Clinical Investigation Core

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The primary objectives of the Clinical Investigation Core are to facilitate the ability of CFAR investigators to initiate or expand HIV/AIDS research projects that require access to HIV-1 -infected individuals, clinical specimens and/or or data, and to mentor junior and other new investigators in both clinical and social and behavioral HIV-related research. The Core will provide CFAR members with access to robust databases with demographic, clinical, and laboratory data from among patients and others enrolled in clinical research studies. Queries to these databases can provide access to previously collected data and facilitate rapid access to subjects who meet eligibility criteria for new studies. The clinical settings include the AIDS Research Program of the Department of Epidemiology and Population Health, the Division of Substance Abuse, the AIDS Center Infectious Diseases Clinic, the Adolescent AIDS Program, and a new Social and Behavioral Component that includes the Prevention Intervention Research Center. The Core also will provide assistance in study design, including recommendations for sample selection, power calculations and the use of appropriate analytical methods. The Core has developed a centralized, user-friendly, efficient gateway to provide access to data across clinical care and clinical research sites, to facilitate clinical research, and to stimulate interactions among clinical and laboratory investigators to promote translational research. Mentoring sessions at which senior investigators mentor junior and new investigators will continue. Finally, the Core will facilitate new international research initiatives. The Specific Aims are: 1) To facilitate the retrieval and sharing of clinical data currently available in disparate data systems; 2) To assist in identifying individuals and/or their specimens for new research projects; 3) To expedite informing potential human subjects of new and ongoing research projects and facilitate interactions between potential research subjects and investigators; 4) To assist clinical, social science, and basic researchers in achieving rigor of study design and validity and generalizability of study results by providing expertise in sample selection, study design, power calculations, and appropriate analytical methods; 5) To mentor junior and new investigators in all aspects of HIV-related research, including study design, subject enrollment, IRB requirements, collaboration with basic scientists, preparation and resubmission of grant applications, and presentation and publication of research findings; 6) To increase the capacity of investigators to perform studies involving social and behavioral elements, and to build social science studies into existing or new clinical research, through state-of-the-art consultation and support services in the social and behavioral sciences; 7) To expand international HIV-related research; and 8) To educate clinicians about the latest developments in HIV research to stimulate interest in investigating important unresolved clinical research questions.