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

总结-临床核心

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.