The CFAR/CSG Clinical Core will provide a mechanism for multidisciplinary collaboration among basic, clinical and behavioral scientistic to address innovative research questions important to a better understanding of HIV disease pathogenesis or better methods of diagnosis or treatment of HIV disease. Specifically, this Core will facilitate translation between basic and clinical HIV research by providing 1) expert clinical research consultation to assist basic scientists in developing the most appropriate protocol design for testing their specific hypotheses, 2) experienced clinical research staff personnel to recruit subjects and implement protocols thus providing basic scientists in developing the most appropriate specimens needed for specific hypothesis testing, 3) behavioral expertise to basic scientists and clinical researchers to assist them in conceptualizing and implementing research protocols and interpreting findings, and 4) behavioral scientists the opportunity to test hypotheses relevant to behavioral research questions in clinical populations. The expert clinical consultation service includes an associate professor of medicine infectious diseases/clinical trials specialist a research pharmacist/coordinator, an associate professor of biostatistics, who will serve as coordinator of the Behavioral Research Unit within in the Clinical Core, each with 8 or more years of academic, HIV-related clinical research experience at UCSF. The Core Director and Research Coordinator already coordinate a dynamic HIV clinical research program as San Francisco General Hospital that is integrated into an outpatient clinic with a patients base of greater than 3,000 individuals at various stages of HIV disease. The Core Director, Study Coordinator and scientists in the Behavioral Research Unit already collaborate on a number of multidisciplinary studies to test specific hypotheses that emerge from basic research. The full Clinical Core service will provide consultation with the investigators to determine optimal study design, preparation of a written study protocol and subjects informed consent form, obtaining IRB approval and ;maintaining required IRBG correspondence for the protocol, recruitment of subjects, obtaining and providing investigator with all protocol-specific specimens are relevant clinical data, long-term storage of specimens in an ultra-low temperature specimen repository, and behavioral assessments. These services will enable different investigators, and multidisciplinary teams of investigators, to efficiently explore innovative hypotheses, ranging from clinical studies of the molecular biology of HIV to behavioral studies of cofactors in treatment response among women and minorities.
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