Clinical trial NCT05637632: Assessment of Recombinant HAT-RDT Specificity
Official title: Assesslebt of Recombinant HAT-RDT Specificity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human African Trypanosomiasis
Keywords: rapid diagnostic test
serologic and molecular diagnosis of HAT
neglected tropical disease
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 1504
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are the people living in villages that are at risk for HAT infection, as the first stade of the disease is asymptomatic or with non-specific symptoms, the whole village is invited to participate in the active screening activity. This is routine active screening done by the mobile team. they study team will recruit people that participate to the screening campaign.

Brief summary: Human African trypanosomiasis HAT, or sleeping sickness, is a tropical disease caused mainly by the parasite Trypanosoma brucei gambiense (gHAT). After a severe epidemic in the 1990s, the World Health Organization (WHO) now targets elimination of transmission of gHAT by the year 2030, which heavily relies on its diagnosis and treatment. Traditional screening tests (like CATT or rapid diagnostic tests (RDTs)) are based on the detection of antibodies against the parasite using native antigens, which are costly and dangerous to produce. New serological tests, using recombinant antigens, have been developed, but little is known about their field performance. The primary objective of this study is to assess the specificity of the newly-developed recombinant RDTs, since it will become very relevant as we move forward towards a screen\&treat strategy. We will also compare the diagnostic accuracy and overall performance of iELISA and molecular testing.

Detailed description: This prospective study will follow two different mobile units as they go on their routine screening of the gHAT endemic population. Study participants will be enrolled during the routine screening, and after providing informed consent, they will be asked for a 4.5 ml venous blood sample. The three RDTs (HAT Sero-K-SeT, rHAT Sero-K-SeT, Bioline HAT 2.0) and CATT will be performed on site, while part of the sample will be mixed with DNA/RNA Shield for molecular analysis and the rest will be left to decant, to collect plasma for iELISA and TL. Confirmatory tests will be performed in the field on any seropositive individual. Should any case be confirmed, treatment will be offered, free of charge, following PNLTHA guidelines.

The obtained data will allow for a very precise estimation of the specificity of the newly developed recombinant RDTs. This study does not aim to determine the sensitivity of these tests since, due to the very low prevalence, the chance of having sufficient seropositive samples and/or finding a true case are very slim. The diagnostic performance of iELISA and novel molecular tests will also be determined.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent (and assent for minors 12-17years old)
* Be enrolled in routine HAT screening activities dony by the mobile unit (PNLTHA mobile unit routine active screening teams that visit villages at risk for HAT). People living in the village are targeted for screening.
* Participants must be at least 12 years old

Exclusion Criteria:

* Chilrden younger than 12 years old
* previously treated for HAT
* refusal to provide informed consent

Primary outcomes:
measure: Specificity of recombinant CORIS rapid diagnostic test for HAT
timeFrame: 1 month
measure: Specificity of recombinant BIOLINE rapid diagnostic test for HAT
timeFrame: 1 months
Secondary outcomes:
measure: iELISA
timeFrame: 3 months
measure: Molecular
timeFrame: 4 months
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA)
Study officials:
affiliation: Insitute of Tropical Medicine
name: Epco Hasker, Phd PH
role: STUDY_DIRECTOR
References: