UNC Center for AIDS Research Core C Clinical

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PROJECT SUMMARY/ABSTRACT – CLINICAL CORE (CORE C) The UNC CFAR Clinical Core’s mission is to provide services and resources, centered on people living with and at risk for HIV, to foster dynamic and innovative clinical and translational HIV research at UNC Chapel Hill, FHI 360 and RTI. The Core, led by Drs. Joseph Eron, Sonia Napravnik, and Claire Farel, is positioned to respond to key emerging questions in HIV prevention, transmission, treatment, and pathogenesis in a region with high HIV burden, morbidity, and mortality. Experienced leadership and close relationships with laboratory, clinical, and public health research locally, nationally, and internationally create a diverse and robust resource. The Core sustains the comprehensive and longstanding UNC CFAR HIV Clinical Cohort (UCHCC), with partnerships in national and international HIV cohort collaborations, including CNICS, NA-ACCORD and IeDEA. The UCHCC integrates real-time electronic medical records, with routine and standardized clinical record reviews, validated and adjudicated clinical outcome ascertainments, and longitudinally collected biological specimens, augmented by HIV sequence data, socio-behavioral surveys, patient reported outcomes, geospatial data, and state and federally available data (e.g., HIV testing, mortality, US Census). The UCHCC supports research that capitalizes on UNC’s fertile academic environment, enduring partnerships with state public health leadership, and international clinical and research sites. The Core infrastructure includes a full time clinic-embedded screener to recruit participants with and at risk for HIV from our well-characterized patient populations. Our study coordinator, regulatory and research team, support protocol development and implementation, including prospective collection of a broad range of samples, such as blood, CSF, gut and organ biopsies, and genital tract secretions and tissue, enhancing clinical and translational research, and investigator productivity. We also provide web- enabled tracking and data entry systems, database design and support for data management. Integration of the Core within the larger UNC, RTI, and FHI 360 communities fosters opportunities to engage and mentor trainees and early stage investigators, using the Core’s data, specimens and resources. The Core supports NIH networks, including ACTG, HPTN, MACS/WIHS, and Ending the HIV Epidemic through recruitment efforts, data provision, expertise and leadership in these groups. Our value-added, cost-effective and unique services and resources support over 70 investigators annually with basic laboratory science, translational, clinical, epidemiology and public health research, with over 40 OAR FRB investigators and over 500 papers supported in this funding cycle. The Core is committed to innovation in improving and expanding services, to ongoing excellence and growth in acquisition and use of specimens, extension and enrichment of data resources, enhancing outreach to early stage and international investigators, and novel seed funding provision through intra-CFAR Core collaboration. The Clinical Core’s synergistic partnerships with CFAR SWGs, other UNC CFAR Cores, national CFARs and NIH networks and programs advance and stimulate far-reaching innovations in HIV research and science.