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

Background: Recruitment for research studies is a challenging endeavor that was further complicated by the coronavirus disease 2019 pandemic. We launched a new multicenter birth cohort, Childhood Allergy and the NeOnatal Environment (CANOE), supported by the National Institutes of Health in January 2020 across 4 sites. Although 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.

Objective: We sought to develop protocol modifications and recruitment methods that promote successful recruitment of diverse populations in clinical research despite a global pandemic.

Methods: Even though study activities were suspended, we modified recruitment strategies to limit in-person contact, shifting toward alternative HIPAA-compliant methods such as 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.

Results: Remote 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.

Conclusions: Study procedures that prioritize health and safety measures such as social distancing, study participant convenience, and use 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.

Keywords: COVID-19 pandemic; Study recruitment; childhood allergy; pregnancy; protocol redesign; public health; women and infants.

Fig 1

Conceptual model and hypothesis of CANOE birth cohort study.

Fig 2

Percentage of enrolled mothers by recruitment method across all sites and by each site until enrollment was closed. HFHS, Henry Ford Health; UWIM, University of Wisconsin-Madison; VAUN, Vanderbilt University; WUSL, Washington University, St Louis.

Fig 3

Number of stressors reported among enrolled pregnant women. Stressors assessed included health concerns, impact on work, impact on child/children, impact on community, impact on family, access to food, access to baby supplies, access to personal care products/household supplies, access to medical care including mental health care, social distancing, and quarantine.

Fig 4

Mother-infant dyad enrollment across all sites over time until enrollment was closed.