Increasing Enrollment in Clinical Trials through Faith-Based Intitiative

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DESCRIPTION (provided by applicant): The primary aim of this study is to evaluate the impact of a university-church partnership to increase minority participation in clinical trials. Specifically, we will work with local black churches, through a participatory process, to implement the Body & Soul faith-based health promotion program. Through this collaborative effort, we aim to achieve two outcomes: 1) Enhance trust between local church members and the University of Michigan, and thereby, 2) Increase willingness to enroll in a clinical trial registry. 12 churches from Southeast Michigan, with no prior Body & Soul (B &S) adoption, will be randomized to receive the Body & Soul program (6 intervention churches) or a delayed Body and Soul program (6 control churches). Beginning approximately 2 months after initial installation of B & S (which will be expanded to address clinical trial participation), we will send participants from BOTH intervention and control churches a mailed invitation to enroll in our ENGAGE clinical trial registry. The invitation will provide a church specific URL to allow us to track enrollment. Over the course of the year, another 4 invitations will be mailed. The primary outcome will be verified enrollment in the ENGAGE registry. Secondary outcomes will include attitudes toward medical research and the University of Michigan as well as future intentions to enroll in a clinical trial. Baseline Treatment (6 churches) 01 Comparison (6 churches) 01 1-Year Follow-up Body & Soul 02 02 Body & Soul E E E E E E=Bimonthly mailed invitations to enroll in ENGAGE 01=Baseline Assessment 02=Posttest Assessment Hypothesis 1) : Providing a culturally-sensitive, evidence-based health promotion program to local black churches will lead to greater trust and positive attitude toward the University of Michigan, and thereby increase willingness among church members to enroll in clinical trials (measured by actual enrollment in our ENGAGE clinical trial registry, attitudes toward clinical trials, and future intentions for trial participation) Hypothesis 2) Effects on ENGAGE enrollment and other outcomes will be mediated by changes in trust toward the University, health care institutions in general, and an index of exposure to B & S activities. Exploratory Hypothesis 3) We will examine whether effects of the intervention are moderated by baseline characteristics such as ethnic identity, gender, age, education, and attitudes toward medical research. PUBLIC HEALTH RELEVANCE: Project Narrative This study will test an academic-community partnership model to increase African American enrollment in clinical trials. We propose that in order to increase minority participation in clinical trials, we must first inculcate feelings of trust, mutual respect, and collaboration. We propose that by collaboratively planning and implementing an evidence-based health promotion program designed for black churches, we can build a relationship characterized by mutual trust and respect. Over time, as a result of these positive experiences as well as the content and spirit of Body & Soul, we think that individuals whose churches received Body & Soul will be more willing to enroll in clinical trials.