The purpose of the Statistical and Clinical Coordinating Center (SC) is to provide statistical leadership, clinical coordination and data management services in support of a network of HIV vaccine trial sites in the US and abroad. The contractor will provide the scientific, technical and operational capabilities necessary to design and implement vaccine trials, as well as analyze the data generated by these trials conducted in the HIV Vaccine Efficacy Trials Network (HIVNET). The SC will work in close collaboration with the Domestic Master Contractor (DMC), International Master Contractor (IMC), Laboratory Contractor (LC), Repository Contractor (RC) and the NIAID. SC core activities will provide statistical and data support activities for vaccine efficacy trial preparedness, including statistical leadership in study design, statistical scientific support services, technical input to assist the DMC and IMC in selecting field sites for baseline/feasibility studies and HIV vaccine efficacy trials in the US and abroad, and analyses of data collected by baseline/feasibility studies. Non-core activities are compromised of statistical and data support activities for vaccine efficacy trials, including statistical leadership in the development of vaccine trials protocols coordination with the DMC and IMC in training of field staff, site monitoring, clinical coordination and quality assurance of data collected in Phase I/II (international) trials and Phase III trials (domestic and international), primary responsibility for all data management and data analysis aspects of Phase II HIV vaccine efficacy trials sponsored by the HIVNET in the US and abroad, and for Phase I/II studies abroad. The overall goal of the HIVNET, with the statistical leadership of the SC, is to expedite the development and testing of vaccines and other biomedical technologies which are capable of preventing the transmission of HIV or of diminishing the disease impact of an HIV infection.

Project Start
1994-03-15
Project End
2000-09-29
Budget Start
2000-09-21
Budget End
2000-09-29
Support Year
Fiscal Year
2000
Total Cost
$852,857
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
075524595
City
Seattle
State
WA
Country
United States
Zip Code
98109
Mimiaga, Matthew J; O?Cleirigh, Conall; Biello, Katie B et al. (2015) The effect of psychosocial syndemic production on 4-year HIV incidence and risk behavior in a large cohort of sexually active men who have sex with men. J Acquir Immune Defic Syndr 68:329-36
Marshall, Brandon D L; Shoveller, Jean A; Kahler, Christopher W et al. (2015) Heavy drinking trajectories among men who have sex with men: a longitudinal, group-based analysis. Alcohol Clin Exp Res 39:380-9
Koblin, Beryl A; Mansergh, Gordon; Chesney, Margaret et al. (2014) Moving the bar to the right place: positioning interventions in HIV prevention. AIDS Behav 18:634-7
Cousins, Matthew M; Konikoff, Jacob; Laeyendecker, Oliver et al. (2014) HIV diversity as a biomarker for HIV incidence estimation: including a high-resolution melting diversity assay in a multiassay algorithm. J Clin Microbiol 52:115-21
Cousins, Matthew M; Konikoff, Jacob; Sabin, Devin et al. (2014) A comparison of two measures of HIV diversity in multi-assay algorithms for HIV incidence estimation. PLoS One 9:e101043
Tieu, Hong-Van; Li, Xin; Donnell, Deborah et al. (2013) Anal sex role segregation and versatility among men who have sex with men: EXPLORE Study. J Acquir Immune Defic Syndr 64:121-5
Laeyendecker, Oliver; Brookmeyer, Ron; Cousins, Matthew M et al. (2013) HIV incidence determination in the United States: a multiassay approach. J Infect Dis 207:232-9
Konikoff, Jacob; Brookmeyer, Ron; Longosz, Andrew F et al. (2013) Performance of a limiting-antigen avidity enzyme immunoassay for cross-sectional estimation of HIV incidence in the United States. PLoS One 8:e82772
Owor, Maxensia; Mwatha, Anthony; Donnell, Deborah et al. (2013) Long-term follow-up of children in the HIVNET 012 perinatal HIV prevention trial: five-year growth and survival. J Acquir Immune Defic Syndr 64:464-71
Bedoya, C Andres; Mimiaga, Mathew J; Beauchamp, Geetha et al. (2012) Predictors of HIV transmission risk behavior and seroconversion among Latino men who have sex with men in Project EXPLORE. AIDS Behav 16:608-17

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