Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials.
Understanding and optimizing brain health in HIV now: protocol for a longitudinal cohort study with multiple randomized controlled trials.
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DOI：
10.1186/s12883-016-0527-1
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发表时间：
2016-01-14
期刊：
影响因子：
2.6
通讯作者：
Positive Brain Health Now Investigators
中科院分区：
文献类型：
--
作者：
Mayo NE;Brouillette MJ;Fellows LK;Positive Brain Health Now Investigators
慢性HIV感染通常影响认知和心理健康，即使有良好的系统病毒控制。大脑健康受损的原因可能是与艾滋病毒相关的生物因素、共病（如衰老和脑血管疾病）以及因患有慢性疾病的生活压力而导致的应对技能、身体健康和社会支持的削弱等多因素组合。本研究旨在更好地了解艾滋病毒患者的认知抱怨、抑郁和客观测量的认知障碍之间的关系，以及与这些表现及其随时间演变有关的关键因素，无论是生物因素还是个人因素。这种异质性的特征将允许更集中的病理生理学研究，并允许更有针对性的干预。该项目广泛利用基于网络的研究和保健提供工具，旨在提供具有成本效益的“可用于临床”的工具，以改善艾滋病毒感染者的大脑健康。该项目有两个总体目标，反映了我们了解和改善艾滋病毒大脑健康的双重目标，重点关注认知障碍，其贡献者和后果。目标是为简短的脑健康评估的有效性提供证据，估计与艾滋病毒相关的认知相关临床因素和以患者为中心的结果相互关联和随时间演变的程度，从而确定支撑脑健康纵向变化的机制，并为可行性、有效性潜力、可接受性、以及优化大脑健康的潜在机制。我们采用队列多重随机对照试验设计。总共900名参与者将在27个月的时间内进行前瞻性特征描述，以回答有关感兴趣的结果演变的问题。所有参与者将获得基本的大脑健康自我管理信息。小组将参与具体、更密集干预措施的试点研究，为可行性、有效性和相对有效性提供务实证据。这项工作将提供必要的艾滋病毒负担、异质性、进化和大脑健康受损机制的估计，并测试一系列有希望的非药物干预措施。这是一项正在进行的研究；该队列中目前正在招募参与者的试验于2015年10月7日注册（Clinicaltrials.gov NCT02571504和NCT02571595）。
Chronic HIV infection commonly affects both cognition and mental health, even with excellent systemic viral control. The causes of compromised brain health are likely to be a multi-factorial combination of HIV-related biological factors, co-morbidities such as aging and cerebrovascular disease, and the erosion of coping skills, physical health, and social supports resulting from the strains of living with a chronic illness. This study aims to provide a better understanding of the relationship between cognitive complaints, depression, and objectively measured cognitive impairment in HIV, and of the key factors, whether biological or personal, which relate to these presentations and to their evolution over time. Characterization of this heterogeneity will permit more focused pathophysiological studies, and allow more targeted interventions. The project makes extensive use of Web-based research and health care delivery tools, aiming to provide cost-effective, “clinic ready” tools to improve brain health in HIV. This project has two overarching aims, reflecting our dual goals of understanding and improving brain health in HIV, focusing on cognitive impairment, its contributors and consequences. The objectives are to contribute evidence for the validity of a brief brain health assessment, to estimate the extent to which HIV-related cognition-relevant clinical factors and patient-centered outcomes inter-relate and evolve over time, allowing identification of the mechanisms underpinning longitudinal change in brain health and to contribute evidence for the feasibility, effectiveness potential, acceptability, and underlying mechanisms of promising interventions for optimizing brain health. We adopt a cohort multiple randomized control trials design. A total of 900 participants will be characterized prospectively over a 27-month period to answer questions about the evolution of outcomes of interest. All participants will be offered basic brain health self-management information. Sub-groups will participate in pilot studies of specific, more intensive interventions to provide pragmatic evidence for feasibility, effectiveness, and comparative effectiveness. This work will provide needed estimates of the burden, heterogeneity, evolution, and mechanisms underlying compromised brain health in HIV, and test a range of promising non-pharmacological interventions. This is an on-going study; the trials nested within this cohort that are currently recruiting participants were registered on 7 October 2015 (Clinicaltrials.gov NCT02571504 and NCT02571595).