TB-CAPT kicks off recruitment for the CORE and HIV trials

Centro de Investigação em Saúde de Manhiça (CISM) in Mozambique kicked off patient recruitment for the TB-CAPT CORE trial in late August this year.

The TB-CAPT consortium recently reached two important milestones, as the group successfully enrolled the first patients in both the CORE trial and the HIV trial. In this article, we look closer at these achievements and provide a brief overview of the two trials.  

Coordinated by FIND, the global alliance for diagnostics, the rationale of the TB-CAPT project is to provide evidence for impactful implementation of tuberculosis (TB) and TB/HIV co-infection diagnostic strategies, including drug-susceptibility testing, through three clinical trials.

The CORE trial is led by Katharina Kranzer, Ludwig Maximilian University of Munich (LMU) in Germany, and the HIV trial is led by Alberto García-Basteiro, Fundación Privada Instituto de Salud Global Barcelona (ISGlobal) in Spain. Both trials will be conducted in Tanzania and Mozambique.

TB-CAPT CORE Trial

Today, on-site rapid testing for TB is not available in most primary healthcare clinics in many countries where the disease is widespread. As a result, patients often need to wait for up to several weeks, sometimes more than a month, before they receive their results and, if positive, can start treatment. During this time, there is also a high risk of disease transmission.

The TB-CAPT CORE trial aims at assessing the impact of making the Molbio MTB assays on the Truenat platform available at the primary healthcare level. This battery-powered rapid diagnostic instrument has the capacity to reduce the turnaround time for TB testing to a few hours, allowing patients who test positive to start TB treatment on the same day.

The first participants were recruited for the CORE trial at Centro de Investigação em Saúde de Manhiça (CISM) in Mozambique in late August this year. Only days later, the first sites in Tanzania also started recruting. Overall, 28 primary healthcare level sites across Tanzania and Mozambique will enrol a total of 4,200 patients in the study before the end of October 2023. Half of the patients will be included in the intervention arm (TB testing using the Truenat platform/TB assays placed at primary health care clinics combined with rapid communication of results and same-day TB treatment initiation) and half in the control arm (standard of care for TB testing using a combination of smear microscopy and laboratory (off-site) Xpert testing) and their disease progression and outcomes will be compared and analysed.

TB-CAPT HIV Trial

People living with HIV are not well served by the current standard sputum-based diagnostics, and the current standard of care in many countries is to only provide TB testing to HIV-positive patients who have TB symptoms or advanced HIV disease. The TB-CAPT EXULTANT trial will assess the impact of an expanded testing strategy for diagnosing TB amongst people living with HIV, irrespective of signs and symptoms of TB, using the highly sensitive Xpert Ultra assay as well as the Abbott Determine-TB LAM Antigen test. The expanded testing strategy will be implemented among newly admitted adult patients with HIV who are not on TB treatment at six hospitals, three in Tanzania and three in Mozambique.

The first patient was enrolled in the HIV trial in early September this year. In total, the TB-CAPT team aims at recruiting 1,172 participants across all six hospitals. Half of the participants will be included in the intervention arm and receive expanded testing, while the other half will be included in a control arm. The outcomes of the patients in the two arms will later be assessed by the team.

Looking ahead

The 5-year TB-CAPT project will provide insight into the clinical benefits of expanded TB diagnostic strategies in resource-limited settings and thereby improve public health in these contexts and decrease TB mortality and disease recurrence.

During and beyond the active project phase, study findings will be shared and discussed with policymakers at the local, national and international levels to enable them to make more informed decisions on the implementation and scale-up of innovative technology.

Instituto Nacional de Saúde (INS) in Moazambique was the second site to start recruitng for the TB-CAPT CORE trial.