NCT05987059 · Morehouse School of Medicine
Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
(Project IMPACT)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Implementation
Time frame: 6 months
Each participant will remain in the study for six months and will complete three interviews (baseline, 3-month, 6-month follow-up). The number of pre-conception counseling sessions received by community members in the standard and enhanced intervention arms will be captured at 6 months. The proposed range for the primary implementation outcome will be 0-7 visits/contacts.
Effectiveness
Time frame: baseline, 3 months, 6 months
1\) 0-10 readiness ruler (inclusive of all 5 stages of change) Each participant will remain in the study for six months and will complete three interviews (baseline, 3-month, 6-month follow-up). The stage of change score will be captured at baseline, 3 and 6 months. A text message reminder will be sent to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the control group participants.
Effectiveness
Time frame: baseline, 3 months, 6 months
2\) 0-10 readiness ruler (inclusive of all 5 stages of change) Each participant will remain in the study for six months and will complete three interviews (baseline, 3-month, 6-month follow-up). The stage of change score will be captured at baseline, 3 and 6 months. A text message reminder will be sent to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the control group participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2025 · Source of record for eligibility and locations