Department of Medicine, University of California, San Francisco, CA, USA.
Department of Medicine, University of California, San Francisco, CA, USA.
Drug Alcohol Depend. 2023 Mar 1;244:109783. doi: 10.1016/j.drugalcdep.2023.109783. Epub 2023 Jan 21.
To test the efficacy of two interventions to reduce alcohol use and increase viral suppression compared to a control in persons with HIV (PWH).
In a three-arm (1:1:1) randomized controlled trial (N = 269), we compared in-person counselling (45-70 minutes, two sessions over three months) with interim monthly booster phone calls (live call arm) or twice-weekly automated booster sessions (technology arm) to a brief advice control arm. We enrolled PWH self-reporting unhealthy alcohol use (Alcohol Use Disorders Identification Test - Consumption, prior three months, women ≥3, men ≥4). Primary outcomes were number of self-reported drinking days (NDD) in the prior 21 and biomarker phosphatidylethanol (PEth) at six and nine months and viral suppression (<40 copies/mL) at nine months; we adjusted for sex and baseline outcomes.
At baseline, mean 21-day NDDs were 9.4 (95 % CI: 9.1-9.8), mean PEth was 407.8 ng/mL (95 % CI: 340.7-474.8), and 89.2 % were virally suppressed. At follow-up, there were significant reductions in mean NDDs for the live call versus control arm (3.5, 95 % CI:2.1-4.9, p < 0.001) and for the technology versus control arm (3.6, 95 % CI: 2.2-5.1, p < 0.001). The mean PEth differences compared to the control arm were not significant, i.e. 36.4 ng/mL (95 % CI: -117.5 to 190.3, p = 0.643) for the live call and -30.9 ng/mL (95 % CI: -194.8 to 132.9, p = 0.711) for the technology arm. Nine-month viral suppression compared to the control was similar in the live call and in the technology arm.
Intervention effects were found on self-reported NDD but not PEth or viral suppression, suggesting no treatment effect. (NCT #03928418).
在 HIV 感染者(PWH)中,比较两种干预措施(面对面咨询和每月电话随访或每周电话随访)与简短建议对照,以评估减少饮酒和提高病毒抑制的效果。
在一项三臂(1:1:1)随机对照试验(N=269)中,我们比较了面对面咨询(45-70 分钟,三个月内进行两次)与每月一次的电话随访(现场电话组)或每周两次的自动电话随访(技术组)与简短建议对照组。我们招募了自我报告饮酒过量(酒精使用障碍识别测试-消费,前三个月,女性≥3,男性≥4)的 PWH。主要结局为过去 21 天的自我报告饮酒天数(NDD)和六个月和九个月的生物标志物磷脂酰乙醇(PEth)以及九个月的病毒抑制率(<40 拷贝/mL);我们调整了性别和基线结局。
基线时,平均 21 天 NDD 为 9.4(95 % CI:9.1-9.8),平均 PEth 为 407.8ng/mL(95 % CI:340.7-474.8),89.2 %的患者病毒抑制。随访时,现场电话组与对照组相比,NDD 显著减少(3.5,95 % CI:2.1-4.9,p<0.001),技术组与对照组相比,NDD 也显著减少(3.6,95 % CI:2.2-5.1,p<0.001)。与对照组相比,PEth 的平均差异无统计学意义,即现场电话组为 36.4ng/mL(95 % CI:-117.5 至 190.3,p=0.643),技术组为-30.9ng/mL(95 % CI:-194.8 至 132.9,p=0.711)。与对照组相比,九个月的病毒抑制率在现场电话组和技术组相似。
干预措施对自我报告的 NDD 有影响,但对 PEth 或病毒抑制没有影响,提示无治疗效果。(NCT 03928418)。