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NCT Number: NCT07742722

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veterans Affairs-Honest, Open, Proud

Behavioral

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David A Smelson, PsyD

CONTACT

[email protected]

(781) 687-7778

Michael A Andre, MPH

CONTACT

[email protected]

(781) 382-5554

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Honest, Open, Proud (HOP) (QUE 25-014)

Acronym: HOP

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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