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NCT Number: NCT06510192

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

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

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Feasibility of the Yuva Sath Intervention: Peer counselor fidelity

    Time frame: 6 months.

    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

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

    Time frame: 6 months

    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

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

    Time frame: 3 months

    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

  4. Acceptability of the Yuva Sath Intervention

    Time frame: 6 months

    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

Secondary outcomes

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

    Time frame: 6 months

    Substance use treatment engagement as measured by the average number of MOUD visits each month over a 6 month period will be compared between the intervention and control arms.

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

    Time frame: 6 months

    Substance use treatment engagement as measured by the the number of weeks of MOUD receipt at >2 times a week will be compared between the intervention and control arms. We will calculate the proportion of participants (%) in each arm who on average received MOUD at a frequency of > 2 times a week.

  3. Substance use treatment engagement: retention in MOUD at 6 months

    Time frame: 6 months

    Substance use treatment engagement as measured by retention in MOUD at 6 months will be compared between the intervention and control arms. We will calculate the proportion (%) of participants in each arm who were retained in MOUD at 6 months

  4. HIV testing receipt

    Time frame: 6 months

    Receipt of regular HIV testing every 6 months will be compared between the intervention and control arms. We will calculate the proportion (%) of participants in each arm who received regular HIV testing

  5. Substance use: Self report at 3-month assessment

    Time frame: 3 months

    Substance use as measured by self report will be compared between the intervention and control arms. We will calculate the proportion of participants (%) in the intervention and control arms who report continued substance use by at the 3-month assessment

  6. Substance use: Self report at 6-month assessment

    Time frame: 6 months

    Substance use as measured by self report will be compared between the intervention and control arms. We will calculate the proportion (%) of participants in the intervention and control arms who report continued substance use by at the 6-month assessment

  7. Substance use: monthly random point-of-care urinalysis

    Time frame: 6 months

    Substance use as measured by monthly point-of-care urinalysis will be compared between the intervention and control arms. We will calculate the proportion (%) of participants in the intervention and control arms who had at least one positive point-of-care test for opioids (excluding buprenorphine) in each arm

  8. Needle sharing: Self report at 3-month assessment

    Time frame: 3 months

    Needle sharing as measured by self report will be compared between the intervention and control arms. We will calculate the proportion of participants (%) in the intervention and control arms who report needle sharing at the 3-month assessment

  9. Needle sharing: self report at 6-month assessment

    Time frame: 6 months

    Needle sharing as measured by self report will be compared between the intervention and control arms. We will calculate the proportion of participants (%) in the intervention and control arms who report needle sharing at the 6-month assessment

  10. Condomless sex: self report at 3-month assessment.

    Time frame: 3 months

    Condomless sex as measured by self report will be compared between the intervention and control arms. We will calculate the proportion of participants (%) in the intervention and control arms who report condomless sex at the 3-month assessment

  11. Condomless sex: self report at 6-month assessment.

    Time frame: 6 months

    Condomless sex as measured by self report will be compared between the intervention and control arms. We will calculate the proportion of participants (%) in the intervention and control arms who report condomless sex at the 6-month assessment

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jul 19, 2024
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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