Firearm InjuryNCT06263647
Launching the Houston Hospital-Based Violence Intervention Program (Houston-HVIP): Developing and Evaluating a Hospital-Based Intervention to Reduce Recurrent Violence
A study testing Houston-HVIP treatment in people with Firearm Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
A prior violent injury is one of the strongest predictors of future violent injury, highlighting the importance of effective hospital-based interventions to prevent reinjury. This project will establish and evaluate the Houston Hospital-Based Violence Intervention Program (Houston-HVIP). Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Firearm Injury
- What is being tested?
- Houston-HVIP treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 31 May 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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- presented for a gunshot injury stemming from community violence at Memorial Hermann Hospital
- English or Spanish-speaking
- provide informed voluntary consent to participate in the study
- live in Harris County at time of enrollment
- live within 40-mile radius of Memorial Hermann Hospital- Texas Medical Center
Who cannot join
- presenting for a firearm injury arising from a self-inflicted gunshot or unintentional gun violence
- actively detained by criminal justice systems at time of enrollment
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sandra McKay, MD, 713-500-5666, Sandra.McKay@uth.tmc.edu
Alexander Testa, PhD, (210) 276-9000, Alexander.Testa@uth.tmc.edu
About this study
Official title: Launching the Houston-HVIP: Developing and Evaluating a Hospital-Based Intervention to Reduce Recurrent Violence
A prior violent injury is one of the strongest predictors of future violent injury, highlighting the importance of effective hospital-based interventions to prevent reinjury. This project will establish and evaluate the Houston Hospital-Based Violence Intervention Program (Houston-HVIP). Using a randomized controlled trial, the study will assess the effectiveness of Houston-HVIP in reducing violent reinjury and improving behavioral, mental, and physical health outcomes over a 12-month follow-up period among those enrolled in the study in ages 16-35 years of age.
- Conditions
- Firearm Injury
- Being tested
- Houston-HVIP treatment, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Houston-HVIP treatmentBehavioural
Participants will be assigned a case manager to provide a brief assessment of , psychological and social needs and a risk assessment and create individualized discharge planning. Participants will be referred to tailored social service programs based on the needs, including assessments of social determinants of health, educational and financial needs, and subsequent referral for programs such as job training, educational support, housing assistance, or financial assistance programs for identified needs. Participants identified at risk for violence perpetration via a risk assessment screener will be referred to the violence interrupter services. Long-term opportunities for engagement with the trauma survivors' network within Memorial Hermann Hospital will be available and encouraged.Participants will receive a structured curriculum that will include regular check-in with an assigned case manager over 6 months to promote successful community-based program integration and completion.
Standard of CareBehavioural
Participants will be assigned a case manager to meet with the injured patients to briefly assess (a) psychological and social needs and (b) a risk assessment and create individualized discharge planning. Resources for the patient to connect with social service programs will be provided by the case manager. Long-term opportunities for engagement with the trauma survivors' network within Memorial Hermann Hospital will be available and encouraged. Follow-up contacts and services from an assigned case manager over two weeks following discharge from the hospital to ensure that the patient has contacted the community-level violence outreach organizations.
| Study group | Role | What they receive |
|---|---|---|
| Houston-HVIP treatment group | Experimental | Not described Receives: Behavioral: Houston-HVIP treatment |
| Standard of Care group | Active comparator | Not described Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in repeat violent victimization as assessed by the number of participants who return to the hospital system for for an intentional firearm injury
Measured: Baseline , 3 months, 6 months, 9 months and 12 months
Secondary outcomes (5)
Change in repeat non-firearm violent victimization as assessed by the number of participants who return to the hospital system for an intentional non-firearm injury
Measured: Baseline , 3 months, 6 months, 9 months and 12 months
Change in attitudes towards firearm violence as assessed by Firearm Violences Attitudes (Sheley; Shapiro) questionnaire
This is a 13-item questionnaire; however, only items 3,4,7,9,10,12 and 13 will be asked. Each is scored from 1(strongly disagree) - 4(strongly agree), Maximum score of 28 .Higher score indicates more aggression.
Measured: Baseline , 3 months, 6 months, 9 months and 12 months
Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5)
This is a 20-item questionnaire; however only items 1 and 4 of the PCL-20 will be asked. These 2 items will be anchored to a stressful experience. And each is scored form 0(not at all)-4(extremely), maximum score of 8, higher score indicating worse outcome
Measured: Baseline , 3 months, 6 months, 9 months and 12 months
Change in aggression as assessed by the Copeland-Linder questionnaire.
