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.

不健康饮酒的艾滋病毒感染者通常没有动力减少饮酒量并且很少因酗酒而接受治疗。为了应对这些挑战，我们计划在 HIV 诊所向患者强调酒精对其健康状况的影响，并使用应急措施管理 (CM) 采用阶梯式护理设计，根据患者反应调整治疗。 CM就是一个证据—— 促进戒除酒精等物质使用的基础疗法。由于CM还没有针对艾滋病毒感染者不健康饮酒的研究，我们将采取阶梯式护理策略，提供成瘾精神科医生管理（APM）（按照指示进行酒精药物治疗）和激励针对 CM 未实现戒断的患者进行强化治疗 (MET)。磷脂酰乙醇 (PEth) 是一种经过验证的生物标志物，可以确认三周内的戒酒情况。捕捉范围酒精对健康的不利影响，我们将包括有饮酒风险、酒精使用障碍和可能受到酒精不利影响的医疗状况，包括那些可检测到艾滋病病毒载量的医疗状况，烟草使用障碍、肝纤维化、未经治疗的丙型肝炎、抑郁症和服用精神药物的人与酒精相互作用的药物。财务激励的目标，逐步随机化治疗（FIRST）试验旨在比较现场 CM 加阶梯式护理与常规治疗 (TAU) 在 7 个 HIV 诊所对 348 名 HIV 感染者进行了不健康饮酒的随机临床试验。厘米患者将接受由社会工作者主持的现场 CM 咨询课程，并获得经济奖励取决于呼吸分析仪和 PEth 证明的戒断情况。还可以获得奖励解决受酒精影响的医疗状况并实现酒精治疗目标。三个月后，如果 PEth 结果表明患者尚未实现戒断，他们将被升级为 APM 和 MET。这随机临床试验将检验 CM 加上阶梯式护理可提高戒欲效果的假设，根据 VACS 指数测量，减少饮酒量并改善 HIV 生物标志物。数据将对患者样本的治疗意图进行分析。主要结果是比例患有 PEth 的个体在六个月时记录了禁欲。次要结果包括酒精使用时间线追踪和 VACS 指数的变化评估消耗量。这方面的新颖之处提案包括：1) 首次对 HIV 诊所中不健康饮酒行为进行 CM 评估，2) 评估现场 CM 加上阶梯式护理，包括 APM 和 MET，3) 使用 PEth 指导 CM 奖励并作为试用结果，4) 通过 CM 解决患者动机并关注受酒精影响的医疗状况，5) 使用 VACS 指数，这是一种经过验证的生物标志物，可反映 HIV 感染者的整体健康状况和禁欲情况接受成瘾治疗的患者。这项研究由经验丰富的艾滋病毒和成瘾研究人员进行，将确定 CM 加阶梯护理对不健康饮酒的 HIV 感染患者的疗效。