Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
TB screening |
Sensitivity of C-reactive protein for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test |
24-32 months |
|
Primary |
TB diagnosis |
Sensitivity of Xpert Host Response Cartridge compared with the sensitivity of Xpert Ultra on sputum or on gastric aspirate using the McNemar test |
24-32 months |
|
Primary |
TPT prevention outcomes |
Comparing TPT completion rates in participants randomized to bi-directional messaging support vs. standard support |
48 months |
|
Primary |
Cost-effectiveness |
Estimating the incremental cost-effectiveness of new shortened TPT regimens measured as cost per DALYS averted for each TPT strategy and the enhanced participant support modality compared with current standard of care |
32 months |
|
Secondary |
Proportion of participants selecting 3HP and the proportion selecting 6H when offered a choice within a decentralized model |
|
48 months |
|
Secondary |
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. |
48 months |
|
Secondary |
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 |
48 months |
|
Secondary |
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. |
48 months |
|
Secondary |
Number of life years saved through novel TPT approaches |
|
32 months |
|
Secondary |
Number of active TB cases averted through novel TPT approaches |
|
32 months |
|
Secondary |
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. |
24-32 months |
|
Secondary |
Laboratory turnaround time |
For all screening and diagnostic tests of the study |
24-32 months |
|
Secondary |
Result reporting rate |
For all screening and diagnostic tests of the study |
24-32 months |
|
Secondary |
Time-to-treatment initiation |
For all screening and diagnostic tests of the study |
24-32 months |
|
Secondary |
Diagnostic performance of mask sampling with differing forms of quiet and forced expiration (i.e., talking, singing) against standard approaches of sampling |
|
24-32 months |
|
Secondary |
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. |
24-32 months |
|
Secondary |
Compare Alere-LAM diagnostic accuracy with that of the SILVAMP-LAM with both spot and early-morning urine samples |
|
24-32 months |
|
Secondary |
Analyze different processing approaches for oral swabs prior to testing by Xpert Ultra vs. other microbiological diagnostic and drug susceptibility tests |
|
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
Prevalence of extrapulmonary TB by means of point of care ultrasound in participants diagnosed with TB |
|
24-32 months |
|
Secondary |
Assess ultrasound inter-reader agreement between hands-on operators |
|
24-32 months |
|
Secondary |
Assess ultrasound inter-reader agreement between hands-on operators AND remote expert reviewers |
|
24-32 months |
|
Secondary |
Compare the proportion of clinician and computer aided detection chest radiograph interpretation with algorithmic approaches against clinical and microbiologic reference standards |
|
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
Sensitivity of SILVAMP-LAM versus the WHO symptom screening |
|
24-32 months |
|
Secondary |
Area under the curve of SILVAMP-LAM versus the WHO symptom screening |
|
24-32 months |
|
Secondary |
Specificity of SILVAMP-LAM versus the WHO symptom screening |
|
24-32 months |
|
Secondary |
Sensitivity of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Specificity of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Area under the ROC curve of Xpert Ultra performed on an oral/buccal swab versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Sensitivity of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Specificity of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Area under the receiver operator curve of Xpert Ultra performed on stool versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Sensitivity of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Specificity of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Area under the receiver operator curve of LF-LAM versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Sensitivity of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Specificity of Xpert Ultra performed on a gelatin filter removed from a participant's mask versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
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 |
|
24-32 months |
|
Secondary |
Sensitivity of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Specificity of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
Area under the receiver operator curve of point of care ultrasound versus Xpert Ultra completed on sputum or gastric aspirate |
|
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
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 |
24-32 months |
|
Secondary |
Sensitivity of chest radiography for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test |
|
24-32 months |
|
Secondary |
Sensitivity of SILVAMP-LAM for TB screening compared to the sensitivity of the WHO symptom screening using the McNemar test |
|
24-32 months |
|