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

13. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

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

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
        • University of Pittsburgh, School of Public Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Linkage to substance use services
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PrEP Referral
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

  • Ledende efterforsker: Emily Dauria, PhD, MPH, University of Pittsburgh

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY22020053 (Aim 3)
  • 5R34DA057891-03 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-forebyggelse

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