Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial.

Suboptimal enrollment and retention efforts can compromise the quality of clinical trials. Barriers to enrolling marginalized populations include low awareness/education about clinical trials. Methods-Motivational Interviewing (MMI) is a patient-centered process that integrates education in providing trial information and engages participants in discussions about the trial before enrollment. Though the MMI approach is effective in enhancing trial recruitment and retention, limited studies have incorporated evidence-based health literacy approaches, especially for underrepresented individuals. In this study, prior to the informed consent process, Black adults completed an interactive orientation followed by a small group discussion. The content used health literacy principles including plain language, infographics, and a pictorial roadmap to guide participants about the purpose of a trial, the randomization process, the study objectives, and timeline. Thereafter, two focus groups explored participants' perceptions of the enrollment process. Fifteen participants attended the orientation with 14 enrolled in the trial after the orientation, (93% enrollment rate). Retention was 93% (control) to 100% (intervention) at the end of 6 months. Participants reported positive orientation experiences due to a better understanding of the study information, expectations, and rationale behind randomization. Implementing an adapted MMI approach focused on health literacy principles may improve trial enrollment and retention rates among Black adults.