Activities

The ENDxTB workplan is organised around four main pillars of activity: The Clinical Studies, Test Evaluation, Data Management & Analysis, and Project Management & Dissemination. Each pillar has a designated leader who will coordinate their respective set of activities, liaise with the other leaders, and regularly meet with the funder to report on progress. 

Clinical Studies

Lead: Gerhard Walzl (SUN)

ENDxTB will conduct a multi-site, longitudinal, clinical project to compare head-to-head the most promising new tests for tuberculosis for different levels of health care settings. Experienced clinical sites in Africa (South Africa: SUN, UCT; The Gambia: MRCG) and South East Asia (Vietnam: OUCRU) will test children, adolescents, and adults who present to primary health care settings with symptoms suggestive of TB and will analyse novel tests alongside standard microbiological evaluation to ensure an unbiased evaluation. Additionally, confirmed TB cases will be followed up and their close contacts assessed to determine the utility of the same tests for treatment monitoring and prognosis for incident TB respectively. The SUN team will provide oversight and internal monitoring of ENDxTB clinical activities at each of the field sites. Protocols, case definitions, and all clinical procedures will be harmonized across all study sites to allow pooling of data and to ensure statistical power to address the research questions. Study cohorts will include children and adults as susceptibility, clinical presentation, and diagnostic features differ between age groups. We will also include people living with HIV infection, due to its major impact on the TB epidemic.

Test Evaluation

Lead: Jayne Sutherland (MCRG) and John Belisle (CSU)

A pipeline of novel tests that are suitable for different levels of health care and that target several key phases of host-pathogen interaction will be assessed and evaluated. These novel assays include point of care triage and diagnostic tests as well as predictive biomarker tests and will be compared to a selected panel of gold standard tests which together represent the composite diagnostics currently in use.

Data Management & Analysis

Leads: Gian van der Spuy and Gerard Tromp (SUN)

Activities will include coordination of database aspects, statistical aspects and informatics. Specifically, a project-specific online database will be set up ib the initial phase of the project to take up data generated in the clinical studies. An online dashboard will allow to monitor essential metrics such as enrollment rates, prevalence of TB cases, data completeness (demographic, clinical and test results), follow-up visit compliance etc., presenting the current status on overall project level as well as per site. Data will be analyzed to assess test performance, with the aim to identify tests that meet or exceed TPPs, and to perform head-to-head comparisons of the tests to identify which test in any given category is superior to others.

Project Management & Dissemination

Lead: Malte Streitz (LINQ)

Project management activities will ensure a smooth and timely implementation of project and include the coordination of internal communication, contract management, organisation and documentation of meetings, as well as project reporting. We will also enable the inclusion of new sites and new tests and support the interaction of ENDxTB with local TB control programs and ministries of health.

To boost visibility of ENDxTB and enhance outreach LINQ will guide external communication and support dissemination activities throughout the project lifetime.