Human African TrypanosomiasisDiTECT-HAT-WP3NCT04099628
Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
A study testing Rapid diagnostic test (RDT); Serological and molecular tests on DBS in people with Human African Trypanosomiasis and Sleeping Sickness, run by Institut de Recherche pour le Developpement at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection
- What is being tested?
- Rapid diagnostic test (RDT); Serological and molecular tests on DBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,747 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Sep 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Permanent resident of village (in low to zero prevalence HAT focus) for minimum 1 year
Who cannot join
- Previously treated for HAT (irrespective of time elapsed since treatment)
- No informed consent
- < 4 years old
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Côte d’Ivoire1 site
Institut Pierre Richet, Institut National de Santé Publique
Bouaké
Democratic Republic of the Congo1 site
Programme Nationale de Lutte contre la trypanosomiase humaine Africaine
Kinshasa
About this study
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.
Read the 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.
- Conditions
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection, West African Sleeping Sickness, African Trypanosomiases, Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense
- Being tested
- Rapid diagnostic test (RDT); Serological and molecular tests on DBS
- Keywords
- monitoring, surveillance, re-emergence, rapid diagnostic test, trypanolysis, LAMP, ELISA, molecular biology, RT-PCR, serology, diagnosis, specificity, sensitivity
- Medical subject headings
- Trypanosomiasis, African, Infections, Trypanosomiasis, Disease, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid diagnostic test (RDT); Serological and molecular tests on DBSDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic tests | Experimental | Diagnostic tests: Rapid diagnostic test (RDT); Serological and molecular tests on DBS Receives: Diagnostic Test: Rapid diagnostic test (RDT); Serological and molecular tests on DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Sep 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human African TrypanosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential assignement
- Masking
- None (open label)
- Enrolment
- 13,747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Institut National de Sante Publique, CIRDES, Institut National de Recherche Biomedicale (INRB), Institute of Tropical Medicine, Belgium, University of Liverpool
- Responsible party
- Sponsor
- Investigators
- Veerle Lejon, PhD, HDR, Principal investigator, Institut de Rechercher pour le Développement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099628
- Sponsor's protocol ID
- DiTECT-HAT-WP3
- Acronym
- DiTECT-HAT-WP3
- Status last verified
- Apr 2022
- First submitted
- 19 Sep 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
- ClinicalTrials.gov ID
- NCT04099628
- Acronym / sponsor ID
- DiTECT-HAT-WP3 / DiTECT-HAT-WP3
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,747 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Institut National de Sante Publique, CIRDES, Institut National de Recherche Biomedicale (INRB), Institute of Tropical Medicine, Belgium, University of Liverpool
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential assignement
| Arm | Type | Receives |
|---|---|---|
| Diagnostic tests | Experimental | Diagnostic Test: Rapid diagnostic test (RDT); Serological and molecular tests on DBSDiagnostic tests: Rapid diagnostic test (RDT); Serological and molecular tests on DBS |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Permanent resident of village (in low to zero prevalence HAT focus) for minimum 1 year
Key exclusion criteria (3 listed)
- Previously treated for HAT (irrespective of time elapsed since treatment)
- No informed consent
- < 4 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid diagnostic test (RDT); Serological and molecular tests on DBSThe 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 test | Diagnostic tests |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: Yes
Related trials for Human African Trypanosomiasis
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Not yet recruitingPhase 3
Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veerle Lejon, PhD, HDR principal investigator
Institut de Rechercher pour le Développement
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid diagnostic test (RDT); Serological and molecular tests on DBS in people with Human African Trypanosomiasis and Sleeping Sickness, run by Institut de Recherche pour le Developpement at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Burkina Faso, Côte d’Ivoire, Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.