StigmaHOPNCT07742722
Honest, Open, Proud (HOP): A Peer Delivered, Co-occurring Disorders Intervention for Justice-involved Veterans
A study testing Veterans Affairs-Honest, Open, Proud in people with Stigma and Co-Occurring Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
As many as two-thirds of Justice-involved Veterans (JIVs) have a substance-use disorder (SUD), and up to 51% have a mental health (MH) condition; however, fewer than one-third of JIVs receive MH or SUD treatment, and addressing stigma is a recommended strategy for improving Veteran willingness to engage in treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stigma, Co-Occurring Disorders, Substance Use Disorder
- What is being tested?
- Veterans Affairs-Honest, Open, Proud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 30 Sep 2030
- 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
- Veterans who are service-connected and enrolled in a VJP program within six VA Medical Centers:
- Fresno, Palo Alto, Butler, Coatesville, Pittsburgh, Wilmington, and therefore have justice involvement
- Veterans who meet DSM-5 criteria for a mental health and/or substance use disorder
- Veterans who are willing to participate in VA-HOP
Who cannot join
- Does not have a history of justice involvement and or not enrolled in a participating site VJP program
- Do not have a mental health and/or substance use disorder diagnosis
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
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
David A Smelson, PsyD, (781) 687-7778, david.smelson@va.gov
Michael A Andre, MPH, (781) 382-5554, michael.andre2@va.gov
About this study
Official title: Honest, Open, Proud (HOP) (QUE 25-014)
As many as two-thirds of Justice-involved Veterans (JIVs) have a substance-use disorder (SUD), and up to 51% have a mental health (MH) condition; however, fewer than one-third of JIVs receive MH or SUD treatment, and addressing stigma is a recommended strategy for improving Veteran willingness to engage in treatment. Honest, Open, Proud (HOP) is an evidence-based stigma reduction intervention for justice-involved Veterans that is delivered by peers, which can ultimately increase access to and engagement in care, lower rates of criminal recidivism, and improve MH and SUD outcomes. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, stigma reduction intervention for justice-involved Veterans with co-occurring SUD and MH disorders.
Read the detailed description
Background: Justice-involved Veterans (JIVs) are highlighted as a highly vulnerable Veteran subgroup, and as many as two-thirds of JIVs have SUD, and up to 51% have a MH condition. However, fewer than one-third of JIVs receive MH or SUD treatment and addressing stigma is a recommended strategy for improving Veteran willingness to engage in treatment. Moreover, self-stigma prevents Veterans from asking for help or engaging in ongoing care. The connection between internalized self-stigma and lack of accessing care or support services impairs Veterans recovery. Interventions grounded in evidence-based, peer-led practices are effective in increasing access to and engagement in care; however, implementation of such strategies are costly and intensive. This study protocol describes a Hybrid Type III effectiveness-implementation trial of Honest, Open, Proud (HOP) with high-need, justice-involved Veterans and will evaluate the impact and cost of a high intensity (vs. low-intensity) strategy on implementation, maintenance, and sustainment outcomes.
Methods: This quality improvement (QI) project involves a Hybrid Type III implementation effectiveness trial in six VA medical centers across the United States. Sites will begin with a 6-month pre-implementation period (e.g., orientation) to examine organizational readiness to adopt VA-HOP (Aim 1). A pre-post pragmatic trial with enhancements to accommodate possible growth trends with features of an interrupted time series in which VJP staff at each site will be offered 6-months of audit and feedback (lower-intensity implementation support) followed by 6-months of implementation facilitation (higher-intensity implementation support) for promoting VA-HOP implementation by VJP staff (Aim 2). The investigators will examine whether the Veterans served by staff who delivered VA-HOP with greater model fidelity will demonstrate an increase in outpatient specialty care days, reductions in emergency department use, and reductions in suicide risk compared to Veterans who received VA-HOP with lower fidelity (Aim 3). Finally, this study will examine implementation erosion and sustainment of VA-HOP following discontinuation of active implementation support (for 9-months after high intensity support ends) using quantitative implementation outcomes and post-implementation qualitative interviews (Aim 4).
