Improving HAART Adherence in Depressed HIV Clinic Patients: A Real-World RCT

提高抑郁 HIV 诊所患者的 HAART 依从性：真实世界随机对照试验

基本信息

批准号：
7837438
负责人：
Brian W Pence
金额：
$ 41.26万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2014-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7837438
关键词：
AIDS/HIV problem Accident and Emergency department Acute Address Adherence Adverse effects Affect Algorithms Anti-Retroviral Agents Antidepressive Agents Antihypertensive Agents Attention Behavior Behavioral Biological Markers Blood Pressure Budgets CD4 Lymphocyte Count Caring Classification Clinic Clinical Clinical Management Cognition Collaborations Communicable Diseases Community Health Centers Counseling Crossover Design Data Depression screen Diabetes Mellitus Disease Disease model Dose Early treatment Elements Ensure Environment Fluoxetine Frequencies Future Genetic Crossing Over Glycosylated hemoglobin A Goals Guidelines HIV HIV Infections Health Health Personnel Health Status Highly Active Antiretroviral Therapy Homelessness Hospitals Immune system Immunologics International Intervention Joints Life Light Link Literature Measurement Measures Medical Mental Health Mental disorders Methods Metric Modeling Modification Monitor Motivation North Carolina Nurses Outcome Outcome Study Outpatients Participant Patient Care Patient Self-Report Patients Pharmaceutical Preparations Phase Physicians Placebo Control Primary Health Care Process Process Measure Protocols documentation Provider Psychiatrist Psychotherapy Published Comment Publishing Quality of Care Quality-Adjusted Life Years RNA Randomized Randomized Controlled Clinical Trials Randomized Controlled Trials Recording of previous events Recruitment Activity Relative (related person)Reporting Research Resources Role Services Shapes Site Social Workers Substance abuse problem Supervision Surveys Symptoms Techniques Testing Time Training Translating United States Universities Upper arm Viral Load result Visit Weight antiretroviral therapy base behavioral health brief intervention clinical care clinical practice clinical research site cognitive behavior therapy computerized data processing cost cost effectiveness depressed depression depressive symptoms design diabetes control evidence base evidence based guidelines expectation experience improved inpatient service interest marginally housed medication compliance men mortality motivational enhancement therapy pill preference provider intervention public health relevance response scale up sex risk standardize measure symposium therapy adherence tool treatment adherence treatment as usual treatment response treatment site treatment strategy trend

项目摘要

DESCRIPTION (provided by applicant): Depression is a serious concern in the clinical management of HIV infection, affecting 20-25% of people living with HIV/AIDS (PLWHA) and predicting a range of negative HIV-related behavioral and clinical health outcomes, including greater sexual risk behavior, worse antiretroviral medication adherence, poor response to antiretroviral therapy (ART), faster immune system decline, and higher mortality. Given the strong and consistent observational associations linking depression to negative HIV-related behaviors and outcomes, do effective depression interventions improve adherence for depressed PLWHA? Standard depression treatment strategies are efficacious in PLWHA, and observational data indicate that PLWHA with treated depression have better ART adherence and clinical outcomes than those with untreated depression. A handful of small randomized controlled trials (RCTs) using psychotherapy-based depression interventions in PLWHA has tended to show improved ART adherence. Much less attention has focused on antidepressant treatment interventions, which have a greater potential than psychotherapy-based interventions to address the resource constraints and lack of psychiatric expertise that define most HIV care settings. An combination of antidepressant therapy with brief adherence counseling in a model that could be integrated into routine clinical practice settings may have great potential to improve adherence in depressed HIV patients. Our goal in this R01 proposal is to conduct an RCT of an evidence-based depression treatment intervention known as Measurement-Based Care (MBC), combined with brief Motivational Interviewing (MI) adherence counseling, in depressed PLWHA to assess its impact on ART adherence and clinical outcomes. MBC employs clinical coordinators (CCs) with expertise in depression management to screen for depression and help non-psychiatric physicians implement guideline-concordant, algorithm-driven antidepressant treatment. The CC uses standardized metrics (depressive symptoms, side effects) and an algorithm to monitor treatment response and recommend changes. Weekly supervision from a psychiatrist ensures quality care. Biweekly contact between patients and the CC will include brief MI adherence counseling. We will recruit 390 PLWHA on ART with confirmed depression, and will conduct a provider-randomized trial of the MBC intervention versus enhanced usual care. Our 3 HIV clinical sites in North Carolina have a long history of collaboration on HIV behavioral health research. Our aims are: (1) to test whether MBC improves ART adherence and HIV clinical outcomes, (2) to assess the cost-effectiveness of MBC, and (3) to collect process measures concerning MBC implementation to inform replication at other sites. Since the CC role can be effectively filled by a behavioral health provider or nurse given appropriate training and supervision and the intervention has limited time requirements, this model is potentially replicable to a wide range of resource- constrained HIV treatment settings. PUBLIC HEALTH RELEVANCE: This project will integrate a depression treatment and brief medication adherence counseling intervention into clinical care at three HIV clinics and will use a randomized controlled trial to assess whether, relative to usual care, the intervention leads to improved HIV medication adherence. The depression treatment intervention uses a model known as Measurement-Based Care which equips Care Coordinators with systematic measurement tools, a decision algorithm, and psychiatric backup and trains them to provide decision support to HIV clinicians to implement, monitor, and adjust antidepressant therapy.

