Navigating recruitment challenges in a prison-based randomized controlled trial

• In Event: PWG - Promoting health and rehabilitation through intervention programmes

Abstract

Background: While randomized controlled trials (RCTs) are considered the gold standard in clinical research, conducting them in prison settings presents unique challenges. This presentation examines the recruitment obstacles encountered in an ongoing RCT evaluating osmotic-release oral system methylphenidate (OROS-MPH) for treating attention deficit hyperactivity disorder (ADHD).
Methods: Drawing from our experience implementing a double-blind, placebo-controlled RCT of OROS-MPH in the Swiss prison system, we analyzed key recruitment challenges identified during the trial's implementation. Our sample comprised incarcerated men that were eligible for the RCT. We examined the main barriers to recruitment using descriptive statistics.
Results: Preliminary findings highlighted several important recruitment barriers. The eligible participant pool has been smaller than anticipated, partly due to strict inclusion criteria and the transient and diverse nature of the prison population. Potential participants have shown hesitancy related to medication stigma and lack of interest. In addition, several eligible participants had medical contraindications for the treatment. Additional challenges included coordinating screening procedures and managing the complex logistics in a prison environment.
Discussion: Our experience underscored the complexity of conducting RCTs in correctional settings. We proposed practical strategies to address these challenges, including modified recruitment approaches, enhanced communication with local staff, and adapted consent procedures. Barriers to participating in clinical trials should be removed to ensure that the prison population can also benefit from clinical research.

Authors

• Stéphanie Baggio, University of Bern

• Patrick Heller, Geneva University Hospitals

• Leonel da Cunha Gonçalves, Geneva University Hospitals & University of Bern