Addiction, OpioidNCT05315492
Strengthening Community Addiction Services in Vietnam
A study testing Community Care Consortium (CCC) in people with Addiction, Opioid, run by University of California, Los Angeles at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Addiction, Opioid
- What is being tested?
- Community Care Consortium (CCC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,620 participants
- Where
- 2 sitesVietnam
- Study dates
- 17 Apr 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
National Institute of Hygiene and Epidemiology
Hanoi
Community Health Centers
Ninh Bình
About this study
Official title: Strengthening Addiction Care Continuum Through Community Consortium in Vietnam
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.
Read the 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.
- Conditions
- Addiction, Opioid
- Being tested
- Community Care Consortium (CCC)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Care Consortium (CCC)Behavioural
The intervention will train community health workers to take an active role in the drug control and addiction service delivery in the community.
| Study group | Role | What they receive |
|---|---|---|
| Intervention communes | Experimental | CCC intervention Receives: Behavioral: Community Care Consortium (CCC) |
| Control communes | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PWUD's STTR fulfillment score
This overall score consists of individual indicators in 4 domains: Seek,Test, Treat, Retain
Measured: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Secondary outcomes (1)
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
Measured: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start17 Apr 2024
- Primary completion24 Oct 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Addiction, OpioidStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, University of California, Los Angeles
- Investigators
- Li Li, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315492
- Sponsor's protocol ID
- Vietnam Addiction Care
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36947125
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Addiction Care Continuum Through Community Consortium in Vietnam
- ClinicalTrials.gov ID
- NCT05315492
- Acronym / sponsor ID
- Vietnam Addiction Care
- Conditions
- Addiction, Opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,620 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention communes | Experimental | Behavioral: Community Care Consortium (CCC)CCC intervention |
| Control communes | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Care Consortium (CCC)The intervention will train community health workers to take an active role in the drug control and addiction service delivery in the community. | Behavioural | Intervention communes |
Primary outcome
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
1 secondary outcome
CHW's addiction-related service provision and support
Time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 36947125Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Care Consortium (CCC) in people with Addiction, Opioid, run by University of California, Los Angeles at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PWUD's STTR fulfillment score (time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.