Program in Addiction Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Yale Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.
Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA; Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.
Contemp Clin Trials. 2023 Aug;131:107242. doi: 10.1016/j.cct.2023.107242. Epub 2023 May 23.
Although unhealthy alcohol use is associated with increased morbidity and mortality among people with HIV (PWH), many are ambivalent about engaging in treatment and experience variable responses to treatment. We describe the rationale, aims, and study design for the Financial Incentives, Randomization, with Stepped Treatment (FIRST) Trial, a multi-site randomized controlled efficacy trial.
PWH in care recruited from clinics across the United States who reported unhealthy alcohol use, had a phosphatidylethanol (PEth) >20 ng/mL, and were not engaged in formal alcohol treatment were randomized to integrated contingency management with stepped care versus treatment as usual. The intervention involved two steps; Step 1: Contingency management (n = 5 sessions) with potential rewards based on 1) short-term abstinence; 2) longer-term abstinence; and 3) completion of healthy activities to promote progress in addressing alcohol consumption or conditions potentially impacted by alcohol; Step 2: Addiction physician management (n = 6 sessions) plus motivational enhancement therapy (n = 4 sessions). Participants' treatment was stepped up at week 12 if they lacked evidence of longer-term abstinence. Primary outcome was abstinence at week 24. Secondary outcomes included alcohol consumption (assessed by TLFB and PEth) and the Veterans Aging Cohort Study (VACS) Index 2.0 scores; exploratory outcomes included progress in addressing medical conditions potentially impacted by alcohol. Protocol adaptations due to the COVID-19 pandemic are described.
The FIRST Trial is anticipated to yield insights on the feasibility and preliminary efficacy of integrated contingency management with stepped care to address unhealthy alcohol use among PWH.
gov identifier: NCT03089320.
尽管不健康的饮酒行为与艾滋病毒感染者（PWH）的发病率和死亡率增加有关，但许多人对接受治疗持矛盾态度，并对治疗有不同的反应。我们描述了金融激励、随机化与阶梯治疗（FIRST）试验的原理、目的和研究设计，这是一项多地点随机对照疗效试验。
从美国各地的诊所招募参加护理的 PWH，他们报告有不健康的饮酒行为，磷脂酰乙醇（PEth）>20ng/mL，且未接受正式的酒精治疗，随机分为综合条件性管理与阶梯护理组与常规治疗组。该干预措施包括两个步骤；第 1 步：条件性管理（n=5 次），根据以下因素给予潜在奖励：1）短期戒断；2）长期戒断；3）完成促进解决饮酒问题或可能受酒精影响的健康活动，以促进解决饮酒问题；第 2 步：成瘾医生管理（n=6 次）加动机增强治疗（n=4 次）。如果参与者在第 12 周没有长期戒断的证据，则将其治疗升级。主要结局是第 24 周的戒断。次要结局包括酒精消费（通过 TLFB 和 PEth 评估）和退伍军人老龄化队列研究（VACS）指数 2.0 评分；探索性结局包括解决可能受酒精影响的医疗状况的进展。描述了由于 COVID-19 大流行而进行的方案调整。
预计 FIRST 试验将提供有关综合条件性管理与阶梯护理治疗 PWH 不健康饮酒的可行性和初步疗效的见解。
gov 标识符：NCT03089320。
