ClinicalTrials.gg
CompletedNCT06089109Updated Oct 5, 2026

Creating VIP Corps to Reduce Maternal Deaths

An interventional study of The Big 3 and Implementation and Effectiveness of VIP Corps Training in Maternal Morbidity and Mortality, sponsored by Ann Coker. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Ann Coker · Not applicable, Interventional, and Prevention

Updated Oct 5, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
598
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The goal of this observational study is to create and rigorously evaluate a violence intervention and prevention corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students; and to develop a novel maternal injury surveillance system (MISS) to complement an existing maternal violent death registry in Kentucky.

Read the detailed description

The participant population defined in this study are undergraduate and professional students within their last educational year in a helping professionals program at the University of Kentucky, ages 18-30. This study will permit the creation of effective programming to train the next generation of health and social service professionals prepared to help reduce Kentucky's maternal mortality and injury rates over time with implementation.

Aim 1:

  1. Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students.
  2. Develop a novel maternal injury surveillance system (MISS) as a complement to an existing maternal violent deaths registry to accurately and reliably enumerate maternal injuries and deaths due to violence.

Aim 2:

  1. Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening.
  2. Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence.
  3. Prospectively evaluate the effectiveness of a novel VIP training as the intervention condition relative to an attention control (SU/D and IPV awareness), to increase knowledge of the effects of intimate partner violence (IPV) on health outcomes, report intimate partner violence (IPV) screening behaviors, intimate partner violence (IPV) detection, and to reduce intimate partner violence (IPV) frequency among patients and clients over time.
02

Conditions studied

  • Maternal Morbidity and Mortality

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Keywords

  • Maternal Morbidity
  • Maternal Mortality
  • VIP Corps
  • Pregnancy-associated injuries
  • Pregnancy-associated deaths
03

In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's enrollment of 598 is below the median of 1,126 across 57 interventional studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Ann Coker is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Students enrolled in a helping professions program
  • 18 years of age through 30 years of age
  • Students whom will have direct interaction with patients or clients that may experience interpersonal violence (IPV)

Exclusion criteria

Exclusion Criteria:

  • Students not enrolled in a helping professions program
  • Students under age 18 or over age 30
  • Students with no direct interaction with patients or clients
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
598 participants (actual)

Study arms

  • Experimental
    Maternal Injury and Death Intervention

    Our research team created a VIP Corps online, interactive learning management system (LMS) training. This VIP Corps online training will be offered to students enrolled in a helping profession. Students are randomized to this experimental intervention arm. This training seeks to provide helping professionals with information and resources to identify, intervene, and prevent maternal injuries from interpersonal violence, substance use/disorder (IPV and SU/D). This training will provide students with the knowledge, skills, and efficacy to intervene and build capacity for prevention of maternal injuries and death due to violence.

    Behavioral: Implementation and Effectiveness of VIP Corps Training

  • Active comparator
    Development of a Maternal Injury Surveillance System

    Proposal of a novel Maternal Injury Surveillance System (MISS) as a complement to the existing maternal mortality surveillance available within Kentucky Violent Death Reporting System (KVDRS)

    Behavioral: The Big 3

Interventions

  • BehavioralThe Big 3

    Our research team has developed an online, interactive learning management system (LMS) training. This training seeks to provide helping professionals with information and resources to identify, intervene, and prevent maternal injuries from interpersonal violence, substance use/disorder (IPV and SU/D). This training will provide healthcare professionals with the knowledge, skills, and efficacy to intervene and build capacity for prevention of maternal injuries and death due to violence.

  • BehavioralImplementation and Effectiveness of VIP Corps Training

    Implement and evaluate the effectiveness of VIP Corps training aimed at students enrolled in helping professions in their last program year. intervention efficacy to change in students' knowledge, attitudes, and practices of intimate partner violence (IPV) screening, detection, and referrals; participant practices will be the primary, longer-term outcome; while changes in knowledge and attitudes will be short-term outcomes. Secondary outcomes will include changes in detecting symptoms of a) SU/D and b) depression and/or anxiety and providing appropriate resources.

06

What researchers measure

Primary outcomes

  1. Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people.

    Change in knowledge of intimate partner violence (IPV) and attitudes toward those experiencing IPV by condition over time. Knowledge of pregnancy-associated causes of maternal mortality and morbidity created for this randomized controlled trial (RCT). This is a 17-item scale ranging from 0-35 with higher scores indicating greater (accurate) knowledge.

    Time frame: Year 2 - Year 4

  2. Knowledge and attitudes toward substance use among pregnant and postpartum people.

    Change in knowledge of substance use and attitudes toward those using substances or having a substance use disorder by condition over time. Attitudes toward pregnant or postpartum people experiencing: a) intimate partner violence (IPV), substance use, and anxiety or depression. This measure is based on the Domestic Violence Myth Acceptance and expanded to substance use and anxiety or depression. 45 items and 3 subscales. Response options: 1-5 indicating ranging from strongly agree to strongly disagree. Lower scores are desired indicating greater acceptance and increased willingness to address intimate partner violence (IPV), substance use, and anxiety or depression among pregnant or postpartum people.

    Time frame: Year 2 - Year 4

  3. Knowledge and attitudes toward anxiety or depression among pregnant or postpartum people.

    Change in knowledge of anxiety or depression and attitudes toward those with anxiety or depression by condition over time. The Violence Against Women Health Care Provider Survey expanded to providers' willingness to ask clients about: a) Intimate partner violence (IPV), b) substance use, and c) anxiety or depression. 41 items querying self-confidence and actions in asking clients about risk factors for maternal morbidity. The response options 1-5 indicate strongly agree to strongly disagree. Higher scores are desired as indicators of greater self confidence and likelihood of actions with clients.

    Time frame: Year 2 - Year 4

Secondary outcomes

  1. Participants' (care provider) self-report of asking pregnant or postpartum people about intimate partner violence (IPV), substance use, and anxiety or depression.

    Change in willingness, perceived efficacy, reports of asking clients about intimate partner violence (IPV) by condition and over time. New Bystander Action Survey developed for this randomized controlled trial (RCT). There are 20 items that measure the opportunity to take action with clients, friends or family members; actions taken, and perceived impact. There are 6 response options ranging from 0 times to more than 12 times (in the past 6 months). More actions and a higher score, are desired as indicators of greater actions to identify risk of maternal morbidity and provide resources to reduce this risk.

    Time frame: Year 3 - Year 5

07

Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40506, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Oct 5, 2026
Primary completion
Sep 29, 2026→May 25, 2026 (actual)
Oct 5, 2026
Study completion
Sep 29, 2027→May 25, 2026 (actual)
Oct 5, 2026
Enrollment
2800 (estimated)→598 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Recruiting→Completed
    Primary completion Sep 29, 2026→May 25, 2026 (now actual)
    Study completion Sep 29, 2027→May 25, 2026 (now actual)
    Enrollment 2800 (estimated)→598 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06089109
Lead sponsor
Ann Coker
Collaborators
Department of Health and Human Services
Responsible party
Ann Coker (Professor, University of Kentucky) — Sponsor-investigator
First posted
Oct 18, 2023
Start date
Sep 25, 2023
Primary completion
May 25, 2026
Completion
May 25, 2026
Last update
Oct 5, 2026

Study contacts

Ann L Coker, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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