Increasing Enrollment in Clinical Trials through Faith-Based Intitiative

描述（由申请人提供）：本研究的主要目的是评估大学-教会合作对增加少数民族参与临床试验的影响。具体而言，我们将与当地黑人教会合作，通过参与式进程，实施以身体与灵魂信仰为基础的健康促进方案。通过这种合作努力，我们的目标是实现两个结果：1)增强当地教会成员和密歇根大学之间的信任，从而2)增加参加临床试验注册的意愿。来自密歇根东南部的12个教会，之前没有采用身体与灵魂（b&s），将随机接受身体与灵魂计划（6个干预教会）或延迟的身体与灵魂计划（6个对照教会）。在B & S初始安装后大约2个月开始（将扩展到临床试验参与），我们将向干预教会和对照教会的参与者发送邮件邀请，邀请他们参加我们的ENGAGE临床试验注册。邀请函将提供一个特定于教会的URL，以便我们跟踪注册情况。在这一年中，还将邮寄另外4份邀请函。主要结果将是在ENGAGE注册中心验证入组情况。次要结果将包括对医学研究和密歇根大学的态度，以及将来参加临床试验的意向。基线治疗（6个教堂）01比较（6个教堂）01 1年随访身体与灵魂02 02身体与灵魂E E E E E E E E=双月邮寄的参与邀请01=基线评估02=测试后评估假设1)：为当地黑人教会提供一个文化敏感的、基于证据的健康促进项目将导致对密歇根大学更大的信任和积极的态度，从而增加教会成员参加临床试验的意愿(通过我们ENGAGE临床试验注册的实际注册人数、对临床试验的态度、假设2)对ENGAGE招生和其他结果的影响将通过对大学，一般医疗机构的信任变化和对b&s活动的暴露指数来调节。探索性假设3)我们将检验干预的效果是否受到种族认同、性别、年龄、教育程度和对医学研究的态度等基线特征的调节。

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.