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

NCT04099628 | Completed

• 1 other identifier: DiTECT-HAT-WP3
• Study Type: interventional
• Target: 13,747
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

monitoring; surveillance; re-emergence; rapid diagnostic test; trypanolysis; LAMP; ELISA; molecular biology; RT-PCR; serology; diagnosis; specificity; sensitivity

Outcome Measures

Primary Outcomes (2)

• Sensitivity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk

  Index tests: 3 RDTs on fresh blood, immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS. Reference standard: for index test positives only: combined results of 2 parasitological examinations. Subjects negative in all index tests are considered HAT negative.

  6 months

• Specificity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk

  Index tests: 3 RDTs on fresh blood, immune trypanolysis on DBS, ELISA on DBS, LAMP on DBS, RT-PCR on DBS. Reference standard: for index test positives only: combined results of 2 parasitological examinations. Subjects negative in all index tests are considered HAT negative.

  6 months

Study Arms (1)

Diagnostic tests

EXPERIMENTAL

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

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

Interventions

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

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)

Diagnostic tests

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent resident of village (in low to zero prevalence HAT focus) for minimum 1 year

You may not qualify if:

• Previously treated for HAT (irrespective of time elapsed since treatment)
• No informed consent
• \< 4 years old

Sponsors & Collaborators

• Institut de Recherche pour le Developpement: lead
• Ministry of Public Health, Democratic Republic of the Congo: collaborator
• Institut National de Sante Publique: collaborator
• CIRDES: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Institute of Tropical Medicine, Belgium: collaborator
• University of Liverpool: collaborator

Study Sites (3)

CIRDES

Bobo-Dioulasso, Burkina Faso

Location

Institut Pierre Richet, Institut National de Santé Publique

Bouaké, Côte d’Ivoire

Location

Programme Nationale de Lutte contre la trypanosomiase humaine Africaine

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Trypanosomiasis, African; Infections; Trypanosomiasis; Disease; Hypersensitivity

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Veerle Lejon, PhD, HDR

  Institut de Rechercher pour le Développement

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Sequential assignement

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CÔ (1); DE (1); BU (1)