Clinical-Trans-Valid Core

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SUMMARY – CLINICAL TRANSLATION AND VALIDATION CORE The C-THAN Clinical Translation and Validation Core (Clinical Trans Valid Core) will be robust and achievable due to many years of HIV-focused clinical research and research training with local partners in Nigeria, South Africa, Mali, and Tanzania. In addition to our key academic partners, we will integrate many other international, national, regional and community stakeholders involved in POC development, validation, and implementation across the partner institutions. Our overarching objective is to develop a pipeline of POC products that meet the clinical needs of HIV-infected individuals in low and middle-income countries. Investigators will be required to demonstrate analytical and clinical performance of technologies as well as suitability and feasibility of use in low resource settings. The Clinical Trans Valid Core specific aims are: 1. validate and establish best practices for innovative POC technologies developed for the diagnosis and management of HIV and HIV related co- morbidities in “real-world” clinical or public health settings, 2. assess outcomes of implementation processes of innovative POC technologies developed for the diagnosis and management of HIV and HIV related co- morbidities in “real-world” clinical or public health settings, and 3. support translation of innovative POC technologies from the Technology Development (Technology Dev) Core into clinical practice though pilot funding, expertise in validation and implementation science, and providing resources including support to develop needed trainings, manuals and other tools to ensure effective uptake. Our Clinical Trans Valid Core will provide a “clinical laboratory” for innovators that will focus on validation, adoption, and assessment of feasibility and implementation of POC technologies. Depending on the status of a developing POC technology, we will work across Cores to select projects to participate in either the Clinical Trans Valid Core or Technology Dev Core. We will also review projects in the Technology Dev Core in later stages for potential transition into the Clinical Trans Valid Core. The primary goal of the Clinical Trans Valid Core is to provide infrastructure and services dedicated to clinical validation of POC technologies and to evaluate implementation outcomes including adoption, fidelity, feasibility and acceptability to ensure that POC technology prototypes supported under C-THAN will have a high rate of success for clinical uptake and maximal public health impact.