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Contemp Clin Trials. 2017 Aug;59:1-12. doi: 10.1016/j.cct.2017.05.006. Epub 2017 May 4.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

Author information

1
Yale School of Public Health, Department of Epidemiology of Microbial Diseases, New Haven, CT, USA; Yale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA. Electronic address: alexander.bazazi@yale.edu.
2
Yale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia.
3
Yale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University of Florida College of Medicine, Department of Health Outcomes and Policy, Gainesville, FL, USA.
4
Yale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University of Illinois at Chicago College of Nursing, Department of Health Systems Science, Chicago, IL, USA.
5
University of Connecticut Health Center, Department of Community Medicine & Health Care, Farmington, CT, USA; University of Connecticut, Department of Allied Health Sciences, Storrs, CT, USA.
6
University Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia; Centre for International Health, Department of Preventive and Social Medicine, University of Otago, Dunedin 9016, New Zealand.
7
University of Illinois at Chicago College of Nursing, Department of Health Systems Science, Chicago, IL, USA.
8
Yale School of Public Health, Department of Epidemiology of Microbial Diseases, New Haven, CT, USA; Yale School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, New Haven, CT, USA; University Malaya, Centre of Excellence for Research in AIDS (CERiA), Kuala Lumpur, Malaysia.

Abstract

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed.

KEYWORDS:

HIV; Malaysia; Methadone maintenance therapy; Opioid dependence; Prisoner health

PMID:
28479216
PMCID:
PMC5557499
[Available on 2018-08-01]
DOI:
10.1016/j.cct.2017.05.006
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