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

April 14, 2022 updated by: Institut de Recherche pour le Developpement
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13747

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recherche pour le Developpement

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute of Tropical Medicine, Belgium
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
University of Liverpool
Ministry of Public Health, Democratic Republic of the Congo
Institut National de Sante Publique
CIRDES

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Veerle Lejon, PhD, HDR, Institut de Rechercher pour le Développement

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DiTECT-HAT-WP3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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