Proportion of participants selecting 3HP and the proportion selecting 6H when offered a choice within a decentralized model
Proportion of participants completing 6H and the proportion completing 3HP among participants randomized to standard support vs. bidirectional messaging
Treatment completion will be defined as receipt of at least 80% of doses during a pre-specified period of time and consistent with WHO definitions.
Proportion of participants initiated on TPT in the control phase vs. the intervention phase
Initiation rates will be estimated by the number of participants initiating TPT divided by the number of instances that TPT was offered
Description of the number of participants with different TB treatment and TPT outcomes at the completion of respective therapies
At individual study end point or at study closure, participants will be classified as i) retained in care, ii) died, iii) lost to follow-up, or iv) transferred out.
Number of life years saved through novel TPT approaches
Number of active TB cases averted through novel TPT approaches
Measure the association between participant factors and screening and diagnostic positivity rates
Participant factors are inclusive but not limited to TB infection status, immunologic, virologic, demographic, socioeconomic and clinical factors. The screening and diagnosis approaches are: point of care C-reactive protein, chest radiography, Fuji-LAM, Xpert Ultra performed on oral swabs and stool specimens and ultrasound.
Laboratory turnaround time
For all screening and diagnostic tests of the study
Result reporting rate
For all screening and diagnostic tests of the study
Time-to-treatment initiation
For all screening and diagnostic tests of the study
Diagnostic performance of mask sampling with differing forms of quiet and forced expiration (i.e., talking, singing) against standard approaches of sampling
Compare alternative stool processing techniques and molecular diagnostics/tests of MTB resistance against clinical and microbiologic reference standards
Done using de-identified stool collected and bio-banked during the study.
Compare Alere-LAM diagnostic accuracy with that of the SILVAMP-LAM with both spot and early-morning urine samples
Analyze different processing approaches for oral swabs prior to testing by Xpert Ultra vs. other microbiological diagnostic and drug susceptibility tests
Compare clinician read of chest radiograph with point-of-care ultrasound interpretation to determine agreement and additive yield of each method
this outcome will be studied only in Eswatini and Malawi
Prevalence of extrapulmonary TB by means of point of care ultrasound in participants diagnosed with TB
Assess ultrasound inter-reader agreement between hands-on operators
Assess ultrasound inter-reader agreement between hands-on operators AND remote expert reviewers
Compare the proportion of clinician and computer aided detection chest radiograph interpretation with algorithmic approaches against clinical and microbiologic reference standards
Sensitivity of point of care CRP versus the WHO symptom screening
CRP will be performed on whole blood using the FDA approved POC iChroma assay. A CRP of > 10 mg/L will be considered positive
Specificity of point of care CRP versus the WHO symptom screening
CRP will be performed on whole blood using the FDA approved POC iChroma assay. A CRP of > 10 mg/L will be considered positive
Area under the receiver operator curve of point of care CRP versus the WHO symptom screening
CRP will be performed on whole blood using the FDA approved POC iChroma assay. A CRP of > 10 mg/L will be considered positive
Sensitivity of chest radiography versus the WHO symptom screening
Chest radiography will be interpreted as normal or abnormal for the purposes of TB screening and will be evaluated using a standardized interpretation form
Area under the receiver operator curve of chest radiography versus the WHO symptom screening
Chest radiography will be interpreted as normal or abnormal for the purposes of TB screening and will be evaluated using a standardized interpretation form
Specificity of chest radiography versus the WHO symptom screening
Chest radiography will be interpreted as normal or abnormal for the purposes of TB screening and will be evaluated using a standardized interpretation form
Sensitivity of SILVAMP-LAM versus the WHO symptom screening
Area under the curve of SILVAMP-LAM versus the WHO symptom screening
Specificity of SILVAMP-LAM versus the WHO symptom screening
Sensitivity of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate
Specificity of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate
Area under the ROC curve of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate
Sensitivity of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate
Specificity of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate
Area under the receiver operator curve of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate
Sensitivity of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate
Specificity of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate
Area under the receiver operator curve of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate
Sensitivity of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate
Specificity of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate
Area under the receiver operator curve of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate
Sensitivity of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate
Specificity of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate
Area under the receiver operator curve of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate
Sensitivity of Xpert Host Response Cartridge on blood specimen versus Xpert Ultra completed on sputum or gastric aspirate
The blood specimen is collected at the time of positive screening
Specificity of Xpert Host Response Cartridge on blood specimen versus Xpert Ultra completed on sputum or gastric aspirate
The blood specimen is collected at the time of positive screening
Area under the receiver operator curve of Xpert Host Response Cartridge on blood specimen versus Xpert Ultra completed on sputum or gastric aspirate
The blood specimen is collected at the time of positive screening
Sensitivity of chest radiography for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test
Sensitivity of SILVAMP-LAM for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test