EXPANDED TB SCREENING DOES NOT SPEED UP TREATMENT IN PATIENTS LIVING WITH HIV

Os dados são revelados no âmbito do estudo EXULTANT

A clinical trial conducted in Mozambique and Tanzania concluded that expanding the use of molecular testing on urine and stool samples, in tandem with sputum, for the diagnosis of tuberculosis (TB) among hospitalised people living with HIV did not lead to earlier treatment initiation or reduce short-term mortality. The results of the trial, known as EXULTANT (Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique), were recently published in the scientific journal, The Lancet Infectious Diseases.

In Mozambique, the study was implemented by the Centro de Investigação em Saúde de Manhiça (CISM) and the Instituto Nacional de Saúde (INS), in coordination with ISGlobal – Barcelona Institute for Global Health and the Foundation for Innovative New Diagnostics (FIND), under the TB-CAPT (Close the gap, increase Access, Provide adequate Therapy) consortium, funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). The project additionally involved partner institutions from Tanzania, where the study was also implemented, namely the Ifakara Health Institute (IFAKARA) and the National Institute for Medical Research (NIMR).

The clinical trial was conducted in a context where tuberculosis remains the leading cause of death among people living with HIV. In these cases, diagnosis continues to be particularly challenging due to the frequent occurrence of non-specific symptoms, extrapulmonary forms of the disease, and the difficulties many patients face in producing sputum (one of the main samples used for TB diagnosis). In this context, EXULTANT evaluated new diagnostic approaches based on alternative samples such as urine and stool, with the aim of improving case detection and accelerating treatment initiation.

The study involved 11 health facilities across the two aforementioned countries and covered approximately 11,700 hospitalised adults living with HIV, irrespective of the presence of TB symptoms. Participants were divided into two groups: an intervention group, which underwent expanded screening using Xpert MTB/RIF Ultra molecular testing on sputum, urine, and stool samples together with the LF-LAM urine test; and a control group, which followed the standard protocol recommended by the World Health Organization (WHO), based on symptom assessment and targeted use of diagnostic tests.

According to Marta Cossa, first author of the study and researcher at CISM, the objective was to assess whether integrating these new approaches would increase the number of patients diagnosed and treated earlier than the typical rate observed with solely sputum samples. However, “the results showed that the expanded strategy did not bring significant differences in early treatment initiation or mortality reduction,” she explained.

The findings demonstrated that 16% of patients in the expanded screening group initiated treatment within the first 72 hours after hospital admission, compared to 15.3% in the standard group. Mortality after eight weeks also showed no statistically significant differences between the two groups. Nevertheless, the study identified important insights regarding the use of alternative samples. According to Dinis Nguenha, also a researcher at CISM, “around half of the participants were able to provide sputum samples, which reinforces the potential of urine and stool as viable alternatives for TB diagnosis among hospitalised patients living with HIV.”

Although the tests performed on urine and stool samples allowed the identification of some additional TB cases, this increase in diagnostic yield did not translate into faster treatment initiation or reduced mortality.

According to the coordinator of the Tuberculosis Unit at CISM, the findings demonstrate the need to continue optimising TB diagnostic algorithms for people living with HIV, while also reinforcing the role of alternative samples as a complement to sputum in hospital settings.

The authors recommend that future studies focus on improving the implementation of currently available tests and on developing more accurate, simple, and context-appropriate diagnostic tools adapted to hospital realities in countries with a high burden of TB and HIV, such as Mozambique.

Reference:

Cossa, M., Ndege, R., Meggi, B., Mangu, C., Leukes, V., Sabi, I., Khosa, C., Kivuma, B., Nguenha, D., Riess, F., Fernández-Escobar, C., de la Torre-Perez, L., Manjate, P., Weisser, M., Machiana, A., Zachariah, C., Tagliani, E., Ehrlich, J., Buech, J., … Garcia-Basteiro, A. L. (2026). Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): A randomised controlled trial. The Lancet Infectious Diseases. https://doi.org/10.1016/S1473-3099(26)00133-7