Facilitating the implementation of TB-CAPT for tuberculosis diagnosis

The TB-CAPT (Close the gap, increase Access, provide adequate Therapy) project aims to provide evidence for implementation of TB and TB/HIV co-infection diagnosis strategies including drug-susceptibility testing through a series of trials in Tanzania, Mozambique, and South Africa.

The clinical trials within the selected countries will evaluate the impact of diagnostic interventions on outcomes, including the effects of expanding TB testing strategies to PLHIV. The trials will be designed to consider local epidemiology, as well as existing infrastructure, and will compare the new strategies with current standards of care.

The primary objective of this study is to evaluate the new technologies and their intended use. The GeneXpert Omni instrument with the Xpert MTB/RIF Ultra cartridge meets the high-priority target product profile (TPP) which has the potential to improve patient outcomes when replacing the current standard of care (sputum-smear testing or centralized testing).

The second objective is to facilitate policy change and inform implementation strategies at a global, national, and regional level. This project will collaborate with national programs, governments, and local implementers to generate data to support the development and execution of implementation plans within the selected trial countries.

Lastly, the third objective of the study is to strengthen in-country infrastructure and human capacity. The TB-CAPT project will work with renowned institutions in the selected trial countries, local researchers, and government infrastructure, to develop an enhanced capacity for conducting clinical trials, implementation research, and implementation plans for new diagnostics.

It is estimated that each year more than 10 million people worldwide fall ill with TB. However, currently, only around 7 million are identified – while others remain unidentified. Of the nearly 2 million deaths each year most are preventable with existing treatments if diagnosed early, but the diagnosis gap in TB remains. To close this gap, it is critical to develop new TB tools and diagnosis technologies that will not only detect disease but will also identify strains that are resistant to the available TB medications.

The introduction of automated and real-time PCR-based technologies (i.e., GeneXpert®) has improved TB case detection and reduced diagnosis delay. Many studies conducted since then have contributed to both an understanding of the limitations of these tests and the need for better tests to achieve the post-2015 TB targets set by WHO.

The TB-CAPT project intends to inform WHO of the recommendations for implementation of the first diagnostic platform suitable to replace smear-microscopy at the most marginal healthcare level. In addition, FIND and the African Society for Laboratory Medicine (ASLM) will assist in translating findings to scale-up beyond trial countries.

The duration of this project is 3.5 years, from 2019 to 2023. It will be funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). The principal investigator for the project is Jerry Hella who will also be the project leader/coordinator. Priscilla Mlay will be the project administrator.

To learn more about this project visit the  TB-CAPT consortium website.