1. Maternal Schedule of Evaluation
P1078 Appendix I-A Version 2.0

2. 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

3. Footnote 2 Added

4. Footnote 3 updated

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

6. Footnote 5 updated

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

8. Removed

9. Footnote 11 updated

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

11. 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)

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

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

14. Frequency reduced

15. Rows merged and footnote updated

16. Glucose and creatinine only assessed at screening

17. Footnote 16 updated

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

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

20. Updated footnote and clarified “(Heparin)”

21. 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

22. Removed maternal urine storage and Hepatitis C testing

23. Added serum collection at entry

24. Updated footnote

25. 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

26. Added hair collection

27. Clarified PK collection timepoints and expanded visit windows