EMTCT Validation: Criteria, Process, Tools, Current Status Chika Hayashi Monitoring and Evaluation HIV Department, WHO

Outline http://www.who.int/hiv/pub/emtct-validation-guidance/en/ Background Criteria for EMTCT Validation Process Operational tools Next Steps

- 58% 2001-2013 - 40% 2009-2013 - 90% 240 000 580 000 New HIV infections among children in low- and middle-income countries declining: 2001-2013 2013 HIV Estimates , UNAIDS/WHO/UNICEF 400 000 550,000260,000 300,000 less cases, and faster decline, accelerating pace, and some countries have very low level of MTCT cases 50% of reduction since 2001 (past 12 years) happened in the past 4 years

Background Global Plan towards EMTCT launched in 2011, PMTCT scaling up 10 target indicators (for 2015, baseline 2009) 22 priority countries Some countries have asked WHO how to validate EMTCT achievement. Soon, more countries will join. For 2013: 31 out of 144 low and middle-income countries have estimated PMTCT ARV coverage of >90% Reported MTCT rates were <2% in 6 countries

Guide Development Process In 2012, No standardized process and criteria to assess and validate EMTCT. Guide on criteria and process was developed based on: pilot exercises with 8 countries global consultation with experts and partners discussion with other elimination programmes (polio, neglected tropical diseases, malaria, maternal and neonatal tentanus). Dual elimination of MTCT of HIV and syphilis Internationally standardized minimum to validate EMTCT achievement globally Elimination of a mode of transmission Keep it simple International standard to allow validation to be carried out using a credible, systematic approach, allows monitoring of EMTCT achievement globally, and facilitate recognition of countries that have successfully eliminated (and sustained elimination) MTCT of HIV or syphilis. Proposal for criteria and process developed with input from all regions. Technical consultation held 6-8 June 2012 To identify appropriate and feasible criteria & processes for validation of EMTCT of HIV and syphilis and next steps Why "validate"? To celebrate successful programs, to ensure credibility, to address disparities in service delivery, to improve monitoring systems and not too resource intensive to facilitate country recognition

CRITERIA for EMTCT Validation

EMTCT Definition Do we define it as 0? Not really possible unless HIV is eradicated. We are going "towards" zero. Do we set an absolute value/target? Same value across the board, equity of results: e.g. MTCT <2% or < 5%, case rate, 90% ARVs Do we set a proportional value? Demonstrate progress considering different baselines, e.g. Reduce new child HIV infections by 90% Disease Burden Proportional Reduction Absolute Value

GP AND GP

HIV: Vertical Transmission not enough for EMTCT Validation 2013 estimates HIV+ pregnant women HIV+ children S. Africa 260,000 Nigeria 190,000 Uganda 120,000 Tanzania 100,000 Zimbabwe 70,000 India 35,000 Cambodia 1,000 Peru 1,000 2% MTCT 5000 250,000 100,000 2000 10,000 200 Maybe delete/hide this one 2010 estimates: S. Africa – 260,000, Nigeria – 230,000 Angola 16000 Botswana 13000 Burundi 7300 Cameroon 30000 Chad 14000 Côte d'Ivoire 18000 Democratic Republic of Congo 50000 Ethiopia Ghana 12000 India Kenya 87000 Lesotho 14000 Malawi Mozambique 100000 Namibia 8000 Nigeria 230000 South Africa 260000 Swaziland 9100 Zimbabwe 46000 1,000 20 P1&2 100 <2 Even if we interrupt vertical transmission, child HIV infections due to MTCT is not getting close to zero unless we reduce prevalence/number of HIV+ pregnant women

Case Rate PAHO <30 Global <50 Live Births 0.50% 27000000 135000 HIV Live Births HIV-exposed New Child HIV Case Rate per 100,000 livebirths if: Prevalence Births 2% 5% 0.50% 27000000 135000 2700 6750 10 25 10000 50 1 2.5 1% 270000 5400 13500 20 100 2 5 540000 10800 27000 40 200 4 1350000 67500 250 500 10% 2700000 54000 1000 15% 4050000 81000 202500 300 750 1500 30 75 PAHO <30 Global <50 Didn't have point estimate for Malawi, Ethiopia, India for EMTCT Global Plan baseline

Qualifying Requirements for EMTCT Validation National EMTCT validation indicators Process indicator targets achieved for 2 years AND Impact indicator targets achieved for 1 or more years*. Review of equity considerations, e.g. Low performance district or high burden area Key populations and other vulnerable groups Robust national monitoring and surveillance system Basic Human Rights Considerations must be met Reporting template in next slide for more introductory presentations

PROCESS for EMTCT Validation

3 Levels Ministry of Health Region & Global: National Validation Committee (NVC) Regional Validation Committee (RVC) Global Validation Committee (GVC) Ministry of Health T E AM T E AM Region & Global: WHO as Secretariat, work with partners NVT and RVT: data collection and analysis, in-country visits. National Validation Team (NVT) Collects and analyses national data for national pre-validation and validation reports Regional Validation Team (RVT) Reviews country data, conducts in-country validation visits with NVT, and prepares the regional validation report for the assigned country.  

