Addressing challenges in outreach and recruitment: A case study of an NIH-funded randomized controlled trial

Success of randomized controlled trials depends on effective recruitment and retention to ensure adequate power and generalizability. Historically underrepresented populations continue to face logistical, psychological, and socioeconomic barriers to participation despite movement toward pragmatic study design. This paper describes the multifaceted recruitment approaches used to identify and engage young pregnant women with low-income in a behavioral intervention study. Adaptive recruitment strategies employed in this study led to recruitment of 341 individuals in 49 months, with 84% of individuals with a first contact completing enrollment. Building community and clinical relationships alongside social media recruitment and participant rapport building were used in tandem to achieve recruitment goals. Fully remote procedures enabled reduced participant burden, flexibility, and statewide study reach to increase engagement. Outreach templates, text message communications, advertising language, and images are all provided to support adaptation of our recruitment processes by other researchers.