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Not yet recruiting NCT07409350

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

No phase Interventional Substance Use HIV Prevention

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: LINKED, Group Intervention.
Who it may be relevant to
Registry conditions: Substance Use, HIV Prevention. Basic parameters: from 18 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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Overview

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.

Interventions

  • Behavioral LINKED
    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.
  • Behavioral Group Intervention
    Group intervention facilitated by trained study staff that supports critical thinking about what constitutes low, medium, and high risks for HIV and overdose.

Primary outcome measures

  • Percentage of Participants with PrEP Uptake [Time frame: Month 6]
  • Percentage of Participants with PrEP Uptake [Time frame: Month 12]
  • Percentage of Participants with MOUD Uptake [Time frame: Month 6]
  • Percentage of Participants with MOUD Uptake [Time frame: Month 12]
  • Percentage of Participants with PrEP Adherence [Time frame: Month 6]
  • Percentage of Participants with PrEP Adherence [Time frame: Month 12]
  • Percentage of Participants with MOUD Adherence [Time frame: Month 6]
  • Percentage of Participants with MOUD Adherence [Time frame: Month 12]

Eligibility criteria

Inclusion criteria

Aim 1 - Virtual Focus Group

  • Is 18 years or older
  • Is a current TSP staff
  • Is capable and willing to provide consent

Aim 2 - Intervention

  • 18 years or older
  • Spend majority of their time in the Los Angeles, CA area where recruited
  • Able to complete surveys and group sessions in English
  • Self-report to have injected drugs in the past 3 months
  • Self-reported HIV negative serostatus
  • Not currently on PrEP or MOUD
  • Not pregnant
  • If a network recruit: presents a valid recruitment coupon
  • Is capable and willing to provide consent

Aim 3 - Virtual Focus Group/Surveys

  • Is 18 years or older
  • Is a current TSP staff
  • Is capable and willing to provide consent

Exclusion criteria

Aims 1 and 3:

  • Individuals who are not current TSP staff members will be excluded from participation.

Aim 2:

  • Under age 18;
  • Does not spend majority of time in the Los Angeles, CA area where recruited;
  • Unable to complete surveys and groups sessions in English;
  • Does not self-report injecting drugs in past 3 months;
  • Self-reported HIV positive serostatus
  • Currently on PrEP or MOUD
  • Currently pregnant
  • If a network recruit: does not present a valid recruitment coupon

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • University of Southern California — Los Angeles
  • The University of Chicago — Chicago
  • NYU Langone Health — New York

Identifiers

NCT: NCT07409350 · 25-01629

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