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

NCT ID: NCT06510192

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-01-31
• Study Completion Date: 2028-12-31

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

Conditions

Hiv; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Yuva Sath Intervention

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.

Group Type: EXPERIMENTAL

Yuva Sath

Intervention Type: BEHAVIORAL

The Yuva Sath Intervention comprises 6 one-on-one sessions with peer counselors who will use an intervention manual. The intervention also includes weekly phone text check-ins by peer counselors

Treatment as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Yuva Sath

The Yuva Sath Intervention comprises 6 one-on-one sessions with peer counselors who will use an intervention manual. The intervention also includes weekly phone text check-ins by peer counselors

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lakshmi Ganapathi

Physician-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1K23DA057151-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P000962

Identifier Type: -

Identifier Source: org_study_id