Bazazi Alexander R, Wickersham Jeffrey A, Wegman Martin P, Culbert Gabriel J, Pillai Veena, Shrestha Roman, Al-Darraji Haider, Copenhaver Michael M, Kamarulzaman Adeeba, Altice Frederick L
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.
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.
Contemp Clin Trials. 2017 Aug;59:1-12. doi: 10.1016/j.cct.2017.05.006. Epub 2017 May 4.
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.
感染艾滋病毒且对阿片类药物成瘾的在押人员在监禁期间及获释回归社区后，在获取循证治疗方面面临巨大挑战，这使他们面临艾滋病毒治疗效果不佳、复吸阿片类药物以及随之而来的艾滋病毒传播风险行为的风险。在此，我们详细描述了“希望项目”的设计与实施情况，该项目是一项前瞻性临床试验，于2010年至2014年在马来西亚从监狱过渡到社区的艾滋病毒感染者及阿片类药物成瘾者中开展。该试验包括两项干预措施：在监狱内启动美沙酮维持治疗，以及一项根据马来西亚国情调整的循证行为干预措施（马来西亚整体健康康复项目，HHRP-M）。研究对象在监禁期间被招募并接受干预措施，获释后接受为期12个月的随访，以评估释放后艾滋病毒传播风险行为及一系列其他与健康相关的结果。“希望项目”被设计为一项完全随机的2×2析因试验，研究对象将被等比例分配到美沙酮维持治疗与HHRP-M联合组、仅美沙酮维持治疗组、仅HHRP-M组或对照组。在研究实施过程中，美沙酮维持治疗的分配方式从随机分配改为由参与者自行选择；而HHRP-M的随机分配则贯穿始终。我们描述了本研究的理由、这些干预措施的制定与实施、方案的变更，以及研究对象的筛选、入组、治疗接受情况和留存情况。还讨论了与本研究实施相关的后勤、伦理和分析问题。
