- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539142
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
Recruiting
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
Interventional
Enrollment (Estimated)
208
Phase
- 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
- Name: Nakita Lovelady, PhD, MPH
- Phone Number: 501-526-6731
- Email: nnlovelady@uams.edu
Study Contact Backup
- Name: Joyce Raynor, BS
- Phone Number: 501-372-3800
- Email: raynorjoyce@uams.edu
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- University of Arkansas for Medical Sciences
-
Contact:
- Nakita Lovelady, PhD, MPH
- Phone Number: 501-526-6731
- Email: nnlovelady@uams.edu
-
Contact:
- Joyce Raynor, BS
- Phone Number: 501-372-3800
- Email: raynorjoyce@uams.edu
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: BB, CM, G
Participants receive brief bedside, case management+ voucher, and SELF group intervention components.
|
|
|
Experimental: BB, CM
Participants receive brief bedside and case management+ voucher intervention components.
|
|
|
Experimental: BB, G
Participants receive brief bedside and SELF group intervention components.
|
|
|
Experimental: BB
Participants receive brief bedside intervention component.
|
|
|
Experimental: ALL
Participants receive brief bedside, peer support, case management+ voucher, and SELF group intervention components.
|
|
|
Experimental: BB, PS, CM
Participants receive brief bedside, peer support, and case management+ voucher intervention components.
|
|
|
Experimental: BB, PS, G
Participants receive brief bedside, peer support, and SELF group intervention components.
|
|
|
Experimental: BB, PS
Participants receive brief bedside and peer support intervention components.
|
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
April 20, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
April 13, 2026
First Submitted That Met QC Criteria
April 13, 2026
First Posted (Actual)
April 20, 2026
Study Record Updates
Last Update Posted (Actual)
June 2, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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