Parasite-based Diagnosis for Malaria in Uganda: Feasibility and Cost-Effectiveness
1 other identifier
interventional
102,087
1 country
1
Brief Summary
The purpose of this study is to compare the cost-effectiveness of treating malaria based on three methods of diagnosis (rapid test, microscopy and presumptive diagnosis) among patients attending level three government health centres located in areas of low and high transmission intensities in Uganda. The study hypotheses are: in both low and high transmission areas, cost-effectiveness of malaria treatment with Artemether-Lumefantrine will be improved by the adoption of rapid diagnostic tests when compared with presumptive diagnosis or microscopy; and the difference between the cost-effectiveness of Artemether-Lumefantrine treatment following rapid diagnostic test or microscopy versus presumptive diagnosis will be greatest in low transmission areas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 28, 2007
CompletedFirst Posted
Study publicly available on registry
November 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 28, 2012
March 1, 2012
5.4 years
November 28, 2007
March 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
diagnostic test validity; unit cost per malaria case diagnosed and treated with Artemether-Lumefantrine; total savings associated with treatment of confirmed malaria cases; compliance with directives for use of rapid test or microscopy
18 months
Secondary Outcomes (1)
unit cost of non-malaria febrile treatment; therapeutic behaviour in light of pressure to prescribe antimalarials
18 months
Study Arms (3)
Field microscopy
OTHERField microscopy is the main method of malaria diagnosis
Paracheck Pf® device
OTHERParacheck Pf® device (Rapid Diagnostic Test) is the main method for malaria diagnosis
Presumptive diagnostic method
NO INTERVENTIONInterventions
Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
Eligibility Criteria
You may qualify if:
- Suspected uncomplicated malaria infection
- Consent to participate
You may not qualify if:
- Pregnancy (policy recommends quinine for treatment of malaria in pregnancy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bushenyi and Iganga districts - Government Health Cetres level III
Bushenyi and Iganga, Uganda
Related Publications (6)
Batwala V, Magnussen P, Nuwaha F. Challenges to implementation of artemisinin combination therapy policy in Uganda. Int Health. 2010 Dec;2(4):262-8. doi: 10.1016/j.inhe.2010.07.002.
PMID: 24037867DERIVEDBatwala V, Magnussen P, Mirembe J, Mulogo E, Nuwaha F. Timing of malaria messages for target audience on radio airwaves. Malar J. 2012 Aug 20;11:283. doi: 10.1186/1475-2875-11-283.
PMID: 22905781DERIVEDBatwala V, Magnussen P, Nuwaha F. Antibiotic use among patients with febrile illness in a low malaria endemicity setting in Uganda. Malar J. 2011 Dec 20;10:377. doi: 10.1186/1475-2875-10-377.
PMID: 22183039DERIVEDBatwala V, Magnussen P, Nuwaha F. Comparative feasibility of implementing rapid diagnostic test and microscopy for parasitological diagnosis of malaria in Uganda. Malar J. 2011 Dec 19;10:373. doi: 10.1186/1475-2875-10-373.
PMID: 22182758DERIVEDBatwala V, Magnussen P, Hansen KS, Nuwaha F. Cost-effectiveness of malaria microscopy and rapid diagnostic tests versus presumptive diagnosis: implications for malaria control in Uganda. Malar J. 2011 Dec 19;10:372. doi: 10.1186/1475-2875-10-372.
PMID: 22182735DERIVEDBatwala V, Magnussen P, Nuwaha F. Are rapid diagnostic tests more accurate in diagnosis of plasmodium falciparum malaria compared to microscopy at rural health centres? Malar J. 2010 Dec 2;9:349. doi: 10.1186/1475-2875-9-349.
PMID: 21126328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fred Nuwaha, MD, PhD
Department of Disease Control and Environmental Health, Makerere Universtiy School of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Fred Nuwaha, MD, PhD, Makerere University School of Public Health
Study Record Dates
First Submitted
November 28, 2007
First Posted
November 29, 2007
Study Start
October 1, 2006
Primary Completion
March 1, 2012
Study Completion
December 1, 2012
Last Updated
March 28, 2012
Record last verified: 2012-03