Parasite-based Diagnosis for Malaria in Uganda: Feasibility and Cost-Effectiveness
NCT ID: NCT00565071
Last Updated: 2012-03-28
Study Results
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Basic Information
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UNKNOWN
NA
102087 participants
INTERVENTIONAL
2006-10-31
2012-12-31
Brief Summary
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Detailed Description
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Specific objectives
1. To assess the feasibility of rapid test and microscopy in diagnosis of malaria at health centre III.
2. To compare the cost-effectiveness of treating malaria with Artemether- Lumefantrine based on microscopy, rapid test and presumptive diagnosis in different transmission intensities
3. To assess whether introduction of malaria parasite-based diagnosis (rapid test or microscopy) at government Health Centre III improves the overall cost-effectiveness of outpatient management of febrile illness
Sample size determination The sample size was determined using standard formula. Estimating the sensitivity of either test to be 90%, Zα =1.96 and after stratifying for age (\<5 years and ≥5 years), the calculated sample is 272 per health centre. Therefore, the total number of patients for 6 health centres in two districts = 6 x 272 = 1632.
Baseline: Baseline data was collected on the current malaria treatment practices; clinicians' view of malaria diagnosis; concerns towards the new treatment; and health centre staffing. Geographical locations of all visited government health centres was recorded using Germin etrex global positioning system (Germin International Inc., Olathe, USA). At six selected health centres, social and demographic data was collected from 613 patients.
Implementation of intervention: The main intervention is comprised of three malaria diagnostic approaches: presumptive diagnosis, field microscopy and rapid test (Paracheck Pf® device - Orchid Biomedical Systems, Goa, India). Each of these approaches was randomly allocated to a health centre. The first-line drug used is Artemether/Lumefantrine (20mg/120mg) (Novartis, Switzerland).
Consenting subjects are consecutively enrolled at the point when the attending clinician suspects that they have uncomplicated malaria. Where microscopy is the main diagnostic method, thick and thin blood smears are prepared per patient enrolled. Where rapid test is the main method, all patients are tested. One hundred patients per health centre are randomly selected to provide blood specimens for validation using expert microscopy and PCR as "gold standard." After enrolment, patients are systematically tracked until departure from the health centre. Patients are followed up on the seventh day of treatment to assess their clinical improvement. Those who fail to return on the scheduled date are traced from their homes on the eighth day.
Follow-up activities include: documentation of drugs prescribed and or dispensed; clinically assess the patient's status in comparison to Day 0; perform further tests including PCR if the patient does not show improvement; pill counting of drugs remaining - if the patient has not completed the dose; documentation of reasons for not completing dose; and documentation if the patient bought the prescribed drugs that were out of stock on Day 0.
Effectiveness is measured as the number of patients commencing treatment with Artemether/Lumefantrine. However, patients are followed up and effectiveness also measured on the 7th day of treatment indicated by their clinical improvement. The feasibility of the diagnostic methods is ongoing from the March 2010 to date.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Field microscopy
Field microscopy is the main method of malaria diagnosis
Field microscopy and Paracheck Pf®
Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
Paracheck Pf® device
Paracheck Pf® device (Rapid Diagnostic Test) is the main method for malaria diagnosis
Field microscopy and Paracheck Pf®
Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
Presumptive diagnostic method
No interventions assigned to this group
Interventions
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Field microscopy and Paracheck Pf®
Malaria diagnosis based on microscopy and or Paracheck Pf®. Artemether/Lumefantrine (20mg/120mg) is first-line drug in all arms
Eligibility Criteria
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Inclusion Criteria
* Consent to participate
Exclusion Criteria
3 Months
ALL
No
Sponsors
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Department for International Development, United Kingdom
OTHER_GOV
Makerere University
OTHER
Responsible Party
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Institute of Public Health
Prof. Fred Nuwaha, MD, PhD, Makerere University School of Public Health
Principal Investigators
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Fred Nuwaha, MD, PhD
Role: STUDY_CHAIR
Department of Disease Control and Environmental Health, Makerere Universtiy School of Public Health
Locations
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Bushenyi and Iganga districts - Government Health Cetres level III
Bushenyi and Iganga, , Uganda
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Batwala 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.
Batwala 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.
Batwala 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.
Batwala 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.
Batwala 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.
Other Identifiers
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2006/HD20/4758U
Identifier Type: -
Identifier Source: org_study_id
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