Integrated Stepped Care for Unhealthy Alcohol Use in HIV

描述（由申请人提供）：不健康的酒精使用威胁到艾滋病毒感染（艾滋病毒+）患者抗逆转录病毒治疗（ART）所带来的健康益处。虽然研究已经证明了短期干预、动机咨询和药物治疗未感染艾滋病毒的患者不健康饮酒的有效性，但在艾滋病毒阳性患者中对这些治疗方法的研究或使用有限。我们已经证明，在艾滋病毒诊所对成瘾进行综合治疗是可行的。阶梯式护理算法可以促进对不健康酒精使用的不同强度治疗的评估：~拟议的研究将在642名不健康酒精使用的HIV+患者的三个为期6个月的随机临床试验中，比较现场综合阶梯式护理治疗（ISC）和常规治疗（TAU）。经筛选的患者在确定符合以下标准后，随机分配到ISC或TAU组：1)高危饮酒，2)酒精滥用或依赖，或3)存在肝脏疾病的中度饮酒。ISC和TAU是为饮酒类别量身定制的。对于高危饮酒者、中度饮酒者和肝病患者，ISC从短暂干预开始，并在符合预定失败标准的患者中逐步进行动机增强治疗（MET）。滥用或依赖的ISC开始于成瘾精神科医生管理（ARM），如果没有禁忌症，包括酒精药物治疗。如果满足预定义的故障标准，ARM将升级为包括MET。该研究将验证ISC导致酒精消费量减少和艾滋病毒生物标志物改善的假设。数据分析将根据处理样本的意向进行。主要结果是通过自我报告评估酒精消费量的变化。次要结局包括VACS指数、抗逆转录病毒治疗依从性和性危险行为的改变。这一建议的新方面包括：1)酒精和艾滋病毒综合治疗；2)阶梯式护理；3)使用VACS指数作为扩展的HIV生物标志物和4)参与COMpAAAS。这项拟议的研究由一个经验丰富的艾滋病毒和成瘾研究人员团队进行，将有助于确定ISC艾滋病毒+与不健康酒精使用的作用。

DESCRIPTION (provided by applicant): Unhealthy alcohol use threatens the health benefits seen with antiretroviral therapy (ART) for HIV-infected (HIV+) patients. Although research has demonstrated the efficacy of brief interventions, motivational counseling, and medications to treat unhealthy alcohol use in HIV unifected patients, there is limited research or use of these treatments in HIV+ patients. We have demonstrated that integrated treatment of addiction in HIV clinics is feasible. Stepped care algorithms can facilitate the evaluation of varying intensities of treatments for unhealthy alcohol use:~The proposed study will compare onsite Integrated Stepped Care treatment (ISC) to treatment as usual (TAU) in three, linked, 6-month randomized clinical trails in 642 HIV+ patients with unhealthy alcohol use. Screened patients are randomized to ISC or TAU after determining that they meet criteria for either 1) at-risk drinking, 2) alcohol abuse or dependence or 3) moderate alcohol consumption in the presence of liver disease. ISC and TAU are tailored to the drinking category. ISC for at- risk drinkers and those with moderate alcohol use and liver disease begins with a brief intervention and is stepped up to Motivational Enhancement Therapy (MET) in those who meet predefined failure criteria. ISC for abuse or dependence begins with addiction psychiatrist management (ARM) including alcohol pharmacotherapy if not contraindicated. ARM is stepped up to include MET if predefined failure criteria are met. The study will test the hypothesis that ISC leads to decreased alcohol consumption and improved HIV biomarkers. Data analyses will be conducted on the intention to treat sample. The primary outcome is change in alcohol consumption assessed by self report. Secondary outcomes include change in the VACS Index, ART adherence, and sexual risk behaviors. Novel aspects of this proposal include: 1) Integrated alcohol and HIV treatment; 2) Stepped care; 3) The use of the VACS Index as an expanded HIV biomarker and 4) Participation in COMpAAAS. The proposed study, conducted by an experienced team of HIV and addiction researchers, will help define the role of ISC HIV+ with unhealthy alcohol use. PUBLIC HEALTH RELEVANCE: The goals of this study are to optimize the treatment of HIV disease by decreasing alcohol consumption, improving medication adherence, improving HIV immune markers, and promoting the prevention of HIV spread by decreasing sexual risk in patients with unhealthy alcohol use. The current project will serve to advance this area of research and expand the types of care that HIV-infected patients receive.