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OpenTrials
Completed

NCT Number: NCT00716599

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uganda Malaria Surveillance Project

Kampala, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all outpatients at participating health centers

Exclusion criteria

  • patient refusal

Treatment and study plan

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

Device

training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Doris Duke Charitable Foundation
  • Exxon Mobil
  • Makerere University
  • National Institutes of Health (NIH)
  • Uganda Malaria Surveillance Project

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 16, 2008
Registry last updated
Jul 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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