Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT05315492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2022-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strengthening Community Addiction Services in Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1620}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Family members' support in the 4 domains:Seek,Test, Treat, Retain", 'timeFrame': 'Changes from baseline to 3-, 6-, 9- and 12- month follow-ups', 'description': "Family member's emotional, informational, monetary support, logistic assistance for PWUD treatment and retention as well as scale measures in their caregiver burden and coping."}], 'primaryOutcomes': [{'measure': "PWUD's STTR fulfillment score", 'timeFrame': 'Changes from baseline to 3-, 6-, 9- and 12- month follow-ups', 'description': 'This overall score consists of individual indicators in 4 domains: Seek,Test, Treat, Retain'}], 'secondaryOutcomes': [{'measure': "CHW's addiction-related service provision and support", 'timeFrame': 'Changes from baseline to 3-, 6-, 9- and 12- month follow-ups', 'description': "CHW's service provision and support such as patient referrals and support for treatment retention measured by frequencies of appointment reminder, follow-up activities"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Addiction, Opioid']}, 'referencesModule': {'references': [{'pmid': '36947125', 'type': 'DERIVED', 'citation': 'Li L, Nguyen TA, Liang LJ, Lin C, Pham TH, Nguyen HTT, Kha S. Strengthening Addiction Care Continuum Through Community Consortium in Vietnam: Protocol for a Cluster-Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 22;12:e44219. doi: 10.2196/44219.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to develop and test an intervention to enhance the addiction service continuum with the joint effort of commune health workers and family members of people who use drugs in Vietnam.', 'detailedDescription': 'The study will develop and test an intervention to strengthen a continuum of addiction services. The intervention, entitled "Community Care Consortium (CCC)," features community health workers\' joint effort with family members to provide patient-centered, individualized addiction care and support. The intervention will be developed and tested through three phases in three regions of Vietnam (Ninh Binh, Da Nang, and Can Tho).\n\nIn Phase 1, we will conduct formative studies with commune (community) health workers (CHW), community representatives, PWUD, and their family members to identify barriers to addiction service utilization and discuss potential strategies to establish a continuum of addiction services. Based on the formative study findings, the CCC Intervention and its implementation plans will be developed through workgroup meetings with researchers, community members, and target users.\n\nIn Phase 2, the CCC Intervention will be piloted in three communes and revised based on acceptability/feasibility data, process evaluation, and feedback from field staff and participants.\n\nIn Phase 3, a randomized controlled trial of the CCC Intervention will be conducted in 60 communes, which will be randomized to either an intervention condition or a control condition (30 communes in each condition). A total of 720 PWUD, 720 of their family members, and 180 commune health workers (CHW) will participate in the study. The intervention outcomes on PWUD, CHW, and family members will be assessed with the data collected at baseline, 3-, 6-, 9- and 12-month follow-ups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Having a history of drug use\n* Having disclosed drug using status to at least one of his/her family members and is willing to invite this family member to our study\n* Currently residing in the selected communes\n* Voluntary written informed consent\n\nExclusion Criteria:\n\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT05315492', 'briefTitle': 'Strengthening Community Addiction Services in Vietnam', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Strengthening Addiction Care Continuum Through Community Consortium in Vietnam', 'orgStudyIdInfo': {'id': 'Vietnam Addiction Care'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention communes', 'description': 'CCC intervention', 'interventionNames': ['Behavioral: Community Care Consortium (CCC)']}, {'type': 'NO_INTERVENTION', 'label': 'Control communes', 'description': 'Standard care'}], 'interventions': [{'name': 'Community Care Consortium (CCC)', 'type': 'BEHAVIORAL', 'description': 'The intervention will train community health workers to take an active role in the drug control and addiction service delivery in the community.', 'armGroupLabels': ['Intervention communes']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'National Institute of Hygiene and Epidemiology', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Ninh Bình', 'country': 'Vietnam', 'facility': 'Community Health Centers', 'geoPoint': {'lat': 20.25809, 'lon': 105.97965}}], 'overallOfficials': [{'name': 'Li Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor-in-Residence', 'investigatorFullName': 'Li Li', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}