Clinical trial NCT00716599: Training in Fever Case Management With Rapid Diagnostic Tests (RDTs) for Malaria in Uganda
Official title: Effectiveness and Safety of Training in Fever Case Management Incorporating Rapid Diagnostic Tests (RDTs) for Malaria at Peripheral Health Centers in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Fever
Keywords: malaria
diagnosis
rapid diagnostic test
rapid diagnostic tests
fever case management
training
fever case management in malaria-endemic areas
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Exxon Mobil
name: Makerere University
name: Uganda Malaria Surveillance Project
name: National Institutes of Health (NIH)
name: Doris Duke Charitable Foundation
First posted: 2008-07-16
Enrollment: 14000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* all outpatients at participating health centers

Exclusion Criteria:

* patient refusal

Primary outcomes:
measure: To compare changes in the proportion of patients prescribed any antimalarial therapy between health centers with and without an RDT training intervention.
timeFrame: point of care
Secondary outcomes:
measure: 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.
timeFrame: 5 days after initial clinic visit
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Uganda Malaria Surveillance Project
Study officials:
affiliation: University of California, San Francisco
name: Heidi Hopkins, MD
role: PRINCIPAL_INVESTIGATOR
References: