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This paper describes the study design and methods used in a large community-based, group-randomized, controlled trial of permethrin-treated bed nets (ITNs) in an area with intense, perennial malaria transmission in western Kenya conducted between 1996 and 1999. A multi-disciplinary framework was used to explore the efficacy of ITNs in the reduction of all-cause mortality in children less than five years old, the clinical, entomologic, immunologic, and economic impact of ITNs, the social and behavioral determinants of ITN use, and the use of a geographic information system to allow for spatial analyses of these outcomes. Methodologic difficulties encountered in such large-scale field trials are discussed.
Acknowledgments: We express our gratitude to the villagers of Asembo and Gem for their participation in this trial. George Olang, Michael Onyango, and Richard Odhiambo are thanked for their field management skills. We are grateful to John Paul Clark, Neen Alrutz, Dennis Carroll, and Mary Ettling (United States Agency for International Development) for their interest and support. We thank Drs. Robert Snow, Laurence Slutsker, Richard Steketee, and Kevin de Cock for reviewing the manuscript. We also thank the Director of the Kenya Medical Research Institute for his permission to publish this manuscript.
Financial support: The ITN project was funded by the United States Agency for International Development.
Disclaimer: The opinions or assertions contained in this manuscript are the private ones of the authors and are not to be construed as official or reflecting the views of the U.S. Public Health Service or Department of Health and Human Services. Use of trade names is for identification only and does not imply endorsement by the U.S. Public Health Service or Department of Health and Human Services.
Authors addresses: Penelope A. Phillips-Howard, Feiko O. ter Kuile, Dianne J. Terlouw, John E. Gimnig, Margarette S. Kolczak, S. Patrick Kachur, Allem W. Hightower, and William A. Hawley, Division of Parasitic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Mailstop F-22, 4770 Buford Highway, Atlanta, GA 30341. Bernard L. Roll Back Malaria, World Health Organization, Avenue Appia 20, 1211 Geneva 27, Switzerland. Jane A. Alaii, Simon K. Kariuki, Ya Ping Shi, and John M. Vulule, Centre for Vector Biology and Control Research, Kenya Medical Research Institute, PO Box 1578, Kisumu, Kenya.
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