The overall purpose of the Administrative Core is to provide scientific leadership, organizational management including regulatory oversight, administrative, fiscal and human resource services, and communications with key stakeholders for this multi-project program through a solid, seamless foundation. This core is critical to the successful implementation of all four individual projects. It is also critical for the overall success of the program project by supporting linkages between the projects and cores under one umbrella. These linkages maximize scientific output, create efficiencies in operations, and ensure harmonious communications with constituencies. The administrative core will be co-led by Drs. Havlir (UCSF) and Kamya (Makerere University). An experienced administrative team will ensure that the complex operational components of the program, including fiscal and regulatory aspects, run smoothly. Collaborative research is one of the defining principles of MU-UCSF organization. Therefore, communications with Ugandan and US partners is critical for success. These stakeholders include the Ministry of Health (MoH), The AIDS Support Organization (TASO), and Makerere University in Uganda, and the National Institute of Child Health and Development (NICHD) in the US. The Administrative Core will facilitate meetings and communications, progress reports, scheduling of calls, and site visits of the sponsoring agency. Finally, the core will receive feedback from three outside entities. An external Scientific Advisory Board (SAB) composed of experts in HIV (pediatric, obstetrics, ART) and malaria (therapeutics) will provide feedback to the scientific leadership of the project. A Tororo community advisory board (CAB) will provide input from the community perspective. A Data Safety and Monitoring Board (DSMB) will provide ongoing review of the 3 clinical trials. Objective 1: To provide scientific leadership to ensure that each project achieves its scientific goals. The Scientific Steering Committee (SSC) will oversee the progress of each of the projects in the program. This internal committee will be composed of the Principal Investigators of each of the individual projects and cores. It will review overall progress of the studies and assist the project investigators to overcome barriers that arise during the study. The SSC will also provide a venue for the project leadership to share scientific developments during the course of the study. The external Scientific Advisory Board (SAB) will be composed of five outside experts who will provide feedback to the SSC on an annual basis. The Tororo CAB will provide the SSC with important feedback on community perceptions and suggested solutions to problems. A DSMB will be formed to evaluate project objectives and safety. Recommendations from the DSMB will be disseminated to the Principal Investigators of each project for critical review. Objective 2: To provide organizational management of all aspects of the program, including fiscal, human and resource management, and regulatory oversight. The administrative core support team will oversee overall operations of the program project including regulatory aspects, budgetary, and human resource management, procurement of supplies, and transportation to ensure that all are managed effectively and appropriately in accordance with UCSF and Makerere University policy. This team will also assist in tracking abstracts, presentations and publications. The administrative core support team will include both UCSF and Makerere University staff and conduct biweekly calls to ensure ongoing communications on administrative issues between the sites. The Principal Investigators will work closely with the administrative core support team at their respective sites to facilitate project implementation. Objective 3: To support internal linkages within the project and external linkages with key stakeholders. The administrative core support team will serve an important """"""""convening function"""""""" for the projects and cores within the program project to ensure that the whole of the program project is greater than the sum of its parts. The administrative core will support scientific seminars and an annual scientific symposium. It will also facilitate communications with key Ugandan Stakeholders including the Ministry of Health, TASO, and the Tororo CAB. It will aim to maximize and facilitate scientific output from the overall project and work with stakeholders to ensure dissemination of research findings.
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