1. PMTCT Impact Measurement and EMTCT Validation Update on Global Guidance Chika Hayashi, World Health Organization

2. Outline 1.Background 2.Measuring PMTCT Impact 3.EMTCT Validation

3. Background WHO – PMTCT Impact Measurement and EMTCT Validation: Update on Global Guidance Global Plan sets 10 ambitious targets for 2015. Exciting: Intervention coverage Outcome Measures New Child HIV Infections HIV-associated deaths in pregnancy MTCT rate Problem: PMTCT outcomes are not reported routinely, and available data in the 22 priority countries does not represent population-level outcomes. Global Plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive, launched June 2011.

4. Progress in New Child HIV Infections 330,000 Reference: Together we will end AIDS. UNAIDS, 2012. Modelled population-level estimates Modelled population-level estimates

5. n n Attrition means available facility-based PMTCT data does not capture the full target population

6. Short Guide: 5 Methods to Measure PMTCT Impact 1.Modelling 2.Facility-based Survey and Follow-Up 3.Cohort Approach 4.Population-based Surveys 5.Use of EID/Child HIV Testing Data 1. Short Guide 2. Detailed Guidance 3. Write some text here WHO – PMTCT Impact Measurement and EMTCT Validation: Update on Global Guidance

7. Population-based Surveys to Measure PMTCT Impact March 2012 Consultation

8. 1.HIV prevalence among all children 1-23 months (by age groups: 1-11 months; 12-23 months) 2. HIV prevalence among HIV-exposed children 11-23 months (born to an HIV+ mother) 3. Proportion of HIV- children 12-23 months born to women who are currently HIV+ (HIV-free survival) 4. Infant Mortality Rate among children born to HIV+ mothers (deaths due to any cause) WHO – PMTCT Impact Measurement and EMTCT Validation: Update on Global Guidance Existing Population-based Surveys for Measuring PMTCT Impact Indicators WHO – PMTCT Impact Measurement and EMTCT Validation: Update on Global Guidance

9. 1.HIV prevalence among children 1-23 months (by age groups: 1-11 months; 12-23 months) Numerator: HIV+ positive (PCR confirmed) children 1-23 months Denominator: All children 1-23 months 2. HIV prevalence among HIV-exposed children 11-23 months (born to an HIV+ mother) Numerator: HIV+ positive (PCR confirmed) children 1-23 months Denominator: Living children born to HIV+ women in the last two years 3. Proportion of HIV- children 12-23 born to women who are currently HIV+ (HIV-free survival) Numerator: Living children 12-23 months who are HIV- Denominator: All HIV+ women who gave birth 12-23 months ago 4. Infant Mortality Rate among children born to HIV+ mothers (deaths due to any cause) Numerator: Deaths among infants <12 months Denominator: Live births to HIV+ mothers in the last 5 years WHO – PMTCT Impact Measurement and EMTCT Validation: Update on Global Guidance Existing Population-based Surveys for Measuring PMTCT Impact Indicators WHO – PMTCT Impact Measurement and EMTCT Validation: Update on Global Guidance

10. Indicator Calculations Preliminary Calculations Reference: Bernard Barrere, MEASURE DHS, ICFI. 4 proposed indicators calculated using data from existing surveys with child HIV testing Uganda AIS 2004-05, Malawi DHS 2010, Mozambique AIS 2009, Rwanda DHS 2010 Keep in mind surveys were not sampled for the proposed PMTCT indicators; that was not the primary objective U5MR by mother’s current HIV status + + + __