Validation Process Validation request from Minister of Health to Regional Secretariat Secretariat notifies Regional Validation Committee (RVC) and Global Secretariat Pre-validation phase: Country prepares report Establishment of Regional Validation Team (RVT) by RVC RVC/RVT review of country report RVC preliminary visit to country if needed

Validation Process (cont’d) 4. Validation phase: in-country assessment 5. RVT prepares and submits report to RVC 6. RVC reviews whether country has met the criteria for validation, and submits report to Global Validation Committee (GVC) 7. GVC ensures global minimum criteria was met, and if so, declares elimination status for the country

Maintenance of EMTCT Validation Secretariat will maintain a list of countries that have achieved EMTCT validation at a particular time. Even after initial validation, ongoing programme interventions are required to maintain validation. Data on impact and process targets will be collected annually from countries. Annual review of maintenance of validation. Any potential issues noted will be communicated to the GVC and the RVC. Lymphatic Filariasis in China and Korea

TOOLS for EMTCT Validation

Operational Tools Governance: to guide on processes and recommended composition of committee members, includes draft TORs Costing Tool: to facilitate costing of validation Data Quality Checklist: to review data quality and impact assessments in a systematic way Lab Quality Checklist: to verify reliability of test results Human Rights Checklist: to support discussion and review of key human rights considerations Question & Answer: to provide a resource for FAQs and document various scenarios and their handling

Status and Next Steps

Country status based on available 2013 data Impact Target: 8 out of 144 countries have < 50 cases of new paediatric HIV infection per 100,000 live births AND MTCT rate of <5% or < 2% ANC: Around 50 countries had estimated ANC coverage of > 95% Known Status: 36 countries have an estimated > 95% of pregnant women who knew their HIV status PMTCT ARV: Around 30 countries have an estimated > 90% of HIV+ pregnant women receiving ARVs for PMTCT

Summary of global and regional plans WHO Region Upcoming Activities in 2014 Global Global Technical Partners meeting planned for end Sept to review operational tools. 1° GVC meeting. Americas RVC established in May. Official request from Cuba. Validation tools drafted. Europe Regional Meeting planned Q4 to review and accelerate progress and move towards validation.   Africa Regional Meeting planned Q4 for dissemination, and to set up and agree on TOR for RVC Asia Core Group Meeting for EMTCT Validation planned Nov 2013 to discuss process and set up structure

Global Plan and EMTCT Validation: Linked Processes -Achievement in 22 priority countries -Need for post-2015 discussion Process (ongoing) -Operational tools and guidance -Regular stocktaking -Readiness assessments Validation of EMTCT(ongoing) -Validation committees (global, regional, national) -Process and impact indicators -Requires robust national M&E system

Acknowledgements WHO ICW UNAIDS Consultation participants UNICEF Lori Newman Nathan Shaffer Sonja Caffe Monica Alonso Ying-ru Lo Dongbao Yu Razia Pendse Lali Khotenashvili Isseu Diop Innocent Nuwagira Lisa Nelson Anita Sands UNAIDS Karusa Kiragu Mary Mahy ICW Beri Hull Consultation participants UNICEF Priscilla Idele Chewe Luo Pilot countries Botswana Cambodia Malaysia Moldova S. Africa St. Lucia UNFPA Lynn Collins PEPFAR Thu-Ha Dinh

Extra Slides

TARGETS AND INDICATORS

Terminology and Definition Permanent reduction to zero of the worldwide incidence of infection Eradication Reduction to zero of the incidence of disease or infection in a defined geographical area Elimination Reduction in the incidence, prevalence, morbidity or mortality of an infectious disease to a locally acceptable level Control Should I include this slide or not? Mention the use of this definition (no longer a PH problem/concern) for NTD etc. Dowdle WR.1998. The principles of disease elimination and eradication. Bull World Health Organ 1998;76 Suppl 2:23-5. Elimination of MTCT Mode of Transmission EMTCT: eliminating MTCT to a very low level that it is no longer a public health problem

What is a low enough level for EMTCT? HIV+ pregnant women HIV+ child No intervention 35 100 "Developed" standard <2 EMTCT goal: eliminating MTCT (mode of transmission) to a very low level that it is no longer a public health problem

Syphilis Case Rate Strong consensus that impact should be measured using congenital syphilis rates. Expectation for WHO to establish a global target that is both achievable and meaningful, and, separately, regions and countries could set more stringent targets if desired. ≤0.5 cases per 1000 live births established in the Americas and Asia–Pacific regions were thought to be achievable and meaningful, and so it was proposed to use this target as the starting point for further discussion and modelling exercises. Country feedback: Process and indicator targets work in Moldova and South Africa estimated it is achievable HIDE During country presentations Moldova reported a low rate of syphilis in pregnancy, high ANC coverage, high testing and treatment coverage, and a congenital syphilis case rate of <0.5 per 1000 live births. South Africa reported <1% syphilis infection rate among pregnant women in the general population, and felt that a case rate of 0.5 may be may be achievable in South Africa.

Process National Validation Committee (NVC) Ministry of Health National Validation Team (NVT) Collects and analyses national data for national pre- validation and validation reports National Validation Committee (NVC) Collects, reviews and decides on the national documentation through consultations Partners and experts Regional Validation Committee (RVC) Reviews country reports and country surveillance system comply with global minimum validation standard and regional standards Regional Validation Team (RVT) Reviews country data, conducts in-country validation visits with NVT, and prepares the regional validation report for the assigned country.   Partners and experts Secretariat: WHO Global Validation Committee (GVC) Reviews country/RVC reports to ensure consistency and compliance with the minimum global criteria. Partners and experts WHO

3 Levels 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 minimum validation standard and regional standards Global Validation Committee (GVC) Reviews country/RVC reports to ensure consistency and compliance with the minimum global criteria. T E AM T E AM NVT and RVT: data collection and analysis, in-country visits. National Validation Team (NVT) Collects and analyses national data for national pre-validation and validation reports Regional Validation Team (RVT) Reviews country data, conducts in-country validation visits with NVT, and prepares the regional validation report for the assigned country.  

09/11/2018