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A community-partnered approach for diversity in COVID-19 vaccine clinical trials.
Castellon-Lopez, Yelba; Landovitz, Raphael; Ntekume, Ejiro; Porter, Courtney; Bross, Rachelle; Hilder, Robin; Lucas-Wright, Aziza; Daar, Eric S; Chavez, Pedro; Blades, Christopher; Carson, Savanna; Morris, D'Ann; Vassar, Stefanie; Casillas, Alejandra; Brown, Arleen.
  • Castellon-Lopez Y; Department of Family Medicine, UCLA David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Landovitz R; Division of Infectious Disease, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Ntekume E; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Porter C; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Bross R; The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
  • Hilder R; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Lucas-Wright A; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Daar ES; Charles R Drew University of Medicine and Science, Los Angeles, CA, USA.
  • Chavez P; The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
  • Blades C; The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
  • Carson S; UCLA Vine Street Clinic, Los Angeles, CA, USA.
  • Morris D; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Vassar S; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Casillas A; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
  • Brown A; Division of General Internal Medicine and Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.
J Clin Transl Sci ; 7(1): e23, 2023.
Article in English | MEDLINE | ID: covidwho-2239572
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.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: J Clin Transl Sci Year: 2023 Document Type: Article Affiliation country: Cts.2022.471

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: J Clin Transl Sci Year: 2023 Document Type: Article Affiliation country: Cts.2022.471