Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India

Mass General Brigham

Status: Begins enrollment in 10 months

Conditions: Substance Use Disorders; Hiv

Treatments: Behavioral: Yuva Sath

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06510192

1K23DA057151-01A1 (U.S. NIH Grant/Contract)

2024P000962

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Yuva Sath Intervention

Experimental group

Description:

The Yuva Sath Intervention entails 6 one-on-one sessions delivered by peer counselors who will use an intervention manual consisting of modules and an intervention script. These sessions will occur over a period of 3 months. The intervention will also entail weekly check-in text messages from peer counselors. These weekly check-ins will occur over a period of 5 months.

Treatment:

Behavioral: Yuva Sath

Treatment as usual

No Intervention group

Description:

The treatment as usual arm consists of a single motivational interviewing session that will be provided by existing counselors at the integrated care center where the trial will take place. Participants in this arm will not receive the Yuva Sath Intervention