Clinical trial NCT06510192: Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India
Official title: Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Substance Use Disorders
Keywords: Youth
India
People who inject drugs
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot randomized controlled trial is to learn if Yuva Sath, a youth-tailored peer-led behavioral intervention, can support substance use treatment engagement and HIV prevention among young people who inject drugs in India. The main questions it aims to answer are:

* Is Yuva Sath feasible and is it acceptable to young people who inject drugs in India ?
* Can Yuva Sath improve engagement in substance use treatment, increase use of HIV prevention services and decrease substance use and risk behaviors among young people who inject drugs in India ?

Researchers will compare participants who receive the Yuva Sath behavioral intervention to participants who do not to see if the behavioral intervention improves substance use treatment engagement and HIV prevention.

Participants will:

* Receive a total of 6 one-on-one sessions, and weekly phone text check-ins from peer counselors over a course of 6 months.
* Complete monthly random urine drug screens
* Complete in-person study questionnaires every 3 months
* Report substance use and risk behaviors weekly to peer counselors through a brief phone text message survey


Eligibility criteria: Inclusion Criteria:

* Age 18-29 years;
* Receiving medications for opioid use disorder (MOUD) for at least 3 months and receipt frequency \< 2 times a week

Exclusion Criteria:

* Receiving medications for opioid use disorder (MOUD) for less than 3 months and receipt frequency \>= 2 times a week
* Requiring urgent medical attention
* Inability to provide informed consent

Primary outcomes:
measure: Feasibility of the Yuva Sath Intervention: Peer counselor fidelity
timeFrame: 6 months.
measure: Feasibility of the Yuva Sath Intervention: Attendance in the first four sessions
timeFrame: 6 months
measure: Feasibility of the Yuva Sath Intervention: Completion of the 3 month assessment
timeFrame: 3 months
measure: Acceptability of the Yuva Sath Intervention
timeFrame: 6 months
Secondary outcomes:
measure: Substance use treatment engagement: the number of MOUD visits each month
timeFrame: 6 months
measure: Substance use treatment engagement: the number of weeks of MOUD receipt at >2 times a week
timeFrame: 6 months
measure: Substance use treatment engagement: retention in MOUD at 6 months
timeFrame: 6 months
measure: HIV testing receipt
timeFrame: 6 months
measure: Substance use: Self report at 3-month assessment
timeFrame: 3 months
measure: Substance use: Self report at 6-month assessment
timeFrame: 6 months
measure: Substance use: monthly random point-of-care urinalysis
timeFrame: 6 months
measure: Needle sharing: Self report at 3-month assessment
timeFrame: 3 months
measure: Needle sharing: self report at 6-month assessment
timeFrame: 6 months
measure: Condomless sex: self report at 3-month assessment.
timeFrame: 3 months
measure: Condomless sex: self report at 6-month assessment.
timeFrame: 6 months
Other outcomes:
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