Maternal Morbidity and MortalityNCT06089109
Creating VIP Corps to Reduce Maternal Deaths
A study testing The Big 3 and Implementation and Effectiveness of VIP Corps Training in people with Maternal Morbidity and Mortality, run by Ann Coker at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal Morbidity and Mortality
- What is being tested?
- The Big 3 and Implementation and Effectiveness of VIP Corps Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Violence Intervention and Prevention (VIP) Corps to Reduce Maternal Injuries and Deaths Due to Violence
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:
- Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students.
- 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:
- Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening.
- Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence.
- 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.
- Conditions
- Maternal Morbidity and Mortality
- Being tested
- The Big 3, Implementation and Effectiveness of VIP Corps Training
- Keywords
- Maternal Morbidity, Maternal Mortality, VIP Corps, Pregnancy-associated injuries, Pregnancy-associated deaths
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Big 3Behavioural
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.
Implementation and Effectiveness of VIP Corps TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Injury and Death Intervention | Experimental | 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. Receives: Behavioral: Implementation and Effectiveness of VIP Corps Training |
| Development of a Maternal Injury Surveillance System | Active comparator | 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) Receives: Behavioral: The Big 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 2 - Year 4
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:
- 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.
Measured: Year 2 - Year 4
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:
- 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.
Measured: 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.
Measured: Year 3 - Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start25 Sep 2023
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Morbidity and MortalityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann Coker
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor-investigator, Ann Coker, University of Kentucky
- Investigators
- Ann L Coker, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089109
- Sponsor's protocol ID
- 77241
- Other IDs
- 5 ASTWH210102-02-00
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Violence Intervention and Prevention (VIP) Corps to Reduce Maternal Injuries and Deaths Due to Violence
- ClinicalTrials.gov ID
- NCT06089109
- Acronym / sponsor ID
- 77241
- Conditions
- Maternal Morbidity and Mortality
- Keywords
- Maternal Morbidity, Maternal Mortality, VIP Corps, Pregnancy-associated injuries, Pregnancy-associated deaths
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Ann CokerUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 18 Oct 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.
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.
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:
- Create and rigorously evaluating Violence Intervention and Prevention Corps (VIP Corps) training using a randomized controlled trial among undergraduate and professional students.
- 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:
- Determine the effectiveness of complementary intervention and prevention strategies to increase interpersonal violence, substance use/disorder (IPV, SU/D), depression or anxiety screening.
- Reduce symptoms among those who screen positive, and ultimately reduce maternal injuries and deaths due to violence.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maternal Injury and Death Intervention | Experimental | Behavioral: Implementation and Effectiveness of VIP Corps TrainingOur 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. |
| Development of a Maternal Injury Surveillance System | Active comparator | Behavioral: The Big 3Proposal 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| The Big 3Our 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. | Behavioural | Development of a Maternal Injury Surveillance System |
| Implementation and Effectiveness of VIP Corps TrainingImplement 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. | Behavioural | Maternal Injury and Death Intervention |
Primary outcome
Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people.
Time frame: Year 2 - Year 4
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.
Knowledge and attitudes toward substance use among pregnant and postpartum people.
Time frame: Year 2 - Year 4
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.
Knowledge and attitudes toward anxiety or depression among pregnant or postpartum people.
Time frame: Year 2 - Year 4
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.
1 secondary outcome
Participants' (care provider) self-report of asking pregnant or postpartum people about intimate partner violence (IPV), substance use, and anxiety or depression.
Time frame: Year 3 - Year 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Official University of Kentucky website pertinent to this studyLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Ann L Coker, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Big 3 and Implementation and Effectiveness of VIP Corps Training in people with Maternal Morbidity and Mortality, run by Ann Coker at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and attitudes toward intimate partner violence (IPV) among pregnant and postpartum people. (time frame: Year 2 - Year 4). 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?
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 5 Oct 2026.