NCT05588245 Trial of Community-based Patient Navigation
| NCT ID | NCT05588245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 540 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2027-06 |
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 540 participants in total. It began in 2024-01-25 with a primary completion date of 2027-06.
⚠ 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 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)
Contact & Investigator
Anne L Dunlop, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05588245 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT05588245 currently recruiting?
Yes, NCT05588245 is actively recruiting participants. Contact the research team at amlang@emory.edu for enrollment information.
Where is the NCT05588245 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05588245 clinical trial?
NCT05588245 is sponsored by Emory University. The principal investigator is Anne L Dunlop, MD at Emory University. The trial plans to enroll 540 participants.