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Community-based Patient Navigation for Pregnant Black Individuals

This study is testing a program called "Community-based prenatal/perinatal/postpartum patient navigator" to help pregnant Black individuals. This program aims to improve access to care, help you manage appointments, connect you with resources like housing or food, and keep you engaged with your healthcare team. The study will compare this program to standard care, which involves a one-time review of a resource guide. We want to see if the patient navigator program can reduce serious health problems during and after pregnancy, especially for Black individuals who experience these issues more often. We plan to enroll 540 pregnant individuals who are Black, English-speaking, at least 18 years old, have a single pregnancy under 20 weeks, and are covered by Medicaid. The study will follow participants from mid-pregnancy through 12 months postpartum.

Study design
This is a randomized controlled trial that will enroll 540 pregnant individuals. Participants will be randomly assigned to either receive the patient navigator program or standard care.
What's involved
Participants will be followed from mid-pregnancy through 12 months postpartum. Those in the standard care group will have a one-time brief session with a clinical research coordinator.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months postpartum to measure changes in severe maternal morbidity (SMM) and maternal death events.

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NCT05588245

Trial of Community-based Patient Navigation

Recruiting
NAAges 18+InterventionalPrevention
Emory University
~540 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Standard of CareCommunity-based prenatal/perinatal/postpartum patient navigator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in number of SMM and maternal death events
Measured over Baseline, 12 months postpartum

Conditions

Pregnancy Related

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Pregnancy

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Anne L Dunlop, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Anne L Dunlop, MD
[email protected]
678-480-5285
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A pregnant woman or individual (inclusive of all gender identities) who is Black and English-speaking (by self-report),
≥18 years of age who is capable of consenting for oneself and who presents for prenatal care with a singleton pregnancy ≤ 20 weeks gestation (confirmed by medical record),
covered by Medicaid
for whom the AHC-Health Related Social Needs Tool (administered as part of standard clinical care for prenatal patients) identifies ≥1 unmet social needs
expectation to receive prenatal care and deliver at Grady and be available through 12-months postpartum to assure opportunity for exposure to the intervention, process, and outcome measure ascertainment.

Exclusion

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)

What this trial measures

  • Change in number of SMM and maternal death eventsBaseline, 12 months postpartum

    This is a count measure that reflects the total number of SMM and/or death events during the delivery admission through 12-months of delivery according to the presence/absence of the 21 SMM indicator diagnosis codes (as published by the Centers for Disease Control and Prevention) and/or a death event documented in the EPIC electronic medical record.