The Johns Hopkins University - Uganda Clinical Trials Unit

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The Johns Hopkins University-Uganda Clinical Trial Unit (JHU-CTU) renewal application aims to continue to support cutting edge HIV related research to expand scientific knowledge; and to identify innovative HIV prevention and treatment interventions that will help end the global HIV pandemic. The JHU-CTU has successfully participated as an NIH supported CTU, conducting HIV prevention and treatment clinical trials with two clinical research sites (CRSs) focused on PMTCT and high-risk women in Uganda over the past 25 years. This application builds on the highly successful JHU-CTU Network research on Prevention of Mother to Child Transmission (PMTCT) of HIV, Pediatric HIV treatment, and HIV Prevention among high risk HIV negative women. We propose to add two new Network affiliation (HIV Vaccines and Adult Therapeutics) and add three new CRSs to access diverse adult HIV-infected and most-at-risk adult populations in Kampala and Rakai Districts. These adult-focused CRSs cover some of the highest-HIV prevalence areas in Uganda with distinct urban, peri-urban, and rural settings, and will greatly enhance the JHU-Uganda CTU’s capacity to recruit diverse HIV-infected and at-risk populations for HIV treatment and prevention trials. The JHU-CTU plans to associate with the four DAIDS funded HIV Clinical Trial networks, which are addressing Adult HIV Therapeutics and Related Co-infections; Maternal Adolescent and Pediatric Therapeutics; HIV Prevention; and HIV Vaccines; and to contribute strongly to support their respective HIV Leadership Research Agendas. The proposed CRSs have access to distinct and diverse populations of HIV infected or at risk groups. These populations, including newly diagnosed HIV infected adults, as well as those on long term treatment, pregnant and breastfeeding HIV infected mothers and their HIV exposed infants; HIV infected adolescents (primarily long-term survivors from perinatal HIV infection); at risk adolescents/adults based on risky sex (e.g. sex workers, MSM); other at risk groups including fisher folk. Each of the Uganda CRSs have outstanding records of conducting HIV research. Research Aims of the JHU-Uganda CTU application include: • Assessing the safety and pharmacokinetics of new antiretroviral and immune interventions and novel models of delivery for both treatment and prevention • Participating in multifaceted PrEP trials among high risk populations using new drugs/ delivery systems • Evaluating the safety and immunogenicity of new HIV, TB, HBV vaccines, as well as vaccines for other co-infections seen among both HIV exposed and HIV infected populated populations • Providing mentoring and training for rising investigators and clinical research staff in clinical trials The JHU-CTU/CRS investigators will continue their strong scientific contributions to the cutting-edge research agendas of the HIV leadership groups by actively contributing to the research agendas of the Network Leadership Scientific Committees and helping lead study protocols and other network related studies.