An interventional study of training in use of rapid diagnostic tests (RDTs) for malaria in Malaria and Fever, sponsored by University of California, San Francisco. Completed at 1 site in Uganda. Per ClinicalTrials.gov, last updated 2008-07-16.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Diagnostic
Malaria remains one of the most devastating infectious diseases in the world. Despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy, the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor malarious areas. New diagnostic methods that are practical for limited health-care settings are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy to use, require little infrastructure or expertise, show good accuracy, and are increasingly advocated for routine use in malaria-endemic areas. A major challenge now is to implement RDTs effectively in typical African clinical settings. We plan to evaluate the clinical effectiveness and safety of a training curriculum incorporating RDT use in peripheral government health centers in Uganda. Results from this study will provide evidence for scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from mid-2008, as well as in other sub-Saharan African countries.
The aim of this study is to evaluate the clinical effectiveness and safety of a basic training program incorporating RDTs, as compared with standard-of-care presumptive treatment, for the management of patients who present with suspected malaria at peripheral health centers in Uganda. Our hypothesis is that training in fever case management and RDT use will allow health center staff to reduce unnecessary antimalarial prescriptions without compromising patient outcomes, compared with the current practice of presumptive antimalarial therapy for all febrile patients.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 14,000 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
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Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Health centers continue with standard-of-care empiric case management
Health centers randomly selected to receive training and RDTs, for use in routine patient case management
Device: training in use of rapid diagnostic tests (RDTs) for malaria
training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers
To compare changes in the proportion of patients prescribed any antimalarial therapy between health centers with and without an RDT training intervention.
Time frame: point of care
To compare changes in the proportion of patients with an inadequate response to initial therapy between health centers with and without an RDT training intervention.
Time frame: 5 days after initial clinic visit
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco