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

13. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Emily Dauria, PhD, MPH
  • Telefonnummer: 412-383-0732
  • E-Mail: efd16@pitt.edu

Studieren Sie die Kontaktsicherung

  • Name: Sheridan Sweet, MPH
  • Telefonnummer: (412) 613-8817
  • E-Mail: SHS406@pitt.edu

Studienorte

  • Vereinigte Staaten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15206
        • University of Pittsburgh, School of Public Health

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verhalten: 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.
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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Linkage to substance use services
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PrEP Referral
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Pittsburgh

Mitarbeiter

National Institute on Drug Abuse (NIDA)

Ermittler

  • Hauptermittler: Emily Dauria, PhD, MPH, University of Pittsburgh

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

30. August 2026

Studienabschluss (Geschätzt)

1. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY22020053 (Aim 3)
  • 5R34DA057891-03 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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