mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System (LYNX)
13 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
50
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
- Nome: Emily Dauria, PhD, MPH
- Número de telefone: 412-383-0732
- E-mail: efd16@pitt.edu
Estude backup de contato
- Nome: Sheridan Sweet, MPH
- Número de telefone: (412) 613-8817
- E-mail: SHS406@pitt.edu
Locais de estudo
-
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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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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
Aceita Voluntários Saudáveis
Sim
Descrição
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
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Linkage to substance use services
Prazo: Time Frame: 4 month post-enrollment
|
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.
|
Time Frame: 4 month post-enrollment
|
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Linkage to PrEP Services
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PrEP Referral
Prazo: 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.
|
Time Frame: 4 month post-enrollment
|
|
Time to PrEP Linkage
Prazo: Time Frame: 4 month post-enrollment
|
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
Prazo: Time Frame: 4 month post-enrollment
|
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.
|
Time Frame: 4 month post-enrollment
|
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Fill of PrEP Prescription
Prazo: Time Frame: 4 month post-enrollment
|
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.
|
Time Frame: 4 month post-enrollment
|
|
PrEP Initiation
Prazo: Time Frame: 4 month post-enrollment
|
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
Prazo: 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.
|
Time Frame: 4-month post-enrollment
|
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PrEP Persistence
Prazo: Time Frame: 4-month post-enrollment
|
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.
|
Time Frame: 4-month post-enrollment
|
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Accepted Substance Use Service Referral
Prazo: Time Frame: 4 month post-enrollment
|
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.
|
Time Frame: 4 month post-enrollment
|
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Time to Substance Use Linkage
Prazo: Time Frame: 4 month post-enrollment
|
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
Prazo: 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
Prazo: Baseline, 1-month post enrollment, 3-months post-enrollment
|
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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Emily Dauria, PhD, MPH, University of Pittsburgh
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
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 (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
30 de agosto de 2026
Conclusão do estudo (Estimado)
1 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
13 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de maio de 2026
Primeira postagem (Real)
20 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY22020053 (Aim 3)
- 5R34DA057891-03 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
No individual participant data will be shared.
Results will be published by the investigators in academic journals.
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
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 .