Adapting to the Pandemic: Protocol of a Web-Based Perinatal Health Study to Improve Maternal and Infant Outcomes (Preprint)

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Abstract
BACKGROUND The identification of interconnected health risks during the perinatal period offers an opportunity to prevent negative maternal and infant health outcomes. Marijuana, opioid, and other substance use during pregnancy is a rapidly growing public health concern with significant and costly health consequences for the woman and the developing fetus. Pregnant persons who misuse substances are disproportionately more likely to engage in risky sexual behaviors resulting in sexually transmitted infections (STIs), which are on the rise in this population and can lead to adverse effects on maternal health and on fetal development. OBJECTIVE Our goal is to continue testing an innovative and low-cost technology-delivered intervention, the Health Check-Up for Expectant Moms (HCEM), which simultaneously targets alcohol and drug use and STI risk during pregnancy, both of which are on the rise during the COVID-19 pandemic. METHODS We describe the ways in which we have adapted the web-based HCEM intervention to continue recruitment and study enrollment during the pandemic. RESULTS Study recruitment, visits, and participant safety assessments were all successfully modified during the initial year of the COVID-19 pandemic. Compared to in-person recruitment that occurred prepandemic, remote recruitment yielded a greater proportion of women enrolled in the study (83/136, 61.0% vs 43/52, 83%) in a shorter period (12 months vs 7 months). CONCLUSIONS Despite study challenges related to the pandemic, including time and effort adapting to a remote protocol, remote recruitment and visits for this study were found to constitute a successful approach. CLINICALTRIAL ClinicalTrials.gov NCT03826342; https://clinicaltrials.gov/ct2/show/NCT03826342 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30367
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