Maternal CareNCT06520566
Holistic Care Partner Program Feasibility and Acceptability
A study testing Holistic care partner perinatal nurse navigation in people with Maternal Care, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Care
- What is being tested?
- Holistic care partner perinatal nurse navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 18 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as Black or within the Black/African Diaspora
- Enrolled in the HCP program while pregnant or within 6 weeks postpartum
- Enrolled in the Faculty Group Practice at NYU Langone Health (NYULH) for obstetric care
- Plan to give birth at NYULH Tisch or gave birth at NYULH Tisch if postpartum at screening.
- Comfortable reading and/or speaking English (approximately 95% of Black women speak English)
- Are 18 years or older
Who cannot join
- Does not identify as Black or within the Black/African Diaspora
- Did not enroll in the HCP program while pregnant or within 6 weeks postpartum.
- Not enrolled in the FGP NYULH for obstetric care
- Does not plan to give birth at NYULH Tisch or did not give birth at NYULH Tisch if postpartum at time of screening.
- Is not 18 years or older
- Multiple gestation
- Significant fetal anomaly requiring exceptional care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Holistic Care Partners: A Black Woman-led Nurse Navigation Program to Improve Care, Reduce Harm, and Enhance Perinatal Wellbeing for Black Birthing People
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
- Being tested
- Holistic care partner perinatal nurse navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic care partner perinatal nurse navigationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Black Birthing Patients enrolled in Holistic Care Partner Program (HCP) | Experimental | 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. Receives: Behavioral: Holistic care partner perinatal nurse navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the study
Measured: Visit 4 (9-12 months postpartum)
Theoretical Framework for Acceptability (TFA) questionnaire score
Anticipated and experienced acceptability will be measured using the Theoretical Framework for Acceptability questionnaire. This is a 13-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the 7 component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy).
Total score ranges from 13-65, with higher scores indicating greater acceptability of the intervention.
Measured: Visit 3 (6-12 weeks postpartum)
Attendance rate for nurse navigator visits
Measured: Visit 4 (9-12 months postpartum)
Attendance rate at lactation classes
Measured: Visit 4 (9-12 months postpartum)
Attendance rate at the support group
Measured: Visit 4 (9-12 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start15 Jul 2024
- Primary completion18 Aug 2026 (estimated)
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal CareStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Audrey Lyndon, PhD, RNC, FAAN, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520566
- Sponsor's protocol ID
- 23-00821
- Other IDs
- 1R21NR020960-01
- Status last verified
- May 2026
- First submitted
- 22 Jul 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The redacted interview transcripts from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data and who provide a methodologically sound proposal executes a data use agreement with NYU Langone Health. Requests may be directed to: al6148@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Care Partners: A Black Woman-led Nurse Navigation Program to Improve Care, Reduce Harm, and Enhance Perinatal Wellbeing for Black Birthing People
- ClinicalTrials.gov ID
- NCT06520566
- Acronym / sponsor ID
- 23-00821
- Conditions
- Maternal Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 18 Aug 2026 (estimated)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Black Birthing Patients enrolled in Holistic Care Partner Program (HCP) | Experimental | Behavioral: Holistic care partner perinatal nurse navigationBlack 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Identify as Black or within the Black/African Diaspora
- Enrolled in the HCP program while pregnant or within 6 weeks postpartum
- Enrolled in the Faculty Group Practice at NYU Langone Health (NYULH) for obstetric care
- Plan to give birth at NYULH Tisch or gave birth at NYULH Tisch if postpartum at screening.
- Comfortable reading and/or speaking English (approximately 95% of Black women speak English)
Key exclusion criteria (7 listed)
- Does not identify as Black or within the Black/African Diaspora
- Did not enroll in the HCP program while pregnant or within 6 weeks postpartum.
- Not enrolled in the FGP NYULH for obstetric care
- Does not plan to give birth at NYULH Tisch or did not give birth at NYULH Tisch if postpartum at time of screening.
- Is not 18 years or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holistic care partner perinatal nurse navigationThe 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. | Behavioural | Black Birthing Patients enrolled in Holistic Care Partner Program (HCP) |
Primary outcome
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)
Anticipated and experienced acceptability will be measured using the Theoretical Framework for Acceptability questionnaire. This is a 13-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the 7 component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy). Total score ranges from 13-65, with higher scores indicating greater acceptability of the intervention.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. The redacted interview transcripts from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data and who provide a methodologically sound proposal executes a data use agreement with NYU Langone Health. Requests may be directed to: al6148@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey Lyndon, PhD, RNC, FAAN principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holistic care partner perinatal nurse navigation in people with Maternal Care, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Lyndon, PhD, RNC, FAAN (212-992-5940, al6148@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete the study (time frame: Visit 4 (9-12 months postpartum)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.