LINKED Intervention for HIV Prevention in Drug Addiction

Not yet recruiting at 2 trial locations

Overseen By Suzan Walters, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Suzan Walters, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for people who inject drugs (PWID) and are interested in improving their HIV prevention and substance use treatment. Participants should be willing to engage with the LINKED social network intervention or a control group activity, with follow-ups at 6 and 12 months.

Inclusion Criteria

I am over 18, work for TSP, and can consent to participate.

Aim 2 - Intervention: Is 18 years or older, Spends majority of their time in the Los Angeles, CA area where recruited, Able to complete surveys and group sessions in English, Self-reports to have injected drugs in the past 3 months, Self-reports 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

I am over 18, work for TSP, and can consent to participate.

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 group sessions in English, Does not self-report injecting drugs in past 3 months, Self-reports HIV positive serostatus, Currently on PrEP or MOUD, Currently pregnant, If a network recruit: does not present a valid recruitment coupon

What Are the Treatments Tested in This Trial?

Interventions

• LINKED

Trial Overview

The study tests the LINKED intervention against an equal-attention control group to see if it helps PWID take up PrEP (a medication to prevent HIV) and MOUD (medications for opioid use disorder). It's a cluster randomized trial, meaning groups of participants are randomly assigned to interventions.

How Is the Trial Designed?

Group I: LINKED Intervention Experimental Treatment 1 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.

Group II: Equal-Attention Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+