Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services

Lead Sponsor:

Yale University

Collaborating Sponsors:

National Institute on Drug Abuse (NIDA)

Conditions:

Opioid-use Disorder

HIV Prevention Program

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and s...

Detailed Description

Consistent with a Hybrid Effectiveness-Implementation Type 1 design, this is a multi-site randomized clinical trial designed to evaluate the effectiveness of Contingency Management with stepped care t...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Aims 1 and 2:
  • Receive or willing to receive care at one of the participating study sites
  • Have a recent negative HIV test with no concern for acute HIV
  • Report injection drug use in their lifetime
  • Meet PrEP eligibility criteria by either a) sharing of injection or drug preparation equipment; b) sexual risk behaviors (i.e. condomless sex or STI) in the past 6 months
  • Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder
  • Have a phone or use of a household member's phone
  • Provide written informed consent
  • Aim 3:
  • Currently employed at one of the participating study sites
  • Willing to complete a web-based survey
  • Exclusion criteria:
  • Aims 1 and 2:
  • Currently prescribed PrEP
  • Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive
  • Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.)
  • Inability to provide at least one collateral contact for a friend or family member.
  • Non-English speaking (for sites without Spanish-speaking staff)
  • Have kidney disease (a contraindication to PrEP)
  • Aim 3:
  • 1\. Non-English speaking

Exclusion

    Key Trial Info

    Start Date :

    October 4 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2026

    Estimated Enrollment :

    526 Patients enrolled

    Trial Details

    Trial ID

    NCT04738825

    Start Date

    October 4 2021

    End Date

    June 30 2026

    Last Update

    June 13 2025

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Recovery Network of Programs, Inc

    Bridgeport, Connecticut, United States, 06484

    2

    Liberations Program, Inc

    Bridgeport, Connecticut, United States, 06604

    3

    Apex Community Care. Inc.

    Danbury, Connecticut, United States, 06810

    4

    Greater Hartford Harm Reduction Coalition- SWAN

    New Haven, Connecticut, United States, 06511