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

Abstract

This is a report of a cluster randomized clinical trial evaluating the effectiveness of a church-based educational intervention aimed at improving African Americans’ (AA) participation in clinical trials. Two hundred and twenty-one AA subjects ages ≥50 years from six predominantly AA churches were randomized to intervention or control condition. The intervention included three educational sessions about clinical trials and health disparities; control participants completed questionnaires. Primary endpoints of the study were differences in individual subjects' intentions to obtain clinical trial information and intention to join a clinical trial, as determined by 10 point scale items at baseline, three and six months. A statistically significant increase in the intention to obtain clinical trial information at the three and six month time points was observed in the intervention group, but not the control group. Older participants (65–95 years) were less likely than younger participants (50–64 years) to increase their motivation to seek clinical trial information by the three and six month time points. No significant increases were observed in intention to join clinical trials. This randomized trial shows that AA church-based educational interventions are likely to increase the motivation of AA subjects to obtain clinical trial information and are therefore potentially effective at ameliorating the underrepresentation of AA subjects in clinical trials.

The role of functional, social, and mobility dynamics in facilitating older African Americans participation in clinical research

“…The support they envision receiving from providers and support staff conducting clinical trials, and their broader social network supporting their enrollment decisions, may therefore be an attractive perceived benefit that they associate with participation in clinical studies. 27 , 30 , 47 , 48 …”

“…Thus, enlisting pastors and faith leaders in trial participation and recruitment might help address the barriers to participation among older seniors who are dependent on others for daily and crisis support. 26 , 30 …”

“…The data were collected from a cohort of 221 African Americans recruited in metropolitan Atlanta, Georgia through a cluster randomized controlled trial design. 26 In conjunction with this analyses, we also evaluated the feasibility and potential effectiveness of the “Dose of Hope” intervention to test whether delivery of a three-session group intervention increased the proportion of older African Americans who enrolled in an array of chronic and infectious disease-related clinical trials. 27 Our inclusion criteria included those who self-reported being primarily Black/African American, ≥50 years of age, a congregant of one of the six African American participating churches, and having no previous history of clinical research participation.…”

“…28 – 33 As such, the measures include those pertaining to nested influences from the community- to individual-level, as well as moderating and mediating influences on attitudes and social norms toward trial participation. 24 – 26 Items analyzed from this study included linked data from the baseline and 3-month questionnaires containing sociodemographic questions (i.e., age, gender, education level, income, and relationship status) as well as functional disability and social support scales. 34 , 35 …”

“…This study assesses considerations associated with clinical research participation drawing upon the socioecological framework for human behavior. 26 Thus, we examined the interaction between individual-level factors (sociodemographics, physical abilities such as strength and mobility, social abilities, errand transportation availability, and other independent assessments of functional abilities), interpersonal-level factors (social support and crisis support), and community-level factors (transportation access).…”