Anticipated Impact: This study will provide information on the relative impacts and relative costs of strategies aimed at implementing a peer-led, stigma reduction intervention for justice-involved Veterans with co-occurring SUD and MH disorders. The findings will provide guidance to VA and other healthcare systems that serve justice-involved Veterans with co-occurring disorders.
- Being tested
- Veterans Affairs-Honest, Open, Proud
- Keywords
- Stigma, Co-Occurring Disorders, Substance Use Disorder, Mental Health, Veterans, Honest, Open, Proud, Implementation Science, Justice Involved
- Medical subject headings
- Social Stigma, Substance-Related Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veterans Affairs-Honest, Open, ProudBehavioural
Also called VA-HOP
VA-HOP is an evidence-based, peer-delivered group intervention designed to help individuals navigate decisions about disclosure of behavioral health conditions. The intervention consists of three lessons comprising nine structured tasks that guide participants through decisions of disclosure aimed at reducing self-stigma. The goal of HOP is not to force disclosure; rather, it empowers participants to decide whether, when, and how disclosure may occur. VA-HOP is facilitated by a peer specialist with a group of 8-10 participants, and sessions can be broken down into a 45-minute weekly session for 9 weeks or 3 weekly 2 1/4-hour blocks. The first lesson covers the short- and long-term benefits and risks of disclosure and non-disclosure. The second lesson addresses the different levels of disclosure, emphasizing that disclosure exists on a continuum and can vary depending on the context and audience. The third lesson focuses on how to tell one's recovery story.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity | Active comparator | Audit and Feedback will be our low intensity implementation strategy. Peer specialists and key stakeholders will receive monthly data reports on VA-HOP delivery (e.g. number of sessions delivered, number of Veterans served) and fidelity data with written feedback. Peers will have the opportunity to join an optional, monthly virtual session to discuss their report with a quantitative expert. Receives: Behavioral: Veterans Affairs-Honest, Open, Proud |
| High Intensity | Experimental | Implementation Facilitation will be our high intensity implementation strategy. Peer specialists and other key stakeholders will participate in biweekly virtual meetings with an external facilitator. Facilitation activities serve a range of functions spanning problem-solving, relationship-building, and goal setting and planning. Activities are selected based on site progress and needs. Receives: Behavioral: Veterans Affairs-Honest, Open, Proud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of VA-HOP Sessions delivered
Uptake is the study primary outcome and is defined as the number of VA-HOP sessions delivered to Veterans during each implementation period. Using EHR data submitted into the VA CDW, uptake statistics will be extracted for each implementation period, i.e. Audit and Feedback (6-months), Implementation Facilitation (6-months), and Sustainment Phase (9-months).
Measured: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Secondary outcomes (2)
Dose Fidelity Adherence to HOP Model
Dose Fidelity will be a secondary outcome. Dose fidelity is defined as a proportion of expected VA-HOP encounters completed by each Veteran. Fidelity will be assessed from standard documentation embedded within each participating sites EHR completed by VA HOP peer facilitators. This data will be extracted for each implementation period, i.e. Audit and Feedback (6-months), Implementation Facilitation (6-months), and Sustainment Phase (9-months).
Measured: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Content Fidelity Adherence to HOP Model
Content Fidelity will be a secondary outcome. Content fidelity is defined as the extent to which peer facilitators complete the three VA-HOP lessons and nine VA-HOP tasks. Content fidelity will be assessed from standard documentation embedded within each participating sites EHR completed by VA HOP peer facilitators. This documentation note tracks each VA-HOP Peer facilitator and their use of the VA-HOP lessons and associated tasks. This data will be extracted for each implementation period, i.e. Audit and Feedback (6-months), Implementation Facilitation (6-months), and Sustainment Phase (9-months).
