Abstract
BACKGROUND: Improving the health of women before pregnancy and throughout a woman's lifespan could mitigate disparities and improve the health and wellbeing of women, infants and children. The preconception period is important for reducing health risks associated with poor maternal, perinatal and neonatal outcomes, and eliminating racial and ethnic disparities in maternal and child health. Low cost health information technology interventions provided in community-based settings have the potential to reach and reduce disparities in health outcomes for socially disadvantaged, underserved and health disparity populations. These interventions are particularly important for Black and African American women who have a disproportionate burden of pregnancy-related complications and infant mortality rates compared to any other racial and ethnic group in the U.S. METHODS: This is a hybrid type II implementation-effectiveness cohort study aimed at evaluating appropriateness, acceptability and feasibility implementation outcomes, while also systematically examining the clinical effectiveness of a preconception care (PCC) intervention, the Gabby System, for Black and African American women receiving health services in community-based sites. The intervention will be implemented in six Community Health Centers and six Healthy Start programs across the U.S. Each study site will recruit and enroll 25-50 young Black and African American women who will participate in the intervention for a 6-month period. Appropriateness, acceptability and feasibility of implementing the PCC intervention will be assessed using: 1) Qualitative data derived from individual interviews with Gabby System end-users (clients and patients) and site staff; and, 2) Quantitative data from staff surveys, Gabby System usage and uptake. Aggregate health risk and utilization measures collected directly from the Gabby server will be used to examine the effectiveness of the Gabby System on self-reported behavior change. DISCUSSION: This study will examine implementation outcomes and clinical effectiveness of an evidence-based PCC intervention for Black and African American women receiving services in Healthy Start programs and Community Health Centers. Contextual factors that influence uptake and appropriate implementation strategies will be identified to inform future scalability of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04514224 . Date of registration: August 14, 2020. Retrospectively Registered.