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

• 批准号: 7991592
• 负责人: Brian W Pence
• 金额: $ 35.56万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 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/7991592
• 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; Clinic; Clinical; Clinical Management; Cognition; Cognitive Therapy; Collaborations; Communicable Diseases; Community Health Centers; Counseling; Crossover Design; Data; Depressed mood; 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 Depression; 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 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; Viral Load result; Visit; Weight; antiretroviral therapy; arm; base; behavioral health; brief intervention; clinical care; clinical practice; clinical research site; computerized data processing; cost; cost effectiveness; 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; randomized trial; response; scale up; sex risk; standardize measure; symposium; therapy adherence; tool; treatment adherence; treatment as usual; treatment response; treatment site; treatment strategy; trend

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 HIV 感染临床管理中的一个严重问题，影响 20-25% 的 HIV 感染者/艾滋病患者 (PLWHA)，并预测一系列与 HIV 相关的负面行为和临床健康结果，包括更高的性危险行为、更差的抗逆转录病毒药物依从性、抗逆转录病毒治疗（ART）反应不佳、免疫系统衰退更快以及死亡率更高。 鉴于抑郁症与艾滋病毒相关的负面行为和结果之间存在强烈且一致的观察关联，有效的抑郁症干预措施是否可以提高抑郁症感染者的依从性？标准抑郁症治疗策略对 PLWHA 有效，观察数据表明，与未经治疗的抑郁症患者相比，接受治疗的抑郁症患者具有更好的 ART 依从性和临床结果。一些针对 PLWHA 使用基于心理治疗的抑郁症干预措施的小型随机对照试验 (RCT) 往往显示出 ART 依从性有所提高。人们对抗抑郁治疗干预措施的关注要少得多，抗抑郁治疗干预措施比基于心理治疗的干预措施更有潜力解决大多数艾滋病毒护理环境中的资源限制和精神科专业知识的缺乏问题。将抗抑郁治疗与简短的依从性咨询相结合，建立一个可以整合到常规临床实践环境中的模型，可能具有提高抑郁症 HIV 患者依从性的巨大潜力。 我们在此 R01 提案中的目标是对抑郁症 PLWHA 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)）的随机对照试验 (RCT)，并结合简短的动机访谈 (MI) 依从性咨询，以评估其对 ART 依从性的影响和临床结果。 MBC 聘请具有抑郁症管理专业知识的临床协调员 (CC) 来筛查抑郁症，并帮助非精神科医生实施符合指南、算法驱动的抗抑郁治疗。 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改变。精神科医生的每周监督可确保优质护理。患者与 CC 之间每两周一次的联系将包括简短的 MI 依从性咨询。我们将招募 390 名患有确诊抑郁症的 ART 感染者，并将针对 MBC 干预与强化常规护理进行随机对照试验。我们位于北卡罗来纳州的 3 个 HIV 临床中心在 HIV 行为健康研究方面有着悠久的合作历史。我们的目标是：(1) 测试 MBC 是否可以改善 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 实施的流程措施，以便为其他地点的复制提供信息。由于行为健康提供者或护士经过适当的培训和监督可以有效地担任 CC 角色，并且干预措施的时间要求有限，因此该模型有可能复制到各种资源有限的艾滋病毒治疗环境中。 公共健康相关性：该项目将把抑郁症治疗和简短的药物依从性咨询干预纳入三个艾滋病毒诊所的临床护理中，并将使用随机对照试验来评估相对于常规护理，该干预措施是否可以改善艾滋病毒药物依从性。抑郁症治疗干预采用一种称为“基于测量的护理”的模型，该模型为护理协调员配备系统的测量工具、决策算法和精神科备份，并培训他们为艾滋病毒临床医生提供决策支持，以实施、监测和调整抗抑郁治疗。