Recruiting

Patient Navigator Intervention

Sponsor:

Emory University

Code:

NCT05588245

Conditions

Pregnancy Related

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Standard of Care

Community-based prenatal/perinatal/postpartum patient navigator

Study Details

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.

Conditions

Pregnancy Related

Study ID

NCT05588245

Start date

Jan 25, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Comparison Group (Standard of Care)

Participants will receive the standard of care.

experimental: Intervention Group

Participants will receive a community-based patient navigator with 3 prenatal contacts and 5 postpartum contacts; during each contact, the community-based patient navigator will offer health assessment and education, along with group education and social support.

Interventions

Standard of Care

Participants will undergo the same SDoH screener (AHC-Health Related Social Needs Tool) as full intervention participants, which will serve as the basis for a one-time brief session with the clinical research coordinator that will involve review of a 'Resource Guide' that provides a listing of available community resources to meet common social needs. Participants in this arm will also complete other prenatal and postpartum data collection items over the course of the study (with the exception of qualitative interviews).

Community-based prenatal/perinatal/postpartum patient navigator

Uses Freeman's principles of navigation to enhance patient access to care (e.g., help patients manage appointments), promote patient self-efficacy (e.g., connect patients to community housing, food, transportation resources), and sustain engagement with the healthcare system (e.g., bridge perinatal and primary care).

Primary outcome measure

  • Change in number of SMM and maternal death events [ Time Frame: Baseline, 12 months postpartum ]

Central Contacts and Locations

Central contacts

Anne L Dunlop, MD

678-480-5285amlang@emory.edu

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

More Information

Sponsor

Emory University

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-23.