Clinical trial NCT04099628: Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
Official title: Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: WP3 Post Elimination Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Public Health, Democratic Republic of the Congo
name: Institut National de Sante Publique
name: CIRDES
name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Institute of Tropical Medicine, Belgium
name: University of Liverpool
First posted: 2019-09-23
Enrollment: 13747
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sequential assignement
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Sensitivity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk
timeFrame: 6 months
measure: Specificity for HAT diagnosis of RDT, RDT combinations, algorithms of RDT and serological and/or molecular tests on the population at risk
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bobo Dioulasso
country: Burkina Faso
facility: CIRDES
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Programme Nationale de Lutte contre la trypanosomiase humaine Africaine
city: Bouaké
country: Côte D'Ivoire
facility: Institut Pierre Richet, Institut National de Santé Publique
Study officials:
affiliation: Institut de Rechercher pour le Développement
name: Veerle Lejon, PhD, HDR
role: PRINCIPAL_INVESTIGATOR
References: