Clinical Core - The Center for Innovation in Point-of-Care Technologies for HIV/AIDS and Emerging Infectious Diseases at Northwestern University (C-THAN)

摘要-临床核心 艾滋病毒/艾滋病和新发传染病护理点技术创新中心 西北大学(C-Than)的疾病将继续成为NIBIB护理点的重要合作伙伴 技术研究和开发中心的技术研究网络(POCTRN)。 C-Than临床核心将受益于多年专注于传染病的研究和培训 在尼日利亚、南非、马里、塞内加尔和坦桑尼亚设有诊所。除了我们的关键学术机构 合作伙伴，我们将整合许多其他国际、国家、区域和社区利益攸关方参与 跨合作机构的POC和基于家庭的技术开发。我们的首要目标是 开发一系列PoC和基于家庭的技术，以满足以下个人的临床需求 低收入和中等收入国家的艾滋病毒/艾滋病和新发传染病。调查人员 将需要展示技术的分析和临床性能以及低成本的可用性 资源设置。临床核心具体目标是：1.验证和建立创新POC的协议 以及为艾滋病毒/艾滋病的诊断和管理而开发的基于家庭的技术，艾滋病毒相关的共同 病态，以及“真实世界”临床或社区环境中的开斋节。2.评估临床使用者(护理者和 患者)对设备的有用性、在社会文化背景下的可接受性、友好性和 舒适的艾滋病毒/艾滋病和开斋节POC和基于家庭的技术，以及3.支持创新的翻译 通过试点资金将PoC和基于家庭的技术从开发核心转化为临床研究， 在临床验证研究设计方面的专业知识，并提供包括生物样品和临床数据在内的服务。 我们的临床核心将继续为创新者提供“临床实验室”，专注于验证和 关于艾滋病毒/艾滋病和EID的POC和基于家庭的诊断的用户评估。根据 开发PoC技术，我们将跨核心合作，选择参与临床 核心或技术核心。临床核心的主要目标是提供基础设施和服务 致力于临床验证(从存储的样本或临床研究中)并评估临床使用者 可接受性，以确保本计划支持的PoC技术原型具有较高的 临床应用的成功和对公共健康的最大影响。

SUMMARY – CLINICAL CORE The Center for Innovation in Point-of-Care Technologies for HIV/AIDS and Emerging Infectious Diseases at Northwestern University (C-THAN) will continue to be a vital partner in the NIBIB Point-of-Care Technologies Research Network (POCTRN) of Technology Research and Development Centers (TRDCs). The C-THAN Clinical Core will benefit from many years of infectious diseases-focused research and training with clinical sites in Nigeria, South Africa, Mali, Senegal, and Tanzania. In addition to our key academic partners, we will integrate many other international, national, regional and community stakeholders involved in POC and home-based technology development across the partner institutions. Our overarching objective is to develop a pipeline of POC and home-based technologies that meet the clinical needs of individuals with HIV/AIDS and emerging infectious diseases (EID) in low and middle-income countries (LMICs). Investigators will be required to demonstrate analytical and clinical performance of technologies as well as usability in low resource settings. The Clinical Core specific aims are: 1. validate and establish protocols for innovative POC and home-based technologies developed for the diagnosis and management of HIV/AIDS, HIV-related co- morbidities, and EID in “real-world” clinical or community settings. 2. assess clinical user (caregiver and patient) perceptions of device usefulness, acceptability within the sociocultural context, friendliness, and comfort of HIV/AIDS and EID POC and home-based technologies, and 3. support translation of innovative POC and home-based technologies from the Development Core into clinical studies though pilot funding, expertise in clinical validation study design, and providing services including biospecimens with clinical data. Our Clinical Core will continue to provide a “clinical laboratory” for innovators that will focus on validation and user assessment of POC and home-based diagnostics on HIV/AIDS and EID. Depending on the status of a developing POC technology, we will work across Cores to select projects to participate in either the Clinical Core or Technology Core. The primary goal of the Clinical Core is to provide infrastructure and services dedicated to clinical validation (from stored samples or clinical studies) and to evaluate clinical user acceptability to ensure that the POC technology prototypes supported under this program have a high rate of success for clinical uptake and maximal public health impact.