描述（由申请人提供）：抑郁症是艾滋病毒感染的临床管理的一个严重关注，影响了20-25％的艾滋病毒/艾滋病患者（PLWHA），并预测了一系列与HIV相关的行为和临床健康结果的负面，包括更大的性风险行为，更大的抗逆转录病毒药物粘附，较差的抗逆转录病毒疗法，对抗逆转录病毒疗法的反应较差，抗逆转录病毒疗法（ART），Faster，Faster，Faster，Faster，Fasters，Fasters），Fasters，Fasters，Fasters，Fasters），更高。鉴于将抑郁症与与HIV负相关的行为和结果联系起来的强烈，一致的观察性关联，有效的抑郁干预措施是否可以改善抑郁症的粘附性？标准抑郁症治疗策略在PLWHA中是有效的，观察数据表明，与未经治疗的抑郁症的PLWHA相比，患有治疗抑郁症的PLWHA具有更好的艺术依从性和临床结果。使用基于心理治疗的抑郁症干预措施的少数小型随机对照试验（RCT）倾向于表现出改善的艺术依从性。注意力少得多，集中在抗抑郁药治疗干预措施上，这些干预措施比基于心理治疗的干预措施具有更大的潜力来解决资源限制和缺乏定义大多数HIV护理环境的精神病专业知识。可以将抗抑郁治疗与可以融入常规临床实践环境中的模型中的简短依从性咨询的结合可能具有提高抑郁艾滋病毒患者依从性的巨大潜力。我们在R01提案中的目标是进行基于证据的抑郁症治疗干预措施，称为基于测量的护理（MBC），再加上简短的动机访谈（MI）依从性咨询，以抑制PLWHA，以评估其对艺术依从性和临床结果的影响。 MBC雇用具有抑郁症管理专业知识的临床协调员（CCS）来筛查抑郁症，并帮助非精神病医生实施指导方针 - 算法，算法驱动的抗抑郁药治疗。 CC使用标准化指标（抑郁症状，副作用）和算法来监测治疗反应并建议更改。精神科医生的每周监督可确保优质护理。患者和CC之间双周接触将包括简短的MI依从性咨询。我们将招募390个PLWHA，并具有确认的抑郁症，并将对MBC干预的提供商随机试验与增强的常规护理试验。我们在北卡罗来纳州的3个艾滋病毒临床部位在艾滋病毒行为健康研究方面的合作历史悠久。我们的目标是：（1）测试MBC是否改善了ART依从性和HIV临床结果，（2）评估MBC的成本效益，以及（3）收集有关MBC实施的过程指标，以告知其他站点的复制。由于在适当的培训和监督的情况下，行为健康提供者或护士可以有效地填补CC角色，并且干预措施的时间要求有限，因此该模型可能在广泛的资源约束HIV治疗环境中可以复制。公共卫生相关性：该项目将在三个HIV诊所将抑郁症治疗和简短的药物依从性咨询干预纳入临床护理中，并将使用随机对照试验来评估相对于通常的护理，干预措施是否会改善HIV药物的依从性。抑郁症治疗干预措施使用一种称为基于测量的护理的模型，该模型将护理协调员配备系统的测量工具，决策算法和精神病学备份，并训练它们为HIV临床医生提供决策支持，以实施，监测和调整抗抑郁药治疗。