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

This study has been completed.
Sponsor:
Collaborators:
Exxon Mobil
Makerere University
Uganda Malaria Surveillance Project
Doris Duke Charitable Foundation
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00716599
First received: July 14, 2008
Last updated: July 15, 2008
Last verified: July 2008
  Purpose

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.


Condition Intervention
Malaria
Fever
Device: training in use of rapid diagnostic tests (RDTs) for malaria

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effectiveness and Safety of Training in Fever Case Management Incorporating Rapid Diagnostic Tests (RDTs) for Malaria at Peripheral Health Centers in Uganda

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 14000
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Health centers continue with standard-of-care empiric case management
Experimental: RDT training
Health centers randomly selected to receive training and RDTs, for use in routine patient case management
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all outpatients at participating health centers

Exclusion Criteria:

  • patient refusal
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00716599

Locations
Uganda
Uganda Malaria Surveillance Project
Kampala, Uganda
Sponsors and Collaborators
University of California, San Francisco
Exxon Mobil
Makerere University
Uganda Malaria Surveillance Project
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Heidi Hopkins, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: Heidi Hopkins, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00716599     History of Changes
Other Study ID Numbers: EM-036
Study First Received: July 14, 2008
Last Updated: July 15, 2008
Health Authority: United States: Institutional Review Board
Uganda: Research Ethics Committee
Mexico: National Council of Science and Technology

Keywords provided by University of California, San Francisco:
malaria
diagnosis
rapid diagnostic test
rapid diagnostic tests
fever case management
training
fever case management in malaria-endemic areas

Additional relevant MeSH terms:
Malaria
Fever
Protozoan Infections
Parasitic Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014