- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315492
Strengthening Community Addiction Services in Vietnam
Strengthening Addiction Care Continuum Through Community Consortium in Vietnam
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
In 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.
In 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.
In 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hanoi, Vietnam
- National Institute of Hygiene and Epidemiology
-
Ninh Bình, Vietnam
- Community Health Centers
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 or older
- Having a history of drug use
- 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
- Currently residing in the selected communes
- Voluntary written informed consent
Exclusion Criteria:
- Inability to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention communes
CCC intervention
|
The intervention will train community health workers to take an active role in the drug control and addiction service delivery in the community.
|
|
No Intervention: Control communes
Standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PWUD's STTR fulfillment score
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
|
This overall score consists of individual indicators in 4 domains: Seek,Test, Treat, Retain
|
Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CHW's addiction-related service provision and support
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
|
CHW's service provision and support such as patient referrals and support for treatment retention measured by frequencies of appointment reminder, follow-up activities
|
Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family members' support in the 4 domains:Seek,Test, Treat, Retain
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
|
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.
|
Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
|
Collaborators and Investigators
Investigators
- Principal Investigator: Li Li, PhD, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vietnam Addiction Care
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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