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

28 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

240

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Bedford, Massachusetts, Estados Unidos, 01730-1114
        • Recrutamento
        • VA Bedford HealthCare System, Bedford, MA
        • Investigador principal:
          • David A. Smelson, PsyD
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Comportamental: 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.
Outros nomes:
  • 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.
Comportamental: 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.
Outros nomes:
  • VA-HOP

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of VA-HOP Sessions delivered
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Dose Fidelity Adherence to HOP Model
Prazo: 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
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Effectiveness-Mental Health Outpatient Care encounters
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

VA Office of Research and Development

Investigadores

  • Investigador principal: David A. Smelson, PsyD, VA Bedford HealthCare System, Bedford, MA

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de julho de 2026

Conclusão Primária (Estimado)

30 de junho de 2030

Conclusão do estudo (Estimado)

30 de setembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

22 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de julho de 2026

Primeira postagem (Real)

3 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • QUX 26-005

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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