Training in Fever Case Management With Rapid Diagnostic Tests (RDTs) for Malaria in Uganda
Primary Purpose
Malaria, Fever
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
training in use of rapid diagnostic tests (RDTs) for malaria
Sponsored by
About this trial
This is an interventional diagnostic trial for Malaria focused on measuring malaria, diagnosis, rapid diagnostic test, rapid diagnostic tests, fever case management, training, fever case management in malaria-endemic areas
Eligibility Criteria
Inclusion Criteria:
- all outpatients at participating health centers
Exclusion Criteria:
- patient refusal
Sites / Locations
- Uganda Malaria Surveillance Project
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
RDT training
Arm Description
Health centers continue with standard-of-care empiric case management
Health centers randomly selected to receive training and RDTs, for use in routine patient case management
Outcomes
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.
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.
Full Information
NCT ID
NCT00716599
First Posted
July 14, 2008
Last Updated
July 15, 2008
Sponsor
University of California, San Francisco
Collaborators
Exxon Mobil, Makerere University, Uganda Malaria Surveillance Project, National Institutes of Health (NIH), Doris Duke Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00716599
Brief Title
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
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
Collaborators
Exxon Mobil, Makerere University, Uganda Malaria Surveillance Project, National Institutes of Health (NIH), Doris Duke Charitable Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Fever
Keywords
malaria, diagnosis, rapid diagnostic test, rapid diagnostic tests, fever case management, training, fever case management in malaria-endemic areas
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Health centers continue with standard-of-care empiric case management
Arm Title
RDT training
Arm Type
Experimental
Arm Description
Health centers randomly selected to receive training and RDTs, for use in routine patient case management
Intervention Type
Device
Intervention Name(s)
training in use of rapid diagnostic tests (RDTs) for malaria
Intervention Description
training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all outpatients at participating health centers
Exclusion Criteria:
patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Hopkins, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uganda Malaria Surveillance Project
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Links:
URL
http://www.muucsf.org
Description
research collaboration website
Learn more about this trial
Training in Fever Case Management With Rapid Diagnostic Tests (RDTs) for Malaria in Uganda
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