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

Abstract 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...

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Main Authors: Olayinka O. Shiyanbola, Meng-Jung Wen, Martha A. Maurer
Format: Article
Language:English
Published: Nature Portfolio 2025-02-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-89413-2
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author Olayinka O. Shiyanbola
Meng-Jung Wen
Martha A. Maurer
author_facet Olayinka O. Shiyanbola
Meng-Jung Wen
Martha A. Maurer
author_sort Olayinka O. Shiyanbola
collection DOAJ
description Abstract 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.
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spelling doaj-art-aa46dcd5e99a4e758ff726969ea5b4bb2025-02-09T12:35:29ZengNature PortfolioScientific Reports2045-23222025-02-011511910.1038/s41598-025-89413-2Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trialOlayinka O. Shiyanbola0Meng-Jung Wen1Martha A. Maurer2Department of Clinical Pharmacy, University of Michigan College of PharmacyDivision of Social and Administrative Sciences, University of Wisconsin-Madison School of PharmacySonderegger Research Center for Improved Medication Outcomes, University of Wisconsin-Madison School of PharmacyAbstract 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.https://doi.org/10.1038/s41598-025-89413-2Health literacyClinical trialsEnrollmentRetentionBlack adultsMotivational interviewing
spellingShingle Olayinka O. Shiyanbola
Meng-Jung Wen
Martha A. Maurer
Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial
Scientific Reports
Health literacy
Clinical trials
Enrollment
Retention
Black adults
Motivational interviewing
title Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial
title_full Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial
title_fullStr Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial
title_full_unstemmed Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial
title_short Incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial
title_sort incorporating health literacy principles into the adaptation of a methods motivational interviewing approach for enrolling black adults in a pilot randomized trial
topic Health literacy
Clinical trials
Enrollment
Retention
Black adults
Motivational interviewing
url https://doi.org/10.1038/s41598-025-89413-2
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