TB-CAPT EXULTANT - HIV

To investigate the effect of an expanded TB screening strategy among HIV-positive patients admitted to hospital (including Ultra on sputum, stool and urine, and AlereLAM on urine, performed regardless of presence of TB symptoms) on the proportion of microbiologically-confirmed TB cases starting treatment within 72 hours of enrolment, compared to Ultra testing (on sputum/any tissue) and AlereLAM (on urine) in only those patients who are symptomatic for TB or fulfilling WHO testing recommendations.

to assess the impact of this screening strategy on 2-month all-cause mortality.

• to assess the feasibility of multiple specimens' collection for TB diagnosis within 72 hours of enrolment.

• Concentrated urine with Xpert Ultra (Diagnostic test): Molecular TB diagnostic test on urine
• Stool with Xpert Ultra (Diagnostic test): Molecular TB diagnostic test on stool

Primary outcomes

• proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment [72 hours after enrolment]: The proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment, separately for intervention and control arm. The numerator is the number of participants per study arm who are diagnosed with microbiologically confirmed TB and start on treatment within 72 hours of enrolment. The denominator is the number of participants enrolled per study arm. We will compare this indicator between both study arms.

Secondary outcomes

• Eight-week all-cause mortality [8 weeks after enrolment]: Eight-week all-cause mortality (main secondary endpoint) among all participants enrolled. The numerator will be number of deaths during eight weeks after enrolment, the denominator is the number of participants enrolled. We will compare this indicator between both study arms.
• The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment. [72 hours after enrolment]: The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment. The numerator is the number of participants diagnosed with TB (with or without bacteriological confirmation) who started treatment within 72 hours of enrolment; the denominator is the number of participants enrolled.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Adults (18 years old and above)
2. Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)
3. Admitted to the hospital (adult medical wards) at the time of enrolment.

Exclusion Criteria:

1. Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)
2. Living outside the catchment area of the participating hospital(s)
3. with plans to migrate outside the catchment area within 2 months after recruitment.
4. Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment
5. Receiving preventive TB treatment in the preceding 6 months
6. Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.
7. Referred from other hospital.

• Results publication: Cossa M, Ndege R, Meggi B, Mangu C, Leukes V, Sabi I, Khosa C, Kivuma B, Nguenha D, Riess F, Fernandez-Escobar C, de la Torre-Perez L, Manjate P, Weisser M, Machiana A, Zachariah C, Tagliani E, Ehrlich J, Buech J, Schacht C, Sanz S, Singh S, Mnzava D, Schumacher SG, Cox H, Scott L, Ntinginya N, Kranzer K, Ruhwald M, Penn-Nicholson A, Garcia-Basteiro AL; TB-CAPT Consortium. 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. Lancet Infect Dis. 2026 May 6:S1473-3099(26)00133-7. doi: 10.1016/S1473-3099(26)00133-7. Online ahead of print. PMID 42105779
• Results publication: Mangu C, Cossa M, Ndege R, Khosa C, Leukes V, de la Torre-Perez L, Machiana A, Kivuma B, Mnzava D, Zachariah C, Manjate P, Tagliani E, Schacht C, Buech J, Singh S, Ehrlich J, Riess F, Sanz S, Kranzer K, Cox H, Sabi I, Nguenha D, Meggi B, Weisser M, Ntinginya N, Schumacher S, Ruhwald M, Penn-Nicholson A, Garcia-Basteiro AL; TB-CAPT Consortium. Expanding Xpert MTB/RIF Ultra(R) and LF-LAM testing for diagnosis of tuberculosis among HIV-positive adults admitted to hospitals in Tanzania and Mozambique: a randomized controlled trial (the EXULTANT trial). BMC Infect Dis. 2024 Aug 15;24(1):831. doi: 10.1186/s12879-024-09651-z. PMID 39148008

• Study Protocol (PDF, 2023-09-13)
• Statistical Analysis Plan (PDF, 2022-12-06)

• Alberto García-Basteiro, MD, Principal investigator, Barcelona Institute for Global Health