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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Postpartum Care, Primary Care, Mental Health, Family Planning, Care Coordination
- 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 group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| M-HARP recipient | Experimental | Participants 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.
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)
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
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
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
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.
- First posted19 Dec 2025
- Study start17 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum CareStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John James Parker
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica de Familia La Romana, Dominican Republic
- Responsible party
- Sponsor-investigator, John James Parker, Northwestern University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Health Assessment and Clinical Referral Integrated Into Pediatric Care (M-HARP) in the Dominican Republic
- ClinicalTrials.gov ID
- NCT07294573
- Acronym / sponsor ID
- M-HARP / STU00224392
- Conditions
- Postpartum Care, Primary Care, Mental Health, Family Planning, Care Coordination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- John James ParkerUniversity, hospital or other
- Collaborators
- Clínica de Familia La Romana, Dominican Republic
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Dec 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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | – |
| M-HARP recipient | Experimental | Behavioral: referralParticipants will complete a brief health questionnaire and will be referred to clinical care if indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| referralParticipants 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. | Behavioural | M-HARP recipient |
Primary outcome
Adoption
Time frame: From enrollment to one week after enrollment
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
4 secondary outcomes
Effectiveness
Time frame: from enrollment until 6 months from enrollment
Reach
Time frame: from enrollment until completion of baseline questionnaire
Implementation
Time frame: from enrollment to 6 months after enrollment
Maintenance
Time frame: from enrollment to 6 months following enrollment
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 13 Aug 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.