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HivNCT06510192

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

A study testing Yuva Sath in people with Hiv and Substance Use Disorders, run by Massachusetts General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 29 years
Conditions the study is for
Hiv, Substance Use Disorders
What is being tested?
Yuva Sath
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Jan 2027to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

About this study

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 ?
Read more

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
Being tested
Yuva Sath
Keywords
Youth, India, People who inject drugs
Medical subject headings
Acquired Immunodeficiency Syndrome, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yuva SathBehavioural

    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

Study groups in NCT06510192
Study groupRoleWhat they receive
Yuva Sath InterventionExperimentalThe 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.
Receives: Behavioral: Yuva Sath
Treatment as usualNo interventionThe 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months.

  2. 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

    Measured: 6 months

  3. 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

    Measured: 3 months

  4. 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

    Measured: 6 months

Secondary outcomes (11)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. 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

    Measured: 3 months

  6. 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

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. 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

    Measured: 3 months

  9. 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

    Measured: 6 months

  10. 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

    Measured: 3 months

  11. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study startJan 2027 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06510192
Sponsor's protocol ID
2024P000962
Other IDs
1K23DA057151-01A1
Status last verified
Oct 2025
First submitted
4 Jul 2024
Last updated
22 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be made available to other researchers at reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Yuva Sath in people with Hiv and Substance Use Disorders, run by Massachusetts General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the Yuva Sath Intervention: Peer counselor fidelity (time frame: 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06510192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

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Clinical Trial NCT06510192 | AzTrials