Assessment of new decentralized childhood TB diagnostic approaches at district health system level
Proper TB diagnosis evaluation is rarely implemented for children at district hospital level and primary health care level in high TB-burden settings. More evidence is needed to recommend the best approach to childhood TB diagnosis in district health systems. This operational research implemented in collaboration with the National Tuberculosis Programs (NTPs) will use an innovative diagnostic approach based on Xpert MTB/RIF (using the newly developed Xpert Ultra cartridge and battery-operated GeneXpert Omni platform) performed on a combination of easy to collect samples (nasopharyngeal aspirate and stool), standardized symptoms screening and chest radiograph interpretation.
- This implementation research will assess the impact on childhood TB case detection of decentralizing childhood TB diagnosis compared to pre-intervention status.
- It will also compare the efficiency, feasibility and acceptability of two decentralisation approaches at district hospital and primary health care levels.
Evaluation of an early TB detection strategy in children with severe pneumonia
TB usually presents as a chronic disease in children, with symptoms such as cough lasting for several weeks. Recent studies have shown that it can also present as a pneumonia, a rapidly progressing disease with acute symptoms including cough, fever, and shortness of breath. In children with pneumonia, tuberculosis is poorly recognized or diagnosed late, which contributes probably to increased mortality.
- Output 2 is a diagnostic clinical trial evaluating whether an early tuberculosis detection strategy with the Xpert Ultra test on respiratory (nasopharyngeal aspirate) and stool samples has an impact on mortality in children with severe pneumonia.
Validation of diagnostic tools and algorithms in HIV-infected and severely malnourished children with presumptive tuberculosis
HIV-infected children and children with severe acute malnutrition are highly vulnerable population with regards to tuberculosis. Immunodepression due to HIV or to malnutrition exposes them to a higher risk of developing tuberculosis disease and higher mortality. In these children, diagnosis of tuberculosis is challenging because they do not present a lot of symptoms, or their symptoms are hard to differentiate form other infections, especially when they are HIV-infected.
- To improve diagnosis of tuberculosis, it is necessary to develop and validate specific algorithms and diagnostic tools in these children. Algorithms are standardized decision rules for diagnosis and treatment initiation. Output 3 is a diagnostic study aiming to develop and validate adapted algorithms for these children.
Identification of optimized, suitable, and affordable specimen processing and collection methods for childhood TB diagnosis in resource limited countries
This output involves microbiological and technological optimization work to identify and test simple and affordable specimen processing and collection methods for childhood TB diagnosis that can be deployed at low health care level in resource-limited countries. Indeed, stool is a very promising sample for diagnosis of TB in children but it requires to be processed before testing with Xpert MTB/RIF assay to remove factors that inhibit the molecular technique. This processing needs to be optimised and simplified to be used at low health care level. Nasopharyngeal aspirates, another promising method for specimen collection in children, requires equipment (aspirator) and device (mucus extractor) that can be expensive and difficult to procure. Therefore more work is needed to ensure secured access of robust and affordable equipment and devices for nasopharyngeal aspirate for limited resource countries.
- This output aims to optimize stool specimen processing for Xpert MTB/RIF testing and nasopharyngeal aspiration method for childhood TB diagnosis in resource-limited countries at low health care level.
Evaluation of cost-effectiveness of the proposed diagnostic approaches
Cost effectiveness and budget impact analyses are needed to evaluate the long-term impact of improving pediatric TB diagnostic, guide health authorities’ decisions and support the implementation of TB-speed approach in resource limited settings.
- To evaluate the cost-effectiveness and budget impact of the TB-Speed interventions
- To assess the market of paediatric diagnostics tools
- To develop a forecasting tool for practical budget planning by NTPs
Dissemination, communication and stakeholders’ engagement
This includes communication on the project progresses, advocacy towards the relevant stakeholders, and dissemination of results to support future scaling-up.
- To inform international/national TB stakeholders about the TB-Speed project
- To ensure policy change and further adoption of the TB-Speed diagnostic approach on a larger scale if supported by project’s results
- To increase project visibility among policy makers, scientific and health community
- To raise awareness about paediatric TB among health community and civil society