Integrated Stepped Care for Unhealthy Alcohol Use in HIV

针对艾滋病毒不健康饮酒的综合分级护理

基本信息

批准号：
8531076
负责人：
David Fiellin
金额：
$ 57.36万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-15 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8531076
关键词：
AIDS prevention AIDS/HIV problem Abstinence Address Adherence Adverse effects Aging Alcohol abuse Alcohol consumption Alcohol dependence Alcohol or Other Drugs use Alcohols Algorithms Area Biological Markers Caring Categories Clinic Clinical Clinical Trials Cocaine Comorbidity Counseling Data Data Analyses Data Collection Dependence Development Disease Disease Progression Enrollment Evaluation Failure Funding Goals Grant HIV Health Benefit Hepatitis C Heroin Immunologic Markers Intention Intervention Intervention Trial Lead Light Link Liver diseases Marijuana Measures Mental Depression Modeling National Institute on Alcohol Abuse and Alcoholism Observational Study Online Systems Operations Research Outcome Outcomes Research Patient Self-Report Patients Pattern Pharmaceutical Preparations Pharmacotherapy Principal Investigator Psychiatrist Randomized Randomized Clinical Trials Reporting Research Research Personnel Risk Role Safety Sampling Services Site Subgroup Testing Tobacco Treatment Efficacy Unsafe Sex Veterans Viral Load result addiction alcohol abuse therapy alcohol misuse antiretroviral therapy brief intervention brief motivational intervention cohort comparative effectiveness compare effectiveness depressive symptoms design drinking experience high risk drinking improved indexing intervention effect liver injury medical specialties medication compliance meetings motivational enhancement therapy novel prescription opioid primary outcome prognostic psychosocial response secondary outcome sex risk therapy adherence treatment as usual treatment site

项目摘要

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.

描述（由申请人提供）：不健康的酒精使用威胁着抗逆转录病毒疗法（ART）的健康益处（HIV+）患者。尽管研究表明，短暂干预，动机咨询和药物治疗艾滋病毒统一患者的不健康饮酒的功效，但在HIV+患者中研究或使用这些治疗方法有限。我们已经证明，艾滋病毒诊所中成瘾的综合治疗是可行的。阶梯护理算法可以促进评估不健康酒精使用的不同治疗方法：〜拟议的研究将在三个，链接的，6个月的随机临床跟踪中的现场综合踩踏护理治疗（ISC）与治疗（ISC）与治疗（TAU）进行比较642名HIV+不健康饮酒的患者。筛查的患者在确定符合1）处于危险饮酒的标准后随机分配给ISC或TAU。 ISC和TAU是针对饮酒类别量身定制的。饮酒者的ISC，患有中度酒精和肝病的人始于短暂的干预措施，并在符合预定义的失败标准的人中加强了动机增强疗法（MET）。滥用或依赖性的ISC始于成瘾精神病医生管理（ARM），包括酒精药物治疗，即使没有禁忌。如果满足预定义的故障标准，则将手臂加紧安装。该研究将检验ISC导致饮酒降低和改善HIV生物标志物的假设。数据分析将以治疗样本的意图进行。主要结果是通过自我报告评估的饮酒的变化。次要结果包括VACS指数的变化，艺术依从性和性风险行为。该提案的新方面包括：1）综合酒精和艾滋病毒治疗； 2）阶梯护理； 3）VACS指数用作扩展的HIV生物标志物和4）参与CompaaaS。由经验丰富的艾滋病毒和成瘾研究人员进行的拟议研究将有助于通过不健康的饮酒来定义ISC HIV+的作用。