Firearm InjuryTRUE HAVENNCT05723614
TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven
A study testing TRUE HAVEN in people with Firearm Injury, run by Yale University at 7 sites in United States.
Trial summary
The overall objective of this study is to implement and test a strengths-based, community-driven intervention to reduce gun violence by (1) improving housing stability through providing financial assistance coupled with comprehensive financial education for the re-entry population as well as their family members, and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Firearm Injury
- What is being tested?
- TRUE HAVEN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61,770 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Feb 2023to Jul 2027
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 18 or above
- Family member currently incarcerated or person returning from prison within the last 12 months
- Live in one of the seven neighborhoods with highest rates of gun violence in New Haven, Connecticut
Who cannot join
- Plans to leave the study area within 1 year
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Beaver Hills
New Haven, Connecticut, 06511
Virginia Spell, vtspell@ulsc.org
- Recruiting
Dixwell
New Haven, Connecticut, 06511
Virginia Spell, 203-327-5810, vtspell@ulsc.org
Christine Montgomery
- Recruiting
Dwight/West River
New Haven, Connecticut, 06511
Virginia Spell, 203-327-5810, vtspell@ulsc.org
Christine Montgomery
- Recruiting
Fair Haven
New Haven, Connecticut, 06513
Virginia Spell, vtspell@ulsc.org
Virginia Spell
- Recruiting
Hill North and South
New Haven, Connecticut, 06513
Virginia Spell, vtspell@ulsc.org
Virginia Spell
- Recruiting
Newhallville
New Haven, Connecticut, 06514
Virginia Spell, vtspell@ulsc.org
Christine Montgomery
- Recruiting
West Rock/West Hills
New Haven, Connecticut, 06515
Virginia Spell, 203-327-5810, vtspell@ulsc.org
Christine Montgomery
About this study
Official title: TRUE HAVEN: TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven
The overall objective of this study is to implement and test a strengths-based, community-driven intervention to reduce gun violence by (1) improving housing stability through providing financial assistance coupled with comprehensive financial education for the re-entry population as well as their family members, and (2) fostering greater support for mental health by training a trusted network of community members in trauma-informed counseling.
Read the detailed description
Proposed is a type I hybrid effectiveness/implementation study using a neighborhood-level, stepped-wedge trial design across seven primarily socially vulnerable neighborhoods in New Haven. Residents of each neighborhood who have been affected by incarceration (i.e., currently have a family member incarcerated or a person returning to the community from prison within the last 12 months) will be eligible for our intervention for a period of 6 months. The Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science frameworks will be used to measure and track processes in achieving outcomes. A mixed methods approach will be used, primarily the use of quantitative methods for this study, along with qualitative focus groups will be conducted to assess some implementation outcomes. The primary outcome, rates of gun violence at the neighborhood level, are obtained from administrative data. Survey data will be collected for some implementation process measures (e.g., assessing acceptability and appropriateness of the intervention).
- Conditions
- Firearm Injury
- Being tested
- TRUE HAVEN
- Keywords
- gun violence, structural racism
- Medical subject headings
- Systemic Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUE HAVENBehavioural
The two components of the TRUE HAVEN intervention are: housing support for recently incarcerated people as well as family members of currently incarcerated people, and mental wellness training for neighborhood residents to participate in trauma-informed care training sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | The two components in the intervention arm of TRUE HAVEN are: housing support for recently incarcerated people as well as family members of currently incarcerated people, and mental wellness training for neighborhood residents to participate in trauma-informed care training sessions. Receives: Behavioral: TRUE HAVEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rates of gun violence
The neighborhood rate of incident gun violence assessed among everyone in the neighborhoods; these data will be provided annually by the New Haven Police Department.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Secondary outcomes (4)
Change in neighborhood social cohesion using the Social Cohesion sub-scale of the Sampson Collective Efficacy Scale
This is a neighborhood-level outcome on residents' perception of the strengths of relationships and solidarity among their neighbors. Data will be provided annually from DataHaven based on a representative sample of approximately 1% of population across each neighborhood of New Haven. The measure is based on Social Cohesion sub-scale of the Sampson Collective Efficacy Scale, which is a 5-point scale (score range: 1(strongly disagree) to 5(strongly agree)).
Measured: Baseline, 6 months, 12 months, and 24 months
Change in participant self-efficacy based on the Generalized Self-Efficacy Scale
Individual-level perceptions and reactions to life's situations will be measured using a survey among the about 700 recruited participants. The measure is based on the Generalized Self-Efficacy Scale, which is a 4-point scale (score range: 1(not at all true) to 4(exactly true)).
Measured: Baseline, 6 months, 12 months, and 24 months
Change in perceived health and well-being based on the Well-being Assessment
Individual-level perceived health and well-being including dimensions of subjective well-being, general health, health problems, sense of direction and purpose in life, emotional support, and sense of belonging to community will be measured using a survey among the about 700 recruited participants. This composite measure is based on Well-being Assessment (Adult - 12 items) - 100 Million Healthier Lives. Each item is an 11-point scale (score range: 0(worst) to 10(best)). Higher scores indicate better perceived health and well-being.
Measured: Baseline, 6 months, 12 months, and 24 months
Change in financial security
Financial readiness for an emergency will be assessed using a survey among the recruited participants. The measure is based on one 5-point item (score range: 1(worst) to 5(best)) measuring financial capability.
Measured: Baseline, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Feb 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Sequential
- Model description
- One component of the intervention will focus on providing housing support for recently incarcerated people as well as family members of currently incarcerated people. The target sample size is about 700. The other component of the intervention is mental wellness training for neighborhood residents to participate in trauma-informed care training sessions.
