Substance UseNCT07409350
A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs
A study testing LINKED and Group Intervention in people with Substance Use and HIV Prevention, run by NYU Langone Health at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use, HIV Prevention
- What is being tested?
- LINKED and Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
The University of Chicago
Chicago, Illinois, 60637
Alida Bouris, PhD, MSW
University of Southern California
Los Angeles, California, 90033
Ricky Bluthenthal, PhD
NYU Langone Health
New York, New York, 10016
Suzan Walters, PhD
About this study
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.
- Conditions
- Substance Use, HIV Prevention
- Being tested
- LINKED, Group Intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LINKEDBehavioural
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 InterventionBehavioural
Group intervention facilitated by trained study staff that supports critical thinking about what constitutes low, medium, and high risks for HIV and overdose.
| Study group | Role | What they receive |
|---|---|---|
| LINKED Intervention | Experimental | 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. Receives: Behavioral: LINKED |
| Equal-Attention Control | Active comparator | Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff. Receives: Behavioral: Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with PrEP Uptake
Measured via filled PrEP prescription.
Measured: Month 6
Percentage of Participants with PrEP Uptake
Measured via filled PrEP prescription.
Measured: Month 12
Percentage of Participants with MOUD Uptake
Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.
Measured: Month 6
Percentage of Participants with MOUD Uptake
Measured via filled MOUD prescription or buprenorphine, methadone, or naltrexone enrollment.
Measured: Month 12
Percentage of Participants with PrEP Adherence
Measured via urine immunoassays to test for oral PrEP.
Measured: Month 6
Percentage of Participants with PrEP Adherence
Measured via urine immunoassays to test for oral PrEP.
Measured: Month 12
Percentage of Participants with MOUD Adherence
Measured via urinalysis to test for metabolites for MOUD.
Measured: Month 6
Percentage of Participants with MOUD Adherence
Measured via urinalysis to test for metabolites for MOUD.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Suzan Walters, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409350
- Sponsor's protocol ID
- 25-01629
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs
- ClinicalTrials.gov ID
- NCT07409350
- Acronym / sponsor ID
- 25-01629
- Conditions
- Substance Use, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LINKED Intervention | Experimental | Behavioral: LINKEDParticipants 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 comparator | Behavioral: Group InterventionParticipants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (11 listed)
- Individuals who are not current TSP staff members will be excluded from participation.
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LINKEDLINKED 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. | Behavioural | LINKED Intervention |
| Group InterventionGroup intervention facilitated by trained study staff that supports critical thinking about what constitutes low, medium, and high risks for HIV and overdose. | Behavioural | Equal-Attention Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzan Walters, PhD principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LINKED and Group Intervention in people with Substance Use and HIV Prevention, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzan Walters, PhD (951-443-6351, Suzan.Walters@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with PrEP Uptake (time frame: Month 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.