Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring

Summary

This study determines the feasibility, diagnostic performance and cost for monitoring of eliminated human African trypanosomiasis (HAT) foci using diagnostic algorithms of serological and molecular high throughput tests with and without previous rapid diagnostic test blood screening for early detection of Trypanosoma brucei gambiense HAT re-emergence.

Conditions

• Human African Trypanosomiasis
• Sleeping Sickness
• Trypanosoma Brucei Gambiense; Infection
• West African Sleeping Sickness
• African Trypanosomiases
• Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense

Interventions

DIAGNOSTIC_TEST

Rapid diagnostic test (RDT); Serological and molecular tests on DBS

The population of low to zero prevalence HAT foci will be actively screened for HAT by taking a blood sample for performing 3 rapid diagnostic tests (RDT) and for preparing dried blood spots to perform 4 serological and molecular high throughput reference tests. If at least one of the RDTs, serological or molecular reference tests is positive, parasitological examination is performed twice. The combined results of parasitological examinations serve as reference standard. Other Names: rHAT Sero-Strip (Coris Bioconcept, Belgium) SD Bioline HAT 1.0 (Standard Diagnostics Korea) HAT Sero-K-Set (Coris Bioconcept, Belgium) Immune trypanolysis: presence of antibodies ELISA: on native LiTat 1.3 + LiTat 1.5 variant surface glycoprotein (VSG) LAMP T. brucei Detection Kit (Eiken) RT-PCR: Trypanozoon 18S, Tbg Trypanosoma gambiense specific glycoprotein (TgsGP)

Sponsors & Collaborators

• Ministry of Public Health, Democratic Republic of the Congo

  collaborator OTHER_GOV

• Institut National de Sante Publique

  collaborator OTHER

• CIRDES

  collaborator UNKNOWN

• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• Institut de Recherche pour le Developpement

  lead OTHER_GOV

Principal Investigators

• Veerle Lejon, PhD, HDR · Institut de Rechercher pour le Développement

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2021-01-31

Completion

2021-01-31

Countries

• Burkina Faso
• Côte d’Ivoire
• Democratic Republic of the Congo

Study Locations