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

NCT07742722 | Recruiting

• 1 other identifier: QUX 26-005
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stigma; Substance Use Disorder; Veterans; Co-Occurring Disorders; Mental Health Disorder

Keywords

Stigma; Co-Occurring Disorders; Substance Use Disorder; Mental Health; Veterans; Honest, Open, Proud; Implementation Science; Justice Involved

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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 Outcomes (4)

• Effectiveness-Mental Health Outpatient Care encounters

  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

  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

  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)

Study Arms (2)

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.

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.

Behavioral: Veterans Affairs-Honest, Open, Proud

Interventions

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.

Also known as: VA-HOP

High Intensity; Low Intensity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

RECRUITING

MeSH Terms

Conditions

Social Stigma; Substance-Related Disorders; Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Chemically-Induced Disorders; Personal Satisfaction

Study Officials

• David A. Smelson, PsyD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Smelson, PsyD

CONTACT

(781) 687-7778; david.smelson@va.gov

Michael A Andre, MPH

CONTACT

(781) 382-5554; michael.andre2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)