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

NCT00716599 | Completed

• 1 other identifier: EM-036
• Study Type: interventional
• Target: 14,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Fever

Keywords

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

Outcome Measures

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.

  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.

  5 days after initial clinic visit

Study Arms (2)

Control

NO INTERVENTION

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

RDT training

EXPERIMENTAL

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

Interventions

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

RDT training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all outpatients at participating health centers

You may not qualify if:

• patient refusal

Sponsors & Collaborators

• University of California, San Francisco: lead
• Exxon Mobil: collaborator
• Makerere University: collaborator
• Uganda Malaria Surveillance Project: collaborator
• National Institutes of Health (NIH): collaborator
• Doris Duke Charitable Foundation: collaborator

Study Sites (1)

Uganda Malaria Surveillance Project

Kampala, Uganda

Location

Related Links

• research collaboration website

MeSH Terms

Conditions

Malaria; Fever; Disease

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Heidi Hopkins, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 16, 2008

Record last verified: 2008-07

Locations

UG (1)