TB-CAPT CORE and HIV trial site initiation visits and trainings completed in Tanzania and Mozambique

The TB-CAPT group is entering an exciting period, with recruitment for two trials – the CORE and HIV trials – scheduled to start this summer. In preparation for this, site initiation visits and trainings were recently conducted in Tanzania and Mozambique.

TB-CAPT will evaluate the impact of novel tuberculosis (TB) diagnostic interventions on patient outcomes in two clinical trials (the CORE and HIV trials) in Mozambique and Tanzania and the accuracy of a new TB diagnostic for drug-resistant TB in a feasibility study (the XDR trial) in South Africa. The teams working on the XDR trial, implemented at the University of Cape Town and the University of Witwatersrand in South Africa, wrapped up sample recruitment earlier this year. The CORE and HIV teams are now at the final stages of preparing for the start of patient enrollment for the respective studies. 

As part of this preparation process, site initiation visits and trainings were recently conducted at the four implementing centres, Instituto Nacional de Saúde (INS) and Centro de Investigação em Saúde de Manhiça (CISM) in Mozambique, and Ifakara Health Institute and The National Institute for Medical Research (NIMR) in Tanzania. Dr Adam Penn-Nicholson, representing the study sponsor FIND, travelled to both countries together with the respective study leads, Prof. Katharina Kranzer of Ludwig Maximilian University of Munich (leading the CORE trial) and Dr Alberto García-Basteiro of Instituto de Salud Global Barcelona (leading the HIV trial).

“It was an incredibly humbling experience to travel to these sites and see the exceptional work and dedication from the study team and routine clinical, hospital and lab staff. By conducting these high-quality trials and closing the gaps from diagnosis to treatment initiation, we have an unprecedented opportunity to save lives, reduce healthcare costs and make a real impact on the healthcare cascade. I was very impressed with the teams and facilities and am excited to take the next steps in this important project”, Dr Penn-Nicholson reports.

The CORE trial will be a pragmatic trial to assess the impact of the Truenat MTB Plus and MTB-RIF assays when used at the peripheral level of the health system (primary healthcare level).

The HIV trial will assess the impact of an expanded testing strategy to diagnose TB with the Xpert Ultra and the urine-based AlereLAM assay for all hospitalised patients living with HIV (PLHIV) irrespective of disease symptoms or extent of HIV disease.

During their stay in Tanzania and Mozambique, Dr Penn-Nicholson, Prof. Kranzer and Dr García-Basteiro had the opportunity to intensively work with the teams on the ground and to visit some of the clinics that will recruit patients, including laboratories and other facilities.

“For the first time in 2.5 years, we met Principal Investigators and teams in Mozambique and Tanzania. It was a very joyous occasion. The feedback received during training and site visits was absolutely crucial to improving data collection tools and procedures. I am extremely grateful to everybody involved in the CORE trial. The data will inform national policies and is eagerly awaited. Also, the lessons learned when implementing a new molecular diagnostic (Truenat) will be helpful when rolling it out in the future,” says Prof. Kranzer.

“The HIV trial kick-off meetings were extremely engaging and fruitful. We had the chance to discuss and optimize how the study procedures will be implemented at each of the participating sites. I look forward to starting recruitment at all sites. The HIV trial will contribute to advance diagnostic algorithms using molecular diagnostics in hospitalized people with HIV,” says Dr García-Basteiro.

After diligent preparations and trainings, the TB-CAPT teams are in a good position and eager to start enrolling patients in the coming weeks.