An interventional study of Yuva Sath in Hiv and Substance Use Disorders, sponsored by Massachusetts General Hospital. Not yet recruiting. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2025-10-22.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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:
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:
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This study's planned enrollment of 60 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
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Exclusion Criteria:
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
Substance use treatment engagement: the number of MOUD visits each month
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.
Time frame: 6 months
Substance use treatment engagement: the number of weeks of MOUD receipt at >2 times a week
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.
Time frame: 6 months
Substance use treatment engagement: retention in MOUD at 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
Time frame: 6 months
HIV testing receipt
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
Time frame: 6 months
Substance use: Self report at 3-month assessment
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
Time frame: 3 months
Substance use: Self report at 6-month assessment
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
Time frame: 6 months
Substance use: monthly random point-of-care urinalysis
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
Time frame: 6 months
Needle sharing: Self report at 3-month assessment
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
Time frame: 3 months
Needle sharing: self report at 6-month assessment
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
Time frame: 6 months
Condomless sex: self report at 3-month assessment.
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
Time frame: 3 months
Condomless sex: self report at 6-month assessment.
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
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data will be made available to other researchers at reasonable request.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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Acquired Immunodeficiency Syndrome→
Massachusetts General Hospital