Preconception HealthPhase 2Project IMPACTNCT05987059
Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
A Phase 2 study testing SBIRT Intervention in people with Preconception Health, run by Morehouse School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Preconception Health
- What is being tested?
- SBIRT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Morehouse School of Medicine
Atlanta, Georgia, 30310
- Recruiting
Morehouse School of Medicine
Atlanta, Georgia, 30310
About this study
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.
Read the detailed description
Severe racial disparities in pregnancy-related cardiovascular morbidity and mortality are preventable and warrant timely community-engaged action. Black women are 3 times more likely to die from a pregnancy-related cause, as compared to white women10 -in part, due to higher rates of cardiovascular risk during pregnancy. More than 80% of pregnancy-related deaths in the U.S. are preventable. Preconception counseling has been shown to improve maternal health for all women, with clear benefits to address cardiovascular risk factors of obesity, diabetes, hypertension. In order to have impact, evidence-based preconception counseling programs must be delivered through community settings that have a mission to reach at-risk populations of women. Healthy Start/community-based settings are appropriate for this, as they serve an at-risk population of Black women in many locations nationally. The investigators have engaged with Healthy Start and similar community-based settings in Georgia, South Carolina, to identify preconception counseling interventions that are evidence-based and feasible for their staff and community members. This community-engaged approach identified Screening, Brief Intervention, and Referral to Treatment (SBIRT) interventions as feasible and acceptable to both staff and patients. In the pilot-test of their SBIRT model approach (Project IMPACT intervention), the investigators demonstrated capacity to screen for pregnancy risks and provide early intervention to n = 23 at-risk persons of reproductive age who wanted to get pregnant within the year. The investigators will build on their pilot work to conduct a hybrid effectiveness/implementation trial (type 2 hybrid) with n = 10 sites serving low-income African American men and women in Georgia, NC, SC, and TN. The investigators will use EPIS as an overarching framework to guide progress across the four phases (exploration, preparation, implementation and sustainment). In Aim 1 (EPIS Preparation phase), the investigators will work with their community partners to tailor the implementation strategy packages (Aim 1a) and their Project IMPACT intervention (Aim 1b) to the context of 10 sites across 4 states -- this tailoring will address contextual determinants of successful implementation from the Pragmatic Robust Implementation and Sustainability Model (PRISM). In Aim 2 (EPIS Implementation phase), we will test an Enhanced vs. Standard implementation strategy package of structured follow-up on the number of pre-conception counseling visits completed and will test any structured follow-up vs. no structured follow-up on readiness to change for key cardiovascular risk factors. In Aim 3 (EPIS Sustainment phase), the investigators will work with their community sites to co-develop an implementation and sustainment guide for the most effective strategy bundle from Aim 2. This work has potential to impact racial disparities in pregnancy-related morbidity/mortality and to advance our collective scientific understanding of the relative benefits of alternate implementation strategy packages.
- Conditions
- Preconception Health
- Being tested
- SBIRT Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBIRT InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard Structured Follow-Up | Experimental | 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. Receives: Behavioral: SBIRT Intervention |
| Enhanced Structured Follow-Up | Experimental | 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. Receives: Behavioral: SBIRT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation
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.
Measured: 6 months
Effectiveness
- 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.
Measured: baseline, 3 months, 6 months
Effectiveness
- 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.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2024
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preconception HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The proposed study will be a Type 2 hybrid effectiveness-implementation RCT with individual level randomization to one of two intervention study arms (standard and enhanced implementation strategy packages) in years 2-4 and data from a non-randomized third study arm (control group) captured in year 1. An expected 10 community-based organizations will participate in the study. A hybrid type 2 design is ideal because there are effectiveness studies conducted on preconception counseling conducted in clinical settings, but there is still a dearth of evidence on both effectiveness and implementation of preconception counseling in community-based settings and specifically with Black women and in Black-led organizations. The hybrid type 2 design would allow for continued evaluation of the effectiveness of the intervention and could capitalize on the implementation occurring to evaluate the impact of implementation strategies.
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Natalie D. Hernandez, PhD, Principal investigator, Associate ProfessorCheryl Franklin, MD, Principal investigator, AssociateProfessorOluyemi Farinu, PhD, Study director, Project Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987059
- Sponsor's protocol ID
- MH-CIP Project IMPACT
- Acronym
- Project IMPACT
- Status last verified
- Nov 2024
- First submitted
- 30 Jun 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costanza-Chock S. Design justice: Community-led practices to build the worlds we need. The MIT Press; 2020.
Wallerstein N, Duran B, Oetzel JG, Minkler M. On community-based participatory research. Community-based participatory research for health: Advancing social and health equity. 2017;3:3-16.
Aguilar-Gaxiola S, Ahmed SM, Anise A, Azzahir A, Baker KE, Cupito A, Eder M, Everette TD, Erwin K, Felzien M, Freeman E, Gibbs D, Greene-Moton E, Hernandez-Cancio S, Hwang A, Jones F, Jones G, Jones M, Khodyakov D, Michener JL, Milstein B, Oto-Kent DS, Orban M, Pusch B, Shah M, Shaw M, Tarrant J, Wallerstein N, Westfall JM, Williams A, Zaldivar R. Assessing Meaningful Community Engagement: A Conceptual Model to Advance Health Equity through Transformed Systems for Health: Organizing Committee for Assessing Meaningful Community Engagement in Health & Health Care Programs & Policies. NAM Perspect. 2022 Feb 14;2022:10.31478/202202c. doi: 10.31478/202202c. eCollection 2022. No abstract available.
PubMed 35891775Surgo Ventures - The US Maternal Vulnerability Index (MVI). mvi.surgoventures.org. Published 2021. Accessed February 2023. https://mvi.surgoventures.org/
Armstrong-Mensah E, Dada D, Bowers A, Muhammad A, Nnoli C. Geographic, Health Care Access, Racial Discrimination, and Socioeconomic Determinants of Maternal Mortality in Georgia, United States. Int J MCH AIDS. 2021;10(2):278-286. doi: 10.21106/ijma.524. Epub 2021 Dec 13.
PubMed 34938596Maternal, Child, and Infant Health. Mecknc.gov. Published 2019. Accessed February 4, 2023. https://www.mecknc.gov/HealthDepartment/HealthStatistics/Pages/MaternalChildInfantHealth.aspx
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
- ClinicalTrials.gov ID
- NCT05987059
- Acronym / sponsor ID
- Project IMPACT / MH-CIP Project IMPACT
- Conditions
- Preconception Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe racial disparities in pregnancy-related cardiovascular morbidity and mortality are preventable and warrant timely community-engaged action. Black women are 3 times more likely to die from a pregnancy-related cause, as compared to white women10 -in part, due to higher rates of cardiovascular risk during pregnancy. More than 80% of pregnancy-related deaths in the U.S. are preventable. Preconception counseling has been shown to improve maternal health for all women, with clear benefits to address cardiovascular risk factors of obesity, diabetes, hypertension. In order to have impact, evidence-based preconception counseling programs must be delivered through community settings that have a mission to reach at-risk populations of women. Healthy Start/community-based settings are appropriate for this, as they serve an at-risk population of Black women in many locations nationally. The investigators have engaged with Healthy Start and similar community-based settings in Georgia, South Carolina, to identify preconception counseling interventions that are evidence-based and feasible for their staff and community members. This community-engaged approach identified Screening, Brief Intervention, and Referral to Treatment (SBIRT) interventions as feasible and acceptable to both staff and patients. In the pilot-test of their SBIRT model approach (Project IMPACT intervention), the investigators demonstrated capacity to screen for pregnancy risks and provide early intervention to n = 23 at-risk persons of reproductive age who wanted to get pregnant within the year. The investigators will build on their pilot work to conduct a hybrid effectiveness/implementation trial (type 2 hybrid) with n = 10 sites serving low-income African American men and women in Georgia, NC, SC, and TN. The investigators will use EPIS as an overarching framework to guide progress across the four phases (exploration, preparation, implementation and sustainment). In Aim 1 (EPIS Preparation phase), the investigators will work with their community partners to tailor the implementation strategy packages (Aim 1a) and their Project IMPACT intervention (Aim 1b) to the context of 10 sites across 4 states -- this tailoring will address contextual determinants of