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抗逆转录病毒疗法(ART)对艾滋病毒感染(HIV+)患者的健康益处。尽管研究已经证明了简单的干预、动机咨询和药物治疗对未感染HIV的患者使用不健康的酒精具有疗效，但在HIV+患者中使用这些治疗方法的研究或使用有限。我们已经证明，在艾滋病毒诊所进行成瘾综合治疗是可行的。分级护理算法可以促进对不同强度的不健康饮酒治疗的评估：~拟议的研究将在642名不健康饮酒的HIV+患者中，在三个相关的6个月随机临床试验中比较现场综合分级护理治疗(ISC)和照常治疗(TAU)。筛查的患者在确定他们符合1)高风险饮酒、2)酗酒或依赖或3)存在肝病的中度饮酒标准后，被随机分配到ISC或TAU。ISC和TAU是为饮酒类别量身定做的。针对高危饮酒者和中度饮酒者和肝病患者的ISC从简短的干预开始，并对那些达到预先定义的失败标准的人加强激励增强疗法(MET)。滥用或依赖的ISC始于成瘾精神科医生的治疗(ARM)，如果没有禁忌证，包括酒精药物治疗。如果满足预定义的故障标准，则ARM将进一步包括MET。这项研究将检验ISC导致酒精消费减少和艾滋病毒生物标志物改善的假设。将对样本处理意向进行数据分析。主要结果是通过自我报告评估酒精消费的变化。次要结果包括VAS指数、抗逆转录病毒治疗依从性和性危险行为的改变。这项提议的新方面包括：1)酒精和艾滋病毒的综合治疗；2)阶梯式护理；3)使用Vacs指数作为扩大的艾滋病毒生物标志物；4)参与COMpAAAS。这项拟议的研究由一个由艾滋病毒和成瘾研究人员组成的经验丰富的团队进行，将有助于确定ISC艾滋病毒+在不健康饮酒中的作用。 公共卫生相关性：这项研究的目标是通过减少饮酒，提高服药依从性，改善艾滋病毒免疫标志物，并通过降低不健康饮酒患者的性风险，促进预防艾滋病毒传播，从而优化艾滋病毒的治疗。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接受的护理类型。

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.