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Designing a National PMTCT Impact Evaluation for Option B+ in Malawi

Designing a National PMTCT Impact Evaluation for Option B+ in Malawi Dr. Beth A. Tippett Barr, CDC-Malawi. Overview. Option B+ in Malawi Study Methods Study Oversight Conclusions. Option B+. Very slow scale-up of PMTCT in Malawi since start of national treatment program in 2004

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Designing a National PMTCT Impact Evaluation for Option B+ in Malawi

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  1. Designing a National PMTCT Impact Evaluation for Option B+ in Malawi Dr. Beth A. Tippett Barr, CDC-Malawi

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

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

  8. 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. 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. 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. 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. 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. Conclusions • This study will provide: • 1st 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. Acknowledgements • OGAC • CDC Atlanta • Dept. of HIV & AIDS, MOH, Malawi

  15. Thank You for listening !

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