The Johns Hopkins University-Blantyre Clinical Trials Unit

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Project Summary Sub-Saharan Africa continues to bear a disproportionate burden of the global HIV epidemic. Conducting studies in the most affected areas of the world is critical to the international HIV research agenda. The Johns Hopkins University-Blantyre, Malawi Clinical Trials Unit (JHU Blantyre-CTU) and its clinical research site (CRS) in Malawi, located in one of the most affected regions of the world, propose to continue and expand high- impact research collaborations with four NIAID Clinical Research Networks in order to prevent, treat, manage and potentially cure HIV and AIDS in adults, key populations, and children. With more than 30 years of HIV research experience and the strong backing of the host institutions (Johns Hopkins University and College of Medicine, University of Malawi), the CTU and CRS leadership will be responsible for the conduct and management of clinical trials at the Blantyre, CRS in accordance with the Research Networks and NIAID policies. The CTU aims to advance the scientific agenda of the proposed Clinical Research Networks for HIV prevention, treatment and vaccine research among adults and children by generating hypotheses and developing new scientific concepts; continuing implementation of active study protocols at the Blantyre CRS under the current CTU; making available the efficient and flexible local research infrastructure to quickly respond to emerging needs of the Networks; and by engaging protocol-specific populations. The CTU will emphasize quality, oversight, cohesiveness and efficiency in all operations as it works to achieve these aims. During the current CTU cycle (2013 to present), the Blantyre CRS has been involved in 35 studies at various stages, from initiation to completion, for four existing Division of AIDS/NIAID Clinical Research Networks. The CRS has established effective institutional and community collaborations and has been responsive to both the Network agendas and the national health research agenda for Malawi. The goal of this application is to describe scientific, leadership and administrative strengths of the proposed JHU-Blantyre CTU and its CRS in Blantyre, Malawi, which will ensure successful implementation of the NIAID international clinical research agenda. The sub-sections (A-L) of this application provide a scientific overview of the proposed CTU and describe its administrative and financial management structures; plans for communication, evaluation and training; and the roles, responsibilities and resources of each CTU element and CRS technical department, including community engagement, pharmacy, laboratory, quality and regulatory assurance, and data management. Our CTU arrangement that encompasses a single CRS has demonstrated capacity and promotes efficiency.