Assessment of Recombinant HAT-RDT Specificity

Assesslebt of Recombinant HAT-RDT Specificity

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.

Study Overview

• Status: Completed
• Conditions: Human African Trypanosomiasis

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.

• Study Type: Observational
• Enrollment (Actual): 1504

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the, 0000
    • Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of recombinant CORIS rapid diagnostic test for HAT	recombinant RDT for detection of HAT developed by CORIS, determine its field performance	1 month
Specificity of recombinant BIOLINE rapid diagnostic test for HAT	recombinant RDT for detection of HAT developed by BIOLINE, determine its field performance	1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iELISA	determine performance of inhibition ELISA test to replace Trypanolyse test	3 months
Molecular	determine if active infection of HAT is present using molecular testing technique, determine its performances	4 months

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Investigators: Study Director: Epco Hasker, Phd PH, Insitute of Tropical Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: rapid diagnostic test; neglected tropical disease; serologic and molecular diagnosis of HAT
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Euglenozoa Infections; Trypanosomiasis; Trypanosomiasis, African
• Other Study ID Numbers: HAT-RDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: anonymity of participants must be guaranteed anonymised study results can be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No