Honest, Open, Proud (HOP): A Peer Delivered, Co-occurring Disorders Intervention for Justice-involved Veterans (HOP)

July 28, 2026 updated by: VA Office of Research and Development

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730-1114
        • Recruiting
        • VA Bedford HealthCare System, Bedford, MA
        • Principal Investigator:
          • David A. Smelson, PsyD
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Low Intensity
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.
Behavioral: Veterans Affairs-Honest, Open, Proud
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.
Other Names:
  • VA-HOP
Experimental: High Intensity
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.
Behavioral: Veterans Affairs-Honest, Open, Proud
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.
Other Names:
  • VA-HOP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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 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)
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 across each implementation period with each participating site; Audit and Feedback (0-6 months), Implementation Facilitation (7-12 months), and Sustainment (13-21 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness-Mental Health Outpatient Care encounters
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)
Among Veterans who receive VA-HOP, the number of outpatient mental health treatment encounters they have in each implementation phase will be compared. These data will be collected using VA administrative data.
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)
Effectiveness-Substance Use Disorder Outpatient Care encounters
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)
Among Veterans who receive VA-HOP, the number of outpatient substance use treatment encounters they have in each implementation phase will be compared. These data will be collected using VA administrative data.
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)
Effectiveness-Emergency Department Hospitalizations
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)
Among Veterans who receive VA-HOP, the number of emergency department visits they have in each implementation phase will be compared. These data will be collected using VA administrative data.
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)
Effectiveness-Suicide Prevention Coordinator Visits
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)
Among Veterans who receive VA-HOP, Suicide risk measured as the number of engagements with the Suicide Prevention Coordinator they have in each implementation phase will be compared. These data will be collected using VA administrative data.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David A. Smelson, PsyD, VA Bedford HealthCare System, Bedford, MA

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QUX 26-005

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.

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