Case Study: Community Engagement and Clinical Trial Success: Outreach to African American Women

Abstract

This brief report examines how the use of community engagement principles and approaches enhanced clinical trial recruitment and retention. The Community-Engaged Research Core (CERC), a CTSA-supported resource designed to facilitate community involvement in clinical and translational research, was consulted to provide assistance with the implementation of the clinical trial, and specifically to enhance participation of the target population-African American women. CERC's key recommendations included: (1) convene a Community Engagement Studio, (2) redesign the recruitment advertisement, (3) simplify the language used to explain the scope of the study, and (4) provide transportation for participants. As a result of these interventions, a comprehensive strategy to recruit, enroll, and retain participants was formulated. After implementation of the plan by the study team, enrollment increased 78% and recruitment goals were met 16 months ahead of schedule. Participant retention and study drug adherence was 100%. We conclude that community engagement is essential to the development of an effective multifaceted plan to improve recruitment of underrepresented groups in clinical trials.

Keywords: blood pressure; cholesterol; diabetes; hypertension; insulin; nitric oxide.

© 2015 Wiley Periodicals, Inc.

Figures

Figure 1

Accrual rate. Green line reflects expected accrual rate. Red line is the actual accrual rate for randomized subjects; Blue line is the actual accrual rate for screened subjects. There is a divergence between the actual randomized and screened participants due to difficulties of the screened participants to meet inclusion criteria. Arrows represent key community interventions.