1. Gayle Sherman Associate Professor, Department of Paediatrics and Child Health, University of the Witwatersrand, Centre for HIV & STI, National Institute for Communicable Diseases 27 November 2015 Challenges in Implementing New Infant Testing Guidelines

2. 2 CONTENT New Infant Diagnostic Guidelines (Confusion) Problems facing Birth HIV PCR testing (Suggestions) Uptake and coverage of birth testing Indeterminate HIV PCR test results Monitoring of MTCT rates towards eMTCT

3. 3 NEW INFANT DIAGNOSTIC GUIDELINES: June 2015 @ Birth (“universal”) @ 10 weeks @ 18 weeks @ 6 weeks post cessation of breastfeeding (if <18m) @ 18 months of age (HIV Rapid Test) Any HIV PCR+: confirmatory HIV PCR asap Any HIV indeterminate: repeat HIV PCR & VL asap

4. 4 BIRTH HIV PCR TESTING Add work load to delivery units & postnatal wards Train maternity & neonatal nurses Results back to neonates: - who takes responsibility? delivery, primary health care, community workers - discharged before HIV PCR results are ready - not issued own hospital number; mother’s used - collect HIV PCR result at a different facility - receiving their 10 week and later testing?

5. 5 BIRTH HIV PCR TESTING

6. 6 IMPROVING BIRTH PCR TESTING Motivate staff to act in best interests of children Improve monitoring of no. & quality of specimens HIV PCR FACILITY REPORTS

7. 7 IMPROVING BIRTH PCR TESTING Results back to neonates: - NHLS requisition form barcode tracking sticker RTHB - “Copy Clinic” on NHLS requisition form - ‘Baby/to’ mother – provide baby’s DOB or age - Active tracking: HIV PCR Results for Action Reports - Co-ordinate and refer

8. 8 STRICTLY CONFIDENTIAL HIV PCR Results for Action REPORTS

10. Birth Testing – City of Johannesburg, GP 10

11. <7 Day Coverage of HIV PCR Testing 11

12. HIV PCR Indeterminate Results Indeterminate: – HIV-infected infant: high M&M if no cART – HIV-uninfected infant: lifelong cART <1% of all HIV PCR tests = indeterminate (±3000 pa) ±20% of all non-negative HIV PCR results Develop more sensitive HIV assays Guideline for managing HIV PCR indeterminates 12

13. 13 MANAGING INDETERMINATE HIV PCR TEST RESULTS http://www.sahivsoc.org/upload/documents/SOP%20for%20PCR%20indetermin ates.pdf

14. 14 MONITORING MTCT District Health Information System Registers: “targeted” birth testing 6 week HIV PCR test Stickers for registers OR report @ birth & @10 wks Definition of HIV PCR tests for reporting: @ birth testing: day 0 – 6 weeks of age @ 10 week test:>6 - ? 20 weeks of age Do not report confirmatory HIV PCR tests

15. 15 3.5% (2.9 – 4.1) 2.7% (2.1-3.2) 2.6% (2.0-3.2) S.A. PMTCT Evaluation survey (MRC) 3.5% National Health Laboratory Service Birth & confirmatory HIV PCR (not VL) De-duplicate – unique identifier

16. 16 ACKNOWLEDGEMENTS Dr Ahmad HaeriMazanderani Sue Candy and NHLS CDW staff Mark Goosen & Deirdre Greyling