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

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，影响着20-25%的HIV/AIDS感染者（PLWHA），并预示着一系列HIV相关的负面行为和临床健康结果，包括更大的性风险行为、更差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、更快的免疫系统衰退和更高的死亡率。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而一致的观察关联，有效的抑郁症干预措施是否能改善抑郁症感染者的依从性？标准的抑郁症治疗策略对PLWHA患者有效，观察数据表明，与未经治疗的抑郁症患者相比，接受过抑郁症治疗的PLWHA患者有更好的抗逆转录病毒治疗依从性和临床结果。少数在艾滋病患者中使用基于心理治疗的抑郁干预措施的小型随机对照试验（rct）倾向于显示抗逆转录病毒治疗依从性得到改善。人们对抗抑郁治疗干预措施的关注要少得多，这种干预措施比基于心理治疗的干预措施更有潜力解决资源限制和缺乏精神病学专业知识的问题，这些问题是大多数艾滋病毒护理环境的特点。将抗抑郁药物治疗与短暂的依从性咨询结合起来，并将其纳入常规临床实践环境中，可能会极大地提高抑郁HIV患者的依从性。我们在这个R01建议中的目标是对一种基于证据的抑郁症治疗干预措施进行RCT，即基于测量的护理（MBC），结合简短的动机性访谈（MI）依从性咨询，在抑郁的PLWHA中评估其对ART依从性和临床结果的影响。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的、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）和一种算法来监测治疗反应并建议改变。每周由精神科医生监督确保高质量的护理。患者与CC之间的每两周接触将包括简短的MI依从性咨询。我们将招募390名接受抗逆转录病毒治疗并确诊患有抑郁症的艾滋病感染者，并将对MBC干预与强化常规护理进行一项提供者随机试验。我们在北卡罗莱纳州的3个HIV临床站点在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是否能改善ART依从性和HIV临床结果，(2)评估MBC的成本效益，(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。由于行为健康提供者或护士在接受适当培训和监督的情况下可以有效地发挥CC的作用，而且干预的时间要求有限，因此这种模式有可能在资源有限的艾滋病毒治疗环境中广泛复制。

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.