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Postpartum CareM-HARPNCT07294573

Maternal Health Assessment in Pediatric Care

A study testing referral in people with Postpartum Care and Primary Care, run by John James Parker at 1 site in Dominican Republic.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The major goal of this study is to develop and pilot M-HARP (Maternal Health Assessment and Referral Integrated into Pediatric Care). M-HARP will adapt a successful US-based health screening and referral protocol to fit the needs of new mothers at Clínica de Familia La Romana, Dominican Republic. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postpartum Care, Primary Care, Mental Health
What is being tested?
referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteDominican Republic
Study dates
17 Nov 2025to Apr 2027
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women attending pediatric visits at Clínica de Familia La Romana during the study period
  • Women in postpartum period, with children up to 6 months of age ≥18 years

Who cannot join

  • Pregnant with another child, since they will be triaged to prenatal care rather than postpartum primary care
  • Unwilling and unable to consent
  • Women who do not speak Spanish or Creole.

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site
  • Clínica De Familia

    La Romana

Other trials in Dominican Republic

About this study

Official title: Maternal Health Assessment and Clinical Referral Integrated Into Pediatric Care (M-HARP) in the Dominican Republic

The major goal of this study is to develop and pilot M-HARP (Maternal Health Assessment and Referral Integrated into Pediatric Care). M-HARP will adapt a successful US-based health screening and referral protocol to fit the needs of new mothers at Clínica de Familia La Romana, Dominican Republic.

Read the detailed description

The major goal of this project is to improve the access and utilization of primary healthcare of women in the postpartum period at Clínica de Familia La Romana (CFLR), by designing and piloting M-HARP. Additionally, by applying best practices in implementation science, our study will provide data that can be utilized in other settings. First, the investigators will develop strategies for integrating M-HARP into CFLR through stakeholder engagement. Second, we will pilot M-HARP at CFLR by recruiting postpartum women during their child's pediatric well child visit and measure implementation outcomes guided by the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework.

Aim 1: Develop strategies and processes for establishing M-HARP into CFLR. In Aim 1 the investigators will conduct two in-person advisory meetings, each held at CFLR. One meeting will be with mothers that receive their obstetric care and/or bring their children to CFLR for pediatric care. A second meeting advisory meeting clinicians at CFLR- obstetricians, pediatricians, family planning providers, family medicine and internal medicine. In each meeting we will review the M-HARP questionnaire, the draft protocol and conduct a patient journey mapping exercise. These meetings will be audio recorded and transcribed so the meetings can be reviewed later. Results from these meetings are solely recommendations for M-HARP protocol optimization and will not be published. Therefore, the advisory board members are not research participants.

Aim 2: Pilot M-HARP:

The pilot will enroll participants into two separate groups- the standard of care (SOC) group or M-HARP receipt group. All participants are mothers that will be recruited and enrolled while accompanying their infant to a pediatric visit at CFLR. Potential participants will be recruited after their child has been placed in the clinical exam room. In standard practice, the nurse or medical assistant from CFLR will intake the child (record vital signs and review immunization history). Then the family will wait in the exam room for the pediatrician. At this time the research assistant will approach the mother and assess interest in participating in the study. If the mother is interested, the research assistant will explain the study and assess the mother's eligibility. If mother agrees to participate, consent will be explained and signed. This will all occur in the exam room, which is a private space.

In phase 1, the investigators will enroll SOC, who will complete a questionnaire on demographics and medical history but will not have the M-HARP questionnaire reviewed by the pediatrician. Phase 2 will consist of M-HARP recipient group enrollment. During Phase 2, participants will also fill out a questionnaire on demographics and medical history but will also be given the M-HARP questionnaire. The M-HARP questionnaire will gather information on healthcare visits since delivery, desire for contraception, PHQ-2 depression screening, and desire for referral. The M-HARP questionnaire will be subsequently reviewed by the pediatrician. If the participants meet the criteria, they will be referred to the appropriate primary care service within the CFLR clinic. CFLR provides many different care services including primary care, obstetrics and gynecology, family planning and psychological care. Follow-up for SOCs and M-HARP recipients will occur 2-3 months after enrollment. All participants will be contacted to complete a survey (online or over the phone), which will be a repeat of the M-HARP questionnaire that assesses use of primary care and/or family planning services. At this time, study team members will review Clinical de Familia's medical records to evaluate if participants had scheduled or attended clinical visits. After the follow-up survey, we will conduct interviews with 15 participants in the M-HARP recipient group. The interview will assess the participants' experience in M-HARP, its acceptability, feasibility, and integration into pediatric care at CFLR. Participant information will be de-identified during data analysis and contact information will only be accessible to research staff to ensure confidentiality. Lastly, to ensure that all participants have the same access to health resources, after the follow-up survey the SOC participants will be provided with the same referrals that were offered to the M-HARP recipient group after the initial questionnaire, but their health care use data will not be tracked after that time.

Being tested
referral
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • referralBehavioural

    Participants in the intervention arm will be given the "M-HARP questionnaire." The M-HARP questionnaire will gather information on healthcare visits since delivery, desire for contraception, depression screening, and desire for referral. The M-HARP questionnaire will be subsequently reviewed by the pediatrician. If the participants meet the criteria, they will be referred to the appropriate clinical service, including primary care, obstetrics and gynecology, family planning and psychological care.

Study groups in NCT07294573
Study groupRoleWhat they receive
Standard of CareNo interventionNot described
M-HARP recipientExperimentalParticipants will complete a brief health questionnaire and will be referred to clinical care if indicated.
Receives: Behavioral: referral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adoption

    Adoption will be measured by the percentage of pediatricians that document review of questionnaire along with the percentage of women that complete the entire questionnaire once enrolled

    Measured: From enrollment to one week after enrollment

Secondary outcomes (4)
  1. Effectiveness

    Effectiveness will be measured by the difference in receipt of postpartum primary care services between in the M-HARP intervention group and the standard of care control group after the study period. Additionally, the proportion of women who are on desired contraceptives between groups is a second effectiveness outcome.

    Measured: from enrollment until 6 months from enrollment

  2. Reach

    Reach will be measured by determining how many women who attend their infants well child visit have already consulted with a primary care service after delivery. This information is collected in the first question of the M-HARP questionnaire.

    Measured: from enrollment until completion of baseline questionnaire

  3. Implementation

    Implementation will be measured by determining the number of referrals given if participant met referral criteria. Additionally, if participants subsequently made referral appointment

    Measured: from enrollment to 6 months after enrollment

  4. Maintenance

    Maintenance will be measured by the number of women who attend primary care appointments after referral. Additionally, it will be assessed by a qualitative discussion with board of key constituents on its maintenance and integration at the clinic after the study period.

    Measured: from enrollment to 6 months following enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start17 Nov 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07294573
Sponsor's protocol ID
STU00224392
Other IDs
1001PC
Acronym
M-HARP
Status last verified
Aug 2026
First submitted
8 Dec 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing referral in people with Postpartum Care and Primary Care, run by John James Parker at 1 site in Dominican Republic.

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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 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 Dominican Republic. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adoption (time frame: From enrollment to one week after enrollment). 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 13 Aug 2026.

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