A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs
1 other identifier
interventional
398
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
Study Completion
Last participant's last visit for all outcomes
December 1, 2028
February 13, 2026
February 1, 2026
1.9 years
February 9, 2026
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
Percentage of Participants with PrEP Uptake
Measured via filled PrEP prescription.
Month 6
Percentage of Participants with PrEP Uptake
Measured via filled PrEP prescription.
Month 12
Percentage of Participants with MOUD Uptake
Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.
Month 6
Percentage of Participants with MOUD Uptake
Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.
Month 12
Percentage of Participants with PrEP Adherence
Measured via urine immunoassays to test for oral PrEP.
Month 6
Percentage of Participants with PrEP Adherence
Measured via urine immunoassays to test for oral PrEP.
Month 12
Percentage of Participants with MOUD Adherence
Measured via urinalysis to test for metabolites for MOUD.
Month 6
Percentage of Participants with MOUD Adherence
Measured via urinalysis to test for metabolites for MOUD.
Month 12
Study Arms (2)
LINKED Intervention
EXPERIMENTALParticipants 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.
Equal-Attention Control
ACTIVE COMPARATORParticipants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff.
Interventions
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 facilitated by trained study staff that supports critical thinking about what constitutes low, medium, and high risks for HIV and overdose.
Eligibility Criteria
You may qualify if:
- 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
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
University of Southern California
Los Angeles, California, 90033, United States
The University of Chicago
Chicago, Illinois, 60637, United States
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzan Walters, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 13, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Suzan.Walters@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Suzan.Walters@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.