Study procedures
|
Study procedure completed
|
---|
Month
|
0
|
0
|
2
|
2
|
5
|
5
|
6
|
6
|
---|
Study arm
|
I
|
C
|
I
|
C
|
I
|
C
|
I
|
C
|
---|
Screening
|
√
|
√
| | | | | | |
Informed consent
|
√
|
√
| | | | | | |
Physical evaluations and interviews
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
Demographic and socio-economic questionnaire
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
Sputum GeneXpert*
|
√
|
√
| | |
√
|
√
|
√
|
√
|
Drug culture and susceptibility testsβ
|
√β
|
√β
|
√β
|
√β
|
√
|
√
|
√β
|
√β
|
Cost-effectiveness questionnaire
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
√
|
Qualitative assessment
|
√
|
√
|
√
|
√
| | |
√
|
√
|
- Note: I-Intervention arm, C-control arm
- *Additional tests to ascertain sputum conversion may be added at the discretion of the investigator.
- βDrug susceptibility testing will be done in-line with national TB guidelines. Sputum cultures may be done at 2 months to ascertain sputum conversion and sputum for genotyping TB stored.
- √ indicates procedure completed at the indicated timeline