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

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.

Conditions

• Malaria
• Fever

Interventions

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

Sponsors & Collaborators

• Exxon Mobil

  collaborator INDUSTRY

• Makerere University

  collaborator OTHER

• Uganda Malaria Surveillance Project

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Doris Duke Charitable Foundation

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Heidi Hopkins, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2008-06-30

Completion

2008-07-31

Countries

• Uganda

Study Locations