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

描述(申请人提供)：抑郁症是艾滋病毒感染的临床管理中的一个严重问题，影响20%-25%的艾滋病毒/艾滋病患者(PLWHA)，并预测一系列与艾滋病毒相关的负面健康结果，包括更多的性行为风险行为，更糟糕的抗逆转录病毒药物依从性，对抗逆转录病毒治疗(ART)的不良反应，免疫系统更快的下降，以及更高的死亡率。鉴于抑郁症与阴性的HIV相关行为和结果之间存在强烈和一致的观察关联，有效的抑郁症干预措施是否能提高抑郁症患者对PLWHA的依从性？标准的抑郁症治疗策略在PLWHA中是有效的，观察数据表明，与未治疗的抑郁症相比，经治疗的抑郁症的PLWHA具有更好的ART依从性和临床结果。在PLWHA中使用基于心理疗法的抑郁症干预的少数小型随机对照试验(RCT)往往显示出改善的ART依从性。对抗抑郁治疗干预措施的关注要少得多，这些干预措施比以心理治疗为基础的干预措施具有更大的潜力，以解决资源限制和缺乏精神病学专业知识的问题，而这些知识定义了大多数艾滋病毒护理环境。在一种可以整合到常规临床实践环境中的模式中，将抗抑郁治疗与短暂的依从性咨询相结合，可能会极大地提高抑郁的艾滋病毒患者的依从性。我们在这份R01提案中的目标是在抑郁症PLWHA中进行一项被称为基于测量的护理(MBC)的循证抑郁症治疗干预措施的RCT，并结合简短的动机访谈(MI)依从性咨询，以评估其对ART依从性和临床结果的影响。MBC聘请了在抑郁症管理方面具有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使用标准化的指标(抑郁症状、副作用)和算法来监控治疗反应并建议改变。精神科医生每周的监督确保了高质量的护理。患者与CC之间的双周接触将包括短暂的MI依从性咨询。我们将招募390名确诊为抑郁症的抗逆转录病毒治疗的PLWHA，并将进行一项MBC干预与增强型常规护理的提供者随机试验。我们在北卡罗来纳州的3个HIV临床站点在HIV行为健康研究方面有着长期的合作历史。我们的目标是：(1)测试MBC是否能改善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实施的过程措施，为其他地点的复制提供信息。由于CC的角色可以由给予适当培训和监督的行为健康提供者或护士有效地填补，并且干预具有有限的时间要求，因此这种模式有可能被复制到广泛的资源受限的艾滋病毒治疗环境中。 公共卫生相关性：该项目将在三家艾滋病毒诊所的临床护理中整合抑郁症治疗和短暂的服药依从性咨询干预，并将使用随机对照试验来评估干预是否相对于常规护理导致艾滋病毒用药依从性的改善。抑郁症治疗干预使用一种被称为基于测量的护理的模式，该模式为护理协调员配备了系统的测量工具、决策算法和精神支持，并培训他们为艾滋病毒临床医生提供决策支持，以实施、监测和调整抗抑郁药物治疗。

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.