Abstract
BackgroundImproving 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.MethodsThis 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.DiscussionThis 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 registrationClinicalTrials.gov NCT04514224.Date of registration: August 14, 2020. Retrospectively Registered.
Highlights
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 study assesses the clinical effectiveness of the Gabby System which is important given that the implementation of efficacious preconception care (PCC) interventions is scarce in Maternal and Child Health (MCH) primary and secondary prevention programming
The hybrid type II cohort study design allows for continued adaptation and modification of the implementation process to meet the unique needs of community-based settings and ensure that lessons learned at each site (Healthy Start or Community Health Center) are incorporated to enhance sustainability at the respective site
Summary
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. 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 important for Black and African American women who have a disproportionate burden of pregnancyrelated complications and infant mortality rates compared to any other racial and ethnic group in the U.S. There are significant racial and ethnic disparities in maternal and child health in the U.S [1,2,3] Despite advances in medical technology, Black and African American women across social and economic strata experience disproportionate rates of pregnancy-related complications and infant mortality. Preconception health and health care (PHHC) for women of reproductive age are critical for reducing the risk of adverse maternal, perinatal and neonatal outcomes, and eliminating racial and ethnic disparities [6]. Despite recommendations from the Centers for Disease Control and Prevention (CDC), [6] and the development of indicators for PHHC, [8, 9] the delivery of PCC- preconception counseling for women of child bearing-age by clinicians in community-based settings remains a challenge [10]
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