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

将俄罗斯麻醉学和艾滋病毒护理联系起来以加强治疗、保留和结果第二部分

• 批准号: 9982283
• 负责人: JEFFREY H. SAMET
• 金额: $ 68.24万
• 依托单位: BOSTON MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9982283
• 关键词: Achievement; Address; Administrator; Alcohol or Other Drugs use; Awareness; CD4 Lymphocyte Count; Caring; Case Management; Clinical; Complex; Country; Data; Diagnosis; Dimensions; Eastern Europe; Economics; Effectiveness; Effectiveness of Interventions; Epidemic; Face; Goals; HIV; HIV Infections; HIV diagnosis; Health; Health Personnel; Health system; Healthcare Systems; Hospitals; Human immunodeficiency virus test; Injecting drug user; International; Intervention; Interview; Length; Link; Medical; Methods; Naltrexone; Outcome; Participant; Patients; Perception; Pharmacology; Pharmacotherapy; Policy Maker; Population; Process; Qualitative Research; Randomized; Randomized Controlled Trials; Research; Risk; Russia; Sexual Partners; Support System; Surveys; System; Testing; Time trend; Viral Load result; Visit; addiction; antiretroviral therapy; base; care coordination; care systems; comparative cost effectiveness; cost; cost effective; cost-effectiveness evaluation; effectiveness evaluation; experience; health data; improved; injection drug use; multi-component intervention; opioid use disorder; primary outcome; scale up; social stigma; standard of care; therapy design; transmission process

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.

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， 注射吸毒者（PWID）及其性伴侣的传播风险最高。虽然常规艾滋病毒 在俄罗斯的成瘾治疗系统（即麻醉科医院）内进行测试是常态， 麻醉学和艾滋病毒护理系统有限且无效。在圣彼得堡，50-60% 的吸毒者患有艾滋病毒 - 感染者，但在这一人群中，只有不到 10% 的人正在接受抗逆转录病毒治疗 (ART)。为俄罗斯制造 实现联合国艾滋病规划署 90-90-90 目标的进展（即 90% 的人了解艾滋病毒诊断，90% 的人在 ART 以及接受 ART 的 90% 的 HIV 病毒载量受到抑制 [HVL]），需要采取大胆的新策略。这 本研究的目标“将传染病和麻醉学护理联系起来 - 第二部分 (LINC-II)”是实施和 通过对 240 名感染 HIV 的吸毒者进行的双组随机对照试验，评估一项多方面的研究 结合药物治疗的干预措施（即快速获得抗逆转录病毒疗法和纳曲酮治疗阿片类药物） 使用障碍）和 12 个月基于优势的案例管理。中心假设是 LINC-II 将 导致在艾滋病毒-人群中实现 90-90-90 艾滋病毒级联护理目标方面取得显着进展 受感染的吸毒者，相对于当前的护理标准，LINC-II 将促进卫生系统协调 麻醉学和艾滋病毒护理。该提案的基本原理源自最初的 LINC 研究 (R01DA032082)，发现 6 个月的病例管理对于改善 HIV- 感染吸毒者接受 HIV 护理，但由于复杂的原因无法影响 HVL、CD4 或保留护理 ART 获取流程、活性物质使用以及 CM 干预时间不足。 LINC-II 的目标 1) 评估 LINC-II 对 12 个月时检测不到的 HVL 的有效性（主要结果），开始 随机分组后 28 天内接受 ART，CD4 计数从基线到 12 个月的变化，保留 HIV 护理 （即，连续 6 个月内就诊次数≥ 1 次），并且 6 个月时未检测到 HVL； 2） 评估 LINC-II 对整个麻醉学和艾滋病毒卫生保健系统协调护理的影响，使用 来自医疗保健提供者、管理人员和患者的混合方法数据； 3）评估成本- 干预措施的有效性，以告知政策制定者在俄罗斯境内扩大 LINC-II 方法 以及其他因注射吸毒而导致艾滋病毒流行的国家。该研究的目标是改进 目前在麻醉科护理中为感染艾滋病毒的俄罗斯吸毒者寻求、测试、治疗和保留工作，这是一个常规小组 进行了艾滋病毒检测。 LINC-II 研究将由在以下领域具有独特经验的国际研究团队进行： 解决俄罗斯的艾滋病毒、药物滥用和临床干预问题。如果 LINC-II 有效并且可以 有效地嵌入俄罗斯和其他受到艾滋病毒感染的吸毒者挑战的医疗系统中，那么它 具有对关键艾滋病毒人群中艾滋病毒流行产生有利影响的巨大潜力。