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

NCT05987059 | Recruiting Phase 2 DMC

• 1 other identifier: MH-CIP Project IMPACT
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• Effectiveness

  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.

  baseline, 3 months, 6 months

• Effectiveness

  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.

  baseline, 3 months, 6 months

Study Arms (2)

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.

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.

Behavioral: SBIRT Intervention

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.

Enhanced Structured Follow-Up; Standard Structured Follow-Up

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Morehouse School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

ACTIVE NOT RECRUITING

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

Related Publications (6)

• Costanza-Chock S. Design justice: Community-led practices to build the worlds we need. The MIT Press; 2020.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35891775 BACKGROUND

• Surgo Ventures - The US Maternal Vulnerability Index (MVI). mvi.surgoventures.org. Published 2021. Accessed February 2023. https://mvi.surgoventures.org/

  BACKGROUND

• 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.

  PMID: 34938596 BACKGROUND

• Maternal, Child, and Infant Health. Mecknc.gov. Published 2019. Accessed February 4, 2023. https://www.mecknc.gov/HealthDepartment/HealthStatistics/Pages/MaternalChildInfantHealth.aspx

  BACKGROUND

Study Officials

• Natalie D. Hernandez, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Cheryl Franklin, MD

  AssociateProfessor

  PRINCIPAL INVESTIGATOR

• Oluyemi Farinu, PhD

  Project Director

  STUDY DIRECTOR

Central Study Contacts

Madison Haiman, PhD

CONTACT

470-670-7071; mhaiman@msm.edu

Adenike McDonald, MPH

CONTACT

470-670-6397; projectimpactteam@msm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 15, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)