- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07563517
Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches & Across INcarceration Settings (LINCS UP & IN)
The goal of this study is to learn whether a virtual peer recovery coach (PRC) intervention can improve engagement in addiction treatment among incarcerated adults with substance use disorders.
The main questions it aims to answer are:
- Does the PRC intervention increase engagement with at least one recovery resource at 30 and 90 days?
- Does it improve secondary outcomes such as substance use, recovery capital, overdose events, and recidivism?
Researchers will compare Treatment-as-Usual with the PRC telehealth intervention to see if PRC support improves engagement in addiction care.
Participants will:
- Complete baseline and follow-up assessments
- Receive either Treatment-as-Usual or a virtual PRC session focused on motivational interviewing and linkage to recovery resources
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study evaluates a virtual peer recovery coach (PRC) intervention designed to support adults with substance use disorders during incarceration and the transition back to the community. The trial is conducted across multiple jail facilities in Metro Atlanta, where individuals experience high rates of substance use disorders and limited access to treatment services. Peer recovery coaches-individuals with lived experience who are trained in motivational interviewing and linkage to care-have demonstrated benefit in healthcare settings, but their effectiveness within jail environments has not been rigorously tested.
The intervention adapts an existing virtual PRC model for use in jail settings. PRCs meet with participants through a secure telehealth platform and provide individualized support focused on motivation, readiness for change, and connection to recovery resources. The model is designed to be scalable, flexible, and responsive to the needs of individuals with diverse substance use profiles, including those for whom no FDA-approved medications exist.
The study uses a phased implementation approach in which participating jail sites transition from usual care to the PRC intervention over time. This structure allows the program to be integrated into each facility's workflow while enabling evaluation of the intervention's impact. Participants are followed for one year to assess engagement with recovery resources and other indicators of health, stability, and community reintegration.
The findings will inform whether virtual PRC services can be effectively delivered in jail settings and whether they improve connection to treatment and recovery supports during a period of heightened vulnerability. Results may guide future implementation of peer-based models in correctional systems and other high-risk environments.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Joseph Carpenter, MD
- Número de telefone: 404-778-5975
- E-mail: jecarpe@emory.edu
Estude backup de contato
- Nome: Yan Li
- E-mail: yan.li@emory.edu
Locais de estudo
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30303
- Recrutamento
- Atlanta City Detention Center
-
Atlanta, Georgia, Estados Unidos, 30318
- Recrutamento
- Fulton County Jail
-
Decatur, Georgia, Estados Unidos, 30032
- Recrutamento
- Dekalb County Jail
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Incarcerated at participating jail
- Able to speak and understand English
- Score of 3 or greater - "moderate level", "substantial level", or "severe level" of problems related to drug abuse - on DAST-10.
- Willing to follow study procedures and complete research follow-up calls
- Have at least two reliable contact numbers, e.g. participant and one or more relatives or close friends
Exclusion Criteria:
- Cognitive impairment (inability to comprehend the informed consent document as assessed by study staff during enrollment)
- Prior participation in the study
- Awaiting transfer to prison or jail outside the state of Georgia
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: PRC group
Participants meet virtually with a trained peer recovery coach using a secure telehealth platform.
PRCs use motivational interviewing, assess readiness to change, and provide individualized linkage to recovery resources.
Support may include connection to medications for opioid use disorder, residential treatment, detoxification centers, harm reduction services, mutual support groups, sober living, or recovery community organizations.
PRCs may also conduct post-release check-ins to support ongoing engagement.
|
A telehealth session with a peer recovery coach who provides motivational interviewing and tailored linkage to addiction treatment and recovery resources.
|
|
Comparador Ativo: Standard of Care
Participants receive the jail's standard approach to substance use support.
This includes a review of available community treatment and recovery resources consistent with existing facility practices.
No peer recovery coach is involved, and no additional study-driven services are provided.
|
Participants are provided information about community-based addiction treatment and recovery resources as part of routine jail processes.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Engagement With at Least One Recovery Resource
Prazo: 30 days and 90 days after enrollment
|
Engagement with at least one recovery resource, defined as:
|
30 days and 90 days after enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Days Receiving Medications for Substance Use Disorders
Prazo: Baseline to 30 days, 90 days, 180 days, and 1 year
|
Number of days participants receive medications for opioid use disorder (MOUD), stimulant use disorder, or alcohol use disorder.
|
Baseline to 30 days, 90 days, 180 days, and 1 year
|
|
Recidivism and Justice Involvement
Prazo: Baseline to 1 year
|
New arrests, bookings, or jail stays documented through participant report or administrative data.
|
Baseline to 1 year
|
|
Healthcare Utilization
Prazo: Baseline to 1 year
|
Emergency department visits, hospitalizations, and other acute care encounters.
|
Baseline to 1 year
|
|
Recovery Capital (BARC-10)
Prazo: Baseline, 30, 90, 180 days, and 1 year
|
Brief Assessment of Recovery Capital (BARC-10) A 10-item validated scale that measures a person's internal and external resources that support recovery from substance use. Items assess domains such as social support, coping skills, housing stability, and personal motivation.
|
Baseline, 30, 90, 180 days, and 1 year
|
|
Number of Peer Recovery Coach Contacts
Prazo: Baseline to 30 days, 90 days, 180 days, and 1 year
|
Number of PRC interactions among participants assigned to the intervention arm.
|
Baseline to 30 days, 90 days, 180 days, and 1 year
|
|
Self-Reported Substance Use (TLFB)
Prazo: Baseline, 30, 90, 180 days, and 1 year
|
Days of substance use in the past 30 days using the Timeline Follow-Back method.
A structured calendar-based interview used to measure self-reported substance use over the past 30 days.
Participants recall days of use using memory anchors (events, routines).
|
Baseline, 30, 90, 180 days, and 1 year
|
|
Fatal Overdose Events
Prazo: Baseline through 1 year
|
Overdose events identified through participant report, medical records, or community partner data.
|
Baseline through 1 year
|
|
Nonfatal Overdose Events
Prazo: Baseline through 1 year
|
Overdose events identified through participant report, medical records, or community partner data.
|
Baseline through 1 year
|
|
Housing status
Prazo: Baseline, 30, 90, 180 days, and 1 year
|
Current housing status (stable, unstable, homeless)
|
Baseline, 30, 90, 180 days, and 1 year
|
|
Employment status
Prazo: Baseline, 30, 90, 180 days, and 1 year
|
Employment status (full-time, part-time, unemployed)
|
Baseline, 30, 90, 180 days, and 1 year
|
|
Social connections and Isolation: PROMIS scale
Prazo: Baseline, 30, 90, 180 days, and 1 year
|
A validated set of items assessing perceived social support, loneliness, and connectedness.
|
Baseline, 30, 90, 180 days, and 1 year
|
|
All-Cause Mortality
Prazo: Baseline through 1 year
|
Death from any cause, confirmed through vital records or the National Death Index.
|
Baseline through 1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joseph Carpenter, MD, Emory University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025P012936
- 1R01DA064519-01 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .