Last reviewed · How we verify

NCT04706624: STAR-OM

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

Completed NA Results posted Last updated 23 January 2026
What this trial tests

NA trial testing Contingency management (12 weeks) in Methamphetamine Abuse in 667 participants. Completed in 31 March 2025.

Timeline
29 June 2021
Primary endpoint
30 June 2024
31 March 2025

Quick facts

Lead sponsorHanoi Medical University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment667
Start date29 June 2021
Primary completion30 June 2024
Estimated completion31 March 2025
Sites4 locations across Vietnam

Drugs / interventions tested

Conditions studied

Sponsor

Hanoi Medical University

Who can join

16 and older, any sex, with Methamphetamine Abuse or Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2 Primary · Baseline (start of Stage 1) and week 24 (end of Stage 2)

HIV viral load was assessed at baseline (Week 0), Week 13, and Week 24 after enrollment. Viral load was categorized as: ≥200 copies/mL; ≥20 to \<200 copies/mL; or undetectable (\<20 copies/mL). This outcome measure reports viral suppression status at baseline (Week 0) and Week 24 in order to evaluate change in viral suppression following completion of the full intervention period.

Baseline
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 231
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 235
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 26
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 23
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 23
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 25
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 233
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 239
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 23
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 21
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 24
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 23
Increase in HIV Viral Suppression for HIV-positive Participants: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2 Primary · Baseline (start of Stage 1) and week 24 (end of Stage 2)

HIV viral load was assessed at baseline (Week 0), Week 13, and Week 24 after enrollment. Viral load was categorized as: ≥200 copies/mL; ≥20 to \<200 copies/mL; or undetectable (\<20 copies/mL). This outcome measure reports viral suppression status at baseline (Week 0) and Week 24 in order to evaluate the change in viral suppression following completion of the full intervention period.

Baseline
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 24
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 210
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 26
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 28
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 21
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 23
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 25
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 29
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 24
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 29
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 22
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 23
Reduction in HIV Risk Behaviors for Both HIV-positive and HIV-negative Participants: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2 Primary · Baseline (start of Stage 1) and week 24 (end of Stage 2)

Structured questionnaires will collect self-reported data at baseline and week 24 after enrolment. HIV risk behaviors were grouped into two types: 1. sexual risk behaviors, such as having sex with partners who were HIV-positive or whose status was unknown, having sex while using drugs or alcohol, or using methamphetamine to find partners or enhance sex 2. needle/syringe risk behaviors, such as reusing needles or syringes that had already been used by others (even if cleaned) or reusing their own needles or syringes multiple times.

Baseline: Sexual risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 241
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 224
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2181
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2168
Week 24: Sexual risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 216
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 214
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2206
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2178
Baseline: HIV needle/syringe risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 23
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2222
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2189
Week 24: HIV needle/syringe risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 21
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2222
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2191
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 Primary · Baseline (start of Stage 1) and week 24 (end of Stage 2)

Structured questionnaires will collect self-reported data at baseline and 24 weeks after enrolment. HIV risk behaviors were grouped into two types: 1. sexual risk behaviors, such as having sex with partners who were HIV-positive or whose status was unknown, having sex while using drugs or alcohol, or using methamphetamine to find partners or enhance sex. 2. needle/syringe risk behaviors, such as reusing needles or syringes that had already been used by others (even if cleaned) or reusing their own needles or syringes multiple times.

Baseline: Sexual risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 25
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 213
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 28
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 213
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 228
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 252
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 233
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 243
Week 24: Sexual risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 23
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 28
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 24
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 210
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 230
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 257
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 237
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 246
Baseline: HIV needle/syringe risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 21
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 233
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 264
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 241
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 255
Week 24: HIV needle/syringe risk behaviors
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 22
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 233
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 265
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 239
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 256
Heroin-negative Test: High- vs. Low-Intensity Frontline Intervention Secondary · Weeks 11-12 (end of Stage 1) and Weeks 24-25 (end of Stage 2)

Heroin use was measured using twice-weekly urine drug tests. Participants were classified as heroin-negative if all four urine drug tests conducted during Weeks 11-12 and during Weeks 24-25 were negative for heroin.

