Maternal Schedule of Evaluation P1078 Appendix I-A Version 2.0

Week 4 antepartum and L/D visit windows widened What is the V2 target window for the L/D visit? What is the V2 allowable window for the L/D visit? Days 0-5 Days 0-14

Footnote 2 Added

Footnote 3 updated

Updated to include all footnotes related to Suspected Active TB Visits (including M.tb. AFB smear and isolate storage)

Footnote 5 updated

Clarified timing of WHO clinical staging for HIV and added assessment of signs/symptoms of neurocognitive impairment

Removed

Footnote 11 updated

When should the TST be read? Exactly 72 hours after placement 2-3 days after placement Up to 7 days after placement Ideally Allowable

Allowed sites to perform TST at Week 4 postpartum, if not done at L/D visit Standardized time that TST should IDEALLY be read (2-3 days after placement) and provided allowable window (up to 7 days after placement)

Added row to indicate additional required counseling related to signs and symptoms of INH side effects

Moved to laboratory evaluations Increased allowable blood volume Testing requirements in eligibility criteria have been updated

Frequency reduced

Rows merged and footnote updated

Glucose and creatinine only assessed at screening

Footnote 16 updated

If HIV viral load assessed as part of screening, result may be used for confirmation and Entry assessments

Detail moved from footnote to table Updated to allow urine or serum testing Required only when pregnancy is suspected

Updated footnote and clarified “(Heparin)”

Increased the number of women to be potentially selected for viable PBMC collection: Entry: from 500 women to 700 women (TB ELISPOT from 260 women to 460 women) Postpartum Weeks 12 and 44: from 260 women to 460 women Postpartum Week 48: no change

Removed maternal urine storage and Hepatitis C testing

Added serum collection at entry

Updated footnote

Clarified text for consistency Clarified that QGIT should not be collected if participant already determined to have suspected or confirmed TB Reduced number of women to be potentially selected for storage of QGIT supernatants

Added hair collection

Clarified PK collection timepoints and expanded visit windows