The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,172
Molecular TB diagnostic test on urine
Molecular TB diagnostic test on stool
Centro de Investigação em Saúde de Manhiça-Fundação
Manhiça, Vila Da Manhiça, Mozambique
Instituto Nacional de Saúde (INS)
Maputo, Mozambique
Ifakara Health Institute (IHI)
Bagamoyo, Tanzania
National Institute of Medical Research (NIMR)
Mbeya, Tanzania
proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of 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.
Time frame: 72 hours after enrolment
Eight-week all-cause mortality
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.
Time frame: 8 weeks 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 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.
Time frame: 72 hours after enrolment
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