11. WHO – PMTCT Impact Measurement and EMTCT Validation: Update on Global Guidance Considerations Mozambique AIS 2009 (child testing in only half the households), Uganda AIS 04-05 HIV prevalence 1-23 month: Mz 2.1% (0.7% - 3.6%) Ug 0.9% (0.5% - 1.3%) HIV prevalence 1-23 month among children with HIV+ mothers(MTCT) : Mz 18.5% (3.3% - 33.7%), n=62 Ug 15.1% (9% - 21%), n=123 Proportion of HIV negative children 12-23 born to women currently HIV+ (HIV-free surival): Mz 68.3% (42.4%-94.2%), n=28 Ug 89.8% (82.5%-97.0%), n=61 Large confidence intervals for most of the suggested indicators and large sample required to provide reliable point estimates. Low testing coverage rate among young children may introduce a bias. Large sample sizes have serious cost implications for the surveys, and put additional burden on survey logistics, such as training, fieldwork and supervision. Hypothetical cost, 10% adult prevalence $1.4 million (n= 9,000 households) $1.8 million (n= 13,000 households) $ 2.2 million (n=18,000 households) Preliminary Calculations Reference: Bernard Barrere, MEASURE DHS, ICFI. Small numbers Large CI

12. Cohort Approach to Measure PMTCT Impact June 2012 Consultation

13. Routine Cohort Outcome Monitoring System Previously, we described how to overcome the lack of cohort data (link existing records, or active follow-up). After the consultation, emphasis is on establishing systems to routinely collect cohort data. WHO - Repeat the Main title here HIV+ preg women (PW) Identified HIV+ PW women ARV EID Final Outcome

14. WHO - Repeat the Main title here 1.Key indicators and time points to meausre them 2.Routine cohort outcome monitoring system as ideal system, in both low and high prevalence countries 3.Minimum essential elements to set up a routine system. (e.g. Unique IDs, tracking strategy) 4. Other ways to construct cohort data if routine system does not exist, with real examples 5. Handling missing data and approaches to estimate outcomes of those LFU; sensitivity analyses 6. Annexes 1.Sampling considerations for representativeness 2.Patient confidentiality 3. Standard way to report results Guidance Document for the Cohort Approach (Mother-Child Follow Up)

15. Detailed Guidance documents for comment 1.Generic protocol to measure the effectiveness and impact of national PMTCT programmes at population- level using a facility-based survey approach. 2.Considerations for measuring the impact of PMTCT programmes using standard population-based surveys in selected high HIV prevalence countries 3. Guidance on cohort/mother-baby pair follow-up. 4. Guidance on management, analysis and interpretation of EID/child HIV testing data Next Steps: Impact Guidance WHO - Repeat the Main title here Send email to: pmtctmoneval @who.int to join: EZ-Collab workspace on PMTCT impact measurement

16. EMTCT Validation Consultation June 2012 Consultation

17. What are the criteria and processes to validated EMTCT of HIV and syphilis? WHO - Repeat the Main title here Impact measure with process measures, e.g. 95% ANC, >95% testing coverage > 90% ARV coverage How to define EMTCT? < 5% MTCT rate? Zero child HIV cases from MTCT? All 4 prong targets? High intervention coverage for 3 years? Same criteria for all countries? Acceptable measurement method? Quality ? Impact data must be directly measured through active case reporting/monitoring system or special studies, triangulate with modelling. Detailed guidance on data standards to review and report.

18. Processes to validate EMTCT? WHO - Repeat the Main title here NVC responsible for preparing validation background work, including ensuring EMTCT criteria is met in selected geographical areas and key populations. Review programme indicators every year and impact every 3 years until routine system is available Ministry of Health National Validation Committee (NVC) Collects, reviews and decides on the national documentation through consultations Regional Validation Committee (RVC) Reviews country reports and country surveillance system comply with global and regional minimum validation standards Global Validation Committee (GVC) Reviews country/RVC reports (including any data from field visits) to ensure consistency and compliance with the minimum global criteria. WHO Also an opportunity to improve data and programmes

19. Acknowledgements Experts and national MOH and programme staff sharing their experiences, thoughts and time in all related PMTCT Impact and EMTCT Validation Consultations IATT PMTCT M&E WG Members: CHAI (Kate Sabot), ICAP (Fatima Tsouiris, Rosalind Carter) CDC: Thu-Ha Dinh, Eddas Bennett Measure DHS, ICFI: Bernard Barrere UNAIDS: Mary Mahy UNICEF: Pricilla Idele, consultant: Zhuzhi Moore WHO: Nathan Shaffer, Yves Souteyrand, Nigel Rollins, Txema Calleja, Lori Newman, Monica Alonso