Trial of Community-based Patient Navigation (NCT05588245)
A Pragmatic Trial of Integrating Community-based Patient Navigation Into the Continuum of Maternal Care for Black Women in a Safety-Net Health System: Effects on Maternal Health, Health Care, Morbidity, and Mortality
🩺 Plain-English Summary (8th-Grade Level)
This study will test the effectiveness of a community-based patient navigator intervention from mid-pregnancy through 12 month postpartum for a high-risk population of medically underserved women. The RCT will enroll 540 pregnant women before 20 weeks of pregnancy and randomly allocate them into two different study arms from the time of prenatal enrollment through 12 months postpartum. If found to be effective, the community-based patient navigator intervention can be implemented as a standard of care at Grady and other provider practices serving high-risk women to improve maternal health outcomes and reduce racial disparities.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).
Location: Grady Memorial Hospital — Atlanta, Georgia
Age range: 18 Years
🧪 Interventions in This Study
- Standard of Care (BEHAVIORAL)
- Community-based prenatal/perinatal/postpartum patient navigator (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- The intent to transfer care to a health system outside of metro Atlanta
- incarceration, which would interfere with intervention provision and outcome ascertainment
- adults unable to give consent
- individuals who are not yet adults
- prisoners
- cognitively impaired individuals with impaired decision-making capacity
- individuals who are not able to clearly understand and speak English (as the PPP-PN intervention is only available in English at this time)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Grady Memorial Hospital — Atlanta, Georgia
📞 Contact the Study Coordinator
Phone: (678) 480-5285
Email: amlang@emory.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: All participants will be compensated for their time.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.