新出现的影响健康的障碍和促进因素 非裔美国人参与COVID-19临床试验研究的权益。 目标2：共同设计以健康公平为重点的原则，支持社区卫生研究 （CEnR）促进试验入组并纳入社区组织的合作伙伴关系，例如 非裔美国人教堂，社区药房和研究密集型机构。 目标3：共同开发工具包，促进以公平为重点的COVID-19临床试验研究 招聘、保留和实施协议。

PROJECT SUMMARY/ABSTRACT This proposal responds to the FDA’s desire to advance racial and ethnic minority participation in COVID-19/COVID-19 variant clinical trials and/or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) or products subject to EUAs/EUA expansion for the treatment, prevention, or diagnosis of COVID-19 (RFA-FD-22-003). We are uniquely qualified to collaborate with the FDA because of our decades of health disparities and health equity research, including identification of factors associated with under-representation in clinical trials and research on community- academic partnerships. During the COVID-19 pandemic, inconsistent and poorly delivered communication by leading scientists and policy makers, and continued health inequities experienced in the African American community, and Baltimore in particular, continue to perpetuate the feelings of mistrust that reduces willingness to participate in clinical care and research. To address these root causes, academic and other research institutions and health care systems must shift their lens from one that focuses solely on changing behaviors among underserved and vulnerable populations. Advancing health equity in COVID-19 clinical trials is extremely challenging, yet achievable when activities are informed by community guided research on barriers/factors as well as active and authentic partnerships with historically underrepresented communities. Through our Community-Engaged Research (CEnR) partnerships with an African American church, community pharmacy, and community advisory board, our proposed study will co-develop an equity-focused toolkit of practical strategies and resources to promote planning for incorporation of equity in clinical trial protocol development and implementation. In collaboration with community and community-based pharmacy partners, our Aims are: Aim 1: Delineate which previously reported and emerging barriers and facilitators impact health equity for African American participation in COVID-19 clinical trials research. Aim 2: Codesign health equity-focused principles that support Community-Engaged Research (CEnR) Partnerships to foster trial enrollment and include community organizations, such as African American churches, community pharmacies, and research-intensive institutions. Aim 3: Codevelop a toolkit to facilitate equity-focused COVID-19 clinical trial research recruitment, retention, and implementation protocols.