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Version date 20 September 2017

Validation of EMTCT of HIV and/or syphilisTools and checklists for in-country evaluation of four required components

1 Data assessment and verification

Background

Assessment of EMTCT surveillance data and data quality are the cornerstones of EMTCT validation. Key to this process is review and evaluation of data quality in addition to data analyses from which the values for the process and outcome indicators are derived. In this tool, checklists for data collection processes and mechanisms are included to assist reviewers in evaluating country-level EMTCT data. At each level of data assessment, data quality dimensions should be considered as these contribute to the

achievement and sustainability of EMTCT processes and indicators. Some relevant documents and systems review for the data verification assessment include:

Electronic surveillance systems Case definitions and reporting systems Routine surveillance reports EMTCT progress reports Surveillance/M&E manual(s), plans and policies Copies of legislation related to surveillance/M&E (i.e. notifiable diseases, etc.) Description of surveillance/M&E system(s), including organizational charts, staffing, etc. Operational definitions of the impact and coverage indicators Copies of data collection and reporting forms and tools Surveillance/M&E reports over the past 1–3 years

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Data quality dimensions

Attribute Definition

Accuracy Data considered accurate or valid if they measure what they were intended to measure and minimize errors

Reliability Data generated based on consistent application of standardized protocols and procedures

Precision Data collected with sufficient detail to accurately reflect group and subgroup characteristics

Completeness Data that represent the complete domain of eligible persons or events

Sensitivity The proportion of cases detected by the system

Timeliness Data that are up to date, generated without much delay, and available when needed

Integrity Data have integrity when the systems used to generate them are protected from deliberate bias or manipulation

ConfidentialityConfidentiality means that clients are assured that their personal information will not be disclosed inappropriately, and that data in hard copy and electronic form are treated with appropriate levels of security.

Source: Measure Evaluation. Data quality audit tool. Guidelines for implementation [webpage] (http://www.cpc.unc.edu/measure/resources/tools/monitoring-evaluation-systems/data-quality-assurance-tools/dqa-auditing-tool-implentation-guidelines.pdf, accessed 11 October 2015).

2

http://www.cpc.unc.edu/measure/resources/tools/monitoring-evaluation-systems/data-quality-assurance-tools/dqa-auditing-tool-implentation-guidelines.pdf

http://www.cpc.unc.edu/measure/resources/tools/monitoring-evaluation-systems/data-quality-assurance-tools/dqa-auditing-tool-implentation-guidelines.pdf


Review and evaluation of process and outcome indicators

This section reviews the process and outcome indicators, common or potential data issues, sources of data for triangulation. For each of the following process indicators, the following checklist can be used to assess and evaluate data for reporting completeness and under or over-estimation. Worksheets for data review at national, subnational and service delivery areas are included in the subsequent sections.

Checklist item Complete

1 List, describe and review each data collection tool and method to understand the data source. This includes a review of patient cards, registers, reporting forms, SOPs for aggregation; any estimation methods; any specific issues to note for population-based surveys

2 Identify any potential issues or biases such as:

completeness of reporting double counting or systematic errors from data aggregation for reporting; over- or underestimation (e.g. UN Population Division estimates of live births, which we would expect to be less than the

number of pregnancies).

3 Data verification results for routinely collected and reported programme data:

review data verification results if available from the preceding 24 months; conduct data verification exercise if recent results not available; minimum standard: within +/- 10%.

4 Data validation (i.e. accuracy and validity of data) through triangulation of data from different sources.

5 Final Assessment

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ANC1 coverage: Validation target: ≥95%

Numerator: Number of pregnant women visiting ANC clinic at least once Denominator: Number of pregnant women

Common or potential data issues1. May not be able to distinguish between other visits (e.g. ANC2, 3, 4, etc.) and first ANC visit.2. Numbers of expected pregnancies in a year may not be accurate.3. Data may not be available from the private sector.

Triangulation Sources ANC1:

Programme records aggregated from facilities Population-based surveys Estimated number of pregnant women:

- national estimates- estimates derived from population-based surveys- UN Population Division estimate of live births.

Testing coverage among pregnant women: Validation target >95%

Numerator: Number of pregnant women who have been tested (or know their positive status*

Denominator: Number of pregnant women

*For example, pregnant women who already knew their HIV-positive status before pregnancy are included in the numerator.

Common or potential data issues1. Re-tests or repeat tests may result in overestimation of the numerator, if repeat tests are not

distinguished from first tests when aggregating data for reporting.2. Denominator (estimated number of pregnant women) may not be accurate.3. May not be representative of actual service delivery practices if conducted under special study

or sentinel surveillance conditions.4. May be unclear if appropriate test type is not used.5. Additional information on whether test results were received may help understand whether

most women know their status (where relevant) and provide insight into the expected treatment coverage and final impact measure.

6. Data may not be available from the private sector.

Triangulation sources Reported number of HIV and syphilis tests among pregnant women:

- programme records Laboratory testing, including laboratory data from private providers

- related case reporting or surveillance data. Estimated number of pregnant women:

o national estimateso estimates derived from population-based surveyso UN Population Division estimate of live births for triangulation purposeso ANC1 data for triangulation purposes.

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Estimated testing coverage:o national estimateso population-based surveys or other surveyso coverage among pregnant women with at least one ANC visit to review facility

performance and use for triangulation purposes.

