Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-02 @ 3:39 AM
Study NCT ID:
NCT01841320
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2013-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000554', 'term': 'Ambulatory Care Facilities'}], 'ancestors': [{'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 378}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2013-04-24', 'studyFirstSubmitQcDate': '2013-04-25', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from randomization to the initiation of antiretroviral therapy (ART)', 'timeFrame': 'At month 3'}], 'secondaryOutcomes': [{'measure': 'CD4+ counts', 'timeFrame': 'At months 6, 12, and 18'}, {'measure': 'HIV-1 RNA levels', 'timeFrame': 'At months 6 and 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV', 'Addiction']}, 'descriptionModule': {'briefSummary': 'This research examines the effectiveness of an intervention that employs seek, test, and treat strategies for Vietnamese injection drug users (IDU) and their network members, by ensuring that high risk individuals are sought for HIV testing and promptly referred to and maintained on antiretroviral therapy (ART). HIV prevention interventions are provided to IDUs who test HIV-negative, as well as those who test HIV-positive. HIV-positive IDUs will be referred to HIV care through a two-arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, ART adherence, and treatment outcome.', 'detailedDescription': 'Opioid injection and HIV infection are major public health problems in Vietnam. Injection drug users (IDUs) have a high burden of HIV infection (20% HIV prevalence, nationally; 6% mortality per year) and the high rate of HIV transmission continues (HIV incidence, 5% per year). The investigators propose an intervention that employs the seek, test, and treat strategies for the IDU population and their network members, by ensuring that high risk individuals are sought for HIV testing, promptly referred to and maintained on ART, while HIV prevention interventions provided to the many who test HIV-negative, as well as those who test HIV-positive. The intervention will seek and test IDUs and their network members in the community, particularly those who are recently released from drug treatment centers. HIV-positive IDUs will be referred to HIV care through a two arm randomized controlled trial to compare the effects of different levels of engagement in care on ART uptake, antiretroviral adherence, and treatment outcome.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 years or older;\n2. Recently released from drug treatment centers;\n3. Positive HIV serology;\n4. Male;\n5. Meet criteria for ART initiation according to Vietnam's national guidelines;\n6. Provide informed consent for the study; and\n7. Reside in study area and do not plan to move away in the next 18 months.\n\nExclusion Criteria:\n\n1. Currently on ART;\n2. Co-enrollment in other HIV interventional research study;\n3. Unwilling to provide locator information."}, 'identificationModule': {'nctId': 'NCT01841320', 'acronym': 'VISTA', 'briefTitle': 'Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Seek, Test, Treat Strategies for Vietnamese Drug Users: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'R01DA030776', 'link': 'https://reporter.nih.gov/quickSearch/R01DA030776', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants who are assigned to intervention arm will receive ART and methadone maintenance at an integrated methadone and antiretroviral therapy (iMART) clinic and ART adherence support through the use of mobile phone technologies.', 'interventionNames': ['Other: Integrated methadone and antiretroviral therapy (iMART) clinic']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants will be referred to standard HIV outpatient clinics and methadone maintenance clinics.'}], 'interventions': [{'name': 'Integrated methadone and antiretroviral therapy (iMART) clinic', 'type': 'OTHER', 'otherNames': ['ART access support', 'ART adherence support through mobile phone technologies'], 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'Tu Liem Medical Center', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Quan M Vu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanoi Center for HIV/AIDS Prevention and Control', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Vu Minh Quan', 'investigatorAffiliation': 'Johns Hopkins University'}}}}