WithdrawnNot Applicable

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

Stopped: Funding

0Started 2022-01-31

Plain-language 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

specificity of the HAT/malaria combo test for gambiense HAT in passive screening

Timeframe: Enrolment

specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening

Timeframe: Enrolment

sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening

Timeframe: Enrolment

sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening

Timeframe: Enrolment

specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening

Timeframe: Enrolment

specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening

Timeframe: Enrolment

Trial details

NCT IDNCT03394976

SponsorFoundation for Innovative New Diagnostics, Switzerland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Human African Trypanosomiasis trials

Plain-language summary

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

specificity of the HAT/malaria combo test for gambiense HAT in passive screening

Timeframe: Enrolment

specificity of the SD BIOLINE HAT 2.0 test for gambiense HAT in passive screening

Timeframe: Enrolment

sensitivity of the HAT/malaria combo test for P. falciparum malaria in passive screening

Timeframe: Enrolment

sensitivity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening

Timeframe: Enrolment

specificity of the HAT/malaria combo test for P. falciparum malaria in passive screening

Timeframe: Enrolment

specificity of the SD BIOLINE Malaria Ag P.f test for P. falciparum malaria in passive screening

Timeframe: Enrolment