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：
8211463
负责人：
David Fiellin
金额：
$ 65.88万
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/8211463
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 Injury Intention Intervention Intervention Trial Lead Light Link Liver 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 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. 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.

描述（由申请人提供）：不健康的饮酒会威胁到抗逆转录病毒疗法（ART）对 HIV 感染者（HIV+）患者的健康益处。尽管研究已经证明了简短干预、动机咨询和药物治疗 HIV 未感染患者不健康饮酒的有效性，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，在艾滋病毒诊所对成瘾进行综合治疗是可行的。分级护理算法可以促进对不健康饮酒的不同治疗强度的评估：〜拟议的研究将在三个相互关联的为期 6 个月的随机临床试验中比较现场综合分级护理治疗 (ISC) 与常规治疗 (TAU) 642 名 HIV + 患者有不健康的饮酒行为。筛选的患者在确定符合以下标准后被随机分配至 ISC 或 TAU：1) 有饮酒风险，2) 酗酒或依赖酒精，或 3) 存在肝病时适度饮酒。 ISC 和 TAU 是针对饮酒类别量身定制的。针对高危饮酒者以及中度饮酒和肝病患者的 ISC 首先进行简短的干预，然后对符合预定失败标准的患者进行动机增强治疗 (MET)。针对滥用或依赖的 ISC 始于成瘾精神科医生管理 (ARM)，包括酒精药物治疗（如果没有禁忌症）。如果满足预定义的故障标准，ARM 将逐步纳入 MET。该研究将检验 ISC 导致饮酒量减少和 HIV 生物标志物改善的假设。将针对处理样本的意图进行数据分析。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 指数的变化、ART 依从性和性风险行为。该提案的新颖之处包括： 1) 酒精和艾滋病毒综合治疗； 2）分级护理； 3) 使用 VACS 指数作为扩展的 HIV 生物标志物以及 4) 参与 COMpAAAS。这项拟议的研究由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 HIV+ 在不健康饮酒中的作用。公共健康相关性：本研究的目标是通过减少饮酒、提高用药依从性、改善 HIV 免疫标志物以及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。当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。