Measured: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Jul 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StigmaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study employs a staggered, multi-site implementation rollout using a Hybrid Type III pre-post pragmatic trial design with repeated measurement of implementation outcomes over time. The design incorporates features commonly used in interrupted time series approaches. Participating sites will first complete a 6-month pre-implementation run-in period, followed by 6 months of lower-intensity implementation support consisting of audit and feedback, 6 months of higher-intensity implementation support consisting of implementation facilitation, and a 9-month sustainment observation period. Sites will enter the implementation phases sequentially in a staggered rollout schedule, with one site initiating implementation approximately every 3 months. This phased rollout approach allows for iterative refinement of implementation procedures and incorporation of operational lessons learned across participating sites.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David A. Smelson, PsyD, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742722
- Sponsor's protocol ID
- QUX 26-005
- Acronym
- HOP
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Honest, Open, Proud (HOP) (QUE 25-014)
- ClinicalTrials.gov ID
- NCT07742722
- Acronym / sponsor ID
- HOP / QUX 26-005
- Keywords
- Stigma, Co-Occurring Disorders, Substance Use Disorder, Mental Health, Veterans, Honest, Open, Proud, Implementation Science, Justice Involved
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 3 Aug 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.
As many as two-thirds of Justice-involved Veterans (JIVs) have a substance-use disorder (SUD), and up to 51% have a mental health (MH) condition; however, fewer than one-third of JIVs receive MH or SUD treatment, and addressing stigma is a recommended strategy for improving Veteran willingness to engage in treatment. Honest, Open, Proud (HOP) is an evidence-based stigma reduction intervention for justice-involved Veterans that is delivered by peers, which can ultimately increase access to and engagement in care, lower rates of criminal recidivism, and improve MH and SUD outcomes. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, stigma reduction intervention for justice-involved Veterans with co-occurring SUD and MH disorders.
Detailed description
Background: Justice-involved Veterans (JIVs) are highlighted as a highly vulnerable Veteran subgroup, and as many as two-thirds of JIVs have SUD, and up to 51% have a MH condition. However, fewer than one-third of JIVs receive MH or SUD treatment and addressing stigma is a recommended strategy for improving Veteran willingness to engage in treatment. Moreover, self-stigma prevents Veterans from asking for help or engaging in ongoing care. The connection between internalized self-stigma and lack of accessing care or support services impairs Veterans recovery. Interventions grounded in evidence-based, peer-led practices are effective in increasing access to and engagement in care; however, implementation of such strategies are costly and intensive. This study protocol describes a Hybrid Type III effectiveness-implementation trial of Honest, Open, Proud (HOP) with high-need, justice-involved Veterans and will evaluate the impact and cost of a high intensity (vs. low-intensity) strategy on implementation, maintenance, and sustainment outcomes.
Methods: This quality improvement (QI) project involves a Hybrid Type III implementation effectiveness trial in six VA medical centers across the United States. Sites will begin with a 6-month pre-implementation period (e.g., orientation) to examine organizational readiness to adopt VA-HOP (Aim 1). A pre-post pragmatic trial with enhancements to accommodate possible growth trends with features of an interrupted time series in which VJP staff at each site will be offered 6-months of audit and feedback (lower-intensity implementation support) followed by 6-months of implementation facilitation (higher-intensity implementation support) for promoting VA-HOP implementation by VJP staff (Aim 2). The investigators will examine whether the Veterans served by staff who delivered VA-HOP with greater model fidelity will demonstrate an increase in outpatient specialty care days, reductions in emergency department use, and reductions in suicide risk compared to Veterans who received VA-HOP with lower fidelity (Aim 3). Finally, this study will examine implementation erosion and sustainment of VA-HOP following discontinuation of active implementation support (for 9-months after high intensity support ends) using quantitative implementation outcomes and post-implementation qualitative interviews (Aim 4).
