3/6 COMpAAAS U01: Intervention Study

不健康饮酒的艾滋病毒感染者往往没有减少饮酒的动机 很少接受治疗。为了应对这些挑战，我们计划提供治疗， 艾滋病诊所，向患者强调酒精对他们的医疗状况的影响，并使用应急措施 管理（CM），采用阶梯式护理设计，根据患者反应调整治疗。CM是一个证据- 一种促进戒除物质使用的基于治疗的方法，包括酒精。由于CM没有 在研究艾滋病毒感染患者的不健康酒精使用时，我们将包括一个阶梯式护理策略， 成瘾精神科医生管理（APM）（根据指示使用酒精药物治疗）和激励 针对CM未达到禁欲的患者的增强治疗（MET）。磷脂酰乙醇 （PEth）是一种经过验证的生物标志物，可以在三周内确认酒精戒断。捕捉到的范围 酒精对健康的不良影响，我们将包括有风险饮酒，酒精使用障碍， 可能受到酒精不利影响的医疗状况，包括可检测到HIV病毒载量的医疗状况， 烟草使用障碍，肝纤维化，未经治疗的丙型肝炎，抑郁症和服用精神活性药物的人 与酒精相互作用的药物。财政激励的目标，随机化与分步 治疗（FIRST）试验旨在比较现场CM加阶梯式护理与常规治疗（TAU）， 在7个HIV诊所对348名使用不健康酒精的HIV感染者进行随机临床试验。CM 患者将接受由社会工作者管理的现场CM咨询会议，并获得经济奖励 取决于酒精测试和肺氧合试验显示的禁欲情况奖励也可以颁发给 解决受酒精影响的医疗状况，实现酒精治疗目标。三个月后， 如果PEth结果表明患者尚未达到禁欲，则将患者升级至APM和MET。这 随机临床试验将检验CM加分级护理导致更大禁欲的假设， 减少饮酒量和改善艾滋病毒生物标志物，如VACS指数所测量的。数据 并会就病人的意向治疗样本进行分析。主要结果是 在六个月内记录了PEth患者的禁欲情况。次要结果包括酒精 使用时间轴随访评估的消耗和VACS指数的变化。新的方面， 建议包括：1）第一次评估CM在艾滋病诊所不健康的酒精使用，2）评估 现场CM加阶梯式护理，包括APM和MET，3）使用PEth指导CM奖励并作为试验 结果，4）用CM解决患者的动机，并关注受酒精影响的医疗状况，5） 使用VACS指数，这是一种经过验证的生物标志物，可反映艾滋病毒感染者的总体健康状况和禁欲情况 接受戒毒治疗的病人。这项由经验丰富的艾滋病毒和成瘾研究人员进行的研究， 将确定CM加阶梯式护理在使用不健康酒精的HIV感染患者中的疗效。

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.