1. Designing a National PMTCT Impact Evaluation for Option B+ in Malawi Dr. Beth A. Tippett Barr, CDC-Malawi AIDS 2012 - Turning the Tide Together

2. PEPFAR Overview Option B+ in Malawi Study Methods Study Oversight Conclusions

3. PEPFAR Option B+ Very slow scale-up of PMTCT in Malawi since start of national treatment program in 2004 Several systems barriers prevented access –CD4 count availability –No ART in ANC –LTFU with referrals Option B+: Test and treat for all pregnant women implemented (July 2011) Integration and Innovation: –Provider-Initiated Family Planning integrated into preART and ART –ART initiation in ANC –HIV Care Clinic (preART & Exposed Infant Follow-up)

4. PEPFAR Funding a National Evaluation of Option B+ COP10: PEPFAR provided $10m additional “PMTCT Plus-up Funds” to Malawi –COP11 – funded again –COP12 – integrated into baseline funding 10% required earmark for evaluation in COP10 –Continued adding to evaluation funds in subsequent COP years –MOH is the implementing mechanism for evaluation funding –CDC providing technical support for protocol development

5. PEPFAR Study Objectives Primary: Measure HIV-free survival in HIV-exposed infants at 6-12 weeks, 12mos, and 24 mos of age Measure MTCT rates (same ages) Secondary: Measure rates of ART initiation, retention and adherence in PMTCT mothers and infants Compare outcomes of annual cohorts of Mother-Infant Pairs (MIPs) Compare mortality and morbidity outcomes of age-based cohorts of infants, and their mothers Estimate any association between MIP outcomes and length of mother’s treatment Measure longer term outcomes in a subset of MIPs

6. PEPFAR Study Methods (1) Duration: 4 years Prospective cohort of HIV-exposed infants aged 6 weeks to 12 months at enrolment through to final HIV diagnosis –Nested cohort of MIPs: 48mo follow-up Mother’s VL as a measure of adherence Regardless of child’s final HIV status

7. PEPFAR Study Methods (2) Nationally representative sample Multistage sampling methods using PPS 1.Random selection of districts from 5 strata 2.Random selection of facilities within districts 3.Consecutive sampling of infants

8. PEPFAR Study Methods (3) Sample Size: 9,125 (annually) Inclusion criteria: All infants 6wks to 12mos coming to under-5 clinic for a scheduled well- child visit Exclusion criteria: –Children aged >12mos –Infants <6wks –Infants 6wk to 12mos attending clinic because of illness –At enrolment, any Infants attending clinic with anyone other than the birth mother will not be eligible for the 48mo extended MIP follow-up cohort

9. PEPFAR A robust base to build on: The National HIV M&E System A comprehensive National Program Management approach is the foundation of the successful program: Nationally standardized M&E tools using a cohort approach –Registers –Patient cards National Quarterly Supportive Supervision visits to every site Clinical Mentoring

10. PEPFAR Supplemental Study Instruments Integrated screening, consent and questionnaire Follow-up questionnaire (when samples collected) Lab forms for Elisa & VL samples collected from infants and mothers Study Register Study labels Initiation team report form Supervision team report form Tracing form

11. PEPFAR Study Implementation “Study start-up team” will work directly at site through enrolment to required facility sample size Sites visited 2x per quarter: –National HIV program quarterly supervision –Study supervisory visit Patient level data abstracted quarterly LTFU: Active patient tracing

12. PEPFAR Study Oversight MOH to contract a partner to implement study Steering committee co-chaired by MOH HIV Dept and CDC-Malawi Quarterly reports from partner Quarterly review meetings Semi-annual reports to the national integrated ART/PMTCT TWG

13. PEPFAR Conclusions This study will provide: –1 st ever accurate national and zonal level data on HIV transmission and HIV-free survival –Concrete patient level data proving B+ effectiveness –Accurate trend data for impact of Option B+ on EMTCT –Clear data on LTFU at and between each step of the PMTCT continuum of care

14. PEPFAR Acknowledgements OGAC CDC Atlanta Dept. of HIV & AIDS, MOH, Malawi

15. PEPFAR Thank You for listening !