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Also in 2022, the TB-CAPT Consortium enrolled the first patients into two of its three clinical trials, the CORE and EXULTANT trials. The CORE trial is assessing the impact of making the Molbio Truenat diagnostic platform available at primary healthcare facilities. The first participant was recruited in Mozambique in August 2022, with Tanzanian sites starting recruitment soon after.
The EXULTANT trial is assessing the impact of an extended testing strategy for diagnosing TB among people living with HIV. Currently, only those with TB symptoms or advanced HIV disease are tested. Given the risks that TB poses to people living with HIV, the study will assess the potential benefits of testing all patients with HIV admitted to hospital, using sensitive molecular and urine-based tests. The first patient in this trial was enrolled in Mozambique in September 2022.
Recruitment also began in 2022 to the TB TRIAGE+ study in Lesotho and South Africa. The project is assessing whether two tests – an innovative digital chest X-ray analysis system (CAD4TB) and a simple-to-use blood test for detection of C-reactive protein (CRP), a marker of infection – can provide a rapid indication of the likelihood of TB disease in the community. It ultimately aims to recruit 20,000 participants.
Complementing this large community study, the TB TRIAGE+ ACCURACY trial is assessing the diagnostic accuracy of the two methods in a small number of individuals, to help define suitable thresholds for a TB screening algorithm to be used in the community. The study was successfully completed in 2022 and the results are expected to be published in 2023.
Conventional culture-based methods of TB diagnosis are slow, leading to a delay in the start of treatment and providing opportunities for the disease to spread. By contrast, currently used molecular tools provide rapid results but are expensive and not always available at primary healthcare facilities. Several EDCTP-funded projects are evaluating alternative ‘triaging’ methods to rapidly identify possible TB cases at local facilities, which can then be confirmed by molecular diagnosis.
The SeroSelect Consortium held its first face-to-face meeting in Cape Town, South Africa, in August 2022, and its first participants were enrolled in Tanzania in September 2022 and in Ethiopia in October 2022. The project is assessing a new lateral flow test for active TB, SeroSelectTB, at health posts in Ethiopia, South Africa and Tanzania. The test detects antigens associated with active TB disease but not latent TB infections.
Several EDCTP-funded TB projects that are assessing innovative technologies for more rapid identification of TB cases recruited their first participants in 2022.
Triaging TB