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: 8532038
• 负责人: Brian W Pence
• 金额: $ 66.36万
• 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 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8532038
• 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 Intervention; 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 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; care delivery; 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; 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; two-arm study

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.

抑郁症是艾滋病毒感染临床管理中的一个严重问题，影响20-25%的人 艾滋病毒/艾滋病（PLWHA）感染者和预测一系列负面的艾滋病毒相关的行为和临床健康 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， 抗逆转录病毒治疗（ART），免疫系统下降更快，死亡率更高。 考虑到抑郁症与艾滋病毒相关的负面影响之间强有力的和一致的观察关联， 行为和结果，有效的抑郁干预措施是否能提高抑郁的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，患有抑郁症的PLWHA具有更好的ART依从性和临床结局 萧条少数使用基于心理治疗的抑郁症的小型随机对照试验（RCT） 对艾滋病毒/艾滋病感染者和艾滋病患者的干预措施往往显示出抗逆转录病毒疗法坚持率的提高。很少有人关注 抗抑郁治疗干预，比基于心理治疗的干预具有更大的潜力 解决资源限制和缺乏精神病学专业知识的问题，这是大多数艾滋病毒护理机构的特点。一个 抗抑郁治疗与简短的依从性咨询相结合的模型，可以整合到 常规的临床实践环境可能有很大的潜力，以提高抑郁症艾滋病毒患者的依从性。 我们在R 01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 被称为基于测量的护理（MBC）的干预，结合简短的动机访谈（MI） 依从性咨询，在抑郁的PLWHA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与指南一致的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 治疗反应和建议的变化。精神科医生的每周监督确保了高质量的护理。 患者与CC之间的每两周联系将包括简短的MI依从性咨询。我们将招募390名 艾滋病毒感染者和艾滋病病毒携带者在抗逆转录病毒治疗中确诊抑郁症，并将对MBC进行提供者随机试验 干预与加强常规护理。我们在北卡罗来纳州的3个艾滋病毒临床站点有着悠久的历史， 艾滋病行为健康研究合作。我们的目的是：（1）测试MBC是否改善ART 依从性和HIV临床结果，（2）评估MBC的成本效益，（3）收集过程 关于执行《最低限度商业合同》的措施，以便为其他地点的推广工作提供信息。由于CC角色可以是 由接受适当培训和监督的行为健康提供者或护士有效填补， 干预所需时间有限，这种模式有可能推广到各种资源， 艾滋病毒治疗环境受到限制。