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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
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Addiction, Opioid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 21, 2022
    Last Updated
    March 29, 2022
    Sponsor
    University of California, Los Angeles
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    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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