A patient-centered, theory-guided approach to examining the barriers and enablers to trial participation among people with SCD.

Objective: Recruitment to clinical trials involving sickle cell disease (SCD) patients can be challenging, leaving trialists uncertain about how to optimize recruitment approaches and strategies. Informed by the Theoretical Domains Framework (TDF), we identified a comprehensive set of barriers and enablers to participation in SCD trials, and suggest how this theory-informed survey approach can improve trial recruitment strategies. Methods: In collaboration with Clinical Trials Ontario and Sickle Cell Awareness Group of Ontario (SCAGO), we conducted a mixed methods study involving interviews with and surveys of SCD patients and families. We iteratively adapted a template survey based on think-aloud interviews, before administering the adapted survey online to SCAGO membership. Results: Fifteen interviews with SCAGO members led to 49 survey items across 13 of 14 TDF domains. Four new items specific to the SCD community were added. Administration challenges led to low survey response, with only 22 people completing the survey. Eighteen items from 8 domains were seen as barriers (eg invasive tests/procedures, travel to study site). Twenty-two items from 9 domains were seen as enablers (eg hope for a cure, helping others). Conclusion: Our theory-guided approach identified a comprehensive set of factors related to SCD trial participation, information that can support recruitment strategy development prior to trial onset. Low survey response rates precluded strong conclusions about the relative priority of the individual barriers and enablers; more work will be needed among a broader sample of SCD patients and families. Identification of theory-guided behavioral domains offers targeted suggestions for trial recruitment.