mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System (LYNX)
13 de mayo de 2026 actualizado por: Emily Dauria, University of Pittsburgh
Technology Enhanced Substance Use and HIV Service Navigation for Justice-Involved Young Adults
This study is designed to test Project LYNX, a program designed to help young adults (ages 18-29) with recent criminal legal system involvement can find and get connected to substance use and HIV-prevention services in the community. The program combines support from a trained peer navigator with easy-to-use digital tools.
The study will:
- Adapt an existing navigator program by adding new digital (eHealth) tools that were co-developed with young adults. These tools will help navigators refer participants to the right health services.
- Refine and test the updated program to make sure it works well and is easy to use.
- Evaluate whether the program is feasible, acceptable, and helpful in linking young adults to substance use treatment and HIV-prevention services.
The overall goal is to create a practical, user-friendly system that supports young adults find and get connected to services for substance use and HIV prevention that they need.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Emily Dauria, PhD, MPH
- Número de teléfono: 412-383-0732
- Correo electrónico: efd16@pitt.edu
Copia de seguridad de contactos de estudio
- Nombre: Sheridan Sweet, MPH
- Número de teléfono: (412) 613-8817
- Correo electrónico: SHS406@pitt.edu
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15206
- University of Pittsburgh, School of Public Health
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Self-report recent criminal legal involvement (past year);
- Self-identify as HIV-negative
- Endorse behaviors in the past 6 months indicating consideration of PrEP per the Center for Disease Control and Prevention's (CDC) risk indices
- Meet the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tools' criteria for identifying the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder
- Are conversant in English.
Exclusion Criteria:
- Being on PrEP
- Cognitive delays that would interfere with consent or participation
- Inability to provide contact information for >2 locator individuals
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Standard of Care
Standard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community.
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Standard of care will involve young adults (18 to 29 years) impacted by the criminal legal system engaging in and connecting with HIV and substance use services in healthcare systems via warm referral to services in the community.
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Experimental: LYNX Intervention
Project LYNX is a new program designed to help young adults involved in the criminal legal system (ages 18-29) get connected to substance use treatment and HIV-prevention services.
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LYNX is an mHealth enhanced, adapted navigator program designed to refer and link young adults (18 to 29 years) impacted by the criminal legal system to services related to substance use and HIV.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Linkage to substance use services
Periodo de tiempo: Time Frame: 4 month post-enrollment
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Substance use service linkage will be attendance at a substance use service appointment via self-report via the question: " Did you attend your first appointment with your substance use treatment provider?"
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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Linkage to PrEP Services
Periodo de tiempo: Time Frame: 4 month post-enrollment
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Pre-exposure Prophylaxis linkage will be self-reported engagement in PrEP related services in the last month via the question " Have you received any PrEP-related services in the past [month/3 months]?" Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PrEP Referral
Periodo de tiempo: Time Frame: 4 month post-enrollment
|
PrEP referral be reported via self-report via the question: "Has your navigator offered to connect you to PrEP services?"
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
|
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Time to PrEP Linkage
Periodo de tiempo: Time Frame: 4 month post-enrollment
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Time to linkage will be reported by the LYNX navigator based on the date they referred the participant to PrEP services and the date they recorded the participant first attended a PrEP related appointment.
We will report the average number of days between the date of referral and first appointment attendance.
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Time Frame: 4 month post-enrollment
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Receipt of PrEP Prescription
Periodo de tiempo: Time Frame: 4 month post-enrollment
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Receipt of a PrEP prescription will be identified via self-report via the question "Have you received a prescription for PrEP?".
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
|
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Fill of PrEP Prescription
Periodo de tiempo: Time Frame: 4 month post-enrollment
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Fill of a PrEP prescription will be identified via self-report via the question: "Have you filled your PrEP prescription?"
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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PrEP Initiation
Periodo de tiempo: Time Frame: 4 month post-enrollment
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PrEP initiation will be identified via self-report via the question: "Have you started to take PrEP?" Yes or No .
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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PrEP Adherence
Periodo de tiempo: Time Frame: 4-month post-enrollment
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PrEP adherence will be identified via self-report via the question: "In the past 30 days, rate your ability to take your PrEP medications as prescribed?"
Very often, Somewhat often, Often, Not very often, Never.
We will report the number of participants that answered with each response option.
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Time Frame: 4-month post-enrollment
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PrEP Persistence
Periodo de tiempo: Time Frame: 4-month post-enrollment
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PrEP persistence will be identified through self-report via the question: "Have you stopped taking PrEP?: Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4-month post-enrollment
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Accepted Substance Use Service Referral
Periodo de tiempo: Time Frame: 4 month post-enrollment
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Accepted substance use treatment referral will be reported via self-report via the question: "Has your navigator offered to connect you to substance use services?"
Yes or No.
We will report the number of participants that answered with each response option.
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Time Frame: 4 month post-enrollment
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Time to Substance Use Linkage
Periodo de tiempo: Time Frame: 4 month post-enrollment
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Time to linkage will be reported by the LYNX navigator based on the date they referred the participant to substance use services and the date they recorded the participant first attended a substance use related appointment.
We will report the average number of days between the date of referral and first appointment attendance.
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Time Frame: 4 month post-enrollment
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Navigation Satisfaction Tool
Periodo de tiempo: Time Frame: 4-month post-enrollment
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The Navigation Satisfaction Tool (NAVSAT) includes twelve items that address client satisfaction with navigation services (e.g., How satisfied are you with the navigator's ability to listen and understand your concerns?
How satisfied are you with the frequency of contact with the navigator?).
Items are rated on a Likert scale from 1 (extremely dissatisfied / extremely unhelpful) to 7 (satisfied/ extremely satisfied).
A total item score is calculated.
Higher scores reflect greater navigator satisfaction.
We will report the mean and the standard deviation for the NAVSAT score.
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Time Frame: 4-month post-enrollment
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Client Intervention Satisfaction
Periodo de tiempo: Baseline, 1-month post enrollment, 3-months post-enrollment
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The Study Participant Feedback Questionnaire (SPFQ) comprises 23-questions and is split into three brief, validated questionnaires capturing trial experience at baseline, mid-point, and end of the study.
The majority of items use a 5-point Likert satisfaction response scale.
Some questions use a yes/no scale.
The SPFQ is not designed to produce a single composite score.
Responses will be analyzed item by item and reported as frequency distributions for each individual question, by response.
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Baseline, 1-month post enrollment, 3-months post-enrollment
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Perceived Navigator Similarity
Periodo de tiempo: Time Frame: 4-month post-enrollment
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The Perceived Navigator Similarity scale consists of 10 items - 5 related to personal similarity and 5 related to ethnic similarity.
Patients respond to each item using a 6-point Likert scale ranging from 0 (very different) to 5 (very similar).
We will calculate a total score by summing all items, with higher scores indicating greater perceived similarity.
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Time Frame: 4-month post-enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Emily Dauria, PhD, MPH, University of Pittsburgh
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
30 de agosto de 2026
Finalización del estudio (Estimado)
1 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY22020053 (Aim 3)
- 5R34DA057891-03 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
No individual participant data will be shared.
Results will be published by the investigators in academic journals.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .