An experiential learning intervention with community advisory boards to enhance clinical trial literacy in sickle cell disease: A baseline analysis Free

Background:

Patient engagement is critical to the success of clinical trials. Community Advisory Boards (CABs) provide a vital feedback loop between individuals with lived experience and researchers, ensuring patient-centered outcomes. The American Society of Hematology Research Collaborative® (ASH RC) established local and national CABs affiliated with its SCD Research Network to deepen engagement in SCD research. However, a gap often exists in the practical research literacy of stakeholders. This study was designed to test whether experiential learning enhances clinical trial literacy among CAB members by guiding them through running their own clinical trial.

Methods:

• Protocol Development: We first conducted pre-implementation listening sessions with the ASH RC National CAB (n=32) and Principal Investigators (PIs) (n=46) to refine the study protocol using a participatory approach.

• Intervention Design: The intervention is a “study within a study” where CAB members are the research team that designs and implements their clinical trial. Over six months, participants guided the entire research lifecycle of an educational intervention to reduce SCD stigma among providers, from finalizing the research question and study protocol to overseeing data collection and planning dissemination.

• Baseline Assessment: To establish a baseline before the intervention, we conducted two virtual focus groups with local CAB members (N=18) from site A (n=10) and site B (n=8). Participants were asked about their understanding of the research process, experiences with clinical trials, and methods for receiving research information. An abductive content analysis was used to identify emerging themes regarding participants’ perceptions of clinical research.

Results:

• Protocol Development Findings: Feedback from the National CAB and PIs was positive. Key suggestions for protocol revision addressed patient-centered concerns (e.g., time requirements, baseline knowledge) and clinical concerns (e.g., institutional constraints, increased staff workload, and consistency across sites). PIs noted the unique value of CAB input on an active study rather than a theoretical proposal.

• Baseline Participant Data: Among local CAB participants (N=21), 40% reported prior research participation, and 30% had served as co-investigators or stakeholders. Thematic analysis revealed that participants with prior experience demonstrated a clearer understanding of research processes. Participants commonly associated research with seeking cures, testing new medications, and gathering information. Trust in healthcare providers was a key facilitator for participation, while concerns included trial risks, potential side effects, and impact on family responsibilities. A strong, articulated desire to increase personal research literacy to better advocate for their community was a dominant theme.

Conclusions:

Baseline data confirm a gap in practical research literacy even among engaged CAB members and a strong motivation to learn. These findings validate the need for our novel, experiential learning model. By empowering CAB members to lead their own research project from concept to conclusion, we hypothesize that we can build more robust and practical trial literacy than traditional didactic methods. Post-intervention focus groups will be crucial to evaluating this empowerment-based educational strategy and its impact on fostering equitable research partnerships in SCD.