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

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

Study Overview

• Status: Completed
• Conditions: Fever; Malaria
• Intervention / Treatment: Device: training in use of rapid diagnostic tests (RDTs) for malaria

• Study Type: Interventional
• Enrollment (Actual): 14000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Uganda Malaria Surveillance Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all outpatients at participating health centers

Exclusion Criteria:

• patient refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institutes of Health (NIH); Makerere University; Uganda Malaria Surveillance Project; Doris Duke Charitable Foundation; Exxon Mobil
• Investigators: Principal Investigator: Heidi Hopkins, MD, University of California, San Francisco

Publications and helpful links

Helpful Links

• research collaboration website

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 15, 2008
• First Posted (Estimate): July 16, 2008

Study Record Updates

• Last Update Posted (Estimate): July 16, 2008
• Last Update Submitted That Met QC Criteria: July 15, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: diagnosis; training; malaria; rapid diagnostic test; rapid diagnostic tests; fever case management; fever case management in malaria-endemic areas
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Body Temperature Changes; Heat Stress Disorders; Malaria; Hyperthermia; Fever
• Other Study ID Numbers: EM-036