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Effect of Malaria Rapid Diagnostic Tests on the Management of Uncomplicated Malaria with Artemether-Lumefantrine in Kenya: A Cluster Randomized Trial

Shortly after Kenya introduced artemether-lumefantrine (AL) for first-line treatment of uncomplicated malaria, we conducted a pre-post cluster randomized controlled trial to assess the effect of providing malaria rapid diagnostic tests (RDTs) on recommended treatment (patients with malaria prescribed AL) and overtreatment (patients without malaria prescribed AL) in outpatients 5 years old. Sixty health facilities were randomized to receive either RDTs plus training, guidelines, and supervision (TGS) or TGS alone. Of 1,540 patients included in the analysis, 7% had uncomplicated malaria. The provision of RDTs coupled with TGS emphasizing AL use only after laboratory confirmation of malaria reduced recommended treatment by 63%-points (P = 0.04), because diagnostic test use did not change (–2%-points), but health workers significantly reduced presumptive treatment with AL for patients with a clinical diagnosis of malaria who did not undergo testing (–36%-points; P = 0.03). Health workers generally adhered to RDT results when prescribing AL: 88% of RDT-positive and 9% of RDT-negative patients were treated with AL, respectively. Overtreatment was low in both arms and was not significantly reduced by the provision of RDTs (–12%-points, P = 0.30). RDTs could potentially improve malaria case management, but we urgently need to develop more effective strategies for implementing guidelines before large scale implementation.

Received December 6, 2008. Accepted for publication March 22, 2009.

Acknowledgments: The authors thank all the patients who participated in the study and all of the field staff who conducted data collection. Dr. Samantha Y. Rowe provided invaluable assistance in statistical analysis and support.

Financial support: R.W.S. is supported by the Wellcome Trust as Principal Research Fellow (079081). The study was funded by the US Agency for International Development through an inter-agency agreement with the US Centers for Disease Control and Prevention (GH99-005). This paper is published with the permission of the Director of Kenya Medical Research Institute.

ClinicalTrials.gov registration NCT00336388.

Disclaimer: This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by the US Centers for Disease Control and Prevention. It does not represent and should not be construed to represent any agency determination or policy.

^* Address correspondence to Jacek Skarbinski, Malaria Branch, Centers for Disease Control and Prevention, Mailstop F-22, 4770 Buford Highway, Atlanta, GA 30341-3724. E-mail: jskarbinski{at}cdc.gov

Authors’ addresses: Jacek Skarbinski, Louise M. Causer, John W. Barnwell, Alexandre Macedo de Oliveira, Alexander K. Rowe, and Laurence Slutsker, Malaria Branch, US Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS-F22, Atlanta, GA 30341, Tel: 770-488-7741, Fax: 770-488-4206, E-mail: jskarbinski{at}cdc.gov. Peter O. Ouma, Simon K. Kariuki, and Jane A Alaii, Centre for Global Health Research, Kenya Medical Research Institute, PO Box 40100-1578, Kisumu, Kenya. Dejan Zurovac and Robert W. Snow, Malaria Public Health and Epidemiology Group, Centre for Geographic Medicine, Kenya Medical Research Institute/ Wellcome Trust Research Laboratories, PO Box 43640, GPO 00100, Kenyatta Hospital, Nairobi, Kenya. Bruce A. Larson, Department of International Health, School of Public Health, Boston University, 801 Massachusetts Avenue, Crosstown 3rd Floor, Boston, MA 02118. Kayla F. Laserson and Mary J. Hamel, KEMRI/CDC Field Research Station, PO Box 1578, Kisumu, Kenya. Willis S. Akhwale, Division of Malaria Control, Ministry of Health, Kenya, PO Box 20750, Nairobi, Kenya.

Reprint requests: Jacek Skarbinski, Malaria Branch, Centers for Disease Control and Prevention, Mailstop F-22, 4770 Buford Highway, Atlanta, GA 30341-3724, Tel: 770-488-7741, Fax: 770-488-4206, E-mail: jskarbinski{at}cdc.gov.

^* Based on "gold standard" re-examination by study staff and gold standard blood slide.

Based on "gold standard" re-examination by study staff.