1. 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
- Author
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Giang, Le Minh, Trang, Nguyen Thu, Diep, Nguyen Bich, Thuy, Dao Thi Dieu, Thuy, Dinh Thanh, Hoe, Han Dinh, Van, Hoang Thi Hai, Truc, Thai Thanh, Nguyen, Hoa H, Lai, Nguyen Ly, Linh, Pham Thi Dan, Vi, Vu Thi Tuong, Reback, Cathy J, Leibowitz, Arleen, Li, Li, Lin, Chunqing, Li, Michael, Do Van Dung, and Shoptaw, Steve
- Subjects
Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,HIV/AIDS ,Health Services ,Opioids ,Prevention ,Infectious Diseases ,Clinical Research ,Clinical Trials and Supportive Activities ,Emerging Infectious Diseases ,Coronaviruses ,Cost Effectiveness Research ,Drug Abuse (NIDA only) ,Health Disparities ,Opioid Misuse and Addiction ,Dissemination and Implementation Research ,Substance Misuse ,Brain Disorders ,Behavioral and Social Science ,Methamphetamine ,Comparative Effectiveness Research ,Sexually Transmitted Infections ,6.1 Pharmaceuticals ,3.1 Primary prevention interventions to modify behaviours or promote wellbeing ,Good Health and Well Being ,Adolescent ,Amphetamine-Related Disorders ,COVID-19 ,HIV Infections ,Humans ,Methadone ,Opioid-Related Disorders ,Randomized Controlled Trials as Topic ,Amphetamine-type stimulants ,Opioid substitution ,Vietnam ,Randomized controlled trial ,Cardiorespiratory Medicine and Haematology ,Clinical Sciences ,Cardiovascular System & Hematology ,General & Internal Medicine ,Clinical sciences ,Epidemiology ,Health services and systems - Abstract
BackgroundMethamphetamine 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.MethodDesign: 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.ParticipantsWe 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.OutcomesOutcomes 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.DiscussionThis 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 registrationClinicalTrials.gov NCT04706624. Registered on 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624.
- Published
- 2022