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Not yet recruiting NCT07599722

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

No phase Interventional HIV Prevention Substance Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LYNX, Standard of Care.
Who it may be relevant to
Registry conditions: HIV Prevention, Substance Use. Basic parameters: 18 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Technology Enhanced Substance Use and HIV Service Navigation for Justice-Involved Young Adults

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Linkage to substance use services [Time frame: Time Frame: 4 month post-enrollment]
  • Linkage to PrEP Services [Time frame: Time Frame: 4 month post-enrollment]
Secondary outcome measures (12)
  • PrEP Referral [Time frame: Time Frame: 4 month post-enrollment]
  • Time to PrEP Linkage [Time frame: Time Frame: 4 month post-enrollment]
  • Receipt of PrEP Prescription [Time frame: Time Frame: 4 month post-enrollment]
  • Fill of PrEP Prescription [Time frame: Time Frame: 4 month post-enrollment]
  • PrEP Initiation [Time frame: Time Frame: 4 month post-enrollment]
  • PrEP Adherence [Time frame: Time Frame: 4-month post-enrollment]
  • PrEP Persistence [Time frame: Time Frame: 4-month post-enrollment]
  • Accepted Substance Use Service Referral [Time frame: Time Frame: 4 month post-enrollment]
  • Time to Substance Use Linkage [Time frame: Time Frame: 4 month post-enrollment]
  • Navigation Satisfaction Tool [Time frame: Time Frame: 4-month post-enrollment]
  • Client Intervention Satisfaction [Time frame: Baseline, 1-month post enrollment, 3-months post-enrollment]
  • Perceived Navigator Similarity [Time frame: Time Frame: 4-month post-enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Pittsburgh, School of Public Health — Pittsburgh

Publications

  • Creasy SL, Sweet S, Myers JJ, Shumway M, Tolou-Shams M, McCaffrey N, Dauria EF. eHealth-Enhanced Peer Navigation for Substance Use Treatment and HIV Prevention Service Linkage for Young Adults Surveilled by the Criminal Legal System: Protocol for a Pilot Randomized Trial Study. JMIR Res Protoc. 2024 Mar 26;13:e54815. doi: 10.2196/54815. PMID 38530335

Identifiers

NCT: NCT07599722 · STUDY22020053 (Aim 3) · 5R34DA057891-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