3/6 COMpAAAS U01: Intervention Study

不健康饮酒的HIV感染患者通常不会有减少饮酒的动机 而且很少因饮酒而接受治疗。为了应对这些挑战，我们计划在 HIV诊所，向患者强调酒精对他们的医疗条件的影响，并使用应急措施 管理(CM)，采用分级护理设计，根据患者的反应调整治疗。CM是一个证据-- 促进戒除物质使用的基础疗法，包括酒精。因为CM还没有 对HIV感染患者使用不健康的酒精进行研究，我们将包括一种阶梯式护理策略，提供 成瘾精神病学家管理(APM)(含酒精药物疗法)和激励 加强疗法(MET)适用于未能实现CM戒断的患者。磷脂酰乙醇 (Peth)，是一种经过验证的生物标志物，可以在三周内确认戒酒。捕捉…的范围 酒精对健康的不利影响，我们将包括有风险饮酒、酒精使用障碍和 可能受到酒精不利影响的医疗条件，包括那些可检测到艾滋病毒病毒载量的情况， 烟草使用障碍、肝纤维化、未经治疗的丙型肝炎、抑郁症和服用精神药物的人 与酒精相互作用的药物。财政激励的目标，步步为营的随机化 治疗(第一个)试验是比较现场CM加分级护理与常规治疗(TAU)在 对7家HIV诊所348名不健康饮酒的HIV感染者进行的随机临床试验。厘米 患者将接受由社会工作者管理的现场CM咨询课程，并获得经济奖励 取决于酒精测定仪和佩斯所显示的禁欲。奖励也可以颁发给 解决受酒精影响的医疗条件，实现酒精治疗目标。三个月后， 如果peth结果表明患者没有达到戒断，患者将被加强APM并得到满足。这 随机临床试验将检验CM加阶梯式护理导致更大禁欲的假设， 减少酒精消费，改善Vacs指数衡量的艾滋病毒生物标记物。数据 将对患者样本的治疗意向进行分析。主要的结果是比例 在六个月时有记录的佩斯禁欲的人。次要结果包括酒精 使用时间线回溯评估消耗量，以及VAS指数的变化。这方面的新奇之处 建议包括：1)第一次对CM在艾滋病毒诊所使用不健康的酒精进行评估，2)评估 现场CM加上阶梯式护理，包括APM和MET，3)使用PEH来指导CM奖励并作为试验 结果，4)用CM解决患者的动机，并关注酒精影响的医疗条件，5) Vacs指数的使用，这是一个经过验证的生物标记物，反映了艾滋病毒感染者的总体健康和禁欲 接受成瘾治疗的患者。这项研究由经验丰富的艾滋病毒和成瘾研究人员进行， 将确定CM加分级护理对使用不健康酒精的艾滋病毒感染患者的疗效。

HIV-infected patients with unhealthy alcohol use are not often motivated to decrease their alcohol consumption and rarely receive treatment for their drinking. To address these challenges, we plan to provide treatment in HIV clinics, highlight to patients the impact alcohol can have on their medical conditions, and use Contingency Management (CM) with a stepped care design to adjust treatment to patient response. CM is an evidence- based therapy that promotes abstinence from substance use, including alcohol. Since CM has not been studied for unhealthy alcohol use in HIV-infected patients we will include a stepped care strategy that provides Addiction Psychiatrist Management (APM) (with alcohol pharmacotherapies as indicated) and Motivational Enhancement Therapy (MET) for patients who do not achieve abstinence with CM. Phosphatidylethanol (PEth), is a validated biomarker that can confirm alcohol abstinence over three weeks. To capture the range of adverse effects of alcohol on health, we will include patients with at-risk drinking, alcohol use disorder, and medical conditions that can be adversely impacted by alcohol including those with a detectable HIV viral load, tobacco use disorder, liver fibrosis, untreated hepatitis C, depression and those taking psychoactive medications that interact with alcohol. The goal of the Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial is to compare onsite CM plus stepped care versus treatment as usual (TAU) in a randomized clinical trial of 348 HIV-infected patients with unhealthy alcohol use at seven HIV clinics. CM patients will receive onsite CM counseling sessions adminstered by a Social Worker with financial rewards contingent on abstinence demonstrated by breathalyzer and PEth. Rewards can also be awarded for addressing medical conditions impacted by alcohol and achieving alcohol treatment goals. After three months, patients will be stepped up to APM and MET if PEth results indicate they have not attained abstinence. This randomized clinical trial will test the hypothesis that CM plus stepped care leads to greater abstinence, decreased alcohol consumption and improved HIV biomarkers as measured by the VACS Index. Data analyses will be conducted on the intention to treat sample of patients. The primary outcome is the proportion of individuals with PEth documented abstinence at six months. Secondary outcomes include alcohol consumption assessed using Timeline Followback, and change in the VACS Index. Novel aspects of this proposal include: 1) The first evaluation of CM for unhealthy alcohol use in HIV clinics, 2) An assessment of onsite CM plus stepped care including APM and MET, 3) Use of PEth to guide CM rewards and as a trial outcome, 4) Addressing patient motivation with CM and a focus on medical conditions impacted by alcohol, 5) Use of the VACS Index, a validated biomarker that reflects overall health and abstinence among HIV-infected patients receiving addiction treatment. This study, conducted by experienced HIV and addiction researchers, will determine the efficacy of CM plus stepped care in HIV-infected patients with unhealthy alcohol use.