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NIH grant 1R01HD124419-01: A Multilevel, Patient-Centered Intervention to Prevent Hypertension in Pregnancy
Institute: {'code': 'HD', 'abbreviation': 'NICHD', 'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development', 'admin_org_id': '12500030', 'admin_funding_url': ''}. PI: Sharla Annette Smith. Award: $535183.
Start: 2026-08-26T00:00:00.
Modified Project Summary/Abstract Section
Hypertensive disorders of pregnancy (HDP)—including gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome—are leading causes of maternal morbidity and mortality in the United States, affecting low-income, high-risk populations. Despite clear clinical guidelines recommending daily low-dose aspirin (81mg) and blood pressure (BP) monitoring for high-risk pregnant females, these preventive measures are vastly underutilized in low-income communities. This gap is driven by a complex web of multilevel barriers, including social determinants of health, provider mistrust, inadequate prenatal counseling, and limited community support. To date, few studies have comprehensively tested patient-engaged, multilevel interventions to overcome these barriers and improve adherence to HDP prevention strategies.
This proposal seeks to fill that critical gap by evaluating the Healthy Outcomes for Pregnancy and Expected Parents (HOPE) intervention, a multilevel, culturally responsive model co-designed with community doula partners. Building on our extensive preliminary work with the Kansas Birth Excellence Network, we propose a 2-arm cluster randomized controlled trial to test the effectiveness of HOPE (treatment) versus standard prenatal care with access to doula services (control) among 700 high-risk pregnant females. The HOPE intervention is guided by the Health Belief Model and Social Cognitive Theory and integrates: (a) individual-level support through Bluetooth BP and wearable device self-monitoring; (b) interpersonal support via doula check-ins to reinforce aspirin adherence and BP monitoring; (c) group-level support through seven virtual doula-led sessions on HDP prevention; and (d) a community-health systems linkage model to strengthen patient-provider communication.
The study has three specific aims: (1) Evaluate the effectiveness of the HOPE intervention on the primary outcome of HDP incidence (gestational hypertension, preeclampsia, eclampsia, HELLP) and secondary maternal/neonatal outcomes; (2) Examine the effect of HOPE on HDP prevention behavior mediators, including BP self-monitoring, aspirin adherence, and self-efficacy; and (3) Conduct a targeted mixed-methods process evaluation to assess the feasibility, acceptability, and fidelity of the HOPE intervention to inform future implementation and sustainability.
This study is among the first to rigorously test a multilevel, doula-led intervention that addresses individual, interpersonal, and systemic barriers to HDP prevention. By leveraging virtual technology and community-based support, this project has the potential to transform hypertension prevention in pregnancy, significantly reduce maternal mortality, and generate a scalable national model to improve maternal health outcomes.document fetched 2026-09-06 02:47