The HVIP+ Community Model

June 1, 2026 updated by: University of Arkansas

The HVIP+ Community Model: A Community Violence Prevention Program in a Southern State

The present study will use an optimization randomized control trial design to test the preliminary efficacy of a Hospital-based Violence Intervention Program (HVIP) in Central Arkansas.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Arkansas is a rural southern state with a high toll of homicide relative to its total population (AR ranks 8th nationally in firearm homicide rates). This study will engage community partners throughout Central Arkansas in a multi-level, multi-faceted intervention to reduce the toll of violent assault on individuals and communities. An optimization randomized control trial (ORCT) design will be used to test the preliminary efficacy of a multi-level intervention with an explicit focus on secondary violence prevention through hospital-community partnerships to prevent escalation of firearm violence among survivors living in counties in Central Arkansas, the region of the state where violent assault is greatest. The study will also incorporate key implementation science metrics to evaluate the feasibility and reach of the proposed intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nakita Lovelady, PhD, MPH
        • Principal Investigator:
          • Joyce Raynor, BS
        • Sub-Investigator:
          • James Selig, PhD
        • Sub-Investigator:
          • Geoffrey Curran, PhD
        • Sub-Investigator:
          • Joshua Ellis, MD, MPH
        • Sub-Investigator:
          • Austin Porter, DrPH, MPH
        • Sub-Investigator:
          • Kelly Urban, PhD, MEd, RN CCRN-K, TCRN, CEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be at least 18 years of age or older
  • Currently live in Central Arkansas
  • Currently being treated for a penetrating gun assault injury at a local hospital

Exclusion Criteria:

Participants must not:

  • Report any medical problems that would limit their ability to express thoughts and answer questions (i.e. active intoxication, developmental delays, dementia, psychosis, etc.)
  • Be currently under arrest or in police custody

