Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Morehouse School of Medicine
- Study ID
- NCT05987059
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Preconception Health
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 44 Years
- Healthy Volunteers
- Accepted
Interventions
- SBIRT Intervention — BEHAVIORALProject 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.
Study Details
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.
Key Dates
- Start date
- Jan 1, 2024
- Status verified
- Nov 2024
- Primary completion
- Mar 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 850 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- PREVENTION
Arms
- Experimental: Standard Structured Follow-UpEmailed informational flyer(s) on prioritized cardiovascular risks and text messaging for logistical reasons. These will be in addition to the SBIRT intervention delivered by Healthy Start and other similar community organization staff that all participants will receive.
- Experimental: Enhanced Structured Follow-UpText or phone message(s) focused on the same prioritized risks + emailed informational flyer(s). These will be in addition to the SBIRT intervention delivered by Healthy Start and other similar community organization staff that all participants will receive.
Primary Outcome Measure
Implementation [ Time Frame: 6 months ]
Central Contacts
- Madison Haiman, PhD470-670-7071
- Adenike McDonald, MPH470-670-6397
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Morehouse School of Medicine | Atlanta | Georgia | 30310 | - |
| Morehouse School of Medicine | Atlanta | Georgia | 30310 | - |
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