- Masking
- None (open label)
- Enrolment
- 61,770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Emily Wang, MD, MAS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723614
- Sponsor's protocol ID
- 2000032184
- Other IDs
- 1R01MD017526-01
- Acronym
- TRUE HAVEN
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made publicly available following study completion.
Publications
Tong G, Spell VT, Horton N, Thornhill T, Keene D, Montgomery C, Spiegelman D, Wang EA, Roy B. Trusted residents and housing assistance to decrease violence exposure in New Haven (TRUE HAVEN): a strengths-based and community-driven stepped-wedge intervention to reduce gun violence. BMC Public Health. 2023 Aug 14;23(1):1545. doi: 10.1186/s12889-023-15997-x.
PubMed 37580653Tong G, Spell VT, Horton N, Thornhill T, Keene D, Montgomery C, Spiegelman D, Wang EA, Roy B. TRUsted rEsidents and Housing Assistance to decrease Violence Exposure in New Haven (TRUE HAVEN): A strengths-based and community-driven stepped-wedge intervention to reduce gun violence. Res Sq [Preprint]. 2023 May 10:rs.3.rs-2874381. doi: 10.21203/rs.3.rs-2874381/v1.
PubMed 37214890
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRUE HAVEN: TRUsted rEsidents and Housing Assistance to Decrease Violence Exposure in New Haven
- ClinicalTrials.gov ID
- NCT05723614
- Acronym / sponsor ID
- TRUE HAVEN / 2000032184
- Conditions
- Firearm Injury
- Keywords
- gun violence, structural racism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61,770 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Feb 2023 (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 overall objective of this study is to implement and test a strengths-based, community-driven intervention to reduce gun violence by (1) improving housing stability through providing financial assistance coupled with comprehensive financial education for the re-entry population as well as their family members, and (2) fostering greater support for mental health by training a trusted network of community members in trauma-informed counseling.
Detailed description
Proposed is a type I hybrid effectiveness/implementation study using a neighborhood-level, stepped-wedge trial design across seven primarily socially vulnerable neighborhoods in New Haven. Residents of each neighborhood who have been affected by incarceration (i.e., currently have a family member incarcerated or a person returning to the community from prison within the last 12 months) will be eligible for our intervention for a period of 6 months. The Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) implementation science frameworks will be used to measure and track processes in achieving outcomes. A mixed methods approach will be used, primarily the use of quantitative methods for this study, along with qualitative focus groups will be conducted to assess some implementation outcomes. The primary outcome, rates of gun violence at the neighborhood level, are obtained from administrative data. Survey data will be collected for some implementation process measures (e.g., assessing acceptability and appropriateness of the intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One component of the intervention will focus on providing housing support for recently incarcerated people as well as family members of currently incarcerated people. The target sample size is about 700. The other component of the intervention is mental wellness training for neighborhood residents to participate in trauma-informed care training sessions.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: TRUE HAVENThe two components in the intervention arm of TRUE HAVEN are: housing support for recently incarcerated people as well as family members of currently incarcerated people, and mental wellness training for neighborhood residents to participate in trauma-informed care training sessions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or above
- Family member currently incarcerated or person returning from prison within the last 12 months
- Live in one of the seven neighborhoods with highest rates of gun violence in New Haven, Connecticut
Key exclusion criteria (1 listed)
- Plans to leave the study area within 1 year
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 |
|---|---|---|
| TRUE HAVENThe two components of the TRUE HAVEN intervention are: housing support for recently incarcerated people as well as family members of currently incarcerated people, and mental wellness training for neighborhood residents to participate in trauma-informed care training sessions. | Behavioural | Intervention |
Primary outcome
Change in rates of gun violence
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
The neighborhood rate of incident gun violence assessed among everyone in the neighborhoods; these data will be provided annually by the New Haven Police Department.
4 secondary outcomes
Change in neighborhood social cohesion using the Social Cohesion sub-scale of the Sampson Collective Efficacy Scale
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in participant self-efficacy based on the Generalized Self-Efficacy Scale
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in perceived health and well-being based on the Well-being Assessment
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in financial security
Time frame: Baseline, 6 months, 12 months, and 24 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 13 Feb 2026.
- Derived from this study: PubMed 37580653Tong G, Spell VT, Horton N, Thornhill T, Keene D, Montgomery C, Spiegelman D, Wang EA, Roy B. Trusted residents and housing assistance to decrease violence exposure in New Haven (TRUE HAVEN): a strengths-based and community-driven stepped-wedge intervention to reduce gun violence. BMC Public Health. 2023 Aug 14;23(1):1545. doi: 10.1186/s12889-023-15997-x.
- Derived from this study: PubMed 37214890Tong G, Spell VT, Horton N, Thornhill T, Keene D, Montgomery C, Spiegelman D, Wang EA, Roy B. TRUsted rEsidents and Housing Assistance to decrease Violence Exposure in New Haven (TRUE HAVEN): A strengths-based and community-driven stepped-wedge intervention to reduce gun violence. Res Sq [Preprint]. 2023 May 10:rs.3.rs-2874381. doi: 10.21203/rs.3.rs-2874381/v1.
- Individual participant dataSharing planned: Yes. Deidentified data will be made publicly available following study completion.
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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.
Emily Wang, MD, MAS principal investigator
Yale University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRUE HAVEN in people with Firearm Injury, run by Yale University at 7 sites 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 1 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Emily Wang, MD, MAS ((203) 737-7624, emily.wang@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rates of gun violence (time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723614, which also lists 2 linked publications.
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 13 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.