3/6 COMpAAAS U01: Intervention Study

3/6 COMPAAAS U01：干预研究

基本信息

批准号：
9767635
负责人：
David Fiellin
金额：
$ 42.06万
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 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9767635
关键词：
Abstinence Address Adherence Adverse effects Age Aging Alcohol abuse Alcohol consumption Alcohol or Other Drugs use Alcohols Anabasine Anti-Retroviral Agents Area Award Awareness Behavior Therapy Biological Markers CD4 Lymphocyte Count Caring Cessation of life Clinic Clinical Consumption Cotinine Counseling DSM-V Data Data Analyses Disease Effectiveness Enrollment Ethanol Evaluation Fingers Goals HIV Health Hematology Hepatitis C Immunologic Markers Individual Infection Intention Intervention Intervention Studies Kidney Legal patent Liver Liver Fibrosis Measures Medical Mental Depression Modeling Morbidity - disease rate Motivation Observational Study Operations Research Outcome Patient Self-Report Patients Pharmaceutical Preparations Pharmacotherapy Population Primary Health Care Psychiatrist Randomized Randomized Clinical Trials Research Research Personnel Research Project Grants Rewards Sampling Social Workers Specificity Study Section Testing TimeLine Tobacco Use Disorder Translating Treatment Efficacy Viral Load result addiction alcohol abstinence alcohol abuse therapy alcohol effect alcohol exposure alcohol misuse alcohol response alcohol use disorder arm base comparative efficacy contingency management depressive symptoms design drinking evidence base experience financial incentive high risk drinking improved improved outcome indexing mortality mortality risk motivational enhancement therapy novel off-patent patient response phosphatidylethanol premature primary outcome public health relevance reinforcer screening secondary outcome smoking cessation treatment as usual treatment effect treatment optimization treatment response treatment trial

项目摘要

HIV-infected patients with unhealthy alcohol use are not often motivated to decrease their alcohol consumption and rarely receive treatment for their drinking. To address these challenges, we plan to provide treatment in HIV clinics, highlight to patients the impact alcohol can have on their medical conditions, and use Contingency Management (CM) with a stepped care design to adjust treatment to patient response. CM is an evidence- based therapy that promotes abstinence from substance use, including alcohol. Since CM has not been studied for unhealthy alcohol use in HIV-infected patients we will include a stepped care strategy that provides Addiction Psychiatrist Management (APM) (with alcohol pharmacotherapies as indicated) and Motivational Enhancement Therapy (MET) for patients who do not achieve abstinence with CM. Phosphatidylethanol (PEth), is a validated biomarker that can confirm alcohol abstinence over three weeks. To capture the range of adverse effects of alcohol on health, we will include patients with at-risk drinking, alcohol use disorder, and medical conditions that can be adversely impacted by alcohol including those with a detectable HIV viral load, tobacco use disorder, liver fibrosis, untreated hepatitis C, depression and those taking psychoactive medications that interact with alcohol. The goal of the Financial Incentives, Randomization with Stepped Treatment (FIRST) Trial is to compare onsite CM plus stepped care versus treatment as usual (TAU) in a randomized clinical trial of 348 HIV-infected patients with unhealthy alcohol use at seven HIV clinics. CM patients will receive onsite CM counseling sessions adminstered by a Social Worker with financial rewards contingent on abstinence demonstrated by breathalyzer and PEth. Rewards can also be awarded for addressing medical conditions impacted by alcohol and achieving alcohol treatment goals. After three months, patients will be stepped up to APM and MET if PEth results indicate they have not attained abstinence. This randomized clinical trial will test the hypothesis that CM plus stepped care leads to greater abstinence, decreased alcohol consumption and improved HIV biomarkers as measured by the VACS Index. Data analyses will be conducted on the intention to treat sample of patients. The primary outcome is the proportion of individuals with PEth documented abstinence at six months. Secondary outcomes include alcohol consumption assessed using Timeline Followback, and change in the VACS Index. Novel aspects of this proposal include: 1) The first evaluation of CM for unhealthy alcohol use in HIV clinics, 2) An assessment of onsite CM plus stepped care including APM and MET, 3) Use of PEth to guide CM rewards and as a trial outcome, 4) Addressing patient motivation with CM and a focus on medical conditions impacted by alcohol, 5) Use of the VACS Index, a validated biomarker that reflects overall health and abstinence among HIV-infected patients receiving addiction treatment. This study, conducted by experienced HIV and addiction researchers, will determine the efficacy of CM plus stepped care in HIV-infected patients with unhealthy alcohol use.

感染不健康饮酒的艾滋病毒的患者并不经常会降低饮酒量而且很少因饮酒而接受治疗。为了应对这些挑战，我们计划在艾滋病毒诊所，突出显示酒精对医疗状况的影响，并使用意外情况采用阶梯护理设计的管理（CM），以调整治疗患者的反应。 CM是一个证据 - 基于促进药物使用（包括酒精）的禁欲的基于疗法。因为CM还没有在感染HIV的患者中研究了不健康的酒精使用成瘾精神病医生管理（APM）（如指示的酒精药物治疗）和激励性对于不戒酒CM的患者的增强疗法（MET）。磷脂酰乙醇（Peth）是一种经过验证的生物标志物，可以在三个星期内确认酒精戒烟。捕获酒精对健康的不利影响，我们将包括患有危险饮酒，酒精饮酒障碍和的患者可能会受到酒精（包括患有可检测到HIV病毒量的患者）的医疗状况，烟草使用障碍，肝纤维化，未经治疗的丙型肝炎，抑郁症和服用精神活性的患者与酒精相互作用的药物。经济激励措施的目标，随机分阶段治疗（第一次）试验是在现场CM加上阶梯护理与往常治疗（TAU）七个HIV诊所的348例HIV感染患者的随机临床试验。厘米患者将接受有经济奖励的社会工作者的席位CM咨询会议呼吸分析仪和Peth证明了节制的因素。奖励也可以授予解决受酒精影响并实现酒精治疗目标影响的医疗状况。三个月后，如果Peth的结果表明他们没有戒酒，将使患者加紧到APM。这随机临床试验将检验以下假设，即CM加阶梯护理会导致更大的戒酒，通过VACS指数衡量的饮酒量减少并改善了HIV生物标志物。数据将针对治疗患者样本进行分析。主要结果是比例有佩斯的人记录了六个月的禁欲。次要结果包括酒精使用时间轴后背评估消费，并更改VAC指数。新颖的方面建议包括：1）对HIV诊所中不健康饮酒的CM的首次评估，2）评估现场CM Plus阶梯护理，包括APM和MET，3）使用Peth指导CM奖励和试验结果，4）用CM解决患者动机，并关注受酒精影响的医疗状况，5）使用VACS索引，这是一种经过验证的生物标志物，反映了HIV感染的整体健康和戒酒接受成瘾治疗的患者。这项研究是由经验丰富的艾滋病毒和成瘾研究人员进行的将确定CM和阶梯护理在患有不健康饮酒的HIV感染患者中的疗效。