Strengthening Community Addiction Services in Vietnam
Primary Purpose
Addiction, Opioid
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community Care Consortium (CCC)
Sponsored by
About this trial
This is an interventional supportive care trial for Addiction, Opioid
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention communes
Control communes
Arm Description
CCC intervention
Standard care
Outcomes
Primary Outcome Measures
PWUD's STTR fulfillment score
This overall score consists of individual indicators in 4 domains: Seek,Test, Treat, Retain
Secondary Outcome Measures
CHW's addiction-related service provision and support
CHW's service provision and support such as patient referrals and support for treatment retention measured by frequencies of appointment reminder, follow-up activities
Full Information
NCT ID
NCT05315492
First Posted
March 21, 2022
Last Updated
March 29, 2022
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT05315492
Brief Title
Strengthening Community Addiction Services in Vietnam
Official Title
Strengthening Addiction Care Continuum Through Community Consortium in Vietnam
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Opioid
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1620 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention communes
Arm Type
Experimental
Arm Description
CCC intervention
Arm Title
Control communes
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Community Care Consortium (CCC)
Intervention Description
The intervention will train community health workers to take an active role in the drug control and addiction service delivery in the community.
Primary Outcome Measure Information:
Title
PWUD's STTR fulfillment score
Description
This overall score consists of individual indicators in 4 domains: Seek,Test, Treat, Retain
Time Frame
Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Secondary Outcome Measure Information:
Title
CHW's addiction-related service provision and support
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
Time Frame
Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Other Pre-specified Outcome Measures:
Title
Family members' support in the 4 domains:Seek,Test, Treat, Retain
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.
Time Frame
Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li, PhD
Phone
13107942446
Email
lililili@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Li, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Strengthening Community Addiction Services in Vietnam
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