Linking Russian Narcology and HIV Care to Enhance Treatment, Retention and Outcomes Part II

俄罗斯和东欧仍然是世界上艾滋病毒流行增长最快的国家之一， 在注射毒品者（PWID）及其性伴侣中传播风险最高。虽然常规的艾滋病毒 俄罗斯成瘾治疗系统内的测试（即，麻醉科医院）是规范， 麻醉学和艾滋病毒护理系统有限且无效。在彼得堡，50-60%的艾滋病毒感染者是艾滋病毒携带者。 虽然艾滋病毒/艾滋病感染者中只有不到10%的人在接受抗逆转录病毒治疗。对于俄罗斯来说， 实现联合国艾滋病规划署90-90-90目标的进展情况（即，90%的人知道艾滋病毒的诊断，90%的诊断者 ART和90%的ART受抑制的HIV病毒载量[HVL]），需要一个大胆的新策略。的 本研究的目的，“连接感染和麻醉护理-第二部分（LINC-II）”，是实施和 通过在240名HIV感染者中进行的双臂随机对照试验， 结合药物治疗的干预（即，快速获得抗逆转录病毒疗法和接受纳洛酮治疗阿片类药物 使用障碍）和12个月的优势为基础的情况下管理。核心假设是LINC-II将 * 在实现艾滋病毒感染者90-90-90艾滋病毒护理级联目标方面取得显著进展， 感染PWID，相对于目前的护理标准，LINC-II将促进卫生系统协调， 麻醉学和艾滋病护理。这一建议的基本原理来自最初的LINC研究 （R 01 DA 032082），发现6个月的病例管理可有效改善HIV- 感染的PWID到HIV护理，但由于复杂的原因，无法影响HVL，CD 4或护理保留的变化 抗逆转录病毒治疗的获取过程、活性物质的使用以及CM干预的时间长度不足。LINC-II目标 1）评价LINC-II在12个月时对检测不到的HVL的有效性（主要结局）， 随机化前28天内接受ART治疗，CD 4计数从基线至12个月的变化，HIV护理的保留 (i.e.,在连续2个6个月期间≥ 1次就医），且6个月时未检出HVL; 2） 评估LINC-II对麻醉学和艾滋病毒卫生保健系统协调护理的影响，使用 来自卫生保健提供者、管理者和患者的混合方法数据;以及3）评估成本- 干预措施的有效性，为决策者提供信息，以扩大LINC-II方法在俄罗斯境内的范围， 以及其他因注射吸毒而导致艾滋病毒流行的国家。这项研究的目的是改善 目前寻求，测试，治疗，并保留在麻醉护理艾滋病毒感染的俄罗斯PWID的努力，一组常规 艾滋病毒检测LINC-II研究将由一个在以下方面拥有独特经验的国际研究团队进行 在俄罗斯解决艾滋病毒、药物使用和临床干预问题。如果LINC-II是有效的， 有效地嵌入到俄罗斯和其他受到艾滋病毒感染的PWID挑战的医疗系统中， 有很大的潜力对艾滋病毒在主要人群中的流行产生有利的影响。

Russia and Eastern Europe continue to have one of the fastest growing HIV epidemics in the world, with highest transmission risks among people who inject drugs (PWID) and their sexual partners. While routine HIV testing within addiction treatment systems in Russia (i.e., narcology hospitals) is the norm, links between the narcology and HIV care systems are limited and ineffective. In St. Petersburg 50-60% of PWID are HIV- infected, yet among this population less than 10% are on antiretroviral therapy (ART). For Russia to make progress toward the UNAIDS 90-90-90 targets (i.e., 90% aware of HIV diagnosis, 90% of those diagnosed on ART and 90% of those on ART with suppressed HIV viral load [HVL]), a bold new strategy is required. The objective of this study, “Linking Infectious and Narcology Care – Part II (LINC-II),” is to implement and evaluate, via a two-armed randomized controlled trial among 240 HIV-infected PWID, a multi-faceted intervention combining pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management. The central hypothesis is that LINC-II will lead to marked progress toward the achievement of the 90-90-90 HIV cascade of care targets among HIV- infected PWID, relative to current standard of care, and that LINC-II will facilitate health system coordination of narcology and HIV care. The rationale that underlies this proposal emerged from the original LINC study (R01DA032082), which found 6 months of case management to be effective for improving linkage of HIV- infected PWID to HIV care, but was unable to effect change in HVL, CD4, or retention in care due to complex processes for ART access, active substance use, and inadequate length of the CM intervention. LINC-II aims to: 1) evaluate the effectiveness of LINC-II on undetectable HVL at 12 months (primary outcome), initiation of ART within 28 days of randomization, change in CD4 count from baseline to 12 months, retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods), and undetectable HVL at 6 months; 2) evaluate the impact of LINC-II on coordinated care across the narcology and HIV health care systems, using mixed methods data from health care providers, administrators, and patients; and 3) evaluate the cost- effectiveness of the intervention to inform policy makers on scaling up the LINC-II approach both within Russia and other countries with HIV epidemics driven by injection drug use. The study's goal is to improve upon current seek, test, treat, and retain efforts for HIV-infected Russian PWID in narcology care, a group routinely tested for HIV. The LINC-II study will be undertaken by an international research team uniquely experienced in addressing HIV, substance use, and clinical interventions in Russia. If LINC-II is effective and can be embedded efficiently within the Russian and other medical systems challenged by HIV-infected PWID, then it has great potential to favorably impact the HIV epidemic in a key HIV population.