- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06263647
Launching the Houston Hospital-Based Violence Intervention Program (Houston-HVIP): Developing and Evaluating a Hospital-Based Intervention to Reduce Recurrent Violence
January 19, 2026 updated by: Sandra L. McKay, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
274
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: Sandra McKay, MD
- Phone Number: (713) 500-5666
- Email: Sandra.McKay@uth.tmc.edu
Study Contact Backup
- Name: Alexander Testa, PhD
- Phone Number: (210) 276-9000
- Email: Alexander.Testa@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Contact:
- Sandra McKay, MD
- Phone Number: (713) 500-5666
- Email: Sandra.McKay@uth.tmc.edu
-
Contact:
- Alexander Testa, PhD
- Phone Number: (210) 276-9000
- Email: Alexander.Testa@uth.tmc.edu
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Houston-HVIP treatment group
|
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.
|
|
Active Comparator: Standard of Care group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Baseline , 3 months, 6 months, 9 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
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.
|
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
|
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
|
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
|
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
|
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
|
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
|
Baseline , 3 months, 6 months, 9 months and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sandra McKay, MD, The University of Texas Health Science Center, Houston
- Principal Investigator: Alexander Testa, PhD, The University of Texas Health Science Center, Houston
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)
September 16, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
May 31, 2028
Study Registration Dates
First Submitted
February 8, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Actual)
February 16, 2024
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-23-0904
- UG3NR021232 (U.S. NIH Grant/Contract)
- UH3NR021232 (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
product manufactured in and exported from the U.S.
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.