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

Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

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


Condition

Human African Trypanosomiasis

Intervention

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

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

13747

Start Date

September 1, 2019

Completion Date

January 31, 2021

Primary Completion Date

January 31, 2021

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
      

Gender

All

Ages

4 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Veerle Lejon, PhD, HDR, , 

Location Countries

Burkina Faso

Location Countries

Burkina Faso

Administrative Informations


NCT ID

NCT04099628

Organization ID

DiTECT-HAT-WP3


Responsible Party

Sponsor

Study Sponsor

Institut de Recherche pour le Developpement

Collaborators

 Ministry of Public Health, Democratic Republic of the Congo

Study Sponsor

Veerle Lejon, PhD, HDR, Principal Investigator, Institut de Rechercher pour le Développement


Verification Date

April 2022