Assessment of Recombinant HAT-RDT Specificity

NCT05637632 | Completed

• 1 other identifier: HAT-RDT
• Study Type: observational
• Target: 1,504
• Locations: 1 country
• Sites: 1

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.

Conditions

Human African Trypanosomiasis

Keywords

rapid diagnostic test; serologic and molecular diagnosis of HAT; neglected tropical disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• iELISA

  3 months

• Molecular

  4 months

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA)

Kinshasa, 0000, Democratic Republic of the Congo

Location

Related Publications (1)

• Tablado Alonso S, Inocencio Da Luz R, Van Reet N, Ngay I, Pemba MM, Roge S, Kwete J, Nicco E, Rigouts L, Miaka EM, Ngoyi DM, Verle P, Buscher P, Hasker E. Prospective evaluation of 2nd generation rapid diagnostic tests for the serological diagnosis of gambiense human African trypanosomiasis in the Democratic Republic of the Congo. BMC Infect Dis. 2025 Dec 6;26(1):46. doi: 10.1186/s12879-025-12278-3.

  PMID: 41351066 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample that contains DNA of the Trypanosoma brucei gambiense parasite. the study team will analyse the parasite DNA

MeSH Terms

Conditions

Neglected Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Epco Hasker, Phd PH

  Insitute of Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 5, 2022
• Study Start: September 20, 2022
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

DE (1)