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

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

3. - 58%
- 40%
- 90%
New HIV infections among children in low- and middle-income countries declining:
2013 HIV Estimates , UNAIDS/WHO/UNICEF
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

4. 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

5. 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

6. CRITERIA for EMTCT Validation

7. 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

8. GP
AND GP

9. HIV: Vertical Transmission not enough for EMTCT Validation
2013 estimates HIV+ pregnant women HIV+ children
S. Africa ,000
Nigeria ,000
Uganda ,000
Tanzania ,000
Zimbabwe ,000
India ,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
Namibia 8000
Nigeria
South Africa
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

10. 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%
135000
2700
6750 10 25
10000 50 1
2.5 1%
270000
5400
13500 20
100 2 5
540000
10800
27000 40
200 4
67500
250
500
10%
54000
1000
15%
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

11. 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

12. PROCESS for EMTCT Validation

13. 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.

14. 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

15. 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

16. 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

17. TOOLS for EMTCT Validation

18. 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

19. Status and Next Steps

20. 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

21. 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

22. 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

23. 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

24. Extra Slides

25. TARGETS AND INDICATORS

26. 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 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

27. 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

28. 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.

29. 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

30. 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.

31. 09/11/2018