successful implementation from the Pragmatic Robust Implementation and Sustainability Model (PRISM). In Aim 2 (EPIS Implementation phase), we will test an Enhanced vs. Standard implementation strategy package of structured follow-up on the number of pre-conception counseling visits completed and will test any structured follow-up vs. no structured follow-up on readiness to change for key cardiovascular risk factors. In Aim 3 (EPIS Sustainment phase), the investigators will work with their community sites to co-develop an implementation and sustainment guide for the most effective strategy bundle from Aim 2. This work has potential to impact racial disparities in pregnancy-related morbidity/mortality and to advance our collective scientific understanding of the relative benefits of alternate implementation strategy packages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study will be a Type 2 hybrid effectiveness-implementation RCT with individual level randomization to one of two intervention study arms (standard and enhanced implementation strategy packages) in years 2-4 and data from a non-randomized third study arm (control group) captured in year 1. An expected 10 community-based organizations will participate in the study. A hybrid type 2 design is ideal because there are effectiveness studies conducted on preconception counseling conducted in clinical settings, but there is still a dearth of evidence on both effectiveness and implementation of preconception counseling in community-based settings and specifically with Black women and in Black-led organizations. The hybrid type 2 design would allow for continued evaluation of the effectiveness of the intervention and could capitalize on the implementation occurring to evaluate the impact of implementation strategies.
| Arm | Type | Receives |
|---|---|---|
| Standard Structured Follow-Up | Experimental | Behavioral: SBIRT InterventionEmailed 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. |
| Enhanced Structured Follow-Up | Experimental | Behavioral: SBIRT InterventionText 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBIRT InterventionProject 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. | Behavioural | Enhanced Structured Follow-Up, Standard Structured Follow-Up |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- BackgroundCostanza-Chock S. Design justice: Community-led practices to build the worlds we need. The MIT Press; 2020.
- BackgroundWallerstein N, Duran B, Oetzel JG, Minkler M. On community-based participatory research. Community-based participatory research for health: Advancing social and health equity. 2017;3:3-16.
- Background: PubMed 35891775Aguilar-Gaxiola S, Ahmed SM, Anise A, Azzahir A, Baker KE, Cupito A, Eder M, Everette TD, Erwin K, Felzien M, Freeman E, Gibbs D, Greene-Moton E, Hernandez-Cancio S, Hwang A, Jones F, Jones G, Jones M, Khodyakov D, Michener JL, Milstein B, Oto-Kent DS, Orban M, Pusch B, Shah M, Shaw M, Tarrant J, Wallerstein N, Westfall JM, Williams A, Zaldivar R. Assessing Meaningful Community Engagement: A Conceptual Model to Advance Health Equity through Transformed Systems for Health: Organizing Committee for Assessing Meaningful Community Engagement in Health & Health Care Programs & Policies. NAM Perspect. 2022 Feb 14;2022:10.31478/202202c. doi: 10.31478/202202c. eCollection 2022. No abstract available.
- BackgroundSurgo Ventures - The US Maternal Vulnerability Index (MVI). mvi.surgoventures.org. Published 2021. Accessed February 2023. https://mvi.surgoventures.org/
- Background: PubMed 34938596Armstrong-Mensah E, Dada D, Bowers A, Muhammad A, Nnoli C. Geographic, Health Care Access, Racial Discrimination, and Socioeconomic Determinants of Maternal Mortality in Georgia, United States. Int J MCH AIDS. 2021;10(2):278-286. doi: 10.21106/ijma.524. Epub 2021 Dec 13.
- BackgroundMaternal, Child, and Infant Health. Mecknc.gov. Published 2019. Accessed February 4, 2023. https://www.mecknc.gov/HealthDepartment/HealthStatistics/Pages/MaternalChildInfantHealth.aspx
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie D. Hernandez, PhD principal investigator
Associate Professor
Cheryl Franklin, MD principal investigator
AssociateProfessor
Oluyemi Farinu, PhD study director
Project Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBIRT Intervention in people with Preconception Health, run by Morehouse School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Haiman, PhD (470-670-7071, mhaiman@msm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05987059, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.