Achieving recruitment and retention successes in a community-engaged randomized clinical trial: lessons from The Misoprostol-Only Regimen Evidence (MORE) Study pilot
Abstract
Low uptake and high attrition threaten the validity of randomized controlled trial (RCT) clinical research across contexts. These challenges are further exacerbated when healthcare is politicized, as in the case of abortion. In this session, we will present a case study of an RCT designed to evaluate a single drug medication abortion (MA) regimen in the United States and discuss how community engaged methods and high-touch, intentional follow-up protocols enabled rapid recruitment and nearly 100% retention in the 6-week pilot.
From October 2025 to March 2026, we piloted study materials, instruments, and systems for The Misoprostol Only Regimen Evidence (MORE) Study at one clinical site in Utah. Enrolled participants were randomized 1:1 to receive either the standard combined regimen or an endorsed misoprostol only regimen. Abortion completion, physical experiences, care-seeking, and satisfaction were assessed with daily surveys in the first 3 days, and subsequent weekly surveys at 7, 14, 21, 28, and 35 days. We also conducted cognitive interviews and convened clinical, advocate, and community advisory boards to inform the conduct and design of the study. Further, to improve respondent experience, response rates, and data quality, we utilized strategies including phone, email and text message survey distribution, automated incentive distribution, password-protection features, and a combination of automated and manual reminders. We also utilized piped survey text across time points to reduce respondent fatigue.
In the pilot phase, we observed recruitment and retention successes that we attribute to the high degree of community input into the study design, as well as the survey structure and follow-up procedures. We enrolled ~6 patients per week, exceeding our expectation of ~4 patients per week. Retention was also high, with 93% completing the final survey, above the 85% we anticipated. Additionally, in the final survey, respondents reported positive experiences participating in the study.
Results from this pilot phase indicate that person-centered, community-engaged strategies in RCT design and implementation can contribute to recruitment and retention success, as well as positive respondent experiences. The specific strategies adopted could translate well to other clinical epidemiology studies.
