NCT05484804 Accountability for Care Through Undoing Racism & Equity for Moms
| NCT ID | NCT05484804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 60,000 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60,000 participants in total. It began in 2023-06-05 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project-also known as "Accountability for Care through Undoing Racism \& Equity for Moms" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support. ACURE4Moms is a pragmatic 4-arm cluster randomized controlled trial conducted with 39 prenatal practices across North Carolina. Practices have been randomly assigned to receive either: Arm 1 (Standard Care): North Carolina Medicaid Care management for high-risk pregnancies; Arm 2 (Data Accountability and Transparency): North Carolina Medicaid Care Management + Practice-level Data Accountability interventions; Arm 3 (Community-Based Doula Support): North Carolina Medicaid Care Management + Community-Based Doula support intervention for high-risk patients during pregnancy and postpartum; or Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): North Carolina Medicaid Care Management + Both Arms 2 and 3 interventions. During each practice's 2-year intervention period, the practice will initiate prenatal care for \~750-1,500 patients (up to 60,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.
Eligibility Criteria
Inclusion Criteria: Practices: * Have at least 180 Black patient deliver over 2 years * Be willing to be randomized * Be willing to adhere to the study protocol Patient survey participants: * Start prenatal care at one of the study clinics during study implementation * Self-identify as Black or African American * Able to give consent and complete surveys and interviews in English Practice staff member participants: * Employed as either a provider, nurse/medical assistant, or office administrator at one of the clinics in this study Doula participants: * Provide doula care to patients at one the clinics in this study Exclusion Criteria: Practices: * Already integrated with Community-Based Doulas * Already have an Early Warning System or Disparities Dashboard
Contact & Investigator
Jennifer H Tang, MD, MSCR
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT05484804 clinical trial?
This trial is open to female participants only, aged 12 Years or older, up to 99 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05484804 currently recruiting?
Yes, NCT05484804 is actively recruiting participants. Contact the research team at jennifer_tang@med.unc.edu for enrollment information.
Where is the NCT05484804 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT05484804 clinical trial?
NCT05484804 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Jennifer H Tang, MD, MSCR at University of North Carolina, Chapel Hill. The trial plans to enroll 60,000 participants.