The Clinical Core is structured to be maximally supportive of the consortium's goal of defining factors which nfluence HIV susceptibility and pathogenesis in the female genital tract. The leaders of the Core are experts n both clinical care and research for women with HIV and will provide expertise in the clinical factors affecting susceptibility and pathogenesis. The primary mission of the Core is to provide high-quality specimens and clinical data to support the described pathogenesis investigations and future pilot initiatives. The Clinical Core is integrated with large cohorts which are representative of the women most often affected by HIV in the US and internationally. This integration of the program project and the large cohorts not only assures that the consortium will study representative women but offers an efficient and cost-effective means of identifying and recruiting research subjects fitting specific inclusion criteria. The Core has four specific aims: 1) To coordinate the timely and efficient acquisition of high-quality clinical specimens to support the Projects. The Core will a) assure that specimens for the projects are collected uniformly and by the best available methodologies across participating clinical sites, b) facilitate acquisition of specimens from the Women's Interagency HIV Study (WIHS) repository, and repositories of other cohorts and c) coordinate specimen acquisition and shipping from the Rwandan Women's Interassociation Study and Assessment (RWISA). 2) To provide the Projects with access to comprehensive, longitudinal clinical and laboratory data on research participants and to assist the Projects in interpretation of these data. The Core will assure that supporting clinical data are collected uniformly across participating clinical sites and in a manner concordant with data from existing cohorts. 3) To collaborate with the Tissue Culture and Virology Laboratory Core to assure that methods of acquiring, processing and transporting tissue provide optimal specimens for the Projects. 4) To assure that recruitment of patients is performed in an ethical manner and in accordance with all local and federal standards for the protection of research participants. To fulfill these aims, the Core will employ the experienced staff and well-studied specimen collection techniques of the cohorts, when necessary, novel specimen collection techniques will be studied to fit the unique needs of the Projects. The Core has been designed to have the flexibility to recruit HIV-infected and uninfected women from many racial and ethnic groups and representing a broad range of HIV disease stages and risk characterics efficiently and with respect for the autonomy and contributions of the research participants .

Public Health Relevance

(Seeinstructions): Heterosexual transmission of HIV is the primary mode of transmission of HIV worldwide. Better understanding of issues of susceptibility and pathogenesis of HIV in women is important in order to optimize strategies for prevention of HIV transmission to women, men and infants.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program Projects (P01)
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Special Emphasis Panel (ZAI1-TP-A)
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Rush University Medical Center
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