Mississippi Delta Community Care Home Visits Program

NCT07006324 | Recruiting

• 1 other identifier: 1U54HD113238-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Maternal Behavior; Postpartum Mood Disturbance

Outcome Measures

Primary Outcomes (1)

• Number of ED visits in the first 6 weeks postpartum care of the home visits intervention

  Difference between the number of ED visits in the first 6 weeks postpartum of the home visits in the intervention vs. non-intervention groups

  Up to 1 year postpartum

Secondary Outcomes (1)

• Severe maternal morbidity rates in target counties compared to non-target counties

  Up to 1 year postpartum

Study Arms (1)

PEN-3 Assessment Model

OTHER

Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes

Behavioral: The PEN-3 Intervention Model

Interventions

The PEN-3 Intervention Model BEHAVIORAL

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.

PEN-3 Assessment Model

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: biological women at birth; women who have vaginal deliveries
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Jackson State University: lead
• Mississippi State Department of Health: collaborator
• University of Mississippi Medical Center: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (2)

Mississippi State Department of Health

Jackson, Mississippi, 39216, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Study Officials

• Mary Shaw, PhD

  Jackson State University

  PRINCIPAL INVESTIGATOR

• Henning Temeier, PhD, MD

  Harvard School of Public Heatlh

  STUDY DIRECTOR

Central Study Contacts

Mary Shaw, PhD

CONTACT

601-979-3103; mary.shaw@jsums.edu

Girmay Berhie, PhD, MSW

CONTACT

304-360-5050; girmay.berhie@jsums.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial with one arm.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: June 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)