Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria
NCT ID: NCT03394976
Last Updated: 2024-01-09
Study Results
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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WITHDRAWN
OBSERVATIONAL
2022-01-31
2022-12-31
Brief Summary
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The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Study population
Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Provision of signed informed consent. For children (under the age of 18) provision of signed informed consent by a parent or legal guardian and an age appropriate assent.
Exclusion Criteria
* Severe medical condition preventing informed consent and trial participation (e.g. coma, cognitive impairment, etc.)
* For HAT true negatives only: history of previous HAT infection
6 Years
ALL
Yes
Sponsors
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Makerere University
OTHER
Ministry of Public Health, Democratic Republic of the Congo
OTHER_GOV
Foundation for Innovative New Diagnostics, Switzerland
OTHER
Responsible Party
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Other Identifiers
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HAT-malaria RDT evaluation
Identifier Type: -
Identifier Source: org_study_id
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