Trial of Community-based Patient Navigation
Emory University · with National Institute of Nursing Research (NINR) · NCT05588245
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 540
- US sites recruiting
- 1
- Study start
- January 25, 2024
- Record last updated
- June 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Standard of Care; Community-based prenatal/perinatal/postpartum patient navigator
Conditions: Pregnancy Related
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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)
Recruiting US locations
Grady Memorial Hospital
Atlanta, GA 30303
Site contact: Anne L Dunlop, MD
Study contacts (from the official record)
- Anne L Dunlop, MD · 678-480-5285 · amlang@emory.edu
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