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BB, CM, G
Participants receive brief bedside, case management+ voucher, and SELF group intervention components.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Behavioral: Case Management + Voucher
  • Service Plan & Referrals
  • Service Check-in/Follow up with partners and participants
  • Navigation of Health Care and Social Service Follow up appointments
  • Transportation Assistance
  • Basic life skills for service provision (riding bus/public transportation, zoom, etc.)
  • Vouchers for Immediate Needs/Obstacles
Behavioral: SELF Group Therapy Sessions
  • Virtual Bi-weekly Group Therapy
  • SELF Curriculum- Trauma Focused Cognitive Behavioral Therapy
  • Lead by Therapists and Community Peer Volunteers
  • One-on-one Introductory/Intake Orientations
Experimental: BB, CM
Participants receive brief bedside and case management+ voucher intervention components.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Behavioral: Case Management + Voucher
  • Service Plan & Referrals
  • Service Check-in/Follow up with partners and participants
  • Navigation of Health Care and Social Service Follow up appointments
  • Transportation Assistance
  • Basic life skills for service provision (riding bus/public transportation, zoom, etc.)
  • Vouchers for Immediate Needs/Obstacles
Experimental: BB, G
Participants receive brief bedside and SELF group intervention components.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Behavioral: SELF Group Therapy Sessions
  • Virtual Bi-weekly Group Therapy
  • SELF Curriculum- Trauma Focused Cognitive Behavioral Therapy
  • Lead by Therapists and Community Peer Volunteers
  • One-on-one Introductory/Intake Orientations
Experimental: BB
Participants receive brief bedside intervention component.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Experimental: ALL
Participants receive brief bedside, peer support, case management+ voucher, and SELF group intervention components.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Behavioral: Case Management + Voucher
  • Service Plan & Referrals
  • Service Check-in/Follow up with partners and participants
  • Navigation of Health Care and Social Service Follow up appointments
  • Transportation Assistance
  • Basic life skills for service provision (riding bus/public transportation, zoom, etc.)
  • Vouchers for Immediate Needs/Obstacles
Behavioral: SELF Group Therapy Sessions
  • Virtual Bi-weekly Group Therapy
  • SELF Curriculum- Trauma Focused Cognitive Behavioral Therapy
  • Lead by Therapists and Community Peer Volunteers
  • One-on-one Introductory/Intake Orientations
Behavioral: Peer Support
  • Weekly Check-ins
  • Status Check (Personal/family; Health; Mental Health; Spiritual, etc.)
  • Encouragement/Motivation (Staying safe, Doing right, etc.)
  • In-Person Visits (Home, Rehab, etc.)
  • Peer Social/Skill-building Activities (Money management, Job interviewing, Computer literacy, Creative arts, Critical thinking film discussions, etc.)
Experimental: BB, PS, CM
Participants receive brief bedside, peer support, and case management+ voucher intervention components.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Behavioral: Case Management + Voucher
  • Service Plan & Referrals
  • Service Check-in/Follow up with partners and participants
  • Navigation of Health Care and Social Service Follow up appointments
  • Transportation Assistance
  • Basic life skills for service provision (riding bus/public transportation, zoom, etc.)
  • Vouchers for Immediate Needs/Obstacles
Behavioral: Peer Support
  • Weekly Check-ins
  • Status Check (Personal/family; Health; Mental Health; Spiritual, etc.)
  • Encouragement/Motivation (Staying safe, Doing right, etc.)
  • In-Person Visits (Home, Rehab, etc.)
  • Peer Social/Skill-building Activities (Money management, Job interviewing, Computer literacy, Creative arts, Critical thinking film discussions, etc.)
Experimental: BB, PS, G
Participants receive brief bedside, peer support, and SELF group intervention components.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Behavioral: SELF Group Therapy Sessions
  • Virtual Bi-weekly Group Therapy
  • SELF Curriculum- Trauma Focused Cognitive Behavioral Therapy
  • Lead by Therapists and Community Peer Volunteers
  • One-on-one Introductory/Intake Orientations
Behavioral: Peer Support
  • Weekly Check-ins
  • Status Check (Personal/family; Health; Mental Health; Spiritual, etc.)
  • Encouragement/Motivation (Staying safe, Doing right, etc.)
  • In-Person Visits (Home, Rehab, etc.)
  • Peer Social/Skill-building Activities (Money management, Job interviewing, Computer literacy, Creative arts, Critical thinking film discussions, etc.)
Experimental: BB, PS
Participants receive brief bedside and peer support intervention components.
Behavioral: Brief Bedside
  • Initial support (in-hospital or shortly after if discharged early)
  • Needs assessment
  • Resource Sheet of Vetted Partners
Behavioral: Peer Support
  • Weekly Check-ins
  • Status Check (Personal/family; Health; Mental Health; Spiritual, etc.)
  • Encouragement/Motivation (Staying safe, Doing right, etc.)
  • In-Person Visits (Home, Rehab, etc.)
  • Peer Social/Skill-building Activities (Money management, Job interviewing, Computer literacy, Creative arts, Critical thinking film discussions, etc.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Risky Firearm Behaviors
Time Frame: Baseline, 3-month, 6-month, 9-month, and 12 months
Composite measure uses items adapted from the Tulane University National Youth Study capturing frequency and severity of risky firearm-related behaviors (i.e. carriage, threats, etc.) (0=Never; 6=20+ Times)
Baseline, 3-month, 6-month, 9-month, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PTSD
Time Frame: Baseline, 3-month, 6-month, 9-month, and 12 months
The Posttraumatic Stress Disorder Checklist (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD (0=Not at all; 4=Extremely)
Baseline, 3-month, 6-month, 9-month, and 12 months
Change in Anxiety
Time Frame: Baseline, 3-month, 6-month, 9-month, and 12 months
OASIS is a brief measure of overall anxiety severity and impairment. (0=No/None; 4=Constant/Extreme)
Baseline, 3-month, 6-month, 9-month, and 12 months
Change in Depression
Time Frame: Baseline, 3-month, 6-month, 9-month, and 12 months
The PHQ-9 is a validated, self-reported tool used for screening, diagnosing, and measuring the severity of depression. (0= Not at all; 3=Nearly every day)
Baseline, 3-month, 6-month, 9-month, and 12 months
Change in Feasibility and Acceptability of Intervention
Time Frame: 3-month, 6-month, 9-month, and 12 months
Composite measure uses items adapted from the Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM), four-item measures of implementation outcomes. (1= Completely disagree; 5= Completely Agree)
3-month, 6-month, 9-month, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nakita Lovelady, PhD, MPH, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 276233
  • 4UH3MD019172-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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