Abstract
Background: Convenience and cost are major determinants of which strategies are used to recruit clinical trial participants. However, little is known about the impacts of recruitment strategy on representation of people from diverse backgrounds. Objective: Using the high-throughput recruitment drives of two trials, we assessed whether referral source was associated with demographic and social characteristics of people who inquired about the trials or participated in screening. Methods: The GoFresh studies (NCT05121337 & NCT05393232) are two randomized trials testing the impact of a home-delivered DASH-patterned grocery intervention on blood pressures of Black adults residing in urban food deserts, with or without treated hypertension (HTN). Both share a common recruitment drive, incentive plan, and study design. Principal recruitment strategies were: mailed brochure to patients, advertising on public transit (bus or subway), or word-of-mouth referral. In prescreening, participants provide their age, HTN treatment status, and how they heard about the trial. Those eligible proceed to in-person screening, where they are asked about biologic sex, ethnicity, birthplace, car ownership, insurance status, education, employment, marital status, home ownership, income, and number of dependents. Results: Of 1,601 people who submitted a prescreening inquiry, 602 (38%) completed screening. At prescreening, people responding via public transit were younger (mean [SD] 36 [13]; overall 46 [16]) and fewer had treated HTN (18%; overall 35%). At screening, there were significant differences by referral source in sex, car ownership, employment, marital status, and home ownership ( Table ). Other factors did not differ (ethnicity, birthplace, insurance status, education, income, and dependents). Conclusion: Demographics and social characteristics of clinical trial participants differed by advertising modality. Trials intending to recruit diverse populations would benefit from multimodal forms of outreach.
Published Version
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