Hospital-based Violence InterventionNCT07539142
The HVIP+ Community Model
A study testing Brief Bedside, Peer Support and Case Management + Voucher in people with Hospital-based Violence Intervention and Community Firearm Violence, run by University of Arkansas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-based Violence Intervention, Community Firearm Violence, Firearm Behaviors
- What is being tested?
- Brief Bedside, Peer Support and Case Management + Voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Nakita Lovelady, PhD, MPH, 501-526-6731, nnlovelady@uams.edu
Joyce Raynor, BS, 501-372-3800, raynorjoyce@uams.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Brief Bedside, Peer Support, Case Management + Voucher, SELF Group Therapy Sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief BedsideBehavioural
- Initial support (in-hospital or shortly after if discharged early)
- Needs assessment
- Resource Sheet of Vetted Partners
Peer SupportBehavioural
- 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.)
Case Management + VoucherBehavioural
- 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
SELF Group Therapy SessionsBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| BB, CM, G | Experimental | Participants receive brief bedside, case management+ voucher, and SELF group intervention components. Receives: Behavioral: Brief Bedside; Behavioral: Case Management + Voucher; Behavioral: SELF Group Therapy Sessions |
| BB, CM | Experimental | Participants receive brief bedside and case management+ voucher intervention components. Receives: Behavioral: Brief Bedside; Behavioral: Case Management + Voucher |
| BB, G | Experimental | Participants receive brief bedside and SELF group intervention components. Receives: Behavioral: Brief Bedside; Behavioral: SELF Group Therapy Sessions |
| BB | Experimental | Participants receive brief bedside intervention component. Receives: Behavioral: Brief Bedside |
| ALL | Experimental | Participants receive brief bedside, peer support, case management+ voucher, and SELF group intervention components. Receives: Behavioral: Brief Bedside; Behavioral: Peer Support; Behavioral: Case Management + Voucher; Behavioral: SELF Group Therapy Sessions |
| BB, PS, CM | Experimental | Participants receive brief bedside, peer support, and case management+ voucher intervention components. Receives: Behavioral: Brief Bedside; Behavioral: Peer Support; Behavioral: Case Management + Voucher |
| BB, PS, G | Experimental | Participants receive brief bedside, peer support, and SELF group intervention components. Receives: Behavioral: Brief Bedside; Behavioral: Peer Support; Behavioral: SELF Group Therapy Sessions |
| BB, PS | Experimental | Participants receive brief bedside and peer support intervention components. Receives: Behavioral: Brief Bedside; Behavioral: Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Risky Firearm Behaviors
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)
Measured: Baseline, 3-month, 6-month, 9-month, and 12 months
Secondary outcomes (4)
Change in PTSD
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)
Measured: Baseline, 3-month, 6-month, 9-month, and 12 months
Change in Anxiety
OASIS is a brief measure of overall anxiety severity and impairment. (0=No/None; 4=Constant/Extreme)
Measured: Baseline, 3-month, 6-month, 9-month, and 12 months
Change in Depression
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)
Measured: Baseline, 3-month, 6-month, 9-month, and 12 months
Change in Feasibility and Acceptability of Intervention
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)
Measured: 3-month, 6-month, 9-month, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start20 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-based Violence InterventionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The optimization randomized control trial design will entail a factorial experiment with eight experimental conditions to test the targeted outcomes. The eight conditions will include various combinations of four intervention components (brief bedside, peer support, case management, and group therapy), with the brief bedside serving as the constant and the other components being on or off across conditions. Additionally, the investigators will maintain a hybrid effectiveness implementation approach by assessing health outcomes along with implementation outcomes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Nakita Lovelady, PhD, MPH, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539142
- Sponsor's protocol ID
- 276233
- Other IDs
- 4UH3MD019172-02
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HVIP+ Community Model: A Community Violence Prevention Program in a Southern State
- ClinicalTrials.gov ID
- NCT07539142
- Acronym / sponsor ID
- 276233
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Apr 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- The optimization randomized control trial design will entail a factorial experiment with eight experimental conditions to test the targeted outcomes. The eight conditions will include various combinations of four intervention components (brief bedside, peer support, case management, and group therapy), with the brief bedside serving as the constant and the other components being on or off across conditions. Additionally, the investigators will maintain a hybrid effectiveness implementation approach by assessing health outcomes along with implementation outcomes.
| Arm | Type | Receives |
|---|---|---|
| BB, CM, G | Experimental | Behavioral: Brief Bedside, Behavioral: Case Management + Voucher, Behavioral: SELF Group Therapy SessionsParticipants receive brief bedside, case management+ voucher, and SELF group intervention components. |
| BB, CM | Experimental | Behavioral: Brief Bedside, Behavioral: Case Management + VoucherParticipants receive brief bedside and case management+ voucher intervention components. |
| BB, G | Experimental | Behavioral: Brief Bedside, Behavioral: SELF Group Therapy SessionsParticipants receive brief bedside and SELF group intervention components. |
| BB | Experimental | Behavioral: Brief BedsideParticipants receive brief bedside intervention component. |
| ALL | Experimental | Behavioral: Brief Bedside, Behavioral: Peer Support, Behavioral: Case Management + Voucher, Behavioral: SELF Group Therapy SessionsParticipants receive brief bedside, peer support, case management+ voucher, and SELF group intervention components. |
| BB, PS, CM | Experimental | Behavioral: Brief Bedside, Behavioral: Peer Support, Behavioral: Case Management + VoucherParticipants receive brief bedside, peer support, and case management+ voucher intervention components. |
| BB, PS, G | Experimental | Behavioral: Brief Bedside, Behavioral: Peer Support, Behavioral: SELF Group Therapy SessionsParticipants receive brief bedside, peer support, and SELF group intervention components. |
| BB, PS | Experimental | Behavioral: Brief Bedside, Behavioral: Peer SupportParticipants receive brief bedside and peer support intervention components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Brief Bedside* Initial support (in-hospital or shortly after if discharged early) * Needs assessment * Resource Sheet of Vetted Partners | Behavioural | ALL, BB, BB, CM, BB, CM, G, BB, G, BB, PS, BB, PS, CM, BB, PS, G |
| 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.) | Behavioural | ALL, BB, PS, BB, PS, CM, BB, PS, G |
| 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 | Behavioural | ALL, BB, CM, BB, CM, G, BB, PS, CM |
| 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 | Behavioural | ALL, BB, CM, G, BB, G, BB, PS, G |
Primary outcome
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)
4 secondary outcomes
Change in PTSD
Time frame: 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
Change in Depression
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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.
Nakita Lovelady, PhD, MPH principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Bedside, Peer Support and Case Management + Voucher in people with Hospital-based Violence Intervention and Community Firearm Violence, run by University of Arkansas 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: looking for participants now, as of the sponsor's last update on 2 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nakita Lovelady, PhD, MPH (501-526-6731, nnlovelady@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Risky Firearm Behaviors (time frame: Baseline, 3-month, 6-month, 9-month, and 12 months). 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 2 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.