Brief Title
Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria
Official Title
Prospective Evaluation of a Rapid Diagnostic Test to Screen for Gambiense Human African Trypanosomiasis and Diagnose Plasmodium Falciparum Malaria
Brief Summary
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.
Study Type
Observational
Primary Outcome
specificity of the HAT/malaria combo test for gambiense HAT in passive screening
Secondary Outcome
specificity of the HAT/malaria combo test for gambiense HAT in passive screening in a population living in a setting where HAT is endemic
Condition
Human African Trypanosomiasis
Intervention
No intervention
Study Arms / Comparison Groups
Study population
Description: Participants will be enrolled passively at health centres. Passive enrolment will include patients referred to or presenting directly at the health facilities.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
2500
Start Date
January 2020
Completion Date
December 31, 2020
Primary Completion Date
December 31, 2020
Eligibility Criteria
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
Gender
All
Ages
6 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, +41227100590, [email protected]
Administrative Informations
NCT ID
NCT03394976
Organization ID
HAT-malaria RDT evaluation
Responsible Party
Sponsor
Study Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Makerere University
Study Sponsor
, ,
Verification Date
February 2019