Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis

Not Applicable

Completed

• Conditions: Sleeping Sickness; West African Sleeping Sickness; Human African Trypanosomiasis; Trypanosoma Brucei Gambiense; Infection
• Interventions: Diagnostic Test: Serological field test for HAT; Diagnostic Test: malaria rapid test; Diagnostic Test: Immunologic laboratory tests; Diagnostic Test: Molecular laboratory tests

• Registration Number: NCT05466630
• Lead Sponsor: Institut de Recherche pour le Developpement

Brief Summary

This study evaluates and compares the diagnostic specificity of 5 serological field tests for screening of the population at risk for human African trypanosomiasis due to Trypanosoma brucei gambiense.

Detailed Description

In the last decade, the prevalence of Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) has fallen and HAT has been targeted for transmission interruption by 2030. To achieve this goal, disease surveillance remains essential and is based on the identification of cases after screening carried out in the field with a serological test.

The SpeSerTryp study is a prospective evaluation of the specificity of serological field tests for the diagnosis of HAT in Côte d'Ivoire and Guinea. Since the prevalence of HAT is low in these countries, sensitivity will not be assessed.

The main objective is to evaluate and compare the specificity of 5 serological field tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT \& HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium ), TDR DCN (USA), and the CATT/T.b. gambiense (Institute of Tropical Medicine Antwerp, Belgium). The secondary objectives are: 1° to assess the specificity of the 5 serological field tests according to malaria status; and 2° to compare the performance of immunological laboratory tests (trypanolysis, ELISA/T.b.gambiense, g-iELISA) and molecular laboratory tests (Trypanozoon RT-qPCR multiplex, SNP RT-qPCR and SHERLOCK) as reference tests to differentiate false positive subjects to serological field tests from subjects who had contact with Tbg. Specificity values will be determined against a composite reference test consisting of the most sensitive HAT parasitological methods. SpeSerTryp is a prospective study that will take place in the endemic health districts of Bonon and Sinfra in Côte d'Ivoire and in the endemic health districts of Forécariah, Dubréka and Boffa in Guinea. In each country, 500 participants will be actively recruited by mobile teams. The inclusion criteria are: Age greater than or equal to 10 years and obtaining signed informed consent. The exclusion criteria are: Severe anemia preventing blood sampling; serious illness preventing the obtaining of informed consent and participation in the study; or history of HAT. After obtaining informed consent, a venous blood sample will be taken (6 mL). This specimen will be used to carry out the 5 serological tests for HAT, the RDT for malaria, and for participants with at least one of the 5 serological tests positive, parasitological confirmation of HAT and molecular and immunological laboratory tests . The duration of participant recruitment is estimated to be around 30 days, while laboratory analyses will take about 6 months. HAT cases identified during the study will be treated in accordance with current national guidelines.

This study will be conducted in accordance with the protocol, the current version of the Declaration of Helsinki, ICH-BPC E6/R2 guidelines, and all national legal and regulatory requirements.

Study Timeline

• Study Start: 2022-06-20
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-20
• Primary Completion: 2022-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1095

Inclusion Criteria

• at least 10 years old
• signed the informed consent form (in case of minor: parent or tutor signs informed consent form and minor signs ascent form)

Exclusion Criteria

• severe anemia hindering blood sampling
• severe illness hindering obtention of informed consent (eg coma, cognitive deficiency etc)
• history of sleeping sickness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
participant	malaria rapid test	All eligible participants will undergo 5 serological field tests for HAT and a malaria test. Those testing positive in at least 1 serological field test will undergo parasitology to confirm HAT and immunological and molecular laboratory tests
participant	Serological field test for HAT	All eligible participants will undergo 5 serological field tests for HAT and a malaria test. Those testing positive in at least 1 serological field test will undergo parasitology to confirm HAT and immunological and molecular laboratory tests
participant	Immunologic laboratory tests	All eligible participants will undergo 5 serological field tests for HAT and a malaria test. Those testing positive in at least 1 serological field test will undergo parasitology to confirm HAT and immunological and molecular laboratory tests
participant	Molecular laboratory tests	All eligible participants will undergo 5 serological field tests for HAT and a malaria test. Those testing positive in at least 1 serological field test will undergo parasitology to confirm HAT and immunological and molecular laboratory tests

Primary Outcome Measures

Name	Time	Method
Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea	1 month	Index tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT (Coris BioConcept, Belgium), HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium), RDT DCN (USA), CATT/Tb gambiense (ITM Antwerp, Belgium). Reference test: parasitological confirmation by combined lymph and blood (mAECT) examination

Secondary Outcome Measures

Name	Time	Method
Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea, in function of malaria status	1 month	Index tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT (Coris BioConcept, Belgium), HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium), RDT DCN (USA), CATT/Tb gambiense (ITM Antwerp, Belgium). Reference test: parasitological confirmation by combined lymph and blood (mAECT) examination. The malaria status will be determined using an RDT detecting HRP2
Specificity of immunologic and molecular laboratory tests for diagnosis of HAT in serological suspects	1 year	Index tests: trypanolysis, ELISA/T.b.gambiense, g-iELISA, Trypanozoon RT-qPCR multiplex, SNP RT-qPCR, SHERLOCK. Reference test: parasitological confirmation by combined lymph and blood (mAECT) examination.

Trial Locations

Locations (2)

Université Jean Lorougnon Guédé de Daloa; 🇨🇮 Bonon, Côte D'Ivoire

Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie; 🇬🇳 Dubréka, Guinea