Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Study Overview
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Brief Summary
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A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the HAT/malaria combo) has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively. 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.

Official Title
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Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria

Conditions
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Human African Trypanosomiasis

Intervention / Treatment
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* Diagnostic Test: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 6 years 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 anaemia preventing collection of a sample of venous blood 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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities. | Diagnostic Test: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specificity of the HAT/malaria combo test for gambiense HAT in passive screening |  | Enrolment | 
| specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening |  | Enrolment | 
| sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening |  | Enrolment | 
| sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening |  | Enrolment | 
| specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening |  | Enrolment | 
| specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening |  | Enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic |  | Enrolment | 
| specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic |  | Enrolment | 
| specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic |  | Enrolment | 
| specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening in a population living in a setting where HAT and animal trypanosomiasis are not endemic |  | Enrolment |