- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Joseph Carpenter, MD
- Número de teléfono: 404-778-5975
- Correo electrónico: jecarpe@emory.edu
Copia de seguridad de contactos de estudio
- Nombre: Yan Li
- Correo electrónico: yan.li@emory.edu
Ubicaciones de estudio
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30303
- Reclutamiento
- Atlanta City Detention Center
-
Atlanta, Georgia, Estados Unidos, 30318
- Reclutamiento
- Fulton County Jail
-
Decatur, Georgia, Estados Unidos, 30032
- Reclutamiento
- Dekalb County Jail
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Engagement With at Least One Recovery Resource
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Days Receiving Medications for Substance Use Disorders
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 1 year
|
New arrests, bookings, or jail stays documented through participant report or administrative data.
|
Baseline to 1 year
|
|
Healthcare Utilization
Periodo de tiempo: Baseline to 1 year
|
Emergency department visits, hospitalizations, and other acute care encounters.
|
Baseline to 1 year
|
|
Recovery Capital (BARC-10)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Baseline through 1 year
|
Overdose events identified through participant report, medical records, or community partner data.
|
Baseline through 1 year
|
|
Nonfatal Overdose Events
Periodo de tiempo: Baseline through 1 year
|
Overdose events identified through participant report, medical records, or community partner data.
|
Baseline through 1 year
|
|
Housing status
Periodo de tiempo: Baseline, 30, 90, 180 days, and 1 year
|
Current housing status (stable, unstable, homeless)
|
Baseline, 30, 90, 180 days, and 1 year
|
|
Employment status
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025P012936
- 1R01DA064519-01 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .