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Not yet recruiting NCT06510192

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

No phase Interventional Hiv Substance Use Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yuva Sath.
Who it may be relevant to
Registry conditions: Hiv, Substance Use Disorders. Basic parameters: 18 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Behavioral 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

Primary outcome measures

  • Feasibility of the Yuva Sath Intervention: Peer counselor fidelity [Time frame: 6 months.]
  • Feasibility of the Yuva Sath Intervention: Attendance in the first four sessions [Time frame: 6 months]
  • Feasibility of the Yuva Sath Intervention: Completion of the 3 month assessment [Time frame: 3 months]
  • Acceptability of the Yuva Sath Intervention [Time frame: 6 months]
Secondary outcome measures (11)
  • Substance use treatment engagement: the number of MOUD visits each month [Time frame: 6 months]
  • Substance use treatment engagement: the number of weeks of MOUD receipt at >2 times a week [Time frame: 6 months]
  • Substance use treatment engagement: retention in MOUD at 6 months [Time frame: 6 months]
  • HIV testing receipt [Time frame: 6 months]
  • Substance use: Self report at 3-month assessment [Time frame: 3 months]
  • Substance use: Self report at 6-month assessment [Time frame: 6 months]
  • Substance use: monthly random point-of-care urinalysis [Time frame: 6 months]
  • Needle sharing: Self report at 3-month assessment [Time frame: 3 months]
  • Needle sharing: self report at 6-month assessment [Time frame: 6 months]
  • Condomless sex: self report at 3-month assessment. [Time frame: 3 months]
  • Condomless sex: self report at 6-month assessment. [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06510192 · 2024P000962 · 1K23DA057151-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