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Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring (DiTECT-HAT-WP3)

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ClinicalTrials.gov Identifier: NCT04099628
Recruitment Status : Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : February 21, 2021
Sponsor:
Collaborators:
Ministry of Public Health, Democratic Republic of the Congo
Institut National de Sante Publique
CIRDES
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Institute of Tropical Medicine, Belgium
University of Liverpool
Information provided by (Responsible Party):
Institut de Recherche pour le Developpement

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.

Condition or disease Intervention/treatment Phase
Human African Trypanosomiasis Sleeping Sickness Trypanosoma Brucei Gambiense; Infection West African Sleeping Sickness African Trypanosomiases Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense Diagnostic Test: Rapid diagnostic test (RDT); Serological and molecular tests on DBS Not Applicable

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 elimination. At low disease prevalence, HAT control is increasingly integrated into routine activities of peripheral health centres. However, the weak capacity of fixed health structures to implement control activities, lack of coverage, the unspecific clinical picture of HAT, and the existence of asymptomatic cases and animal reservoirs may result in under detection of HAT. To ensure sustainability of zero transmission and to avoid re-emergence caused by remaining Tbg reservoirs, continued post-elimination monitoring is therefore required.

Health workers performing house to house visits in foci with very low HAT prevalence can easily collect blood on filter paper and send it to regional HAT reference centres for analysis. The objective of the DiTECT-HAT-WP3 study is to determine the feasibility and cost of diagnostic algorithms of serological and molecular high-throughput tests on blood on filter paper for post-elimination monitoring, with or without a previous screening with rapid diagnostic tests.

In villages in low to zero prevalence foci in Democratic Republic (DR) Congo, Côte d'Ivoire and Burkina Faso, a health worker will go from house to house to 1) register all consenting inhabitants in a Personal Digital Assistant; 2) take a blood sample on filter paper 3) perform 3 rapid diagnostic tests. All dried blood spots (DBS) are sent to the reference laboratory for high-throughput testing (ELISA, trypanolysis, loop-mediated isothermal amplification method (LAMP) and real time (RT) -PCR). Subjects positive in at least 1 test - the RDTs or high-throughput tests - are revisited twice for parasitological confirmation.

In each country, blood specimens of 6000 persons will be tested. The relative effectiveness and overall cost of the different diagnostic algorithms will be investigated. We will quantify the break-even point for an imperfect test algorithm by formulating a decision criterion to assess how many false negatives, but particularly how many false positives can be tolerated while still achieving an intervention with a reasonable cost burden. The results will enable us to propose a test algorithm and a threshold to send out specialised mobile teams for stopping HAT re-emergence, without unnecessarily raising the alarm.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Sequential assignement
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic tests
Diagnostic tests: Rapid diagnostic test (RDT); Serological and molecular tests on DBS
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)





Primary Outcome Measures :
  1. Sensitivity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk [ Time Frame: 6 months ]

    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.


  2. Specificity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk [ Time Frame: 6 months ]

    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.




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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099628


Locations
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Burkina Faso
CIRDES
Bobo Dioulasso, Burkina Faso
Congo, The Democratic Republic of the
Programme Nationale de Lutte contre la trypanosomiase humaine Africaine
Kinshasa, Congo, The Democratic Republic of the
Côte D'Ivoire
Institut Pierre Richet, Institut National de Santé Publique
Bouaké, Côte D'Ivoire
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Ministry of Public Health, Democratic Republic of the Congo
Institut National de Sante Publique
CIRDES
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Institute of Tropical Medicine, Belgium
University of Liverpool
Investigators
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Principal Investigator: Veerle Lejon, PhD, HDR Institut de Rechercher pour le Développement
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Responsible Party: Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier: NCT04099628    
Other Study ID Numbers: DiTECT-HAT-WP3
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Recherche pour le Developpement:
monitoring
surveillance
re-emergence
rapid diagnostic test
trypanolysis
LAMP
ELISA
molecular biology
RT-PCR
serology
diagnosis
specificity
sensitivity
Additional relevant MeSH terms:
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Trypanosomiasis
Trypanosomiasis, African
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases