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N/A N=665 Randomized Treatment

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

Methamphetamine Abuse · Opioid-use Disorder · HIV Seropositivity

Enrolled (actual)
665
Serious AEs
4.2%
Results posted
Jan 2026
Primary outcome: Primary: Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2 — 31; 35; 6; 3 Participants — p=0.447

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Contingency management (12 weeks) (Behavioral); Contingency management (6 weeks) (Behavioral); SMS reminders (Behavioral); Matrix only (Behavioral); Matrix + Contingency management (Behavioral); Group education (6 weeks) (Behavioral)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
All
Sponsor
Hanoi Medical University
Primary completion
Jun 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
31; 35; 6; 3; 3; 5 0.447
PRIMARY
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
4; 10; 6; 8; 1; 0 0.600
PRIMARY
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
41; 24; 181; 168; 16; 14 0.096
PRIMARY
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
5; 13; 8; 13; 28; 52 0.835
PRIMARY
Reduction in Methamphetamine Use: High- vs. Low-Intensity Frontline Intervention
230; 198; 194; 187 0.001 sig
PRIMARY
Reduction in Methamphetamine Use: Matrix vs. Matrix + CM Adaptive Intervention
13; 28 0.006 sig
SECONDARY
Heroin-negative Test: High- vs. Low-Intensity Frontline Intervention
252; 237; 238; 248 0.021 sig
SECONDARY
Heroin-negative Test: Matrix vs. Matrix + CM Adaptive Intervention
48; 50 0.737
SECONDARY
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
38; 41; 0; 0; 37; 37 0.361
SECONDARY
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
6; 12; 6; 10; 1; 0 0.371
SECONDARY
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
181; 148; 179; 149 0.451
SECONDARY
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
25; 52; 35; 43; 26; 52 0.320
SECONDARY
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
1; 0; 0; 0 >0.99
SECONDARY
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
1; 0; 0; 0; 0; 0 0.166
SECONDARY
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2
0.9; 0.9; 74.8; 74.4; 1.0; 1.0 0.280
SECONDARY
Changes in Quality of Life: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2
1.0; 0.9; 0.9; 0.9; 73.8; 74.4 0.284

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.

Eligibility Criteria

Inclusion Criteria

  • ASSIST scores from 10+ for methamphetamine use OR Confirmed methamphetamine use with urine analysis;
  • Willing to provide at least three pieces of contact information;
  • Having a cell phone to receive texts.

Exclusion Criteria

  • Psychosis or other interfering problems;
  • Cannot understand study procedures as judged by research assistants.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04706624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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