N/A
N=665
Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics
Methamphetamine Abuse · Opioid-use Disorder · HIV Seropositivity
Bottom Line
View on ClinicalTrials.gov: NCT04706624 ↗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
| Outcome | Result | p-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.
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.