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NCT Number: NCT07409350

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

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders HIV Prevention Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants with PrEP Uptake

    Time frame: Month 6

    Measured via filled PrEP prescription.

  2. Percentage of Participants with PrEP Uptake

    Time frame: Month 12

    Measured via filled PrEP prescription.

  3. Percentage of Participants with MOUD Uptake

    Time frame: Month 6

    Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.

  4. Percentage of Participants with MOUD Uptake

    Time frame: Month 12

    Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.

  5. Percentage of Participants with PrEP Adherence

    Time frame: Month 6

    Measured via urine immunoassays to test for oral PrEP.

  6. Percentage of Participants with PrEP Adherence

    Time frame: Month 12

    Measured via urine immunoassays to test for oral PrEP.

  7. Percentage of Participants with MOUD Adherence

    Time frame: Month 6

    Measured via urinalysis to test for metabolites for MOUD.

  8. Percentage of Participants with MOUD Adherence

    Time frame: Month 12

    Measured via urinalysis to test for metabolites for MOUD.

Study contacts

Contact information is provided by the study sponsor or research team.

Suzan Walters, PhD

CONTACT

[email protected]

951-443-6351

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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