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  1. Advancing Regulatory Science

Communicating about COVID-19 Testing to Underrepresented Populations

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CERSI Collaborators: Jasmine K. Cooper, Ph.D., Moaz Abdelwadoud, MD, MPH, DrPH, Bernard Bright Davies-Teye, MD, MPH, DeJuan Patterson, MPA, Cynthia Baur, Ph.D., Claudia Baquet, MD, Ph.D., C. Daniel Mullins, Ph.D.

FDA Collaborators: Jessica Weinberg, MPP, José Medina Torres, DrPH, MPH, CHES, Ryan Karsner, MD, Toby Lowe, Christine Lee, PharmD, Ph.D., Michelle Tarver, MD, Ph.D.

Project Start Date: September 1, 2020
Project End Date: June 30, 2022

Regulatory Science Challenge

One of the FDA regulatory science priority areas is to develop methods and tools to improve its post-approval evaluation of a product. 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 approved product.

Project Description and Goals

The goal of this project was to develop accurate and meaningful communications about COVID-19 testing in general and specifically to underserved populations. To achieve this goal, researchers aimed to understand underserved populations’ attitudes toward COVID-19 testing and their willingness to share their data in national information banks. Findings from this study will help the FDA Center for Devices and Radiological Health (CDRH) tailor its health messages and inform its outreach efforts for monitoring COVID-19 spread and genetic changes.

To achieve these aims, The PATIENTS Program at the University of Maryland, Baltimore, two Credible Messengers and collaborators from the University of Maryland at College Park, and the FDA conducted a qualitative study using virtual video focus group discussions and individual interviews for sixty-three (63) participants using the Zoom online platform, between October 29th and December 12th, 2020, to gather information from underserved participants in the greater Baltimore area. Researchers wrote the questions in the interview guide in plain language to the simplest reading level, informed by input from health communications experts and local community leaders. The final English guide was translated professionally into Spanish.

Researchers identified and interviewed six underserved and racial minority groups that included:

  1. Black or African Americans across the age spectrum
  2. Individuals whose primary language is Spanish across the age spectrum
  3. Older adults regardless of race or ethnicity
  4. People with lower COVID-19 health literacy
  5. People with chronic conditions
  6. Individuals who lived with someone who was COVID-19 positive

Twenty-six (26) transcripts without personal identifiers were generated and organized by theme to ensure that no new theme appeared across focus groups and interviews. Information was analyzed using NVivo 12 software, and findings were used to develop a one-page “give back” to provide information on the project to participants.

Research Outcomes/Results

A total of 33 themes were extracted from the qualitative data in this study. All 33 themes were encompassed within the following 10 major topic areas:

  1. COVID-19 Knowledge and Experiences;
  2. COVID-19 Testing Benefits and Concerns;
  3. COVID-19 Testing Hindering Factors;
  4. COVID-19 Testing Motivating Factors;
  5. COVID-19 Testing Attitudes;
  6. COVID-19 Testing Results;
  7. Sharing COVID-19 Testing Data;
  8. COVID-19 National Databases;
  9. Suggestions for Communicating about COVID-19 Testing; and
  10. Concerns Over Political Influence.

Conclusion

This study was exploratory by design and limited to a geographical locale; accordingly, findings should be interpreted with caution. However, these findings and recommendations portray considerations for COVID-19 testing communication among underserved populations and racial minorities and inform further large-scale research addressing COVID-19 testing disparities in the United States.

Research Impacts

The investigators present below the project’s accomplishments as they relate to the CERSI research impact metrics of (1) Disseminating Scientific Knowledge, and (2) Catalyzing Action:

Disseminate Scientific Knowledge
  1. Presentation at conferences, meetings, and FDA Advisory Committee meetings:
    1. Information on this research was presented at the School of Pharmacy Dean’s Office virtual series for alumni and friends on December 10, 2020. The presentation titled “FDA and The PATIENTS Collaborating to Understand Perspectives Around COVID-19 Testing” informed the attendees of the research and the importance of collaborating with the FDA in a time of a pandemic.
    2. At the May 2021 Virtual ISPOR Annual Conference, an issue panel on early lessons learned from this research project was presented. The issue panel was moderated by Dr. C. Daniel Mullins, and it discussed with meeting attendees how medical technology researchers can engage underrepresented populations during a Pandemic such as COVID-19 using the lessons learned from this project as an exemplar.
    3. Also, the authors presented the findings of the research at the “CERSI Program Showcase” event held virtually on March 31, 2022. The presentation was titled “Community feedback and lessons learned from Underserved Urban Populations regarding early COVID-19 testing communications: Opportunities and Challenges,” Importantly, the presenters emphasized that the findings reflect perspectives for enhancing trustworthy COVID-19 testing communications during the early phase of the COVID-19 pandemic among the underserved populations in Baltimore. As such, enhancing COVID-19 testing communication strategies and tailoring messaging to underserved populations should continue to address COVID-19 testing information disparities in the United States, although some of the findings may no longer apply in the contemporary timeframe.
  2. Scientific publications/citations in literature:
    1. The research resulted in a publication authored by the PATIENTS Program’s community partner, DeJuan Patterson. Titled “This time, it must be different: Public Health crisis messaging using a credible messenger approach,” the article discussed the use of a credible messengers’ approach, the need to provide people with the right tools (information) to make informed decisions on their own instead of institutions telling people what to do, why the partnership in the current research project is different and emphasized a call to action to repair community and institutional partnerships that restore trust and increase health equity.
  3. Data-sharing with the public:
    1. A plain language summary in both English and Spanish was developed to “give back” and share information on the research project with the study participants and the public. “Give back” materials can be accessed using the links below:
Catalyze Action
  1. Catalyst for future research:
    The findings from this collaborative research provided unique insights into the perspectives for enhancing trustworthy COVID-19 testing communication, which guided The PATIENTS Program’s RADx-UP extramural grant proposal in response to Social, Ethical, and Behavioral Implications (SEBI) Research on Disparities in COVID-19 Testing Among Underserved and Vulnerable Populations (RFA-OD-21-009). The RADx-UP initiatives’ overall goal is to understand the factors associated with disparities in COVID-19 morbidity and mortality and to lay the foundation to reduce disparities for those underserved and vulnerable populations who are disproportionately affected. The RADx-UP initiatives intend to leverage the lessons learned from this research to address mistrust and Social, Ethical, and Behavioral Implications (SEBI) factors that impact access, acceptability, and uptake of COVID-19 testing to reduce disparities for those underserved and vulnerable populations.
 
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