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Mississippi Delta Community Care Home Visits Program

Community Care Home Visiting Program to Reduce Maternal Health Inequities

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07006324
Acronym
Time4Mom
Enrollment
500
Registered
2025-06-05
Start date
2025-08-01
Completion date
2030-06-30
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Behavior, Postpartum Mood Disturbance

Brief summary

Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.

Detailed description

Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This research center will conduct two multi-layered research projects. Research Project 1 will determine the effectiveness of an evidenced-based community health worker home visiting program grounded in extensive patient and community participation. Research Project 2 will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity care.

Interventions

The PEN-3 Model is a sociocultural model for planning and assessing participant behavior within the context a cultural phenomenon. It will be used to assess intervention impact on patient-clinical linkages in the Mississippi Delta. 3-4 home visits with appropriate interventions through a referral and support process.

Sponsors

Mississippi State Department of Health
CollaboratorOTHER_GOV
University of Mississippi Medical Center
CollaboratorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER
Jackson State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Clinical trial with one arm.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Identified as high risk pregnancy * Postpartum mothers/parents 18-45 years * Resident of the one of 5 target counties (Washington, Bolivar, Scott, Humphreys, and Carroll)

Exclusion criteria

* not identified as high risk pregnancy * 18 years of age postpartum * cesarean birth * non-resident of the 5 target counties

Design outcomes

Primary

MeasureTime frameDescription
Number of ED visits in the first 6 weeks postpartum care of the home visits interventionUp to 1 year postpartumDifference between the number of ED visits in the first 6 weeks postpartum of the home visits in the intervention vs. non-intervention groups

Secondary

MeasureTime frameDescription
Severe maternal morbidity rates in target counties compared to non-target countiesUp to 1 year postpartumThe difference in de novo severe maternal morbidity rates.

Countries

United States

Contacts

Primary ContactMary Shaw, PhD
mary.shaw@jsums.edu601-979-3103
Backup ContactGirmay Berhie, PhD, MSW
girmay.berhie@jsums.edu304-360-5050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026