NCT07599722

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

HIV PreventionSubstance Use

Outcome Measures

Primary Outcomes (2)

  • Linkage to substance use services

    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

    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

Secondary Outcomes (12)

  • PrEP Referral

    Time Frame: 4 month post-enrollment

  • Time to PrEP Linkage

    Time Frame: 4 month post-enrollment

  • Receipt of PrEP Prescription

    Time Frame: 4 month post-enrollment

  • Fill of PrEP Prescription

    Time Frame: 4 month post-enrollment

  • PrEP Initiation

    Time Frame: 4 month post-enrollment

  • +7 more secondary outcomes

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care

LYNX Intervention

EXPERIMENTAL

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.

Behavioral: LYNX

Interventions

LYNXBEHAVIORAL

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.

LYNX Intervention
Standard of CareBEHAVIORAL

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.

Standard of Care

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Being on PrEP
  • Cognitive delays that would interfere with consent or participation
  • Inability to provide contact information for \>2 locator individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh, School of Public Health

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Publications (1)

  • 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: 38530335BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Emily Dauria, PhD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Dauria, PhD, MPH

CONTACT

412-383-0732efd16@pitt.edu

Sheridan Sweet, MPH

CONTACT

(412) 613-8817SHS406@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 20, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)