Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 4:18 PM
Study NCT ID:
NCT04853394
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tajik Migrant Health Education Study
Sponsor:
Organization:
Raw JSON
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'EG000', 'numAtRisk': 210, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Syringe Sharing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MASLIHAT Peer Education', 'description': 'A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.\n\nMASLIHAT: peer educator intervention'}, {'id': 'OG001', 'title': 'TANSIHAT Health Education', 'description': 'A health education program consisting of five weekly 2-hour sessions small group sessions.\n\nTANSIHAT: health education intervention'}], 'classes': [{'title': '3-month follow-up', 'categories': [{'measurements': [{'value': 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and network cluster'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'injected with a previously used syringe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sex Without Condom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MASLIHAT Peer Education', 'description': 'A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.\n\nMASLIHAT: peer educator intervention'}, {'id': 'OG001', 'title': 'TANSIHAT Health Education', 'description': 'A health education program consisting of five weekly 2-hour sessions small group sessions.\n\nTANSIHAT: health education intervention'}], 'classes': [{'title': '3-months', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}, {'title': '9-months', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.67', 'ciLowerLimit': '.46', 'ciUpperLimit': '.97', 'estimateComment': 'Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects modified Poisson regression model with random intercepts for participant and network cluster'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'vaginal or anal sex without a 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'5.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': '9-months', 'categories': [{'measurements': [{'value': '5.6', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': '12-months', 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.86', 'ciLowerLimit': '.77', 'ciUpperLimit': '.95', 'estimateComment': 'Effect of MASLIHAT vs. comparison TANSIHAT condition at 6-month follow-up', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects Poisson regression model with random intercepts for participant and network cluster'}, {'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 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'210', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'six or more drinks at a time at least once a month', 'unitOfMeasure': 'Participants'}, {'title': 'Days of alcohol use past month', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '5.3', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HIV positive test result', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among participants with reported test results'}, {'title': 'Hepatitis C antibody positive test result', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Among participants with reported test results'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-18', 'size': 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'cluster-randomized parallel groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2021-04-16', 'resultsFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2021-04-16', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Injection Equipment Sharing', 'timeFrame': '3 months', 'description': 'used shared injection equipment'}], 'primaryOutcomes': [{'measure': 'Syringe Sharing', 'timeFrame': '3 months', 'description': 'injected with a previously used syringe'}, {'measure': 'Sex Without Condom', 'timeFrame': '3 months', 'description': 'vaginal or anal sex without a condom in the past 3 months'}, {'measure': 'Alcohol Use', 'timeFrame': '30 days', 'description': 'Number of days drinking alcohol in past month'}], 'secondaryOutcomes': [{'measure': 'HIV Infection', 'timeFrame': '12 months', 'description': 'incident HIV infection'}, {'measure': 'Hepatitis C Infection', 'timeFrame': '12 months', 'description': 'incident hepatitis C virus (HCV) infection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['injection drug use', 'migrant workers', 'risk behavior'], 'conditions': ['HIV Infections', 'Hepatitis C', 'Risky Health Behavior', 'Risk Reduction Behavior']}, 'referencesModule': {'references': [{'pmid': '37297541', 'type': 'BACKGROUND', 'citation': 'Mackesy-Amiti ME, Levy JA, Bahromov M, Jonbekov J, Luc CM. HIV and Hepatitis C Risk among Tajik Migrant Workers Who Inject Drugs in Moscow. Int J Environ Res Public Health. 2023 May 24;20(11):5937. doi: 10.3390/ijerph20115937.'}, {'pmid': '38212755', 'type': 'BACKGROUND', 'citation': 'Luc CM, Levy J, Bahromov M, Jonbekov J, Mackesy-Amiti ME. HIV knowledge, self-perception of HIV risk, and sexual risk behaviors among male Tajik labor migrants who inject drugs in Moscow. BMC Public Health. 2024 Jan 11;24(1):156. doi: 10.1186/s12889-023-17543-1.'}, {'pmid': '39030891', 'type': 'RESULT', 'citation': 'Mackesy-Amiti ME, Bahromov M, Levy JA, Jonbekov J, Luc CM. Changes in risk behaviour following a network peer education intervention for HIV prevention among male Tajik migrants who inject drugs in Moscow: a cluster-randomized controlled trial. J Int AIDS Soc. 2024 Jul;27 Suppl 3(Suppl 3):e26310. doi: 10.1002/jia2.26310.'}, {'pmid': '40495129', 'type': 'DERIVED', 'citation': 'Mackesy-Amiti ME, Levy JA, Luc CM, Jonbekov J. Peer education intervention reduced sexually transmitted infections among male Tajik labor migrants who inject drugs: results of a cluster-randomized controlled trial. BMC Public Health. 2025 Jun 10;25(1):2154. doi: 10.1186/s12889-025-23387-8.'}, {'pmid': '39185538', 'type': 'DERIVED', 'citation': 'Mackesy-Amiti ME, Levy JA, Luc CM, Jonbekov J. Peer Education Intervention Reduced Sexually Transmitted Infections Among Male Tajik Labor Migrants Who Inject Drugs: Results of a Cluster-randomized Controlled Trial. medRxiv [Preprint]. 2025 May 1:2024.08.15.24312070. doi: 10.1101/2024.08.15.24312070.'}], 'seeAlsoLinks': [{'url': 'https://osf.io/7g3yh/', 'label': 'Open Science Framework Project page'}, {'url': 'https://osf.io/krjqs/?view_only=7c93ea8cf8384dce91b2b531000e63e3', 'label': 'Data files'}]}, 'descriptionModule': {'briefSummary': 'This study will test the efficacy of a peer-education prevention intervention to reduce risky drug, alcohol, and sexual behaviors among male Tajik labor migrants who inject drugs (MWID) while working in Moscow. The peer educator intervention will be compared to a health education control intervention. Each intervention consists of 5 weekly 2-hour small group sessions. Follow-up assessments will be conducted at 3, 6, 9, and 12 months after the intervention. It is hypothesized that, compared to MWID who receive the health education control intervention, those who receive the peer educator intervention will have a greater reduction in the frequency of risk behaviors. Similar effects are expected for network members of intervention participants.', 'detailedDescription': 'The investigators will recruit male Tajik migrants who inject drugs from 12 different sites in Moscow, including bazaars and other work sites. In both study arms, the recruited men (index participants) will be required to recruit two eligible MWID peers for interviews prior to being interviewed themselves. Participants will be randomly assigned to either the peer educator intervention program or the health education intervention program. After peer-recruited network members are enrolled and interviewed, the index participant will participate in the peer educator training or the control group activities. All participants and recruited network members will then be followed and re-interviewed at 3-month intervals for one year to assess changes in risky drug, alcohol, and sexual behaviors due to intervention participation and through diffusion to network members. The investigators will also collect data from voluntary HIV and HCV testing conducted at 6 months (HCV only) and at 12 months (HIV and HCV) post-intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult Tajik man\n* injected drugs in past 30 days\n* living and working as migrant laborer in Moscow\n\nExclusion Criteria:\n\n* does not intend to stay in Moscow for the next 12 months'}, 'identificationModule': {'nctId': 'NCT04853394', 'briefTitle': 'Tajik Migrant Health Education Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'MASLIHAT Intervention for Tajik Male Migrants Who Inject Drugs', 'orgStudyIdInfo': {'id': '2020-0795'}, 'secondaryIdInfos': [{'id': 'R01DA050464', 'link': 'https://reporter.nih.gov/quickSearch/R01DA050464', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MASLIHAT peer education', 'description': 'A peer educator prevention intervention program consisting of five weekly 2-hour small group sessions.', 'interventionNames': ['Behavioral: MASLIHAT']}, {'type': 'SHAM_COMPARATOR', 'label': 'TANSIHAT health education', 'description': 'A health education program consisting of five weekly 2-hour sessions small group sessions.', 'interventionNames': ['Behavioral: TANSIHAT']}], 'interventions': [{'name': 'MASLIHAT', 'type': 'BEHAVIORAL', 'description': 'peer educator intervention', 'armGroupLabels': ['MASLIHAT peer education']}, {'name': 'TANSIHAT', 'type': 'BEHAVIORAL', 'description': 'health education intervention', 'armGroupLabels': ['TANSIHAT health education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'PRISMA Research Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Mary E Mackesy-Amiti, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be made available upon study completion.', 'ipdSharing': 'YES', 'description': 'The final data will be shared by depositing it in a public data repository. The final dataset will include self-reported sociodemographic characteristics, HIV transmission knowledge and risk awareness, sexual partners and risk behavior, illicit drug use and injection risk behavior, prevention self-efficacy, and injection drug use network interactions at 5 time points, and HIV and HCV test results at 2 time points. No identifying information will be included in the final dataset.', 'accessCriteria': 'Access will be provided upon request with a description of the intended use.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Prisma Research Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Mary Ellen Mackesy-Amiti', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}