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Project Topic
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Infection with Trypanosoma brucei gambiense (Tbg) causes human African trypanosomiasis (HAT), a neglected tropical disease. In the last decade the prevalence of HAT has strongly decreased and it has now been targeted for elimination. To reach a sustainable Tbg HAT elimination, integration of HAT diagnosis by passive case detection in the peripheral health centers and continued monitoring of eliminated foci are vital. Development of safe and easy-to-use drugs, applicable in an elimination context, would be accelerated by availability of an early test of cure. The overall goal of the DiTECT-HAT project is to validate the performance of diagnostic tools and algorithms for early and rapid diagnosis of Tbg HAT, within a context of 1) passive case detection; 2) post-elimination monitoring and 3) assessing the therapeutic response in clinical trials. For passive case detection, the diagnostic performance and cost of rapid diagnostic tests performed on clinical suspects in peripheral health centres, whether or not combined with serological and/or molecular tests on filter paper done at regional reference laboratories is investigated. Study sites in DR Congo, Côte d’Ivoire and Guinea have been selected. The study documents, after having obtained ethical clearance in Europe, have been submitted to the respective national ethics committees. Purchase of the study material is ongoing. Training of the involved medical personnel is planned, after which field activities will be initiated. If diagnostic algorithms with high positive predictive values are identified, these might allow test-and-treat scenarios without the need for complicated parasitological confirmation. For post-elimination monitoring, health workers performing house to house visits can easily collect blood on filter paper and send it to regional HAT reference centres for analysis. The feasibility and cost of diagnostic algorithms based on rapid diagnostic tests, serological and/or molecular high-throughput tests for post-elimination monitoring will be determined. Low to zero prevalence disease foci in DR Congo, Côte d’Ivoire and Burkina Faso have been identified, ethical clearance in Europe has been obtained and asked for at the national level. Field activities will take place during the respective dry seasons, after appropriate training of health workers. Based on the results we will establish an appropriate threshold to trigger active case finding to avoid re-emergence of HAT, without unnecessarily raising the alarm. Finally, the accuracy of neopterin and trypanosomal RNA detection as early test-of-cure is studied in an ongoing therapeutic trial in DR Congo. Full ethical clearance has been obtained, all study material is in place and activities are ready to start. If one of the proposed markers allows for earlier treatment outcome assessment, this will considerably speed up the future development of new treatments for HAT, and improve the management of relapses in routine care. The above described field activities are supported by two regional reference laboratories in DR Congo and Burkina Faso. An innovative quality control system has been set up for the project. In the study sites, an application for electronic data recording is put in place that incorporates pictures of rapid diagnostic tests and videos of parasitological tests. On 10% of the analyses at the regional reference laboratory, an external quality control will be performed. The proposed research will provide evidence to support policies for improved HAT diagnosis and patient management within a context of disease elimination, and will contribute to successful and sustainable HAT elimination. More information about the project and its progress is available on the DiTECT-HAT website.
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