Core D: Clinical Sciences

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PROJECT SUMMARY/ABSTRACT – CLINICAL SCIENCES CORE D The RUSTBELT CFAR Clinical Sciences Core D, managed by an integrated group of highly experienced HIV/AIDS clinical investigators and staff, will serve as the centralized resource for CFAR users proposing or conducting clinical or translational research involving human participants, clinical data, or samples. The primary services provided by the core are (i) rapid access to existing clinical data and repository samples from persons with HIV (PWH), (ii) on-demand acquisition of fresh biologic samples from PWH, persons at risk for infection, and uninfected low risk individuals, and (iii) centralized clinical support provided by the CFAR to investigators for the design, implementation, conduct, and analysis of clinical research studies across the sites in the expanded RUSTBELT CFAR. In this next grant cycle, our capabilities will be dramatically enhanced by the addition of the outstanding Pittsburgh clinical cohorts. The merged Core will include expertise in HIV prevention, substance use, and cure research. Furthermore, the range of specimens that can be obtained will also be dramatically enhanced through the procurement of leukopheresis samples, gastrointestinal tissue, cerebrospinal fluid (CSF), cervical tissue, placenta, cord blood, bronchoalveolar lavage fluid (BAL), stool, and genital secretions for translational research. Core D maintains strong relationships with patient communities and affiliated AIDS service organizations and agencies through regular meetings of the Community Advisory Boards (CABs) and ongoing initiatives including AIDS-free Pittsburgh and End the Epidemic in Cleveland (EtHE in CLE). RUSTBELT CFAR Core D leaders will guide and link CFAR investigators to ongoing cohorts and study groups such as the Pittsburgh HIV Lung Research Cohort and the CFAR Network of Integrated Clinical Systems to enhance utilization of these powerful existing resources. Core D will also work closely with the Developmental Core B to ensure success of the projects selected for pilot and catalytic awards. Additionally, Core D will collaborate closely with Cores E (Viral Pathogenesis & Persistence) and F (Systems Biology & Biostatistics) to ensure that CFAR users are provided with the full spectrum of available resources in an efficient and coordinated fashion. Finally, Core D will collaborate with the Uganda Core C to provide CFAR users access to participant data and samples from the CFAR international site in Uganda, as well as to link international CFAR investigators to resources available from Core D. Thus, Core D broadens utilization of existing resources with users from multiple institutions and engages new and/or young investigators in HIV/AIDS research at the local, national, and international levels.