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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03394976

Enrollment

Registered

2018-01-09

Start date

2022-01-31

Completion date

2022-12-31

Last updated

2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human African Trypanosomiasis

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.

Interventions

DIAGNOSTIC_TESTNo intervention

No intervention

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
specificity 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 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 HAT 2.0 test for gambiense HAT in passive screening	Enrolment

Secondary

Measure	Time frame
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026