Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-27 @ 6:15 PM
Study NCT ID:
NCT05987059
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
Sponsor:
Morehouse School of Medicine
Organization:
Study Overview
Official Title:
Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Project IMPACT
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: