Training in Fever Case Management With Rapid Diagnostic Tests (RDTs) for Malaria in Uganda

Not Applicable

Completed

• Conditions: Malaria; Fever
• Interventions: Device: training in use of rapid diagnostic tests (RDTs) for malaria

• Registration Number: NCT00716599
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-06
• Status Verified: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-15
• Last Update Submitted: 2008-07-15
• Study First Posted: 2008-07-16
• Last Update Posted: 2008-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14000

Inclusion Criteria

• all outpatients at participating health centers

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Exclusion Criteria

• patient refusal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RDT training	training in use of rapid diagnostic tests (RDTs) for malaria	Health centers randomly selected to receive training and RDTs, for use in routine patient case management

Primary Outcome Measures

Name	Time	Method
To compare changes in the proportion of patients prescribed any antimalarial therapy between health centers with and without an RDT training intervention.	point of care

Secondary Outcome Measures

Name	Time	Method
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.	5 days after initial clinic visit

Trial Locations

Locations (1)

Uganda Malaria Surveillance Project; 🇺🇬 Kampala, Uganda