Timepoint | Entry | Weeks | Months | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
0 | 2 | 4 | 6 | 8 | 3 | 4 | 5 | 6 | 12 | 18 | 24 | |
Enrollment | ||||||||||||
Eligibility screen | • | |||||||||||
Informed consent | • | |||||||||||
Randomization | • | |||||||||||
Study activities | ||||||||||||
Baseline TB screening by trial arm | • | |||||||||||
Urine pregnancy testing | • | |||||||||||
Capillary blood β-hCG testing | • | |||||||||||
Banking of serum/plasma and urine | • | • | • | • | • | • | ||||||
Screen-negatives | ||||||||||||
TPT eligibility assessment | • | |||||||||||
Liver enzyme testing (if eligible for TPT) | • | |||||||||||
TPT initiation | • | |||||||||||
TPT adherence monitoring | • | • | ||||||||||
Screen-positives | ||||||||||||
Urine LAM | • | |||||||||||
Xpert Ultra (if LAM-negative or at risk for DR TB) | • | |||||||||||
TB treatment initiation | • | |||||||||||
TB treatment adherence monitoring | • | • | ||||||||||
Final TB status assessment | ||||||||||||
Xpert Ultra | • | |||||||||||
Liquid mycobacterial culture | • | |||||||||||
Drug susceptibility testing | • | |||||||||||
Routine clinic activities | ||||||||||||
CD4 count | • | |||||||||||
Blood chemistry | • | |||||||||||
Complete blood count | • | |||||||||||
ART initiation | • | |||||||||||
Routine clinic follow-up visit | • | • | • | • | • | • | • | |||||
HIV viral load | • | • | • | • | ||||||||
Participants initiated on anti-TB therapy | ||||||||||||
AE monitoring | • | • | • | • | • | • | • | |||||
TB treatment adherence monitoring | • | • | • | • | • | • | • | |||||
Medication refills | • | • | • | • | • | • | • |