This is a 7-item questionnaire; however, only items 1, 5, and 6 will be asked. Each is scored from 1(strongly disagree) - 4(strongly agree). Maximum score is 12. Higher score indicates more aggression
Measured: Baseline , 3 months, 6 months, 9 months and 12 months
Change in general health as assessed by the 12-item Short Form Health Survey (SF-12)
This is a 12 item questionnaire; however, only item #1 will be asked. It is scored from 1(excellent) - 5(poor), higher number indicating worse outcome
Measured: Baseline , 3 months, 6 months, 9 months 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 posted16 Feb 2024
- Study start16 Sep 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Sandra L. McKay, The University of Texas Health Science Center, Houston
- Investigators
- Sandra McKay, MD, Principal investigator, The University of Texas Health Science Center, HoustonAlexander Testa, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263647
- Sponsor's protocol ID
- HSC-MS-23-0904
- Other IDs
- UG3NR021232, UH3NR021232
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2024
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Launching the Houston-HVIP: Developing and Evaluating a Hospital-Based Intervention to Reduce Recurrent Violence
- ClinicalTrials.gov ID
- NCT06263647
- Acronym / sponsor ID
- HSC-MS-23-0904
- Conditions
- Firearm Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 16 Feb 2024 (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.
A prior violent injury is one of the strongest predictors of future violent injury, highlighting the importance of effective hospital-based interventions to prevent reinjury. This project will establish and evaluate the Houston Hospital-Based Violence Intervention Program (Houston-HVIP). Using a randomized controlled trial, the study will assess the effectiveness of Houston-HVIP in reducing violent reinjury and improving behavioral, mental, and physical health outcomes over a 12-month follow-up period among those enrolled in the study in ages 16-35 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Houston-HVIP treatment group | Experimental | Behavioral: Houston-HVIP treatment |
| Standard of Care group | Active comparator | Behavioral: Standard of Care |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- presented for a gunshot injury stemming from community violence at Memorial Hermann Hospital
- English or Spanish-speaking
- provide informed voluntary consent to participate in the study
- live in Harris County at time of enrollment
- live within 40-mile radius of Memorial Hermann Hospital- Texas Medical Center
Key exclusion criteria (2 listed)
- presenting for a firearm injury arising from a self-inflicted gunshot or unintentional gun violence
- actively detained by criminal justice systems at time of enrollment
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 |
|---|---|---|
| Houston-HVIP treatmentParticipants will be assigned a case manager to provide a brief assessment of , psychological and social needs and a risk assessment and create individualized discharge planning. Participants will be referred to tailored social service programs based on the needs, including assessments of social determinants of health, educational and financial needs, and subsequent referral for programs such as job training, educational support, housing assistance, or financial assistance programs for identified needs. Participants identified at risk for violence perpetration via a risk assessment screener will be referred to the violence interrupter services. Long-term opportunities for engagement with the trauma survivors' network within Memorial Hermann Hospital will be available and encouraged.Participants will receive a structured curriculum that will include regular check-in with an assigned case manager over 6 months to promote successful community-based program integration and completion. | Behavioural | Houston-HVIP treatment group |
| Standard of CareParticipants will be assigned a case manager to meet with the injured patients to briefly assess (a) psychological and social needs and (b) a risk assessment and create individualized discharge planning. Resources for the patient to connect with social service programs will be provided by the case manager. Long-term opportunities for engagement with the trauma survivors' network within Memorial Hermann Hospital will be available and encouraged. Follow-up contacts and services from an assigned case manager over two weeks following discharge from the hospital to ensure that the patient has contacted the community-level violence outreach organizations. | Behavioural | Standard of Care group |
Primary outcome
Change in repeat violent victimization as assessed by the number of participants who return to the hospital system for for an intentional firearm injury
Time frame: Baseline , 3 months, 6 months, 9 months and 12 months
5 secondary outcomes
Change in repeat non-firearm violent victimization as assessed by the number of participants who return to the hospital system for an intentional non-firearm injury
Time frame: Baseline , 3 months, 6 months, 9 months and 12 months
Change in attitudes towards firearm violence as assessed by Firearm Violences Attitudes (Sheley; Shapiro) questionnaire
Time frame: Baseline , 3 months, 6 months, 9 months and 12 months
Change in post-traumatic stress as assessed by the post-Traumatic Stress Disorder Checklist Version 5(PCL-5)
Time frame: Baseline , 3 months, 6 months, 9 months and 12 months
Change in aggression as assessed by the Copeland-Linder questionnaire.
Time frame: Baseline , 3 months, 6 months, 9 months and 12 months
Change in general health as assessed by the 12-item Short Form Health Survey (SF-12)
Time frame: Baseline , 3 months, 6 months, 9 months 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 16 Oct 2026.
- Individual participant dataSharing planned: No
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Prevention
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.
Sandra McKay, MD principal investigator
The University of Texas Health Science Center, Houston
Alexander Testa, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Houston-HVIP treatment in people with Firearm Injury, run by The University of Texas Health Science Center, Houston 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 5 inclusion and 2 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 16 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?
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 Sandra McKay, MD ((713) 500-5666, Sandra.McKay@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in repeat violent victimization as assessed by the number of participants who return to the hospital system for for an intentional firearm injury (time frame: Baseline , 3 months, 6 months, 9 months 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 16 Oct 2026.