CERSI Collaborators: C. Daniel Mullins, PhD, University of Maryland-Baltimore; Cynthia Baur, PhD, University of Maryland-College Park
FDA Collaborators: Michelle Tarver, MD, PhD, Jessica Weinberg, MPP, Jose Medina-Torres, DrPH, MPH, CHES; CDRH
Project Start Date: September 1, 2020
Regulatory Science Challenge
One of the FDA’s regulatory science priority areas is to develop methods and tools to improve postmarket evaluation of regulated products. It is important for the FDA to include subpopulation groups in this evaluation based on age, sex, race, and ethnicity. Part of this evaluation is to assess how best to provide comprehensive and useful communications about the regulated product and to help the FDA better understand ways to protect public health.
Project Description and Goals
The ultimate goal of this project is to develop accurate and meaningful communications about COVID-19 testing in general and specifically to underrepresented populations. To achieve this goal, we aim to understand underrepresented populations’ attitudes toward COVID-19 testing and their willingness to share their data in national information banks. What we learn from this study will help the FDA Center for Devices and Radiological Health (CDRH) tailor its health messages and inform its efforts for monitoring COVID-19 spread.
To achieve these aims, the University of Maryland School of Pharmacy PATIENTS Program and University of Maryland at College Park collaborators will conduct a qualitative study using virtual focus group discussions and key informant interviews to gather information from underrepresented participants in the greater Baltimore area. Three to five participants per group with approximately 10-12 members per population of interest, will provide a total of 3-6 key informant interviews or focus groups per population.
Underrepresented population groups of interest include:
- African Americans across the age spectrum
- Individuals whose primary language is Spanish across the age spectrum
- Older adults regardless of race or ethnicity
- People with lower literacy or health literacy
- People with chronic conditions
- Asymptomatic individuals with COVID-19 test positive household member(s).