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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Fever; Malaria

Treatments: Device: training in use of rapid diagnostic tests (RDTs) for malaria

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00716599

EM-036

Details and patient eligibility

About

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.

Enrollment: 14,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• all outpatients at participating health centers

Exclusion criteria

• patient refusal

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14,000 participants in 2 patient groups

Control

No Intervention group

Description:

Health centers continue with standard-of-care empiric case management

RDT training

Experimental group

Description:

Health centers randomly selected to receive training and RDTs, for use in routine patient case management

Treatment:

Device: training in use of rapid diagnostic tests (RDTs) for malaria