Outcomes from the Body & Soul Clinical Trials Project: A university-church partnership to improve African American enrollment in a clinical trial registry

Abstract

Objectives Historically, African Americans have been underrepresented in clinical trials (CTs) compared to whites. A growing number of research institutions have created CT registries to match volunteers with appropriate studies. In a sample of 745 African Americans from 16 churches, we tested the impact of a culturally tailored intervention aimed at increasing enrollment in a university-based CT registry. Methods Half of the churches received a culturally tailored CT education program (intervention) and half of the churches received a program about healthy eating (comparison). The main outcomes were the odds of posttest self-reported enrollment and verified enrollment. Using linear regression, posttest willingness to participate in a CT was also assessed. Results Odds of verified enrollment were higher in the intervention than comparison group (OR= 2.95, 95% CI: 1.33–6.5, p=0.01). Posttest self-reported enrollment in the registry was also higher among the intervention group than comparison group members (OR=1.94, 95% CI: 1.08–3.47, p=0.03). Willingness to participate in a future CT was higher in the intervention group (β=0.74, p=0.02). Conclusions A culturally tailored education program about CTs can increase enrollment of African Americans in a university-based clinical trials registry. Practice implications Community engagement and health education workshops may improve minority CT enrollment over time.

Factors associated with biomedical research participation within community‐based samples across 3 National Cancer Institute–designated cancer centers

“…Prior studies regarding diversity in research participation have emphasized raising awareness and education, building community relationships, and implementing community‐based research to increase awareness, access, and ultimately participation in biomedical research . The diversity of the research participants in the current study, and the increased likelihood of participation in biomedical research among underrepresented racial and ethnic groups, may be due in part to each site's collaborations with local, well‐established, and long‐standing community partners and our ongoing outreach, engagement, and research programs …”

“…17,[31][32][33] The diversity of the research participants in the current study, and the increased likelihood of participation in biomedical research among underrepresented racial and ethnic groups, may be due in part to each site's collaborations with local, well-established, and long-standing community partners and our ongoing outreach, engagement, and research programs. 13,[34][35][36] The results of the current study also highlight opportunities for NCI-designated cancer centers to build on and leverage community and institutional relationships to better understand and enhance health communication and behavior around biomedical research participation. Such studies will have a meaningful impact on actual enrollment, thereby increasing diversity in research participation and improving population health.…”

“…12 The paucity of diversity in biospecimen science and cancer genomic studies are potentially more tied to a lack of communication and engagement of diverse and underserved populations as opposed to their willingness/unwillingness to participate and/or reasons related to medical distrust. [13][14][15][16] Formative research efforts that are inclusive of diverse and underserved populations regarding biospecimen science have shed some light on the following areas: awareness and interest in biospecimen donation for research, reasons for nonparticipation, collaborative study designs that include community-based approaches to engage and integrate community research partners, and underserved populations in this type of research, in addition to data regarding cultural perspectives and requirements for research specific to biospecimen science. [14][15][16][17][18] In fact, exploratory studies examining motivational factors and barriers to participation in biospecimen donation from diverse racial and ethnic minorities have suggested that the majority of African Americans and Hispanics/ Latinos are willing to donate different types of biospecimens and that they do donate when asked.…”

Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans

“…Other studies have also highlighted the role of African American churches in recruitment of Southern African Americans, as this influence extends beyond religion [ 27 , 28 ]. For many older African Americans, the church is the centerpiece of religious, social, and political life.…”

An electronic health record-based strategy to recruit for a Patient Advisory Council for Research: Implications for inclusion

“…Historically, patient and family advisory councils were convened to enhance the user experience and patient and family support services in the context of clinical care [1][2][3][4][5][6][7]. In recent years, patient, family, and community advisory councils (PFACs) have been convened to help ensure that clinical trials and health research studies are designed with patients and communities in mind [8][9][10][11][12]. Often, these research-specific PFACs are created in the hope that they will improve the quality of research in general and recruitment and retention rates in particular [9,10,12].…”