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

临床核心 - 西北大学艾滋病毒/艾滋病和新发传染病即时护理技术创新中心 (C-THAN)

• 批准号: 10762201
• 负责人: Chad J Achenbach
• 金额: $ 34.8万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-11 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10762201
• 关键词: Adoption; COVID-19 diagnostic; COVID-19 point of care; Caregivers; Characteristics; Chicago; Clinical; Clinical Data; Clinical Investigator; Clinical Research; Collaborations; Communicable Diseases; Communities; Community Health Networks; Dedications; Development; Devices; Diagnosis; Diagnostic; Emerging Communicable Diseases; Engineering; Enrollment; Evaluation; FDA Emergency Use Authorization; Faculty; Fogarty International Center; Funding; Goals; Grant; HIV; HIV/AIDS; Health; Home; Human; Illinois; Individual; Infrastructure; Institution; International; Laboratories; Leadership; Mali; Methodology; National Institute of Biomedical Imaging and Bioengineering; Nigeria; Participant; Patients; Perception; Performance; Pilot Projects; Point of Care Technology; Protocols documentation; Public Health; Public Health Practice; RADx; RADx Tech; Research; Research Design; Research Personnel; Research Project Grants; Research Training; Resource-limited setting; Reverse Transcriptase Polymerase Chain Reaction; Sampling Studies; Senegal; Services; Site; South Africa; Tanzania; Technology; Technology Assessment; Testing; Training; Training Programs; Translations; U-Series Cooperative Agreements; United States National Institutes of Health; Universities; Validation; Work; clinical research site; community setting; comorbidity; data repository; experience; innovation; low and middle-income countries; manufacture; medical schools; novel; pandemic disease; point of care; programs; prototype; research clinical testing; social culture; success; technology development; technology research and development; uptake; usability; validation studies; virtual repository

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.

总结-临床核心 艾滋病毒/艾滋病和新兴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 技术研究和发展中心的技术研究网络。 C-THAN临床核心将受益于多年以传染病为重点的研究和培训 在尼日利亚、南非、马里、塞内加尔和坦桑尼亚设有临床基地。除了我们的主要学术 我们将与许多其他国际、国家、区域和社区利益攸关方合作， 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POC和基于家庭的技术管道，满足个人的临床需求， 低收入和中等收入国家的艾滋病毒/艾滋病和新出现的传染病。调查人员 将被要求证明技术的分析和临床性能以及在低 资源设置。临床核心的具体目标是：1。验证和建立创新POC的协议 和家庭为诊断和管理艾滋病毒/艾滋病开发的技术，与艾滋病毒有关的合作， 发病率，以及“现实世界”临床或社区环境中的EID。2.评估临床用户（护理人员和 患者）对器械有用性、社会文化背景下的可接受性、友好性的感知，以及 舒适的艾滋病毒/艾滋病和EID POC和家庭为基础的技术，和3。支持翻译创新 通过试点资助，将POC和基于家庭的技术从开发核心转化为临床研究， 临床验证研究设计方面的专业知识，并提供包括生物样本和临床数据在内的服务。 我们的临床中心将继续为创新者提供一个“临床实验室”，重点是验证和 对艾滋病毒/艾滋病和早期感染者进行POC和家庭诊断的用户评估。根据一个 在开发POC技术时，我们将与核心公司合作，选择参与临床研究的项目， 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 专门用于临床验证（来自储存的样本或临床研究）和评价临床用户 可接受性，以确保该计划下支持的POC技术原型具有较高的 临床应用的成功和最大的公共卫生影响。