Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research

Maria I Danila; Jeroan J Allison; Karin Valentine Goins; Germán Chiriboga; Melissa Fischer; Melissa Puliafico; Amy S Mudano; Elizabeth J Rahn; Jeanne Merchant; Colleen E Lawrence; Leah Dunkel; Tiffany Israel; Bruce Barton; Fred Jenoure; Tiffany Alexander; Danny Cruz; Marva Douglas; Jacqueline Sims; Al Richmond; Erik D Roberson; Carol Chambless; Paul A Harris; Kenneth G Saag; Stephenie C Lemon

doi:10.1017/cts.2021.797

Development of a multi-component intervention to promote participation of Black and Latinx individuals in biomedical research

J Clin Transl Sci. 2021 Jun 14;5(1):e134. doi: 10.1017/cts.2021.797. eCollection 2021.

Authors

Maria I Danila^{1

2}, Jeroan J Allison^{3

4}, Karin Valentine Goins^{3

4}, Germán Chiriboga^{3

4}, Melissa Fischer^{4

5}, Melissa Puliafico^{4

5}, Amy S Mudano^{1

2}, Elizabeth J Rahn¹, Jeanne Merchant^{1

2}, Colleen E Lawrence⁶, Leah Dunkel⁶, Tiffany Israel⁶, Bruce Barton⁴, Fred Jenoure³, Tiffany Alexander², Danny Cruz⁶, Marva Douglas², Jacqueline Sims⁶, Al Richmond⁷, Erik D Roberson⁸, Carol Chambless⁸, Paul A Harris⁹, Kenneth G Saag^{1

2}, Stephenie C Lemon^{3

4}

Affiliations

¹ Department of Medicine, Division of Clinical Immunology/Rheumatology, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
² University of Alabama at Birmingham Center for Clinical and Translational Science, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
³ UMass Center for Clinical and Translational Science, University of Massachusetts Medical School, Worcester, MA, USA.
⁴ Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.
⁵ Department of Medicine, University of Massachusetts Medical School, Worcester, MA, USA.
⁶ Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
⁷ Community Campus Partnerships for Health, Raleigh, NC, USA.
⁸ Department of Neurology, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA.
⁹ Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.

Abstract

Introduction: Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups.

Methods: We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components.

Results: The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a "storytelling" intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process.

Conclusions: The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

Keywords: Research participation; eConsent; health disparities; intervention.

Abstract

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