The overall purpose of the Administrative Core is to provide scientific leadership, organizational managementincluding regulatory oversight, administrative, fiscal and human resource services, and communications withkey stakeholders for this multi-project program through a solid, seamless foundation. This core is critical to thesuccessful implementation of all four individual projects. It is also critical for the overall success of the programproject by supporting linkages between the projects and cores under one umbrella. These linkages maximizescientific 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 experiencedadministrative team will ensure that the complex operational components of the program, including fiscal andregulatory aspects, run smoothly. Collaborative research is one of the defining principles of MU-UCSForganization. Therefore, communications with Ugandan and US partners is critical for success. Thesestakeholders include the Ministry of Health (MoH), The AIDS Support Organization (TASO), and MakerereUniversity in Uganda, and the National Institute of Child Health and Development (NICHD) in the US. TheAdministrative Core will facilitate meetings and communications, progress reports, scheduling of calls, and sitevisits of the sponsoring agency. Finally, the core will receive feedback from three outside entities. An externalScientific 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 advisoryboard (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. Thisinternal 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 ariseduring the study. The SSC will also provide a venue for the project leadership to share scientific developmentsduring the course of the study. The external Scientific Advisory Board (SAB) will be composed of five outsideexperts who will provide feedback to the SSC on an annual basis. The Tororo CAB will provide the SSC withimportant feedback on community perceptions and suggested solutions to problems. A DSMB will be formed toevaluate project objectives and safety. Recommendations from the DSMB will be disseminated to the PrincipalInvestigators 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 willoversee overall operations of the program project including regulatory aspects, budgetary, and humanresource management, procurement of supplies, and transportation to ensure that all are managed effectivelyand appropriately in accordance with UCSF and Makerere University policy. This team will also assist intracking abstracts, presentations and publications. The administrative core support team will include bothUCSF and Makerere University staff and conduct biweekly calls to ensure ongoing communications onadministrative issues between the sites. The Principal Investigators will work closely with the administrativecore support team at their respective sites to facilitate project implementation.Objective 3: To support internal linkages within the project and external linkages with keystakeholders. The administrative core support team will serve an important 'convening function' for theprojects and cores within the program project to ensure that the whole of the program project is greater thanthe sum of its parts. The administrative core will support scientific seminars and an annual scientificsymposium. It will also facilitate communications with key Ugandan Stakeholders including the Ministry ofHealth, TASO, and the Tororo CAB. It will aim to maximize and facilitate scientific output from the overallproject and work with stakeholders to ensure dissemination of research findings.
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