Clinical Core

Modified Project Summary/Abstract Section PROJECT SUMMARY – Clinical Core The Clinical Core’s main mission is to support CFAR investigators and early-stage investigators (ESI) to effectively implement their clinical research and promote innovative interdisciplinary team science to increase scientific and public health impact through provision of service, resources, and mentorship. Specifically, we provide consultation to ESIs and researchers new to HIV/AIDS on study feasibility, design, and implementation of research involved human participants and human samples, and we provide unparalleled regulatory and study coordination support to help investigators avoid delays in IRB approvals and study start up and to help recruit and enroll patients into clinical studies. A key resource is the Core’s broad expertise, extensive domestic and international research portfolios, and deep connections across Duke CFAR Cores, SWGs, and Duke Centers and Institutes to support CFAR researchers and promote interdisciplinary team science approaches to domestic and global HIV agenda. In the new cycle the Clinical Core will focus on supporting the growth of three priority research areas. The first priority is to reduce the incidence of HIV in the US South with innovative, multiple-pronged, and decentralized approaches to primary HIV prevention. The second priority is to use implementation science methodology to optimize the HIV care continuum, from primary prevention to comorbidity management, focusing on innovative use of data science to improve uptake of PrEP, linkage and retention of care, and management of cardiovascular and coinfections. The third priority is to establish the Duke Global HIV Initiative, working across Cores to serve as a resource for Duke investigators and to foster development of ESI. The Clinical Core will fulfill these priorities through three specific aims: Aim 1: Collaborate across CFAR Cores to provide consultation in study feasibility, design, recruitment, retention, and regulatory and study coordinating support to catalyze new collaborative science to address contemporary health challenges consistent with NIH’s research priorities. Aim 2: Enable recruitment of prospective PWH for research participation with an emphasis on patient-derived biological specimens linked with well-phenotyped clinical data. Aim 3. Support and foster development of a community of next generation HIV investigators and leaders focused in the Core’s priority areas and develop interdisciplinary team science across Cores, SWGs, and Institutes to achieve greater public health impact.