This competing renewal application proposes continuation of the Northern California WIHS site (the Connie Wofsy Women's HIV Study - CWWHS), a regional HIV consortium that links community clinics with a leading research institution, the University of California, San Francisco. The CWWHS will contribute several key resources to WIHS: continued high retention rates of a local cohort that is representative of the community of HIV-infected and at-risk women, high rates of adherence to WIHS protocols and data collection completion, data analyses (coordinated with WDMAC) and continued leadership of many WIHS IV scientific initiatives. This WIHS IV application is divided into two main sections as per RFA instructions: the first section reports the contributions of our site to WIHS progress, including cohort and sub-study recruitment and retention, scientific leadership, and contributions to organizational leadership. This section contains several standardized tables and figures (provided by WDMAC) as well as a table summarizing the activities at our site. These WIHS-related activities include those directly funded by the WIHS as well as those supported by other sources. The second section provides our site's specific aims and methods for the research proposed for WIHS IV (proposed in Part A). This includes methods for retention of participants, protocols specific to WIHS IV, data and specimen handling procedures, site structure and ongoing scientific leadership efforts. Investigators at our site continue to make significant contributions to the overall WIHS and with a focus on HIV pathogenesis, pharmacology, hepatology, genetics, malignancies, endocrinology and metabolism, and statistics. The CWWHS staff members are highly trained and productive, as evidenced by our high rates of protocol completion and compliance, low rates of entry error and missing data, and very high rates of participant and staff retention, which we anticipate will continue into WIHS IV. Our site has demonstrated very high rates of recruitment and completion of complex and invasive procedures, such as liver biopsy. As we have done in the past, we expect to expand our collaborations through investigator-initiated research grants. We have established excellent ties with regional and national scientists, many of whom are world-renowned experts in their respective fields, to further WIHS research goals and make an optimal contribution to HIV science. In addition, the CWWHS has leveraged its resources to provide a venue for career development among early career clinical and translational investigators. We are delighted to have this opportunity to propose the continuation of the CWWHS, which we believe can provide unique and important findings on a representative group of HIV-infected and at-risk women in the United States as they transition through menopause, age and evolve in their treatment.
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