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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, 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; Shoptaw, Steve.
Afiliación
  • Giang LM; Centre for Training and Research on Substance use and HIV, Hanoi Medical University, Hanoi, Vietnam.
  • Trang NT; Centre for Training and Research on Substance use and HIV, Hanoi Medical University, Hanoi, Vietnam. trangthu@hmu.edu.vn.
  • Diep NB; Centre for Training and Research on Substance use and HIV, Hanoi Medical University, Hanoi, Vietnam.
  • Thuy DTD; Centre for Training and Research on Substance use and HIV, Hanoi Medical University, Hanoi, Vietnam.
  • Thuy DT; Centre for Training and Research on Substance use and HIV, Hanoi Medical University, Hanoi, Vietnam.
  • Hoe HD; Centre for Training and Research on Substance use and HIV, Hanoi Medical University, Hanoi, Vietnam.
  • Van HTH; Global Health Department, Hanoi Medical University, Hanoi, Vietnam.
  • Truc TT; Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
  • Nguyen HH; University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
  • Lai NL; South Vietnam HIV and Addiction Technology Transfer Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
  • Linh PTD; South Vietnam HIV and Addiction Technology Transfer Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
  • Vi VTT; South Vietnam HIV and Addiction Technology Transfer Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
  • Reback CJ; Friends Research Institute, Friends Community Center, Center for HIV Identification, Prevention and Treatment Services, University of California, Los Angeles, Los Angeles, USA.
  • Leibowitz A; Department of Public Policy, Luskin School of Public Affairs, University of California, Los Angeles, Los Angeles, USA.
  • Li L; Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, USA.
  • Lin C; Department of Psychiatry and Biobehavioral Sciences, Jane & Terry Semel Institute for Neuroscience & Human Behavior, University of California, Los Angeles, Los Angeles, USA.
  • Li M; Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California, Los Angeles, Los Angeles, USA.
  • Do Van Dung; Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.
  • Shoptaw S; Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California, Los Angeles, Los Angeles, USA.
Trials ; 23(1): 342, 2022 Apr 23.
Article en En | MEDLINE | ID: mdl-35461300
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / Trastornos Relacionados con Anfetaminas / Metanfetamina / Trastornos Relacionados con Opioides Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Qualitative_research Límite: Adolescent / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Vietnam Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Infecciones por VIH / Trastornos Relacionados con Anfetaminas / Metanfetamina / Trastornos Relacionados con Opioides Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Qualitative_research Límite: Adolescent / Humans Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2022 Tipo del documento: Article País de afiliación: Vietnam Pais de publicación: Reino Unido