Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial
Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial
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DOI：
10.1016/s2352-3018(19)30076-1
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发表时间：
2019-08-01
期刊：
影响因子：
16.1
通讯作者：
Fiellin, David A.
中科院分区：
文献类型：
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作者：
Edelman, E. Jennifer;Maisto, Stephen A.;Fiellin, David A.
背景：我们研究了综合分级酒精治疗(ISAT)对HIV和酒精使用障碍患者的酒精使用和HIV结局的有效性。方法在美国五家以退伍军人事务部为基础的HIV诊所(佐治亚州亚特兰大、纽约布鲁克林曼哈顿、德克萨斯州达拉斯和休斯顿以及华盛顿特区)进行的这项多点随机对照试验中，我们招募了未接受正规酒精治疗的HIV和酒精使用障碍患者。如果患者年龄在18岁或以上，艾滋病毒阳性，会说英语，并符合《精神疾病诊断和统计手册-IV酒精滥用或依赖标准》对酒精使用障碍的标准，患者就有资格。关键排除标准包括患者是否有急性自杀倾向，或是否患有影响其参与咨询干预的能力的精神疾病，或是否有任何可能妨碍完成研究或在研究过程中造成伤害的医疗条件。使用基于网络的临床试验管理系统，我们随机分配参与者(1：1)接受ISAT或照常治疗；患者、研究人员和临床医生被公开分配。ISAT包括三个步骤：第一步，成瘾医生管理，包括八次会议；第二步，成瘾医生管理加上动机增强疗法，包括四次会议；以及第三步，专科转介。如果参与者在第4周和第12周超过了事先的饮酒标准，他们就会被加强。一如既往的治疗包括转介到药物使用治疗服务。主要结果是在治疗意向人群中使用时间线回溯法评估过去30天24周的每周饮酒量。在所有随机分配的参与者中，在整个研究期间跟踪不良事件。这项试验在ClinicalTrials.gov注册，编号NCT01410123。在2013年1月28日至2017年7月14日期间，351名接受资格评估的患者中有128名符合条件并随机分配接受ISAT(n=63)或照常治疗(n=65)。平均年龄为54岁(23-70岁)，128名参与者中125名(98%)为男性，101名(79%)为黑人。失访25例(20%)。在ISAT组，在57名没有死亡或停药的参与者中，30名(52%)进入第二步，30名参与者中有17名(57%)进入第三步。被分配到ISAT组的63名参与者中有32名(51%)接受了至少一种酒精治疗药物(p=0.004)，而被分配到常规治疗组的65名参与者中有17名(26%)接受了至少一种酒精治疗药物。两组参与者都减少了饮酒量，但在第24周，我们没有发现两组之间每周饮酒量的差异(最小二乘法平均为10次。ISAT组每周喝4杯[SD 16.5]，常规治疗组每周喝15.6杯[SD 17.6]；调整后的平均差异-4.2，95%CI-9.4至0.9；P=0.11)。一个可能与治疗有关的不良事件发生在ISAT组(头痛)。解释ISAT在第24周增加了酒精治疗药物和咨询的接受，而饮酒没有变化。需要实施和加强国际SAT的战略。未来的努力应侧重于促进ISAT，同时注意提高患者在酒精相关护理中的参与度和保留率。版权所有(C)2019爱思唯尔有限公司。保留所有权利。
Background We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV and alcohol use disorder.Methods In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment. Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence. Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study. Using a web-based clinical trial management system, we randomly assigned participants (1: 1) to receive ISAT or treatment as usual; patients, investigators, and clinicians were unmasked to allocation. ISAT involved three steps: step 1, addiction physician management, comprising eight sessions; step 2, addiction physician management plus motivational enhancement therapy, comprising four sessions; and step 3, specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual involved referral to substance use treatment services. The primary outcome was number of drinks per week over the past 30 days at week 24 by use of the timeline followback method, assessed in the intention-to-treat population. Adverse events were tracked throughout the study period in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, number NCT01410123.Findings Between Jan 28, 2013, and July 14, 2017, 128 of 351 patients assessed for eligibility were eligible and randomly assigned to receive ISAT (n=63) or treatment as usual (n=65). Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black. 25 (20%) were lost to follow-up. In the ISAT group, of 57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3. 32 (51%) of 63 participants assigned to ISAT versus 17 (26%) of 65 assigned to treatment as usual received at least one alcohol treatment medication (p=0.004). Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10 . 4 drinks per week [SD 16.5] in the ISAT group vs 15.6 drinks per week [SD 17.6] in the treatment as usual group; adjusted mean difference -4.2, 95% CI -9.4 to 0.9; p=0.11). One adverse event occurred that was possibly related to treatment occurred in the ISAT group (headache).Interpretation ISAT increases the receipt of alcohol treatment medications and counselling without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed. Future efforts should focus on promoting ISAT with attention to enhancing patient engagement and retention in alcohol-related care. Copyright (C) 2019 Elsevier Ltd. All rights reserved.