| Registry | NCT07409350 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 398 (Estimated) |
| Sponsor | NYU Langone Health (Other); collaborators: National Institute on Drug Abuse (NIDA) |
| Conditions | Substance Use, HIV Prevention |
| Interventions | LINKED, Group Intervention (Behavioral) |
| Dates | start 2027-01-01 (estimated), primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-02-13, last updated 2026-02-13 |
| Locations | 3 sites in United States |
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All trials for Substance Use All trials for HIV Prevention All trials of LINKED All trials of Group Intervention
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LINKED Intervention | Experimental | Behavioral: LINKED | 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. |
| Equal-Attention Control | Active comparator | Behavioral: Group Intervention | Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Southern California | Los Angeles, California | United States | |
| The University of Chicago | Chicago, Illinois | United States | |
| NYU Langone Health | New York, New York | United States |