Anticipated Impact: This study will provide information on the relative impacts and relative costs of strategies aimed at implementing a peer-led, stigma reduction intervention for justice-involved Veterans with co-occurring SUD and MH disorders. The findings will provide guidance to VA and other healthcare systems that serve justice-involved Veterans with co-occurring disorders.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study employs a staggered, multi-site implementation rollout using a Hybrid Type III pre-post pragmatic trial design with repeated measurement of implementation outcomes over time. The design incorporates features commonly used in interrupted time series approaches. Participating sites will first complete a 6-month pre-implementation run-in period, followed by 6 months of lower-intensity implementation support consisting of audit and feedback, 6 months of higher-intensity implementation support consisting of implementation facilitation, and a 9-month sustainment observation period. Sites will enter the implementation phases sequentially in a staggered rollout schedule, with one site initiating implementation approximately every 3 months. This phased rollout approach allows for iterative refinement of implementation procedures and incorporation of operational lessons learned across participating sites.
| Arm | Type | Receives |
|---|---|---|
| Low Intensity | Active comparator | Behavioral: Veterans Affairs-Honest, Open, ProudAudit and Feedback will be our low intensity implementation strategy. Peer specialists and key stakeholders will receive monthly data reports on VA-HOP delivery (e.g. number of sessions delivered, number of Veterans served) and fidelity data with written feedback. Peers will have the opportunity to join an optional, monthly virtual session to discuss their report with a quantitative expert. |
| High Intensity | Experimental | Behavioral: Veterans Affairs-Honest, Open, ProudImplementation Facilitation will be our high intensity implementation strategy. Peer specialists and other key stakeholders will participate in biweekly virtual meetings with an external facilitator. Facilitation activities serve a range of functions spanning problem-solving, relationship-building, and goal setting and planning. Activities are selected based on site progress and needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans who are service-connected and enrolled in a VJP program within six VA Medical Centers:
- Veterans who meet DSM-5 criteria for a mental health and/or substance use disorder
- Veterans who are willing to participate in VA-HOP
Key exclusion criteria (2 listed)
- Does not have a history of justice involvement and or not enrolled in a participating site VJP program
- Do not have a mental health and/or substance use disorder diagnosis
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 |
|---|---|---|
| Veterans Affairs-Honest, Open, ProudAlso: VA-HOPVA-HOP is an evidence-based, peer-delivered group intervention designed to help individuals navigate decisions about disclosure of behavioral health conditions. The intervention consists of three lessons comprising nine structured tasks that guide participants through decisions of disclosure aimed at reducing self-stigma. The goal of HOP is not to force disclosure; rather, it empowers participants to decide whether, when, and how disclosure may occur. VA-HOP is facilitated by a peer specialist with a group of 8-10 participants, and sessions can be broken down into a 45-minute weekly session for 9 weeks or 3 weekly 2 1/4-hour blocks. The first lesson covers the short- and long-term benefits and risks of disclosure and non-disclosure. The second lesson addresses the different levels of disclosure, emphasizing that disclosure exists on a continuum and can vary depending on the context and audience. The third lesson focuses on how to tell one's recovery story. | Behavioural | High Intensity, Low Intensity |
Primary outcome
Number of VA-HOP Sessions delivered
Time frame: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Uptake is the study primary outcome and is defined as the number of VA-HOP sessions delivered to Veterans during each implementation period. Using EHR data submitted into the VA CDW, uptake statistics will be extracted for each implementation period, i.e. Audit and Feedback (6-months), Implementation Facilitation (6-months), and Sustainment Phase (9-months).
2 secondary outcomes
Dose Fidelity Adherence to HOP Model
Time frame: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)
Content Fidelity Adherence to HOP Model
Time frame: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 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 3 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Stigma
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
RecruitingObservational study
Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism
Hypogonadism, Male, Endocrine Disease
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
Substance Use Disorder
Recruiting
Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being
Stigma, HIV
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.
David A. Smelson, PsyD principal investigator
VA Bedford HealthCare System, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veterans Affairs-Honest, Open, Proud in people with Stigma and Co-Occurring Disorders, run by VA Office of Research and Development 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 4 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 3 Aug 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 David A Smelson, PsyD ((781) 687-7778, david.smelson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of VA-HOP Sessions delivered (time frame: Measured across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 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 3 Aug 2026.