Optimizing Medication-Assisted Therapy for Opioid Dependence in Ukraine: HIV Impact Modeling and Cost-Effectiveness Evaluation

项目总结/摘要 乌克兰是东欧和全世界阿片类药物使用流行率最高的国家之一， 同时发生的涉及传染病的流行病，特别是 艾滋病毒，主要是由注射吸毒引起的。目前对艾滋病毒和阿片类药物问题的反应 在乌克兰的使用障碍是不够的。需要新的方法来解决覆盖差距并优化 患者结局。阿片类激动剂治疗（OAT）被证明是一种有效且具有成本效益的方法。 减少阿片类药物使用相关危害的干预措施。乌克兰实施美沙酮疗法以来， 2008年;然而，310，000名乌克兰PWID中只有2.7%获得OAT，这一比例太低，无法减少 药物注射介导的艾滋病毒传播。将OAT的可用性扩展到初级医疗保健（PHC）环境 可以减少进入的障碍，增加治疗计划的保留。OAT的替代品， 可注射阿片受体拮抗剂，缓释纳洛酮（XR-NTX）是另一种基于证据的 治疗阿片类药物依赖。通过减少药物渴望和非法药物使用，XR-NTX降低了艾滋病毒风险 与安慰剂相比，行为和生活质量得到改善。XR-NXT提供了一个有前途的替代方案 可能针对不同药物亚群的阿片类药物使用障碍的药物治疗 使用者-特别是那些不能或不愿意接受基于激动剂的治疗的人。的主要优点 与口服纳洛酮相比，XR-NTX是每月注射一次，而不是服用 日报这被证明可以提高治疗依从性;然而，依从性仍然存在问题。 本研究项目的假设是，新的干预措施：a）将OST的提供扩大到PHC B）在乌克兰用XR-NTX治疗阿片类药物依赖相对于目前的 乌克兰的护理标准。这些干预措施的结果将在患者和人群中进行评价 程度.该研究将采用数学建模方法：将采用状态转移马尔可夫模型， 开发用于评估患者水平的结果;以及动态房室HIV传播模型将 估计干预措施在人口一级的效益。分析将利用现有的 文献和我最近参与的两项研究：1）形成性研究： 《乌克兰初级卫生保健机构阿片类药物使用者综合护理》（研究期：2014-2015年）; 和2）在乌克兰扩大药物辅助治疗（R 01 DA 033679，研究期：2012-2017）。的 拟议研究的结果可能会导致阿片类药物依赖治疗的政策变化， 东欧和中亚，为未来的比较有效性研究提供优先事项，并激励 在阿片类药物使用和艾滋病毒负担高的其他国家进行类似的政策研究。

PROJECT SUMMARY / ABSTRACT Ukraine has one of the highest opioid use prevalence levels in Eastern Europe and worldwide, causing substantial morbidity and mortality through co-occurring epidemics involving infectious diseases, in particular HIV, which is primarily driven by injecting drug use. The current response to the problem of HIV and opioid use disorders in Ukraine is insufficient. Novel approaches are needed to address coverage gaps and optimize patient outcomes. Opioid agonist therapy (OAT) was demonstrated to be an effective and cost-effective intervention in reducing harm associated with opioid use. Ukraine has implemented methadone therapy since 2008; however, only 2.7% of the 310,000 Ukrainian PWIDs are receiving OAT, which is far too low to reduce drug injection-mediated HIV transmission. Expanding OAT availability to primary healthcare (PHC) settings may reduce barriers to entry and increase retention in treatment programs. An alternative to OAT, an injectable opioid receptor antagonist, extended-release naltrexone (XR-NTX) is another evidence-based treatment for opioid dependence. By reducing drug craving and illicit drug use, XR-NTX reduces HIV risk behavior and improves quality of life compared to placebo. XR-NXT offers a promising alternative pharmacological treatment for opioid use disorders that would likely target a different sub-population of drug users – specifically those who cannot or is unwilling to receive agonist-based therapy. The main advantage of XR-NTX in comparison with oral naltrexone is that it is administered as a monthly injection rather than taken daily. This was shown to improve treatment compliance; however, adherence is still problematic. The hypothesis of this research project is that the novel interventions: a) expanding OST delivery to PHC facilities; and b) treating opioid dependence with XR-NTX in Ukraine are cost effective relative to the current standard of care in Ukraine. Outcomes of these interventions will be evaluated at both patient and population levels. The study will employ a mathematical modeling approach: a state transition Markov model will be developed to assess patient-level outcomes; and a dynamic compartmental HIV transmission model will estimate the benefits from the interventions at the population level. The analysis will capitalize on the available literature and two recent studies in which I have been involved: 1) Formative Research: Piloting the Provision of Integrated Care to Opioid Drug Users in Primary Healthcare Facilities in Ukraine (study period: 2014-2015); and 2) Expanding Medication-Assisted Therapies in Ukraine (R01 DA033679, study period: 2012-2017). The results of the proposed study can potentially lead to policy changes in treatment of opioid dependence in Eastern Europe and Central Asia, inform priorities for future comparative effectiveness research, and motivate similar policy research in other countries with high burden of opioid drug use and HIV.