Process Evaluation of a Multilevel Intervention to Increase Rural, African American Participation in HIV/AIDS Clinical Trials

Abstract

Background: While African Americans are disproportionately affected by the HIV/AIDS epidemic, they continue to be underrepresented in clinical trial research. This underrepresentation has led to a critical gap in research and limited access to state of the art treatment for their disease. To increase African American willingness to participate in clinical trials, Project EAST conducted a multilevel intervention that targeted rural providers and their HIV/AIDS clients. The dissertation study evaluated the implementation of this intervention. Methods: This study conducted the process evaluation of the intervention. Data sources included: (a) session audio recordings, (b) verbatim transcripts from sessions, facilitator debriefings, and participant focus group discussions, (c) narrative summaries from participant observation, (d) recruitment tracking forms, (e) attendance logs, and (f) community advisory board (CAB) meeting transcripts. All qualitative data were managed using ATLAS.ti. Findings: Intervention reach was 84% and 184% for clients and providers, respectively. Mean dose delivered scores were .88 for patient sessions and .97 for provider sessions. Attendance for each of the four client groups were .92, .86, .83, and .83, respectively and .97 and 1 for the two provider groups. Fidelity evaluated via facilitator debriefings was essential for identifying deviations from the curriculum. However, implementation checklists proved to be more comprehensive in capturing these deviations as they related to the quality and integrity of intervention delivery. Focus group data indicated clients had high satisfaction with: interactive activities, being in a group setting with other clients living with HIV/AIDS, facilitator characteristics, and an opportunity to discuss concerns and clarifications with a clinical trial expert. Providers also indicated high satisfaction with: interactive activities, facilitator characteristics, session content. These themes were convergent with facilitator perspectives on participant engagement Conclusions: The findings provide important insights regarding education about and accessibility to HIV/AIDS clinical trial opportunities for rural, African Americans and their local providers. As researchers work to establish best practices in recruitment, referral, and enrollment of racial and ethnic minorities in HIV/AIDS clinical trials, conducting a process evaluation can yield essential understanding and recommendations for comparable educational interventions to be undertaken in rural regions of the United States

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