Muyindike Winnie R, Fatch Robin, Lodi Sara, Emenyonu Nneka I, Kekibiina Allen, Adong Julian, Beesiga Brian, Marson Kara, Thirumurthy Harsha, McDonell Michael G, Kamya Moses R, Chamie Gabriel, Hahn Judith A
Faculty of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda.
HIV Section, Mbarara Regional Referral Hospital, Mbarara, Uganda.
EClinicalMedicine. 2025 Jan 8;80:103045. doi: 10.1016/j.eclinm.2024.103045. eCollection 2025 Feb.
In a recent randomized trial, six months of financial incentives contingent for recent alcohol abstinence led to lower levels of hazardous drinking, while incentives for recent isoniazid (INH) ingestion had no impact on INH adherence, during TB preventive therapy among persons with HIV (PWH). Whether the short-term incentives influence long-term alcohol use and HIV viral suppression post-intervention is unknown.
We analyzed twelve-month HIV viral suppression and alcohol use in the Drinkers' Intervention to Prevent Tuberculosis study, a randomized controlled trial among PWH with latent TB and unhealthy alcohol use in south-western Uganda. We randomly assigned 680 participants (1:1:1:1) initiating six months of INH to: Arm 1, no incentives (control); Arm 2, financial incentives contingent on recent alcohol abstinence; Arm 3, incentives contingent on recent INH use; and Arm 4, incentives for recent alcohol abstinence and INH use, rewarded separately. The 6 months post-intervention outcomes evaluated were pre-specified and included: HIV viral suppression (<200 copies/mL) and no/low alcohol use, defined as Alcohol Use Disorders Identification Test-Consumption negative (<3: women, <4: men) and phosphatidylethanol, an alcohol biomarker, <35 ng/mL. We estimated adjusted risk differences (aRD) for alcohol reduction and INH adherence interventions using multivariable logistic regression adjusting for randomization stratification factors (sex and study site), and baseline alcohol use (alcohol intervention model only). Clinicaltrials.gov registration: NCT03492216, Registered 04/10/2018.
Of 600 participants with 12-month viral load results, 556/585 (95%) with baseline results were virally suppressed, and 583/600 (97%) were virally suppressed at 12-months. Twelve-month viral suppression did not differ significantly between either intervention group versus control (alcohol reduction incentives versus control aRD = -0.9% (95% CI: -3.6 to 1.7); INH adherence incentives versus control aRD = 2.2% (95% CI: -0.4 to 4.9)). Of the 617 participants with 12-month alcohol use measures, alcohol reduction incentives led to a significantly greater proportion with no/low alcohol use at 12-months (20.2% [64/317]) versus no alcohol reduction incentives (11.0% [33/300]); aRD = 8.4%, (95% CI: 3.3-13.4), p = 0.001.
Viral suppression was high (>95%) at baseline and at 12 months: we found no effect of either 6-month alcohol reduction or INH adherence incentives on long-term viral suppression. Six months of alcohol reduction incentives were effective at promoting no/low alcohol use at 12 months, demonstrating persistent effects post-intervention.
National Institutes of Health (NIH/NIAAA) U01AA026223 (PI: Hahn) and U01AA026221 (PI: Chamie), NIH/NIAAAK24 AA022586 (PI: Hahn), NIH/NIAAAK24 AA031211 (PI: Chamie), Providence/Boston Center for AIDS ResearchP30AI042853 (PI: Sara Lodi).
在最近一项随机试验中,针对近期戒酒给予六个月的经济激励导致危险饮酒水平降低,而在艾滋病毒感染者(PWH)的结核病预防治疗期间,针对近期服用异烟肼(INH)给予激励对INH依从性没有影响。短期激励措施是否会影响干预后的长期饮酒情况和艾滋病毒病毒抑制尚不清楚。
我们在“饮酒者预防结核病干预研究”中分析了十二个月的艾滋病毒病毒抑制情况和饮酒情况,该研究是在乌干达西南部对患有潜伏性结核病和不健康饮酒的PWH进行的一项随机对照试验。我们将680名开始接受六个月INH治疗的参与者(1:1:1:1)随机分配到:第1组,无激励措施(对照组);第2组,基于近期戒酒的经济激励;第3组,基于近期INH使用的激励;第4组,分别针对近期戒酒和INH使用的激励。干预后6个月评估的预先设定的结果包括:艾滋病毒病毒抑制(<200拷贝/毫升)以及无/低饮酒,无/低饮酒定义为酒精使用障碍识别测试-消费阴性(女性<3,男性<4)且酒精生物标志物磷脂酰乙醇<35纳克/毫升。我们使用多变量逻辑回归估计酒精减少和INH依从性干预的调整风险差异(aRD),并针对随机分层因素(性别和研究地点)以及基线饮酒情况(仅酒精干预模型)进行调整。Clinicaltrials.gov注册号:NCT03492216,于2018年10月4日注册。
在600名有12个月病毒载量结果的参与者中,556/585(95%)有基线结果的参与者实现了病毒抑制,583/600(97%)在12个月时实现了病毒抑制。干预组与对照组之间的十二个月病毒抑制情况没有显著差异(酒精减少激励与对照组相比,aRD = -0.9%(95%置信区间:-3.6至1.7);INH依从性激励与对照组相比,aRD = 2.2%(95%置信区间:-0.4至4.9))。在617名有12个月饮酒测量结果的参与者中,酒精减少激励导致在12个月时无/低饮酒的比例显著高于无酒精减少激励(20.2% [64/317])与(11.0% [33/300]);aRD = 8.4%,(95%置信区间:3.3 - 13.4),p = 0.001。
基线和12个月时的病毒抑制率都很高(>95%):我们发现六个月的酒精减少或INH依从性激励对长期病毒抑制均无影响。六个月的酒精减少激励在促进12个月时的无/低饮酒方面是有效的,表明干预后有持续效果。
美国国立卫生研究院(NIH/NIAAA)U01AA026223(项目负责人:哈恩)和U01AA026221(项目负责人:查米),NIH/NIAAAK24 AA022586(项目负责人:哈恩),NIH/NIAAAK