A Guide Through the WHO eMTCT Validation Process

Last week, Cuba became the first country to receive validation from the World Health Organization (WHO) for the elimination of mother-to-child transmission of HIV and syphilis. This historic announcement represented considerable progress in the ongoing global efforts to end AIDS in children. EGPAF is supportive of the validation process as mandated and carried out by the WHO, and is hopeful that soon, many other countries will undergo a similar process to demonstrate the considerable strides being made in eliminating mother-to-child transmission of HIV.

Per WHO’s official guidance, the validation process is a very thorough and meticulous process. The Q&A below helps breakdown the various steps in the validation process and defines some terms.

What does the term “validation” mean?

According to the WHO, the term “validation” is used when a country has successfully met the criteria for eliminating mother-to-child transmission (eMTCT) of HIV at a specific moment in time. Additionally validation “implies that countries will also need to maintain ongoing, routine, effective programme interventions and quality surveillance systems to monitor eMTCT of HIV.”

What does the term “elimination” mean for this validation process?

Typically, when disease or infection incidence falls to zero within a geographical area, it is considered “eliminated.” However, HIV still remains a major public health threat, and while prevention measures of mother-to-child transmission (PMTCT) have been increasingly effective, nearly 700 children are newly infected with HIV every day because many mothers lack access to life-saving services. Therefore, currently the minimum eMTCT impact targets as outlined by the WHO are:

• For HIV, less than 50 new pediatric infections per 100 000 live births and a transmission rate of either <5% in breastfeeding populations or <2% in non-breastfeeding populations;
• For syphilis, less than 50 cases of congenital syphilis per 100 000 live births.

Additionally, to accomplish eMTCT of HIV, there are four process targets that need to be met including:

1. Antenatal care coverage (at least one visit) of more than or equal to 95%,
2. Coverage of HIV and/or syphilis testing of pregnant women of more than or equal to 95%, treatment
3. Coverage of HIV-positive pregnant women of more than or equal to 90% and treatment of syphilis-seropositive pregnant women of more than or equal to 95%.

What are some of the other criteria that countries need to meet before applying for eMTCT of HIV?

Countries are eligible to apply to validation when they have met the impact targets for one year and they have consistently met the process targets for two years. Additionally there must be evidence that the eMTCT of HIV has been achieved in at least one of the lowest-performing administrative units (these units are known to perform poorly on various health indicators).  Countries must also already have an established national monitoring and surveillance system that captures data accurately to detect the majority of MTCT of HIV. Lastly, the validation criteria must haven been met by taking basic human rights considerations into account.

What are the validation procedures?

If a country determines that they have met the global eMTCT validation requirements, they can then officially apply for validation. The validation process has the following stages starting with a request for validation:

1. Request for Validation

• The Country’s Ministry of Health (MoH) submits an application letter to the WHO regional secretariat.
• The WHO regional secretariat shares the request with the Regional Validation Committee (RVC) who then decides to convene a Regional Validation Team (RVT) that will conduct an extensive review of all the data submitted before passing it on to an established National Validation Committee (NVC).

2. Pre-Validation

• The NVC determines whether they will establish a National Validation Team that will collect the national data and draft a national validation report that describes the national monitoring and surveillance systems. The NVC and MoH review this report for accuracy and submit to the regional secretariat.

3. Country Validation

• After the validation report is received by the regional secretariat and the RVC, the RVT that was appointed by the RVC reviews it and submits recommendations to determine whether that country is ready for a more in-depth assessment and in-country visit.
• If the country passes that initial inspection, the RVC works with the NVC and the MoH to plan an in-country visit where all of the process and impact indicators are assessed, and all data sources, systems for monitoring and surveillance, and other key stakeholders are thoroughly vetted.

4. Regional Validation

• The RVC also reviews the national validation report and develops regional recommendations for validation. If the country meets the criteria, the RVC then prepares a regional validation report that then goes to the WHO global secretariat.

5. Global Validation

• The Global Validation Advisory Committee (GVAC) that is appointed by the global secretariat prepares a global validation report based on review of the recommendations and outcomes of the regional validation report.

6. Official Validation

• The WHO headquarters will then issue a letter that officially recognizes the country’s achievement of EMTCT of HIV and/or syphilis and also provides recommendations no how to maintain EMTCT status.

While the process is lengthy, establishing and implementing standardized, global evaluation and validation processes is a crucial part of tracking and understanding our progress in the global effort to end the AIDS epidemic.