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（HIV+）患者抗逆转录病毒治疗（ART）的健康益处。虽然研究已经证明了简短的干预措施，动机咨询和药物治疗HIV未感染患者的不健康酒精使用的有效性，但这些治疗方法在HIV+患者中的研究或使用有限。我们已经证明，在艾滋病毒诊所综合治疗成瘾是可行的。阶梯式护理算法可以促进对不健康酒精用途：~拟议的研究将在642名不健康酒精使用的HIV+患者中进行三项相关的6个月随机临床试验，比较现场综合阶梯式护理治疗（ISC）与常规治疗（TAU）。筛选的患者在确定他们符合以下标准后被随机分配到ISC或TAU：1）有风险饮酒，2）酒精滥用或依赖或3）在存在肝病的情况下适度饮酒。ISC和TAU是为饮酒类别量身定制的。针对高危饮酒者和中度饮酒和肝病患者的ISC从简短的干预开始，并在符合预定义失败标准的患者中逐步升级为动机增强疗法（MET）。滥用或依赖的ISC开始于成瘾精神科医生管理（ARM），包括酒精药物治疗，如果没有禁忌。如果满足预定义的失效标准，则ARM将逐步增加以包括MET。这项研究将检验ISC导致酒精消费减少和HIV生物标志物改善的假设。将对意向处理样本进行数据分析。主要结果是通过自我报告评估的饮酒量变化。次要结果包括VACS指数、ART依从性和性风险行为的变化。该提案的新方面包括：1）酒精和艾滋病毒综合治疗; 2）阶梯式护理; 3）使用VACS指数作为扩展的艾滋病毒生物标志物和4）参与COMpAAAS。这项由经验丰富的HIV和成瘾研究人员团队进行的拟议研究将有助于确定ISC HIV+与不健康酒精使用的作用。 公共卫生相关性：本研究的目的是通过减少饮酒，提高药物依从性，改善HIV免疫标志物，并通过降低不健康饮酒患者的性风险来促进预防HIV传播，从而优化HIV疾病的治疗。目前的项目将有助于推进这一领域的研究，并扩大艾滋病毒感染者得到的护理种类。

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.