Specific Aims

This proposal responds to the FDA’s desire to advance the understanding of COVID-19 and long COVID or post-COVID conditions for racial and ethnic minorities and to advance the understanding of how to mitigate spread of COVID-19 misinformation and disinformation (RFA-FD-23-009). This Community-Engaged Research (CEnR) project investigates ongoing COVID-19 experiences, related health equity barriers, and clinical trial participation, for African Americans/Blacks, Hispanics/Latinos, and multicultural populations in Southern Maryland’s rural/small-towns of Charles and St. Mary’s counties. During the early COVID-19 pandemic, mis/distrust in rural underrepresented communities was propelled by inconsistent science and repeated public health misinformation/disinformation. Ongoing COVID-19 experiences of African American/Black and Hispanic/Latino communities continue to perpetuate mistrust, reducing willingness to participate in research.

Addressing health equity in COVID-19 experiences and post-acute care, along with underrepresentation in COVID-19 research and clinical trials participation, will require bidirectional engagement; active and authentic partnerships; and activities continuously informed by community-guided research. Moreover, in CEnR, incorporating ongoing COVID-19-related experiences of rural/small town communities, coupled with the need for mitigation of mis/disinformation surrounding public health emergencies, can contribute greatly to overcoming complex health equity barriers.

We are uniquely qualified to collaborate with the FDA because of decades of health equity research in partnership with diverse communities. Our principal community partner in Southern Maryland, C-Datcher & Associates, LLC (CDA), is a leader in health equity education, CEnR, and policy, as well as collaboration with rural, small town, micropolitan and medically underserved populations. Our submission also builds on previous CEnR research aimed at identifying barriers/facilitators to participation in clinical trials; COVID-19, testing, and data sharing barriers/facilitators; vaccine attitudes; community-academic partnerships; and trust and trustworthiness in urban and rural underserved populations, conducted by Ms. Medeiros, Dr. Baquet (MPIs), Dr. Cooper-Williams (Co-Investigator) and Dr. Delores Datcher (CDA).

We propose to leverage this ongoing experience supported by previous NIH, FDA and state CRF funded community-engaged research partnerships, coupled with the PATIENTS Program and UMB School of Pharmacy’s longstanding partnerships to advance health equity in research. In addition, we will assemble a multi-stakeholder Community Advisory Committee (CAC) of COVID-19 patients and leaders of CDA-affiliated community/religious organizations, to ensure relevance of our approach and outcomes. The FDA OMHHE initiative to enhance EQUITY in Clinical Trials framework will guide this study, along with current FDA collaborations on COVID-19 COMMIT EQ and underrepresented populations. 

In this application, we submit “Community-defined Measures to Bridge Health Equity Gaps for COVID-19: Small Town and Rural Needs” to achieve the following aims:  

  • Aim 1: Delineate which COVID-19-related factors impact health equity for rural/small-town Black/African American and Hispanic/Latino residents in Southern MD. 
    • Output: Emergent themes surrounding COVID-19 pandemic, e.g., exacerbation of distrust/mistrust in science/research resulting from inconsistent communication, increase in misinformation, concerns about post-acute care, and participation in and availability of COVID-19 trials.
  • Aim 2: Codesign health equity-focused principles to guide CEnR partnerships to recognize and address mis/disinformation, and to foster COVID-19 research enrollment, including community/faith-based organizations. 
    • Output: Equity-focused principles that address reciprocal relationships; resource sharing among community organizations and research institutions; mistrust/distrust; misinformation/disinformation; other barriers to enrollment in COVID-19 trials; along with access to/dissemination of accurate COVID-19 information. 
  • Aim 3: Codevelop a toolkit to facilitate equity-focused COVID-19 clinical trial research recruitment/retention/implementation protocols; strategies to counter misinformation/disinformation; and methods for greater engagement in FDA Advisory Committees, and other community-based partnerships.
    • Output: Toolkit to guide COVID-19 sponsors, community and faith-based leaders, and researchers in best practices to incorporate evidence-based equity principles related to diverse rural and small-town communities throughout the research process in a practical, sustainable, and scalable manner, along with strategies to counter misinformation/disinformation.