Background: Underrepresentation of older-age racial and ethnic minorities in clinical research is a significant barrier to health in the United States, as it impedes medical research advancement of effective preventive and therapeutic strategies.
Objective: The objective of the study was to develop and test the feasibility of a community-developed faith-based intervention and evaluate its potential to increase the number of older African Americans in clinical research.
Methods: Using a cluster-randomized design, we worked with six matched churches to enroll at least 210 persons. We provided those in the intervention group churches with three educational sessions on the role of clinical trials in addressing health disparity topics, and those in the comparison group completed surveys at the same timepoints. All persons enrolled in the study received ongoing information via newsletters and direct outreach on an array of clinical studies seeking participants. We evaluated the short-, mid-, and longer-term effects of the interventional program on clinical trial-related outcomes (ie, screening and enrollment).
Results: From 2012 to 2013, we enrolled a balanced cohort of 221 persons in the program. At a 3-month follow-up, mean intention to seek information about clinical trials was higher than baseline in both treatment (mu=7.5/10; sigma=3.1) and control arms (mu=6.6/10; sigma=3.3), with the difference more pronounced in the treatment arm. The program demonstrated strong retention at 3-month (95.4%, 211/221) and 6-month timepoints (94.1%, 208/221).
Conclusions: The "Dose of Hope" program addressed an unmet need to reach an often overlooked audience of older African Americans who are members of churches and stimulate their interest in clinical trial participation. The program demonstrated its appeal in the delivery of effective messages and information about health disparities, and the role of clinical research in addressing these challenges.
Keywords: African Americans; churches; clinical trials; health disparities; study recruitment.