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

Abstract

Background: Methamphetamine use could jeopardize the current efforts to address opioid use disorder and HIV infection. Evidence-based behavioral interventions (EBI) are effective in reducing methamphetamine use. However, evidence on optimal combinations of EBI is limited. This protocol presents a Type-1 effectiveness-implementation hybrid design to evaluate the effectiveness, cost-effectiveness of adaptive methamphetamine use interventions and their implementation barriers in Vietnam. Method: Design: Participants will be first randomized into two frontline interventions for 12 weeks. They will then be placed or randomized to three adaptive strategies for another 12 weeks. An economic evaluation and an ethnographic evaluation will be conducted alongside the interventions. Participants: We will recruit 600 participants in 20 methadone clinics. Eligibility criteria: 1) age 16+, 2) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scores 10 or more for methamphetamine use or confirmed methamphetamine use with urine drug screening; 3) willing to provide three pieces of contact information; 4) having a cell phone.Outcomes: Outcomes are measured at 13-, 26- and 49-week and throughout the interventions. Primary outcomes include: (1) increase in HIV viral suppression; (2) reduction in HIV risk behaviors; and (3) reduction in methamphetamine use. COVID-19 response: We developed a response plan for interruptions caused by COVID-19 lockdowns to ensure data quality and intervention fidelity. Discussion: This study will provide important evidence for scale-up of EBIs for methamphetamine use among methadone patients in limited-resource settings. As the EBIs will be delivered by methadone providers, they can be readily implemented if the trial demonstrates effectiveness and cost-effectiveness. Trial registration: NCT04706624. Registered 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624