Abstract
BACKGROUND: Due to underrepresentation of racial/ethnic minority and low-income groups in clinical studies, there is a call to improve the recruitment and retention of these populations in research. Pilot studies can test recruitment and retention practices for better inclusion of medically underserved children and families in subsequent clinical trials. We examined this using a school-based asthma intervention, in preparation for a larger clinical trial in which our goal is to include an underserved study population. METHODS: We recruited children with poorly controlled asthma in a two-site pilot cluster randomized controlled trial of school-supervised asthma therapy versus enhanced usual care (receipt of an educational asthma workbook). We sought a study population with a high percentage of children and families from racial/ethnic minority and low-income groups. The primary outcome of the pilot trial was recruitment/retention over 12 months. Strategies used to facilitate recruitment/retention of this study population included engaging pre-trial multi-level stakeholders, selecting trial sites with high percentages of underserved children and families, training diverse medical providers to recruit participants, conducting remote trial assessments, and providing multi-lingual study materials. RESULTS: Twenty-six children [42.3% female, 11.5% Black, 30.8% Multiracial (Black & other), 76.9% Hispanic, and 92.3% with family income below $40,000] and their caregivers were enrolled in the study, which represents 55.3% of those initially referred by their provider, with 96.2%, 92.3%, and 96.2% retention at 3-, 6-, and 12-month follow-up, respectively. CONCLUSION: Targeted strategies facilitated the inclusion of a medically underserved population of children and families in our pilot study, prior to expanding to a larger trial.