Project: CAP-TB: Close the Gap, Increase Access, Provide Adequate Therapy

Acronym	CAP-TB (Reference Number: RIA2017S-2007)
Duration	01/09/2019 - 31/08/2022
Project Topic	The introduction of automated real-time PCR-based technologies (i.e., Xpert) 5 years ago raised the hope for improved tuberculosis (TB) case-detection and reduced diagnostic delay. Many studies conducted since then have contributed to both an understanding of the test’s limitations and the need for better tests to achieve the post-2015 TB targets of the World Health Organization (WHO). Even more importantly, the studies highlighted the need for optimized implementation strategies for novel tests and improved linkage to treatment. Next generation tests need to be placed at the point-of-care at microscopy centre level, fully integrated in the diagnostic and treatment network, connectivity enabled, more sensitive and able to perform expanded drug susceptibility testing (DST). With the market introduction of the Cepheid Omni, a battery-powered, connected point-of-care platform that runs the highly-sensitive Ultra assay and, from 2019 onward, will also run an XDR assay, we believe that we will have a technology that will meet the WHO target product profiles (TPPs) for TB testing. Using our substantial TB diagnostic trial experience, the CAP-TB consortium will conduct a well-coordinated series of trials evaluating interventions to define implementation approaches of the Omni platform, which will have highest impact in different settings. The proposed trials will demonstrate (i) the impact of Omni/Ultra and Omni/XDR at microscopy-center level on patient-important outcomes; (ii) the impact of Ultra testing of pulmonary and extra-pulmonary samples on mortality in patients with advanced HIV; (iii) the utility of process innovation and supportive solutions for diagnostics (e.g. connectivity) to improve linkage to care, surveillance, stock and device management; and (iv) the needs for staffing, training, stock management and maintenance for implementation of a molecular test at microscopy centre level. Furthermore, it will enable socio-economic and population level impact modelling. The trial is designed to provide evidence for most impactful implementation strategies depending on local epidemiology and existing infrastructure, rather than just providing evidence on technology introduction. As such, the work outlined in the proposal aims to support the policy-making mandate of WHO and participating ministries of health and implementation planning for scale-up. Further, the project will establish centres of excellence for implementation of diagnostic trials that will serve in the evaluation of future tests.
Network	EDCTP2
Call	Strategic actions supporting large-scale clinical trials 2017

Project partner

Number	Name	Role	Country
1	Foundation for Innovative New Diagnostics	Coordinator	Switzerland
2	African Society for Laboratory Medicine	Partner	Ethiopia
3	Fundaçao Manhiça	Partner	Mozambique
5	Fundación Privada Instituto de Salud Global Barcelona	Partner	Spain
6	Ifakara Health Institute Trust	Partner	Tanzania
7	Instituto Nacional de Saúde	Partner	Mozambique
9	Ludwig-Maximilians-Universitaet Muenchen	Partner	Germany
11	National Institute for Medical Research - Tanzania	Partner	Tanzania
13	Ospedale San Raffaele SRL	Partner	Italy
14	Swiss Tropical and Public Health Institute	Partner	Switzerland
15	University of Cape Town	Partner	South Africa
16	Wits Health Consortium (Pty) Ltd	Partner	South Africa