PItt-Ohio State-Georgetown Clinical Trials Unit

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DESCRIPTION (provided by applicant): The OSUPITTGU Clinical Trials Unit (CTU), composed of 3 Clinical Research Sites (CRSs) at the University of Pittsburgh (PITT CRS) in Pittsburgh, PA, Ohio State University (OSU CRS) in Columbus, Ohio, and Georgetown University (GU CRS) in Washington, DC, proposes to continue its productive affiliations with the AIDS Clinical Trials Group (ACTG) and the Microbicide Trials Network (MTN), contributing scientific and administrative leadership, as well as enrollment and follow-up of participants in a broad range of studies conducted by both Networks. Additionally, the OSUPITTGU CTU is poised to continue its participation as protocol specific sites for studies in the HIV Prevention Trials Network (HPTN) and the HIV Vaccine Trials Network (HVTN), and has capacity to expand further in terms of scientific capabilities and access to both affected and at risk populations. As such, the OSUPITTGU CTU will contribute to the research agendas of several DAIDS HIV/AIDS Clinical Trials Networks and thereby achieve the desired efficiency for a CTU. The Aims of this application are: 1) to advance the scientific agenda of the ACTG through development and implementation of high-priority research studies focused on HIV Reservoirs and Viral Eradication (HIV Cure), Hepatitis, and End-organ Disease and Inflammation; 2) to advance the scientific agenda of the MTN through development and implementation of high-priority research studies on the safety and efficacy of antiretroviral-containing vaginal rings, rectal microbicides, and combination approaches; 3) to rapidly expand existing CTU capacity into new areas of HIV and antimicrobial resistance research to meet the evolving needs of DAIDS- and DMID-sponsored Networks; 4) to provide access to DAIDS-sponsored trials for hard-to-reach and impoverished populations most impacted by the HIV/AIDS epidemic in western PA, central OH, northern Appalachia, and Washington, DC, where no other access to therapeutic trials exists; 5) to recruit, enroll, retain and monitor study participants in high-priority protocols of the ACTG, MTN, HPTN, and HVTN, and meet or exceed performance standards for these Networks; 6) to partner with affected communities and community advisory boards at each CRS throughout these endeavors; and 7) to mentor promising young investigators at each CRS to become skilled researchers. The collective expertise, administrative efficiency, and performance record of the OSUPITTGU CTU over the last grant cycle ensure that these Aims are achievable and that the CTU will make important contributions to the research agendas of DAIDS and DMID Networks. RELEVANCE: The Pitt-Ohio State-Georgetown Clinical Trials Unit is a collaborative effort that will support the DAIDS HIV/AIDS research networks with a particular focus on critical areas of research in HIV therapy and prevention including: HIV cure, non-infectious comorbidities, hepatitis C, and tuberculosis; HIV prevention strategies including pre-exposure prophylaxis and microbicides; and DMID-sponsored clinical trials for antimicrobial resistant bacteria.