Week 12
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1252
Received Low Intensity Frontline Intervention in Stage 1237
Week 25
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1238
Received Low Intensity Frontline Intervention in Stage 1248
Heroin-negative Test: Matrix vs. Matrix + CM Adaptive Intervention Secondary · Week 24-25 (end of Stage 2)

Heroin use was measured using twice-weekly urine drug tests. Participants were classified as heroin-negative if all four urine drug tests conducted during Weeks 24-25 were negative for heroin.

GroupValue95% CI
Received Matrix in Stage 248
Received Matrix + Contingency Management in Stage 250
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2 Secondary · Baseline (start of Stage 1) and week 24 (end of Stage 2)

This information will be collected using the study questionnaire at baseline, weeks 12th, and 24th. People who adhered to ART was defined as currently on ART and either (1) within 4 days they never forgot to take HIV medication or (2) never took HIV medication later 2 hours than required or (3) forgot to take their HIV medication at the weekend. This outcome measure reports ART adherence at baseline (Week 0) and Week 24 in order to evaluate change in ART adherence following completion of the full intervention period.

Baseline
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 238
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 241
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 20
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 237
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 237
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 24
Adherence to ART if HIV-positive: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2 Secondary · Baseline (start of Stage 1) and week 24 (end of Stage 2)

This information will be collected using the study questionnaire at baseline, weeks 12th and 24th. People who adhered to ART was defined as currently on ART and either (1) within 4 days they never forgot to take HIV medication or (2) never took HIV medication later 2 hours than required or (3) forgot to take their HIV medication at the weekend. This outcome measure reports ART adherence at baseline (Week 0) and Week 24 in order to evaluate change in ART adherence following completion of the full intervention period.

Baseline
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 26
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 212
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 26
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 210
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 22
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 27
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 211
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 26
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 212
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2 Secondary · Week 12 (end of Stage 1) and Week 24 (end of Stage 2)

HIV testing will be assessed based on whether HIV-negative participants received HIV testing services at each assessment point

Week 12
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2181
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2148
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 2179
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 2149
Frequency of HIV Testing if HIV-negative: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2 Secondary · Week 12 (end of Stage 1) and Week 24 (end of Stage 2)

HIV testing will be assessed based on whether HIV-negative participants received HIV testing services at each assessment point

Week 12
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 225
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 252
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 235
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 243
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 226
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 252
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 235
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 244
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With SMS in Stage 2 Secondary · Week 12 (end of Stage 1) and Week 24 (end of Stage 2)

Opioid overdose will be assessed in the past 3 months through participant self-report using the question: "In the past 3 months, how many times have you had an opioid/heroin overdose?". Overdose is defined as an acute event due to heroin or other opioid use that required assistance from another person to recover (e.g., ambulance call, resuscitation, being awakened by others). This definition excludes episodes where the participant "just slept it off." Both non-fatal and fatal overdoses are included, and intentional overdoses (suicidal attempts) are also counted. For analysis, participants repo

Week 12
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 20
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and SMS in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and SMS in Stage 20
Frequency of Opioid Overdose: High- vs. Low-Intensity Frontline Intervention With Matrix/Matrix + CM in Stage 2 Secondary · Week 12 (end of Stage 1) and Week 24 (end of Stage 2)

Opioid overdose will be assessed in the past 3 months through participant self-report using the question: "In the past 3 months, how many times have you had an opioid/heroin overdose?". Overdose is defined as an acute event due to heroin or other opioid use that required assistance from another person to recover (e.g., ambulance call, resuscitation, being awakened by others). This definition excludes episodes where the participant "just slept it off." Both non-fatal and fatal overdoses are included, and intentional overdoses (suicidal attempts) are also counted. For analysis, participants repo

Week 12
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 21
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Week 24
GroupValue95% CI
Received High Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix in Stage 20
Received High Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20
Received Low Intensity Frontline Intervention in Stage 1 and Matrix + CM in Stage 20

