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 for methamphetamine use or confirmed methamphetamine use with urine drug screening; (3) willing to provide three pieces of contact information; and (4) having a cell phone. Outcomes: Outcomes are measured at 13, 26, and 49 weeks and throughout the interventions. Primary outcomes include the (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 ClinicalTrials.gov NCT04706624. Registered on 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624

Using ADAPT‐ITT framework to tailor evidence‐based interventions for addressing methamphetamine use among methadone patients in Vietnam

“…Among 253 patients who tested positive with methamphetamine and self‐reported being at moderate risk (scored 4 or greater on the Alcohol, Smoking, and Substance Involvement Screening Test [31]), we selected 50 participants from two sites by creating a random sample on Excel and recruited 42 participants (22 in Hanoi, 20 in HCMC); eight participants refused to participate. Note that the eligibility criteria used in the pilot testing were different from the trial's registration on http://clinicaltrials.gov/, as explained in our protocol paper [21]. Indeed, findings from this pilot study informed subsequent changes in the eligibility criteria described in http://clinicaltrials.gov, which were necessary to ensure adequate representation and power in the main trial [21].…”

“…Note that the eligibility criteria used in the pilot testing were different from the trial's registration on http://clinicaltrials.gov/, as explained in our protocol paper [21]. Indeed, findings from this pilot study informed subsequent changes in the eligibility criteria described in http://clinicaltrials.gov, which were necessary to ensure adequate representation and power in the main trial [21]. All participants provided their written consent before enrolling in the study.…”

“…Since 2020, we have been implementing the randomised controlled trial, ‘Screen, Test and Retain People with Opioid Use Disorder who Use Methamphetamine in Methadone Clinics’ (STAR‐OM), which aims to develop optimal combinations of EBIs to improve HIV and substance use outcomes among POUD who also use methamphetamine and who are receiving methadone treatment in Vietnam [21]. The aim of the first phase of this study was to adapt four EBIs (motivational interviewing, contingency management, Matrix model and SMS) to be used among POUD who use methamphetamine [22].…”

Should contingency management protocols and dissemination practices be modified to accommodate rising stimulant use and harm reduction frameworks?

“…For example, Hirchak and colleagues presented the elements of CM sessions more holistically when implementing the intervention in American Indian and Alaska Native communities while retaining the core session elements [83]. are under way, and show that CM can be implemented successfully when cultural context is considered and addressed [98,101].…”

“…Many of the points discussed in this paper relate to US‐based CM implementation efforts—barriers to implementing CM in other countries only partly overlap with those addressed. While there have been studies on CM in Australia, Europe, Vietnam, Iran and other regions [40, 96–98], we are unaware of past or current large‐scale implementation efforts outside the United States. Preliminary research outside the United States supports themes raised in this paper, however—for example, patients in Australia reported positive attitudes regarding CM but noted the need for higher initial incentives and a treatment model more aligned with harm reduction principles [40, 99].…”