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

抑郁症是艾滋病毒临床治疗中的一个严重问题，20%-25%的人受到影响 艾滋病毒携带者/艾滋病(PLWHA)和预测一系列与艾滋病毒相关的阴性行为和临床健康 结果，包括更大的性行为风险，更差的抗逆转录病毒药物依从性，对 抗逆转录病毒疗法(ART)、更快的免疫系统衰退和更高的死亡率。 考虑到抑郁症与HIV相关阴性之间的强烈和一致的观察联系 行为和结果，有效的抑郁干预是否提高了抑郁的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 与未经治疗的抑郁症患者相比，接受治疗的抑郁症患者的ART依从性和临床结果更好 抑郁症。几个使用心理治疗抑郁症的小型随机对照试验(RCT) PLWHA的干预措施往往表明，抗逆转录病毒治疗的依从性有所改善。更少的关注集中在 抗抑郁治疗干预，这比基于心理治疗的干预具有更大的潜力 以解决界定大多数艾滋病毒护理环境的资源限制和缺乏精神病学专业知识的问题。一个 将抗抑郁药物治疗与短暂的依从性咨询相结合的模式可以整合到 常规的临床实践设置可能会极大地提高抑郁的艾滋病毒患者的依从性。 我们在R01提案中的目标是进行一项循证抑郁症治疗的随机对照试验 干预被称为基于测量的护理(MBC)，与简短的动机访谈(MI)相结合 依从性咨询，在抑郁症的PLWHA中评估其对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、算法驱动的抗抑郁药物 治疗。CC使用标准化的指标(抑郁症状、副作用)和算法来监控 治疗反应和建议改变。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人 PLWHA对确诊为抑郁症的抗逆转录病毒治疗，并将进行MBC的提供者随机试验 干预与加强常规护理的对比。我们在北卡罗来纳州的3个艾滋病毒诊所有很长的历史 艾滋病行为健康研究方面的合作。我们的目标是：(1)测试MBC是否提高了ART 依从性和HIV临床结果，(2)评估MBC的成本效益，以及(3)收集过程 关于MBC实施的措施，以告知其他站点的复制情况。因为抄送角色可以是 由接受过适当培训和监督的行为健康提供者或护士有效填补，并且 干预有有限的时间要求，这种模式有可能复制到广泛的资源- 受限制的艾滋病毒治疗环境。

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.