Process and Outcome Evaluation of Project EAST: An Intervention to Increase Minority Participation in HIV/AIDS Clinical Trials

Background: HIV/AIDS statistics show that minorities are disproportionately affected by the epidemic, particularly in the Southeast. Nonetheless, ethnic and racial minorities are underrepresented in HIV clinical trials. To address this problem, Project EAST (Education and Access to Services and Testing) has developed culturally sensitive outreach/enrollment interventions to increase minority participation in clinical trials. Workshops have been developed for service providers, people living with HIV/AIDS (PLWHA) and community leaders.

Methods: A process and an outcome evaluation will be conducted on the series of 4-session workshops developed for service providers. Process evaluation data collection methods will include: session observations, attendance logs, field observations, meeting notes, debriefings with facilitators, interviews, and focus group discussions. To assess the outcome of the intervention, a self-administered questionnaire will be distributed to participants immediately prior to the first session (baseline), immediately following the last session, and six months after the intervention (6 month follow-up). The survey will assess knowledge, attitudes about clinical trials; likelihood of referral, and actual referral.

Results: Quantitative and qualitative data on these process evaluation components—fidelity, dose delivered, dose received, recruitment, and reach—will be collected and analyzed. Data on the four outcome variables will be compared across the three points of administration to track changes.

Conclusions: The process evaluation results have implications for enhancing effective delivery of public health interventions with service providers. Additionally, outcome evaluation findings will indicate the effectiveness of the workshops in increasing service providers' knowledge about clinical trials, and their likelihood to refer their clients to clinical trials.