在俄罗斯注射吸毒的 HIV 感染者中，快速获得抗逆转录病毒治疗、纳曲酮治疗和基于优势的病例管理与标准护理相比对 HIV 病毒载量抑制的影响（LINC-II）：一项开放标签、随机对照试验。
Rapid access to antiretroviral therapy, receipt of naltrexone, and strengths-based case management versus standard of care for HIV viral load suppression in people with HIV who inject drugs in Russia (LINC-II): an open-label, randomised controlled trial.
机构信息
Department of Medicine, Boston University Chobanian & Avedisian School of Medicine, Boston Medical Center, Boston, MA, USA.
First Pavlov State Medical University of St Petersburg, Saint Petersburg, Russia.
出版信息
Lancet HIV. 2023 Sep;10(9):e578-e587. doi: 10.1016/S2352-3018(23)00143-1.
BACKGROUND
Antiretroviral therapy (ART) coverage in Russia is low for people with HIV who inject drugs. HIV and addiction treatment in Russia are not well integrated. We aimed to evaluate an intervention to link people with HIV in addiction treatment to HIV care to achieve HIV viral load suppression.
METHODS
LINC-II was a two-arm, open-label, randomised controlled trial at the City Addiction Hospital, Saint Petersburg, Russia. Eligible participants were aged 18 years or older, had a positive HIV status, were not currently on ART, were admitted to a narcology hospital, and had a current diagnosis of opioid use disorder. Participants were randomly assigned (1:1) to a multicomponent intervention (ie, rapid access to ART, naltrexone for opioid use disorder, and strengths-based case management) or standard of care. Blocked randomisation was stratified by history of ART use. The primary outcome was undetectable HIV viral load at 12 months, defined as less than 40 copies per mL. The trial was conducted and analysed according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, NCT03290391.
FINDINGS
Between Sept 19, 2018, and Dec 25, 2020, 953 individuals were screened for eligibility, 225 of whom were randomly assigned to the intervention (n=111) or standard of care (n=114). 136 (60%) participants were male and 89 (40%) were female. Participants in the intervention group had higher odds of HIV viral load suppression at 12 months compared with participants in the standard-of-care group (52 [47%] vs 26 [23%]; adjusted odds ratio 3·0 [95% CI 1·4-6·4]; p=0·0039). 21 adverse events (18 in the intervention group and three in the standard-of-care group)and 14 deaths (four in the intervention group and ten in the standard-of-care group) were reported in the study.
INTERPRETATION
Given the effectiveness of the LINC-II intervention, scaling up this model could be one strategy to advance the UNAIDS goal of ending the HIV epidemic.
FUNDING
National Institute on Drug Abuse and Providence/Boston Center for AIDS Research.
背景
俄罗斯为注射吸毒的艾滋病毒感染者提供的抗逆转录病毒疗法（ART）覆盖率很低。俄罗斯的艾滋病毒和成瘾治疗并未很好地结合在一起。我们旨在评估一项将接受成瘾治疗的艾滋病毒感染者与艾滋病毒护理联系起来以实现艾滋病毒病毒载量抑制的干预措施。
方法
LINC-II 是在俄罗斯圣彼得堡市成瘾医院进行的一项两臂、开放性、随机对照试验。符合条件的参与者年龄在 18 岁或以上，HIV 检测呈阳性，未接受 ART 治疗，已入院接受戒毒治疗，且目前诊断为阿片类药物使用障碍。参与者被随机分配（1:1）至多组分干预组（即快速获得 ART、纳曲酮治疗阿片类药物使用障碍和基于优势的病例管理）或标准护理。分层随机分组按 ART 使用史进行。主要结局是 12 个月时不可检测的 HIV 病毒载量，定义为小于 40 拷贝/毫升。该试验根据意向治疗原则进行了实施和分析。该试验在 ClinicalTrials.gov 上注册，NCT03290391。
结果
在 2018 年 9 月 19 日至 2020 年 12 月 25 日之间，共有 953 人接受了筛查以确定是否符合入选标准，其中 225 人被随机分配至干预组（n=111）或标准护理组（n=114）。136 名参与者（60%）为男性，89 名（40%）为女性。与标准护理组相比，干预组参与者在 12 个月时 HIV 病毒载量抑制的可能性更高（52 [47%] 对 26 [23%]；调整后的优势比 3.0[95%CI 1.4-6.4]；p=0.0039）。在研究中报告了 21 起不良事件（干预组 18 起，标准护理组 3 起）和 14 起死亡事件（干预组 4 起，标准护理组 10 起）。
解释
鉴于 LINC-II 干预措施的有效性，扩大这种模式可能是实现联合国艾滋病规划署终结艾滋病流行目标的一项战略。
资金来源
国家药物滥用研究所和普罗维登斯/波士顿艾滋病研究中心。
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