Research Protocol and Recruitment Redesign of a Study of Pregnant Women and Their Infants During the COVID-19 Pandemic: Childhood Allergy and the NeOnatal Environment (CANOE)

Abstract

BackgroundRecruitment for research studies is a challenging endeavor that was further complicated by the COVID-19 pandemic. We launched a new NIH-supported multi-center birth cohort, “Childhood Allergy and the NeOnatal Environment” (CANOE) in January 2020 across four sites. While the pandemic temporarily halted clinical research, we restructured the study and instituted novel recruitment methods that we hypothesized would enable brisk enrollment when research activities resumed. ObjectiveDevelop protocol modifications and recruitment methods that promote successful recruitment of diverse populations in clinical research despite a global pandemic. MethodsWhile study activities were suspended, we modified recruitment strategies to limit in-person contact, shifting toward alternative HIPAA-compliant methods like clinician referrals, institutional social media, and telemedicine screening and consent procedures. Protocol changes included reducing the frequency of in-person visits, leveraging clinical care visits to collect biospecimens, expanded self-collection of samples at home, and making study materials available online. ResultsRemote methods, including targeted social media posts, mailed letters, and email, combined with in-clinic recruitment with modifications for social distancing led to successful recruitment at all sites. Rates of consent have been similar across recruitment sites, with the highest rates of enrollment of mother-infant dyads realized by sites that implemented multiple recruitment strategies. ConclusionsStudy procedures that prioritize health and safety measures such as social distancing, study participant convenience, and diverse recruitment strategies enable successful enrollment of pregnant women and their newborns into clinical research while adhering to public health restrictions during a global pandemic.