PEPFAR

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

Dr. Beth A. Tippett Barr, CDC-Malawi

AIDS 2012 - Turning the Tide Together

PEPFAR

Overview

• Option B+ in Malawi• Study Methods• Study Oversight• Conclusions

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)

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

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

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

PEPFAR

Study Methods (2)

• Nationally representative sample • Multistage sampling methods using PPS

1. Random selection of districts from 5 strata2. Random selection of facilities within districts 3. Consecutive sampling of infants

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

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

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

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

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

PEPFAR

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

PEPFAR

Acknowledgements

• OGAC • CDC Atlanta • Dept. of HIV & AIDS, MOH, Malawi

PEPFAR

Thank You for listening !