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Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT

NCT05987059 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2025-06-15

No results posted yet for this study

Summary

With support from the National Heart, Lung, and Blood Institute, The Center for Maternal Health Equity at Morehouse School of Medicine is conducting a research study to test the implementation of Pre-Pregnancy Counseling in community-based settings.

Conditions

  • Preconception Health

Interventions

BEHAVIORAL

SBIRT Intervention

Project IMPACT intervention will follow a Screening, Brief Intervention, and Referral to Treatment (SBIRT) Model. In the proposed study, staff at community sites will deliver a tailored SBIRT model for people seeking to get pregnant as our "Project IMPACT intervention". SBIRT was originally developed as a public health model designed to provide universal screening, secondary prevention (detecting risky or hazardous substance use before the onset of abuse or dependence), early intervention, and treatment for people who have problematic or hazardous alcohol problems within primary care and other health care settings. Morehouse School of Medicine (MSM) has adapted this SBIRT model for people who are seeking to get pregnant to assess their risks and provide early intervention to at-risk people of reproductive age who want to get pregnant. Brief preconception counseling interventions addressing multiple behavioral risk factors have been found to be effective in prior studies.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Morehouse School of Medicine

    lead OTHER

Principal Investigators

  • Natalie D. Hernandez, PhD · Associate Professor

  • Cheryl Franklin, MD · AssociateProfessor

  • Oluyemi Farinu, PhD · Project Director

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2028-03-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987059 on ClinicalTrials.gov