Primary |
Absolute number and point estimate (with 95% confidence intervals (CIs)) of the proportion of enrolled participants who are diagnosed with microbiologically confirmed TB and are starting TB treatment within 7 days of enrolment |
Secondary |
-Diagnosis |
Time to bacteriological confirmation of TB (up to 60 days) from enrolment and point estimate with 95% CIs of the proportion of patients treated for TB who are diagnosed up to 60 days from enrolment (microbiologically and/or clinically) |
-Treatment |
Point estimate with 95% CIs of the proportion of participants evaluated for pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment |
Absolute number, and point estimate (with 95% CIs) of the proportion of enrolled participants evaluated for pulmonary TB starting TB treatment regardless of microbiological confirmation within 7 and 60 days from enrolment |
Time to TB treatment initiation for those with microbiological confirmation and for all participants (censored at 60 days) from enrolment |
Point estimate of the proportion of patients with ongoing treatment |
-Morbidity |
Prevalence of current cough, limited appetite, weakness at 60 days from enrolment |
-Cost effectiveness |
Estimate of patient costs related to care, number of lost working days, monthly earnings, unit costs of diagnosis and treatment, incremental cost-effectiveness ratio |
-Operational characteristics |
Proportion of Invalid/Error Truenat MTB-Assay test results and platform failure |
-User acceptability |
User survey to assess usability |