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mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System (LYNX)

13 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Emily Dauria, PhD, MPH
  • Numéro de téléphone: 412-383-0732
  • E-mail: efd16@pitt.edu

Sauvegarde des contacts de l'étude

  • Nom: Sheridan Sweet, MPH
  • Numéro de téléphone: (412) 613-8817
  • E-mail: SHS406@pitt.edu

Lieux d'étude

  • États-Unis
    • Pennsylvania
      • Pittsburgh, Pennsylvania, États-Unis, 15206
        • University of Pittsburgh, School of Public Health

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Comportemental: 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.
Expérimental: 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.
Comportemental: LYNX
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Linkage to substance use services
Délai: 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
Linkage to PrEP Services
Délai: Time Frame: 4 month post-enrollment
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.
Time Frame: 4 month post-enrollment

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PrEP Referral
Délai: 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
Délai: 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.
Time Frame: 4 month post-enrollment
Receipt of PrEP Prescription
Délai: 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
Fill of PrEP Prescription
Délai: 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
Délai: 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.
Time Frame: 4 month post-enrollment
PrEP Adherence
Délai: Time Frame: 4-month post-enrollment
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
PrEP Persistence
Délai: 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
Accepted Substance Use Service Referral
Délai: 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
Time to Substance Use Linkage
Délai: 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.
Time Frame: 4 month post-enrollment
Navigation Satisfaction Tool
Délai: Time Frame: 4-month post-enrollment
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.
Time Frame: 4-month post-enrollment
Client Intervention Satisfaction
Délai: 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.
Baseline, 1-month post enrollment, 3-months post-enrollment
Perceived Navigator Similarity
Délai: Time Frame: 4-month post-enrollment
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.
Time Frame: 4-month post-enrollment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Pittsburgh

Collaborateurs

National Institute on Drug Abuse (NIDA)

Les enquêteurs

  • Chercheur principal: Emily Dauria, PhD, MPH, University of Pittsburgh

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

30 août 2026

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

13 mai 2026

Première soumission répondant aux critères de contrôle qualité

13 mai 2026

Première publication (Réel)

20 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY22020053 (Aim 3)
  • 5R34DA057891-03 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No individual participant data will be shared. Results will be published by the investigators in academic journals.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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