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected throughout the study period, from June 29, 2021, to April 27, 2024. For each participant, data were collected over a 48-week period, beginning at enrollment and continuing through the 48-week follow-up visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High Intensity Frontline Intervention
Serious: 7/328 (2%)
Deaths: 2/328
Low Intensity Frontline Intervention
Serious: 9/337 (3%)
Deaths: 1/337
High Intensity Frontline + SMS Reminders
Serious: 14/230 (6%)
Deaths: 1/230
High Intensity Frontline + Matrix Only
Serious: 6/40 (15%)
Deaths: 0/40
High Intensity Frontline + Matrix + Contingency Management
Serious: 5/45 (11%)
Deaths: 2/45
Low Intensity Frontline + SMS Reminders
Serious: 5/198 (3%)
Deaths: 1/198
Low Intensity Frontline + Matrix Only
Serious: 6/68 (9%)
Deaths: 0/68
Low Intensity Frontline + Matrix + Contingency Management
Serious: 3/62 (5%)
Deaths: 1/62

Serious adverse events (5 terms)

ReactionSystemHigh Intensity Frontline I…Low Intensity Frontline In…High Intensity Frontline +…High Intensity Frontline +…High Intensity Frontline +…Low Intensity Frontline + …Low Intensity Frontline + …Low Intensity Frontline + …
Sent to compulsory drug rehabilitation programsSocial circumstances
IncarcerationSocial circumstances
HospitalizationGastrointestinal disorders
HospitalizationPsychiatric disorders
HospitalizationSurgical and medical procedures
Other adverse events (2 terms — click to expand)

ReactionSystemHigh Intensity Frontline I…Low Intensity Frontline In…High Intensity Frontline +…High Intensity Frontline +…High Intensity Frontline +…Low Intensity Frontline + …Low Intensity Frontline + …Low Intensity Frontline + …
COVID-19 infection (mild to moderate)General disorders
Accidents and injuriesMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Sent to compulsory drug rehabilitation programs, Incarceration, Hospitalization, Hospitalization, Hospitalization.

Data from ClinicalTrials.gov NCT04706624 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Using ADAPT-ITT framework to tailor evidence-based interventions for addressing methamphetamine use among methadone patients in Vietnam.
    Giang LM, Trang NT, Thuy DT, Nguyen HH, et al · · 2023 · cited 7× · PMID 37614129 · DOI 10.1111/dar.13739
  2. An adaptive design to screen, treat, and retain people with opioid use disorders who use methamphetamine in methadone clinics (STAR-OM): study protocol of a clinical trial.
    Giang LM, Trang NT, Diep NB, Thuy DTD, et al · · 2022 · cited 6× · PMID 35461300 · DOI 10.1186/s13063-022-06278-w
  3. Patient Trust in Healthcare Providers among People on Methadone Maintenance Treatment Using Methamphetamine in Vietnam.
    Vu MA, Nguyen BD, Nguyen TT, Dinh TTT, et al · · 2026 · PMID 42249554 · DOI 10.1080/10826084.2026.2676993
  4. Interventions for methamphetamine use among people on methadone maintenance treatment in Vietnam: a sequential multiple assignment randomized trial (STAR-OM).
    Giang LM, Li MJ, Trang NT, Diep NB, et al · · 2026 · PMID 42080150 · DOI 10.1016/j.lansea.2026.100773
  5. Non-adherence to treatment and concurrent opioid use among people on methadone maintenance treatment using methamphetamine in Vietnam.
    Diep NB, Trang NT, Huy DD, Van HTH, et al · · 2025 · PMID 40157650 · DOI 10.1016/j.josat.2025.209686
  6. An Adaptive Design To Screen, Treat And Retain People With Opioid Use Disorders Who Use Methamphetamine In Methadone Clinics (STAR-OM) Study Protocol of A Clinical Trial
    Minh GL, Thu TN, Bich DN, Dieu TDT, et al · · 2022 · DOI 10.21203/rs.3.rs-1002929/v1

Verify or expand the search:

Other recruiting trials for Methamphetamine Abuse

Currently open trials in the same condition.

Other Hanoi Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04706624.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing