A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs

Part of paid clinical trials in Los Angeles, California.

Sponsor
NYU Langone Health
Study ID
NCT07409350
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LINKED — BEHAVIORAL
    LINKED is a theory-driven social network intervention (SNI) that leverages peer influence within the social networks of people who inject drugs (PWID) to disseminate information, encourage communication, and increase pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD) uptake and persistence in harm reduction organization (HRO) settings.
  • Group Intervention — BEHAVIORAL
    Group intervention facilitated by trained study staff that supports critical thinking about what constitutes low, medium, and high risks for HIV and overdose.

Study Details

This study includes finalization of the LINKED social network intervention to improve PrEP and MOUD uptake among people who inject drugs (PWID) in collaboration with an Expert Advisory Board and staff (N=16) at The Sidewalk Project (TSP), followed by a Hybrid Type II cluster randomized trial of the LINKED intervention (versus an equal-attention control) among N=372 people who inject drugs, with 6- and 12-month follow-up assessment of PrEP and MOUD uptake. The investigators will also evaluate implementation outcomes to inform future sustainable implementation of LINKED in harm reduction organizations.

Key Dates

Start date
Jan 31, 2027
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
398 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: LINKED Intervention
    Participants randomized to the LINKED arm will receive a peer change agent intervention consisting of a 3-hour workshop divided into four learning and practice modules.
  • Active Comparator: Equal-Attention Control
    Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff.

Primary Outcome Measure

Percentage of Participants with PrEP Uptake [ Time Frame: Month 6 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Ricky Bluthenthal, PhD (PRINCIPAL_INVESTIGATOR)
The University of ChicagoChicagoIllinois60637
Alida Bouris, PhD, MSW (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Suzan Walters, PhD (PRINCIPAL_INVESTIGATOR)

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