Clinical trial NCT05315492: Strengthening Community Addiction Services in Vietnam
Official title: Strengthening Addiction Care Continuum Through Community Consortium in Vietnam
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Addiction, Opioid
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 1620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: PWUD's STTR fulfillment score
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Secondary outcomes:
measure: CHW's addiction-related service provision and support
timeFrame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
Other outcomes:
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
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Hygiene and Epidemiology
city: Ninh Bình
country: Vietnam
facility: Community Health Centers
Study officials:
affiliation: University of California, Los Angeles
name: Li Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: