Integrating Addiction Treatment and HIV Services into Primary Care Clinics in Ukraine

乌克兰的艾滋病毒疫情不稳定，是欧洲最严重的，主要集中在注射毒品者（PWID）身上。最 一个具有成本效益的初级和二级艾滋病毒预防和治疗战略，为乌克兰是扩大美沙酮 维持治疗（MMT），特别是对艾滋病毒感染者（PLH），但覆盖率仍然很低（2.7%）， 31万个PWID。MMT的规模扩大受到复杂的、多层次的患者、提供者、诊所和社区因素的阻碍。 为了改革医疗保健，乌克兰优先加强初级保健。我们的试点研究，基于合作 护理模式，肯定了将MMT纳入PLH的初级保健是可接受的，可行的，方便的，减少 耻辱和管理医疗合并症（艾滋病毒，结核病，丙型肝炎病毒，抑郁症等）没有在MMT中处理的 专科诊所三个建议的循证实践将加强协作护理模式的要素。项目 ECHO使用协作学习环境来持续培训、指导和加强专业护理实践 (e.g.,管理合并症）为非专科医生使用远程教育技术。质量改进 (QI)技术改变临床和组织过程以实现期望的结果，提供分析工具， 确保利益相关者的参与。绩效工资（P4P）激励措施鼓励医生实现核心集 基于质量健康指标（QHI）的成果，这些指标基于预先规定的过程措施， 最好的P4P结果研究目的：1）比较初级（综合QHI评分）和次级（个体QHI评分） 来自15个地区（集群）和45个地区（集群）的1，350名接受MMT的HIV+ PWID的结果 临床环境，采用分层、分阶段、随机分组对照设计，为期24个月。分层后 基于当前接受MMT的PWID，他们将被随机分配到专业成瘾诊所接受MMT （N=450）或ECHO-IC/QI增强型初级保健诊所（N=450）或无（N=450）P4P激励; 2） 使用多层次的实施科学框架，我们将研究客户，临床医生， 组织因素，有助于实现最佳的综合QHI得分在1,350招募PWID， 目标1;和3）进行建模和成本效益分析（CEA）的整合MMT的人生活 与接受MMT成瘾的PWID对照组相比， 专业设置。重要性是基于乌克兰的艾滋病毒和其他合并症的高负担，其 在保健改革中发挥区域领导作用，并优先加强初级保健。创新体现在 通过MMT整合加强初级保健，使用全国RCT集群设计， 实施科学框架，提供经验数据，告知CEA，其创造性地使用ECHO，QI 技术，和P4P，其重点是综合护理的过程和结果（多科性QHI）。可行性 是基于试点测试，和广泛的合作研究者的经验，与综合护理，随机对照试验，实施科学， 耻辱，ECHO，QI，P4P和CEA，与众多致力于国家和国际利益相关者和 在乌克兰开展成瘾、艾滋病毒和结核病研究的长期经验。

Ukraine's volatile HIV epidemic, the worst in Europe, is concentrated in people who inject drugs (PWIDs). The most cost-effective primary and secondary HIV prevention and treatment strategy for Ukraine is to expand methadone maintenance treatment (MMT), especially for people living with HIV (PLH), but coverage remains low (2.7%) for the 310,000 PWIDs. MMT scale-up is hampered by complex, multi-level patient, provider, clinic and community factors. To reform healthcare, Ukraine has prioritized strengthening primary care. Our pilot study, based on the Collaborative Care Model, affirmed that integrating MMT into primary care for PLH was acceptable, feasible, convenient, reduced stigma and managed medical comorbidities (HIV, TB, HCV, depression, etc.) that was not otherwise handled in MMT specialty clinics. Three proposed evidence-based practices will reinforce Collaborative Care Model elements. Project ECHO uses a collaborative learning environment to continuously train, coach, and reinforce specialty care practices (e.g., managing comorbidities) for non-specialist physicians using tele-education technology. Quality Improvement (QI) techniques change clinical and organizational processes to achieve desired outcomes, provide analytical tools, and ensure stakeholder engagement. Pay-for-performance (P4P) incentives encourage physicians to achieve a core set of outcomes based on quality health indicators (QHIs), which are based on pre-specified process measures that yield the best P4P results. Study aims: 1) To compare both primary (composite QHI score) and secondary (individual QHI scores, quality of life, and stigma) outcomes in 1,350 HIV+ PWIDs receiving MMT from 15 regions (clusters) and 45 clinical settings using a stratified, phase-in, randomized cluster-controlled design over 24 months. After stratifying PWIDs based on current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) P4P incentives; 2) Using a multi-level implementation science framework, we will examine the contribution of client, clinician, and organizational factors that contribute to attaining optimal comprehensive QHI scores in the 1,350 recruited PWIDs in aim 1; and 3) To conduct modeling and cost-effectiveness analyses (CEA) of integrating MMT for people living with HIV into primary care, with or without P4P, compared to a control group of PWIDs receiving MMT in addiction specialty settings. Significance is based on Ukraine's high burden of HIV and other comorbidities in PWIDs, its regional leadership role in healthcare reform, and its priority to strengthen primary care. Innovation is reflected in strengthening of primary care through MMT integration using a nationwide RCT cluster design linked to an implementation science framework that provides empiric data to inform the CEA, its creative use of ECHO, QI techniques, and P4P, and its focus on processes and outcomes (multi-comorbidity QHIs) of integrated care. Feasibility is based on pilot testing, and extensive co-investigator experience with integrated care, RCTs, implementation science, stigma, ECHO, QI, P4P, and CEA, combined with numerous committed national and international stakeholders and a longstanding experience of conducting research on addiction, HIV, and TB in Ukraine.