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

NCT06510192 | Not Yet Recruiting DMC

• 2 other identifiers: 2024P0009621K23DA057151-01A1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

Youth; India; People who inject drugs

Outcome Measures

Primary Outcomes (4)

• Feasibility of the Yuva Sath Intervention: Peer counselor fidelity

  Feasibility of the Yuva Sath intervention as measured by peer counselor fidelity to the intervention protocol will be determined by independent observer fidelity checklists. The checklist will score content delivery on a 3-point ordinal scale (1=no key content covered to 3=all key content covered), and peer-navigator actions (i.e., identification of barriers; generation of solutions) on a 5-point Likert scale (1=not at all to 5=very much). The intervention will be deemed to be feasible if 80% of the sessions addressed key Life-Steps module content and employed flexible problem-solving

  6 months.

• Feasibility of the Yuva Sath Intervention: Attendance in the first four sessions

  Feasibility of the Yuva Sath intervention as measured by attendance in the first four sessions will be calculated as a proportion: participants who completed the first four sessions of the total 6 sessions of the intervention/ All participants in the intervention arm. The intervention will be deemed to be feasible if at least 75% of participants completed the first four sessions

  6 months

• Feasibility of the Yuva Sath Intervention: Completion of the 3 month assessment

  Feasibility of the Yuva Sath intervention as measured by completion of the 3 month session will be calculated as a proportion: participants who completed the 3 month assessment / All participants in the intervention arm. The intervention will be deemed feasible if at least 60% of participants completed the 3-month assessment

  3 months

• Acceptability of the Yuva Sath Intervention

  Acceptability of the intervention as measured by the overall satisfaction of participants rated on a 5-point Likert scale (1=not at all to 5=very much). The intervention will be deemed acceptable if at least 75% of the participants rate \>=4 on overall satisfaction

  6 months

Secondary Outcomes (11)

• Substance use treatment engagement: the number of MOUD visits each month

  6 months

• Substance use treatment engagement: the number of weeks of MOUD receipt at >2 times a week

  6 months

• Substance use treatment engagement: retention in MOUD at 6 months

  6 months

• HIV testing receipt

  6 months

• Substance use: Self report at 3-month assessment

  3 months

Study Arms (2)

Yuva Sath Intervention

EXPERIMENTAL

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.

Behavioral: Yuva Sath

Treatment as usual

NO INTERVENTION

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

Interventions

Yuva Sath 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

Yuva Sath Intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician-Investigator

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 19, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available once study analysis is completed and will be available for at least 5 years after study completion