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 — BEHAVIORAL
    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.

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-Up
    Emailed 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-Up
    Text 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

Locations (2)

FacilityCityStateZIPSite coordinators
Morehouse School of MedicineAtlantaGeorgia30310-
Morehouse School of MedicineAtlantaGeorgia30310-

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