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Not yet recruitingNCT07409350ClinicalTrials.gov record

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

Substance Use · HIV Prevention

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
398 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
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.

Behavioral: LINKED

Equal-Attention Control

Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff.

Behavioral: Group Intervention

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Percentage of Participants with PrEP Uptake

Time frame: Month 6

Measured via filled PrEP prescription.

Percentage of Participants with PrEP Uptake

Time frame: Month 12

Measured via filled PrEP prescription.

Percentage of Participants with MOUD Uptake

Time frame: Month 6

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

Percentage of Participants with MOUD Uptake

Time frame: Month 12

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

Percentage of Participants with PrEP Adherence

Time frame: Month 6

Measured via urine immunoassays to test for oral PrEP.

Percentage of Participants with PrEP Adherence

Time frame: Month 12

Measured via urine immunoassays to test for oral PrEP.

Percentage of Participants with MOUD Adherence

Time frame: Month 6

Measured via urinalysis to test for metabolites for MOUD.

Percentage of Participants with MOUD Adherence

Time frame: Month 12

Measured via urinalysis to test for metabolites for MOUD.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

University of Southern CaliforniaLos Angeles, California, United StatesStatus unknown
Ricky Bluthenthal, PhDPRINCIPAL_INVESTIGATOR
View location on map ↗
The University of ChicagoChicago, Illinois, United StatesStatus unknown
Alida Bouris, PhD, MSWPRINCIPAL_INVESTIGATOR
View location on map ↗
NYU Langone HealthNew York, New York, United StatesStatus unknown
Suzan Walters, PhDPRINCIPAL_INVESTIGATOR
View location on map ↗

Study team and timeline

Lead sponsor
NYU Langone Health
Study start
Jan 1, 2027 Estimated
Primary completion
Dec 1, 2028 Estimated
Study completion
Dec 1, 2028 Estimated
First posted
Feb 13, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Official study title

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026