A Social Network Approach to Improve HIV Prevention and Substance Use Treatment For People Who Use Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 398
- Locations
- 3
- Primary Endpoint
- Percentage of Participants with PrEP Uptake
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Arms & Interventions
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.
Intervention: LINKED (Behavioral)
Equal-Attention Control
Participants randomized to the equal attention control group will receive a group intervention facilitated by trained study staff.
Intervention: Group Intervention (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported