Strengthening Community Addiction Services in Vietnam

Addiction, Opioid Clinical Trial

Official title:

Strengthening Addiction Care Continuum Through Community Consortium in Vietnam

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315492
• Other study ID #: Vietnam Addiction Care
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: Li Li, PhD
• Phone: 13107942446
• Email: lililili[@]ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1620
• Est. completion date: July 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction, Opioid
• Behavior, Addictive
• Opioid-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Vietnam	National Institute of Hygiene and Epidemiology	Hanoi
Vietnam	Community Health Centers	Ninh Bình

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family members' support in the 4 domains:Seek,Test, Treat, Retain	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
Primary	PWUD's STTR fulfillment score	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	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	Changes from baseline to 3-, 6-, 9- and 12- month follow-ups