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

Effectiveness and Safety of Training in Fever Case Management Incorporating Rapid Diagnostic Tests (RDTs) for Malaria at Peripheral Health Centers in Uganda

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00716599
Enrollment
14000
Registered
2008-07-16
Start date
2008-01-31
Completion date
2008-07-31
Last updated
2008-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Malaria

Keywords

malaria, diagnosis, rapid diagnostic test, rapid diagnostic tests, fever case management, training, fever case management in malaria-endemic areas

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.

Interventions

DEVICEtraining 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

Sponsors

Exxon Mobil
CollaboratorINDUSTRY
Makerere University
CollaboratorOTHER
Uganda Malaria Surveillance Project
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
Doris Duke Charitable Foundation
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* all outpatients at participating health centers

Exclusion criteria

* patient refusal

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026