Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics

Summary

The investigators propose to develop and evaluate optimal combinations of evidence-based interventions to improve HIV outcomes and reduce methamphetamine use (hereafter: meth use) among people with opioid use disorder who are in methadone maintenance therapy (MMT) in Vietnam. Over the past decade, the expansion of MMT has contributed to stemming both HIV and opioid epidemics. However, rising meth use threatens these achievements.

Evidence-based interventions such as Motivational Enhancement Therapy, Contingency Management, Matrix Model, and SMS reminders are effective in reducing meth use. The study will be conducted in the two largest cities in Vietnam, Hanoi and Ho Chi Minh City (HCMC), where there are the highest number of MMT patients and the highest burden of HIV cases. Building on the pilot work of the research team in Hanoi, through collaborative work with local MMT providers and patients, the investigators will first further refine adapted EBIs to develop adaptive strategies. The adaptive design includes: (1) Two frontline interventions: 6 weeks of contingency management then 6 weeks of weekly group educational sessions and 12 weeks of contingency management; (2) One (short-term) tailoring outcome: urine tests negative with meth metabolites in both week 11 and 12 are considered responsive to frontline interventions; (3) Three alternative interventions: those with positive outcomes will move to 12-week maintenance stage and receive two daily SMS reminders plus one weekly self-monitoring assessment messages. Non-responders will move to 12-week enhanced treatment stage and are randomly assigned to either Matrix group counseling only or Matrix group counseling plus contingency management.

The full randomization trial will be conducted with 200 HIV-positive and 400 HIV-negative MMT patients who report moderate- and high-risk meth use on self-screening with ASSIST or have urine positive with meth metabolites. In each location, the study will stratify participants by HIV status before randomizing them to one of two frontline interventions. Primary outcomes - including HIV viral suppression, HIV risk behaviors, and meth use (reported and urine tests) - will be assessed at 12, 24 and 48 weeks. The study team also conducts ethnographic observations and in-depth interviews with MMT clinic managers, clinical staff and MMT patients to explore implementation barriers and facilitators.

Conditions

• Methamphetamine Abuse
• Opioid-use Disorder
• HIV Seropositivity

Interventions

BEHAVIORAL

Contingency management (12 weeks)

Participants receive 12 weeks of contingency management.

BEHAVIORAL

Contingency management (6 weeks)

Participants receive 6 weeks of contingency management.

BEHAVIORAL

SMS reminders

Participants receive two daily SMS reminders plus one weekly self-monitoring assessment.

BEHAVIORAL

Matrix only

Participants attend 12 weekly Matrix group counseling sessions.

BEHAVIORAL

Matrix + Contingency management

Participants attend 12 weekly Matrix group counseling sessions plus 12 weeks of contingency management.

BEHAVIORAL

Group education (6 weeks)

6 weeks of group education

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• University of Medicine and Pharmacy at Ho Chi Minh City

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Hanoi Medical University

  lead OTHER

Principal Investigators

• Le Minh Giang, PhD · Hanoi Medical University

• Steve Shoptaw, PhD · University of California, Los Angeles, Department of Family Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-29

Primary Completion

2024-06-30

Completion

2025-03-31

Countries

• Vietnam

Study Locations