Community program to reduce heart-related pregnancy risks before conception
Official title: Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
Run by Morehouse School of Medicine · NCT05987059 · Data updated 2026-11-12
This program will try pre-pregnancy counseling using a Screening, Brief Intervention, and Referral to Treatment (SBIRT) approach in community settings to help Black women lower cardiovascular risks before pregnancy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 44 Years |
| Sex | All |
| Enrollment | 850 (estimated) |
| Sponsor | Morehouse School of Medicine Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | March 2028 |
| Study ends | December 2028 |
| Registry record updated | June 15, 2025 |
| Trial ID | NCT05987059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Non-pregnant, English-speaking Black/African-American women who receive services at the participating community-based sites and own a phone are the intended participants.
✕Probably not a fit
Women who are already pregnant, do not identify as Black/African-American, are not English speakers, or do not access the participating community sites are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project partners with Healthy Start and similar community-based sites to deliver evidence-based preconception counseling focused on cardiovascular risk factors such as obesity, diabetes, and hypertension. Investigators use a community-engaged approach and a SBIRT model that staff can feasibly deliver to at-risk Black women who are not currently pregnant. The Phase 2 intervention builds on pilot testing that demonstrated capacity to screen for pregnancy risks and provide early intervention in community settings. Implementation occurs through participating community sites with support from Morehouse School of Medicine and NHLBI.
Why it matters
Potential benefit: If successful, the program could lower pregnancy-related cardiovascular risks and help prevent avoidable maternal morbidity and deaths among Black women by delivering counseling where they already receive services.
How similar studies have gone: Preconception counseling has previously shown benefits for managing obesity, diabetes, and hypertension, and SBIRT approaches have been feasible in pilots, but large-scale community-based trials specifically targeting maternal cardiovascular disparities remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Self-identify as Black/ African-American * Fluent English-Speaker * Not pregnant at the time of enrollment * Own a phone * Receive services at the community-based site Exclusion Criteria: \-
Where it's running
-
Morehouse School of Medicine
Atlanta, Georgia, United States Recruiting -
Morehouse School of Medicine
Atlanta, Georgia, United States Active not recruiting
Study contacts
- Principal investigator: Natalie D. Hernandez, PhD — Associate Professor
- Study coordinator: Madison Haiman, PhD
- Email: mhaiman@msm.edu
- Phone: 470-670-7071
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.