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

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 post-test self-reported enrollment and verified enrollment. Using linear regression, post-test 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). Post-test 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.