PROJECT SUMMARY – Clinical Core The Clinical Core supports patient-centered HIV/AIDS research through activities and services: (1) facilitating access to key populations of people with HIV (PWH), patient-derived biologic specimens, and relevant databases, in both domestic and international settings; (2) providing consultation to address clinical challenges consistent with NIH HIV/AIDS research priorities, including study design and implementation, and sophisticated domestic and international regulatory support; and (3) serving as the liaison for community engagement in CFAR research. The Core is involved in recruitment and enrollment of PWH and biologic specimens through Duke University and partnering institution clinics, coordinating access to the Duke CFAR Biorepository and support to access Network repositories. Importantly, the Clinical Core is intimately involved in prevention and treatment efforts for the Southern HIV Epidemic, and HIV-related co-morbidities, through research on pre- exposure prophylaxis, acutely infected persons, substance abuse including persons who inject drugs, and retention in care for marginalized populations, as well as through outreach to historically black colleges and universities. The Core has identified high-value, well-phenotyped populations through the Duke CFAR Biorepository, especially useful for investigators researching co-morbidities, recently infected persons, and long-term non-progressors. The Clinical Core leadership and staff are highly experienced and active, and since 2015 the Core has provided 226 consultations on study design and implementation, regulatory support on 601 applications, and assistance with subject recruitment in 14 studies. The Clinical Core is highly networked within the CFAR, and with other entities both internal and external to Duke. Notably, the Core has supported the opening of an HIV Vaccine Trials Network site at Duke, creating exciting new opportunities for vaccine-related science. The Core serves as the gateway to access our international partners in Tanzania, Kenya and South Africa, and populations of PWH. These networks have attracted investigators new to HIV/AIDS, which has further enhanced the impact of Clinical Core researchers. The Clinical Core welcomed seven new Duke faculty as Core investigators, and in conjunction with other CFAR Cores, plays an important role in their co-mentorship, promoting highly rigorous, impactful, and ethically sound investigations. In the next funding cycle, the Clinical Core expects continued expansion of research activities focused on the Southern HIV Epidemic, with partnerships in other academic institutions, public health professionals, and the community, building upon our work in HIV testing, prevention, early treatment, and retention in care. The Core anticipates increased activities in HIV-related co-morbidities, especially with our international partners. Growing expertise and research in HIV-related cardiovascular disease and disp...