Suspended

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

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Over 6 Years

+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.

Observational

Study Start: January 2022

See protocol details

Summary

Principal SponsorFoundation for Innovative New Diagnostics, Switzerland

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 31, 2022

Actual date on which the first participant was enrolled.

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

NCT03394976

Principal SponsorFoundation for Innovative New Diagnostics, Switzerland

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

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.

3 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers