A community-partnered approach for diversity in COVID-19 vaccine clinical trials

Yelba Castellon-Lopez; Raphael Landovitz; Ejiro Ntekume; Courtney Porter; Rachelle Bross; Robin Hilder; Aziza Lucas-Wright; Eric S. Daar; Pedro Chavez; Christopher Blades; Savanna Carson; D’Ann Morris; Stefanie Vassar; Alejandra Casillas; Arleen Brown

doi:10.1017/cts.2022.471

Journal of Clinical and Translational Science (Jan 2023)

A community-partnered approach for diversity in COVID-19 vaccine clinical trials

Yelba Castellon-Lopez,
Raphael Landovitz,
Ejiro Ntekume,
Courtney Porter,
Rachelle Bross,
Robin Hilder,
Aziza Lucas-Wright,
Eric S. Daar,
Pedro Chavez,
Christopher Blades,
Savanna Carson,
D’Ann Morris,
Stefanie Vassar,
Alejandra Casillas,
Arleen Brown

Affiliations

Yelba Castellon-Lopez: ORCiD; Department of Family Medicine, UCLA David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Raphael Landovitz: Division of Infectious Disease, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Ejiro Ntekume: ORCiD; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Courtney Porter: Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Rachelle Bross: The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA
Robin Hilder: Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Aziza Lucas-Wright: Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA Charles R Drew University of Medicine and Science, Los Angeles, CA, USA
Eric S. Daar: The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA
Pedro Chavez: The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA
Christopher Blades: UCLA Vine Street Clinic, Los Angeles, CA, USA
Savanna Carson: ORCiD; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
D’Ann Morris: Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Stefanie Vassar: Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Alejandra Casillas: Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Arleen Brown: ORCiD; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA

DOI: https://doi.org/10.1017/cts.2022.471
Journal volume & issue: Vol. 7

Abstract

Read online

Abstract Introduction: Communities of color have faced disproportionate morbidity and mortality from COVID-19, coupled with historical underrepresentation in US clinical trials, creating challenges for equitable participation in developing and testing a safe and effective COVID-19 vaccine. Methods: To increase diversity, including racial and ethnic representation, in local Los Angeles County NIH-sponsored Phase 3 SARS-CoV-2 vaccine clinical trials, we used deliberative community engagement approaches to form a Community Consultant Panel (CCP) that partnered with trial research teams. Thirteen members were recruited, including expertise from essential workers, community-based and faith-based organizations, or leaders from racial and ethnic minority communities. Results: Working closely with local investigators for the vaccine studies, the CCP provided critical insight on best practices for community trust building, clinical trial participation, and reliable information dissemination regarding COVID-19 vaccines. Modifying recruitment, outreach, and trial protocols led to majority–minority participants (55%–78%) in each of the three vaccine clinical trials. CCP’s input led to cultural tailoring of recruitment materials, changes in recruitment messaging, and supportive services to improve trial accessibility and acceptability (transportation, protocols for cultural competency, and support linkages to care in case of an adverse event). Barriers to clinical trial participation unable to be resolved included childcare, requests for after-hours appointment availability, and mobile locations for trial visits. Conclusion: Using deliberative community engagement can provide critical and timely insight into the community-centered barriers to COVID-19 vaccine trial participation, including addressing social determinants of health, trust, clinical trial literacy, structural barriers, and identifying trusted messenger and reliable sources of information.

Published in Journal of Clinical and Translational Science

ISSN: 2059-8661 (Online)
Publisher: Cambridge University Press
Country of publisher: United Kingdom
LCC subjects: Medicine
Website: https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science

About the journal

Abstract

Keywords