Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-19 @ 6:21 AM
Study NCT ID:
NCT06510192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2024-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the Yuva Sath Intervention: Peer counselor fidelity', 'timeFrame': '6 months.', 'description': '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'}, {'measure': 'Feasibility of the Yuva Sath Intervention: Attendance in the first four sessions', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Feasibility of the Yuva Sath Intervention: Completion of the 3 month assessment', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Acceptability of the Yuva Sath Intervention', 'timeFrame': '6 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Substance use treatment engagement: the number of MOUD visits each month', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Substance use treatment engagement: the number of weeks of MOUD receipt at >2 times a week', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Substance use treatment engagement: retention in MOUD at 6 months', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'HIV testing receipt', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Substance use: Self report at 3-month assessment', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Substance use: Self report at 6-month assessment', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Substance use: monthly random point-of-care urinalysis', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Needle sharing: Self report at 3-month assessment', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Needle sharing: self report at 6-month assessment', 'timeFrame': '6 months', 'description': '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'}, {'measure': 'Condomless sex: self report at 3-month assessment.', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Condomless sex: self report at 6-month assessment.', 'timeFrame': '6 months', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Youth', 'India', 'People who inject drugs'], 'conditions': ['Hiv', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': '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:\n\n* Is Yuva Sath feasible and is it acceptable to young people who inject drugs in India ?\n* 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 ?\n\nResearchers 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.\n\nParticipants will:\n\n* Receive a total of 6 one-on-one sessions, and weekly phone text check-ins from peer counselors over a course of 6 months.\n* Complete monthly random urine drug screens\n* Complete in-person study questionnaires every 3 months\n* Report substance use and risk behaviors weekly to peer counselors through a brief phone text message survey'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-29 years;\n* Receiving medications for opioid use disorder (MOUD) for at least 3 months and receipt frequency \\< 2 times a week\n\nExclusion Criteria:\n\n* Receiving medications for opioid use disorder (MOUD) for less than 3 months and receipt frequency \\>= 2 times a week\n* Requiring urgent medical attention\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06510192', 'briefTitle': 'Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Yuva Sath: A Peer-led Behavioral Intervention to Support Substance Use Treatment and HIV Prevention Among Young People Who Inject Drugs in India', 'orgStudyIdInfo': {'id': '2024P000962'}, 'secondaryIdInfos': [{'id': '1K23DA057151-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1K23DA057151-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yuva Sath Intervention', 'description': '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.', 'interventionNames': ['Behavioral: Yuva Sath']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': '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': [{'name': 'Yuva Sath', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Yuva Sath Intervention']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The data will become available once study analysis is completed and will be available for at least 5 years after study completion', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be made available to other researchers at reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-Investigator', 'investigatorFullName': 'Lakshmi Ganapathi', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}