Maternal BehaviorTime4MomNCT07006324
Mississippi Delta Community Care Home Visits Program
A study testing The PEN-3 Intervention Model in people with Maternal Behavior and Postpartum Mood Disturbance, run by Jackson State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Maternal Behavior, Postpartum Mood Disturbance
- What is being tested?
- The PEN-3 Intervention Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to 30 Jun 2030
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- not identified as high risk pregnancy
- 18 years of age postpartum
- cesarean birth
- non-resident of the 5 target counties
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mississippi State Department of Health
Jackson, Mississippi, 39216
Krista Guynes, LMSW, 601-576-7145, krista.guynes@msdh.ms.gov
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
James Tucker, MD, 601-984-1000, jtucker1@umc.edu
James Tucker, MD, jtucker1@umc.edu
About this study
Official title: Community Care Home Visiting Program to Reduce Maternal Health Inequities
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.
Read the 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.
- Conditions
- Maternal Behavior, Postpartum Mood Disturbance
- Being tested
- The PEN-3 Intervention Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PEN-3 Intervention ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PEN-3 Assessment Model | Other | Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes Receives: Behavioral: The PEN-3 Intervention Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year postpartum
Secondary outcomes (1)
Severe maternal morbidity rates in target counties compared to non-target counties
The difference in de novo severe maternal morbidity rates.
Measured: Up to 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Aug 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- 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
- Model description
- Clinical trial with one arm.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jackson State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mississippi State Department of Health, University of Mississippi Medical Center, Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Mary Shaw, PhD, Principal investigator, Jackson State UniversityHenning Temeier, PhD, MD, Study director, Harvard School of Public Heatlh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006324
- Sponsor's protocol ID
- 1U54HD113238-01
- Acronym
- Time4Mom
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Care Home Visiting Program to Reduce Maternal Health Inequities
- ClinicalTrials.gov ID
- NCT07006324
- Acronym / sponsor ID
- Time4Mom / 1U54HD113238-01
- Conditions
- Maternal Behavior, Postpartum Mood Disturbance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jackson State UniversityUniversity, hospital or other
- Collaborators
- Mississippi State Department of Health, University of Mississippi Medical Center, Harvard School of Public Health (HSPH)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 5 Jun 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Clinical trial with one arm.
| Arm | Type | Receives |
|---|---|---|
| PEN-3 Assessment Model | Other | Behavioral: The PEN-3 Intervention ModelApplication of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- not identified as high risk pregnancy
- 18 years of age postpartum
- cesarean birth
- non-resident of the 5 target counties
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 |
|---|---|---|
| The PEN-3 Intervention ModelThe 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. | Behavioural | PEN-3 Assessment Model |
Primary outcome
Number of ED visits in the first 6 weeks postpartum care of the home visits intervention
Time frame: Up to 1 year postpartum
Difference between the number of ED visits in the first 6 weeks postpartum of the home visits in the intervention vs. non-intervention groups
1 secondary outcome
Severe maternal morbidity rates in target counties compared to non-target counties
Time frame: Up to 1 year 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 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Mary Shaw, PhD principal investigator
Jackson State University
Henning Temeier, PhD, MD study director
Harvard School of Public Heatlh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PEN-3 Intervention Model in people with Maternal Behavior and Postpartum Mood Disturbance, run by Jackson State University at 2 sites 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 3 inclusion and 4 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Mary Shaw, PhD (601-979-3103, mary.shaw@jsums.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ED visits in the first 6 weeks postpartum care of the home visits intervention (time frame: Up to 1 year postpartum). 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 Sep 2025.