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

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.