Process Evaluation Results from an Intervention to Increase Rural Minority Participation in HIV Clinical Trials

Background: Minorities are disproportionately affected by the epidemic, particularly in the rural Southeast. However, they are underrepresented in HIV clinical trials. To address this issue, Project EAST (Education and Access to Services and Testing) developed culturally sensitive outreach/enrollment interventions to increase minority participation in clinical trials. Educational curricula have been developed for service providers and people living with HIV/AIDS (PLWHA). Methods: A process evaluation was conducted during the pretest of the PLWHA sessions. This was done through observations, attendance logs, meeting notes, debriefings with facilitators, interviews and focus group discussions with participants. Quantitative and qualitative data were analyzed to assess the following process evaluation components: fidelity, dose delivered, dose received, and recruitment. Results: Overall, PLWHA curriculum was implemented as planned. All intended methods, strategies, content, and activities were employed. We recruited eight individuals to participate in the six sessions. Participants were actively engaged with the intervention components and reacted positively to the session facilitators. Finally, they reported high satisfaction levels with respect to the content and delivery of the intervention. Conclusions: Process evaluation insures effective implementation of public health programs with PLWHA. It is an essential step in intervention development as it allows for detailed assessment of intervention components. Furthermore, pretesting an intervention is vital for examining feasibility and applicability of an intervention. Triangulation of data from Project EAST staff members, facilitators and participants insures content appropriateness, effective delivery methods, while indicating potential areas of improvement.