Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.
Department of Psychiatry and Behavioral Sciences, School of Medicine, Johns Hopkins University, Baltimore, Maryland.
JAMA Netw Open. 2020 Sep 1;3(9):e2017115. doi: 10.1001/jamanetworkopen.2020.17115.
Hazardous and heavy alcohol use is common among people living with HIV and may decrease antiretroviral therapy (ART) adherence, but limited data exist from randomized clinical trials about the effects of interventions on viral load.
To compare the efficacy of 2 scalable ART clinic-based interventions on alcohol use and viral suppression.
DESIGN, SETTING, AND PARTICIPANTS: This 3-group randomized clinical trial was conducted among 440 adults with HIV who were being treated at 7 ART clinics in Thai Nguyen, Vietnam. Adults receiving ART with hazardous alcohol use (Alcohol Use Disorders Identification Test-Consumption score ≥4 for men or ≥3 for women) and no plans to leave Thai Nguyen were included. Data were collected from March 2016 to May 2018 and analyzed from June 2018 to February 2020.
Participants were randomly assigned (1:1:1) to standard of care (SOC), a combined intervention of motivational enhancement therapy and cognitive behavioral therapy (6 in-person sessions of 1 hour each and 3 optional group sessions), or a brief intervention with similar components as the combined intervention but consisting of 2 shorter in-person sessions and 2 telephone sessions.
The primary study outcomes were percentage of days abstinent from alcohol, confirmed using the alcohol biomarker phosphatidylethanol, and viral suppression at 12 months after enrollment.
A total of 440 eligible individuals (mean [SD] age, 40.2 [5.8] years; 426 [96.8%] men) were enrolled; 147 (33.4%) were assigned to the combined intervention, 147 (33.4%) to the brief intervention, and 146 (33.2%) to SOC. In the combined intervention group, 112 participants (76.2%) attended all 6 sessions, and in the brief intervention group, 124 (84.4%) attended all 4 sessions; in the whole sample, 390 (88.6%) completed 12 months of follow-up. At 12 months, the mean (SE) percentage of days abstinent was 65% (3.1%) among those in the combined intervention group, 65% (3.2%) among those in the brief intervention group, and 50% (3.4%) among those in the in the SOC group (Cohen d for combined intervention vs SOC and brief intervention vs SOC: 39%; 95% CI, 15% to 64%). Viral suppression (ie, <20 copies of HIV-1 RNA per milliliter) at 12 months was higher after the brief intervention than SOC (difference, 11%; 95% CI, 2% to 20%), but the difference between the combined intervention and SOC was not significantly different (difference, 5%; 95%, CI, -5% to 15%).
In this study, the brief intervention resulted in a significant increase in percentage of days abstinent from alcohol and a significant increase in viral suppression after 12 months. Future implementation science studies evaluating scale-up of the brief intervention are needed.
ClinicalTrials.gov Identifier: NCT02720237.
在感染艾滋病毒的人群中,危险和大量饮酒很常见,这可能会降低抗逆转录病毒治疗(ART)的依从性,但关于干预措施对病毒载量影响的随机临床试验数据有限。
比较 2 种基于 ART 诊所的可扩展干预措施对饮酒和病毒抑制的疗效。
设计、地点和参与者:这是一项 3 组随机临床试验,在越南太原省的 7 个 ART 诊所接受治疗的 440 名 HIV 感染者中进行。包括接受 ART 治疗且有危险饮酒行为(酒精使用障碍识别测试-消费评分男性≥4 分或女性≥3 分)且无离开太原计划的成年人。数据于 2016 年 3 月至 2018 年 5 月收集,并于 2018 年 6 月至 2020 年 2 月进行分析。
参与者被随机分配(1:1:1)接受标准护理(SOC)、动机增强治疗和认知行为治疗的联合干预(6 次 1 小时的面对面会议和 3 次可选的小组会议)或简短干预与联合干预具有相同的组成部分,但由 2 次较短的面对面会议和 2 次电话会议组成。
主要研究结局是使用酒精生物标志物磷脂酰乙醇确定的酒精戒断天数的百分比,以及在纳入后 12 个月的病毒抑制情况。
共有 440 名符合条件的个体(平均[标准差]年龄,40.2[5.8]岁;426[96.8%]名男性)被纳入;147 名(33.4%)被分配到联合干预组,147 名(33.4%)被分配到简短干预组,146 名(33.2%)被分配到 SOC 组。在联合干预组中,112 名参与者(76.2%)参加了所有 6 次会议,在简短干预组中,124 名(84.4%)参加了所有 4 次会议;在整个样本中,390 名(88.6%)完成了 12 个月的随访。在 12 个月时,联合干预组的平均(SE)酒精戒断天数百分比为 65%(3.1%),简短干预组为 65%(3.2%),SOC 组为 50%(3.4%)(联合干预与 SOC 和简短干预与 SOC 的 Cohen d:39%;95%CI,15%至 64%)。12 个月时,简短干预组的病毒抑制(即 HIV-1 RNA 每毫升<20 拷贝)高于 SOC(差异,11%;95%CI,2%至 20%),但联合干预与 SOC 之间的差异无统计学意义(差异,5%;95%CI,-5%至 15%)。
在这项研究中,简短干预导致酒精戒断天数百分比显著增加,12 个月后病毒抑制显著增加。需要进一步开展评估简短干预扩大应用的实施科学研究。
ClinicalTrials.gov 标识符:NCT02720237。