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Accession Number PB2013-500016
Title Randomized Control Trial of Male Circumcision to Reduce HIV Incidence in Kisumu, Kenya.
Publication Date Sep 2010
Media Count 1CD-ROM
Personal Author N/A
Abstract These data are the public release version of darta collected for a randomized controlled trial conducted in Kisumu, Kenya on 2784 men aged 18-24 years to test the efficacy of male circumcision in HIV prevention. Men were enrolled between 4 February 2002 and 6 September 2005 and randomly assigned to intervention (circumcision, n=1391) or control (delayed circumcision, n=1393).They were assessed by HIV testing, medical examination and behavioral interview during follow-ups at 1,3,6,12,18 and 24 months. The trial was stopped early on 12 December 2006 after a third interim analysis, reviewed by a Data and Safety Monitoring Board (DSMB), gave conclusive evidence of a protective effect of male circumcision The data showed a 53% reduction in risk of acquiring HIV infection in an intent-to-treat analysis and 60% reduction after adjustment for non-adherence and exclusion of four men thought to be HIV seropositive at enrollment. The results of the trial have been documented in Bailey, R.C., S.Moses, C.B.Parker, K. Agot, I. Maclean, J.N. Krieger, C.F.M. Williams, R.T.Campbell, J.O. Ndinya-Achola (2007). 'Male Circumcision for HIV Prevention in Young Men in Kisumu Kenya: A Randomized Controlled Trial.' Lancet, Vol.369,pp. 643-656. Although the trial was halted, the participants were continued to be followed at 6 month intervals through 30 September 2010. An update on the HIV results to 24 months and subsequent results to 42 months as well as to 54 shows the protective effect of circumcision to HIV acquisition sustained at 60%. The data reflects data collection through 30 September 2010 at which time data collection was concluded. Modifications have been made to the data for public release to protect participant confidentiality. The steps taken to desensitze the data were approved by the study investigators. As a general rule, for each data item collected, response categories that occurred in less than 5 individuals were carefully reviewed.
Keywords Circumcision
Clinical trials
Data collection
Developing countries
Disease prevention
Human immunodeficiency virus
Infectious diseases
Public health
Source Agency National Institute of Allergy and Infectious Disease
NTIS Subject Category 57E - Clinical Medicine
57U - Public Health & Industrial Medicine
92C - Social Concerns
92E - International Relations
Corporate Author National Inst. of Allergy and Infectious Diseases, Bethesda, MD.
Document Type Computer software
Title Note N/A
NTIS Issue Number 1310
Contract Number N/A

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