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

NCT ID: NCT00716599

Last Updated: 2008-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria Fever

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

RDT training

Health centers randomly selected to receive training and RDTs, for use in routine patient case management

Group Type EXPERIMENTAL

training in use of rapid diagnostic tests (RDTs) for malaria

Intervention Type DEVICE

training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* all outpatients at participating health centers

Exclusion Criteria

* patient refusal
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exxon Mobil

INDUSTRY

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role collaborator

Uganda Malaria Surveillance Project

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Doris Duke Charitable Foundation

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Francisco

Principal Investigators

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Heidi Hopkins, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Uganda Malaria Surveillance Project

Kampala, , Uganda

Site Status

Countries

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Uganda

Related Links

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http://www.muucsf.org

research collaboration website

Other Identifiers

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EM-036

Identifier Type: -

Identifier Source: org_study_id