Recruiting

Holistic Care Partner Program

Sponsor:

NYU Langone Health

Code:

NCT06520566

Conditions

Maternal Care

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Holistic care partner perinatal nurse navigation

Study Details

Brief summary:

The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal nurses, Black women/birthing people, and their care partners enrolled in the Holistic Care Partner Program (HCP) to understand the program's feasibility and acceptability. HCP was developed at NYU Langone Health by Blank women-led perinatal nurses to address the effects of obstetric racism and the associated fear of pregnancy and birth faced by Black women and birthing people. Utilizing a mixed-methods approach, the study will focus on understanding HCP's acceptability and feasibility via surveys and qualitative interviews with Black women and birthing people and their partners/support persons to identify strategies and recommendations for intervention improvement. Exploratory analysis of maternal and infant outcomes will be conducted using a propensity score matched historical control group.

Conditions

Maternal Care

Study ID

NCT06520566

Start date

Jul 15, 2024

Status verified date

May, 2026

Completion date

Aug 18, 2026

Anticipated

Primary completion date

Aug 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Identify as Black or within the Black/African Diaspora
2. Enrolled in the HCP program while pregnant or within 6 weeks postpartum
3. Enrolled in the Faculty Group Practice at NYU Langone Health (NYULH) for obstetric care
4. Plan to give birth at NYULH Tisch or gave birth at NYULH Tisch if postpartum at screening.
5. Comfortable reading and/or speaking English (approximately 95% of Black women speak English)
6. Are 18 years or older

Exclusion Criteria:

1. Does not identify as Black or within the Black/African Diaspora
2. Did not enroll in the HCP program while pregnant or within 6 weeks postpartum.
3. Not enrolled in the FGP NYULH for obstetric care
4. Does not plan to give birth at NYULH Tisch or did not give birth at NYULH Tisch if postpartum at time of screening.
5. Is not 18 years or older
6. Multiple gestation
7. Significant fetal anomaly requiring exceptional care

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Black Birthing Patients enrolled in Holistic Care Partner Program (HCP)

Black birthing patients enrolled in HCP will be invited to participate in a brief survey and/or a qualitative interview throughout 1 year of their enrollment.

Interventions

Holistic care partner perinatal nurse navigation

The nurse navigators assess patient medical, social, and structural needs at enrollment, 20-, 28-, and 36-weeks gestation; and at 1-week, and 3, 6, and 9 months postpartum. They provide coordination, support, and referrals, and enhanced communication with or escalate concerns to the primary physician as indicated. The nurse navigator tailors additional visits to the individual needs of the patients (for example, managing comorbidities, social isolation, breastfeeding support). Participants also have access to a Black woman-led support group during pregnancy and the first postpartum year, and access to Black woman-led childbirth and lactation classes.

Primary outcome measure

  • Number of participants who complete the study [ Time Frame: Visit 4 (9-12 months postpartum) ]
  • Theoretical Framework for Acceptability (TFA) questionnaire score [ Time Frame: Visit 3 (6-12 weeks postpartum) ]
  • Attendance rate for nurse navigator visits [ Time Frame: Visit 4 (9-12 months postpartum) ]
  • Attendance rate at lactation classes [ Time Frame: Visit 4 (9-12 months postpartum) ]
  • Attendance rate at the support group [ Time Frame: Visit 4 (9-12 months postpartum) ]

Central Contacts and Locations

Central contacts

Audrey Lyndon, PhD, RNC, FAAN

212-992-5940al6148@nyu.edu

Gwendolyn Quinn, PhD

646-501-6878gwendolyn.quinn@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-02.