Treatment coverage among HIV+ pregnant women validation target: ≥95%

Numerator: Number of HIV+ pregnant women who received ARTDenominator: Number of HIV+ pregnant women

For syphilis: Validation target: ≥95%

Numerator: Number of syphilis-positive pregnant women who have been treatedDenominator: Number of syphilis-positive pregnant women

Common or potential data issues1. There may be overestimation due to double counting of women who silently transfer to a

different facility (without telling original facility they have transferred out) as other women receiving treatment.

2. If women receive treatment from a different site, the number of women receiving treatment may not be accurately recorded and aggregated without a standard SOP to accommodate this scenario.

3. Treatment data may not be recorded.4. Treatment coverage does not assess quality of treatment, which is important to achieve impact

targets: appropriate regimen, retention and adherence.5. Data may not be available from the private sector.

Triangulation sources Number of pregnant women who received ART:

- programme records- also collate and review data on regimen and retention to contextualize treatment

coverage estimate- pharmacy records.

Number of pregnant women who received syphilis treatment:- programme records- pharmacy records.

Estimated number of HIV-positive pregnant women needing ART:- country estimates.

Other modelled estimates (e.g. Spectrum if country estimates are different):- programme records of identified HIV-positive pregnant women.

Estimated # syphilis-positive pregnancies:- modelled estimate- programme records of identified syphilis-positive pregnant women.

Coverage:- country estimate of treatment coverage- coverage from a representative survey- coverage among pregnant women identified as HIV positive or syphilis positive, to

review facility performance and use for triangulation purposes.

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HIV impact indicators for EMTCT validation

≤50 new paediatric HIV infections due to MTCT per 100 000 live births

and

MTCT rate of either <5% in breastfeeding populations or <2% in non-breastfeeding populations

Syphilis impact indicators for EMTCT validation

≤50 cases of congenital syphilis per 100 000 live births (No MTCT rate)

Common or potential data issues1. Surveys may not be representative of the population of interest (HIV- and syphilis-positive

pregnant women and outcomes of their exposed infants).2. Case reporting data may be incomplete or unrepresentative.3. Outcome data may be missing including final outcome data in for HIV in breastfeeding settings4. Data may not be available from the private sector5. The use of treponemal tests may overestimate pregnant women with new syphilis (pregnant

women with previously treated syphilis will have a positive test).6. National definition of pediatric HIV due to MTCT may not be standardized for reporting

surveillance purposes (e.g. in Ukraine, a 2-year-old child diagnosed with HIV is not counted as an MTCT infant HIV case, same for syphilis).

7. National CS case definition may not be harmonized with the global case definition (e.g. inclusion of stillbirths or not, definition of stillbirths, definition of appropriate treatment, diagnostic test or clinical criteria).

Triangulation sources for HIV General:

- total number of live births – country estimates or UN Population Division estimates- total number of HIV positive mothers giving birth

HIV: MTCT rate and new child HIV infections due to MTCT:- final outcome data on known HIV-exposed children from programme records- case-reporting data on new child HIV infections- programme data on child HIV testing and other indicators for triangulation- laboratory data on child HIV testing- data from surveys, e.g. health facility surveys for effectiveness of prevention of mother-

to-child transmission (PMTCT)- data from mother–infant follow-up cohort - modelled estimates, for example, from Spectrum.

Programme data – outcome of HIV-exposed infants, MTCT where cohort-pair data are linked Estimate what % of estimated HIV-exposed infants the available data represent, and what type

of children may be missing asymptomatic, dead, etc.). Estimate possible outcomes of HIV-exposed infants with missing data, including sensitivity

analyses.

Laboratory data Check if data can be sorted by unique patient ID and patient age at the time of testing (helps

interpret data derived from laboratory).

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Estimate what % of estimated HIV-exposed infants the available data represent and what type of children may be missing (asymptomatic, dead, etc.).

Estimate possible outcomes of HIV-exposed infants with missing data, including sensitivity analyses.

Case reporting Estimate what % of estimated HIV-exposed children the available data represent and what type

of children may be missing (asymptomatic, dead, etc.). Estimate possible outcomes of HIV-exposed infants with missing data, including sensitivity

analyses. Consider review of fetal death and infant and paediatric death records, death certificates, cause

of death. Estimate outcomes of HIV-exposed infants where mothers are untreated, lost to follow up, or

have died.

Facility-based surveys for PMTCT effectiveness Assess representativeness and generalizability of survey. Estimate possible outcomes of HIV-exposed infants with missing data, including sensitivity

analyses.

Cohort-pair data Estimate what % of estimated HIV-positive mothers and HIV-exposed children the available

data represent and what type of children may be missing (e.g. asymptomatic, dead, unreported death; relocated, refugee, migrant, orphaned, abandoned etc.), and assess representativeness and generalizability.

Triangulation sources for syphilis- sentinel case report ANC data - maternal syphilis treatment records- modelled estimates, for example, based on process indicators (methods not currently

validated).

National case-reporting data Assess how discrepancies between national and global case definitions may affect the CS rate. Assess how consistently CS is diagnosed within the country and examine criteria for diagnosis.

Are mothers of stillborn children tested for syphilis? Identify any potential concerns about the representativeness of reported CS cases. Conduct a retrospective record review of stillbirths from a sentinel site(s) to assess what

proportion of stillbirths may have been associated with syphilis, and if any of these potential syphilitic stillbirths were not reported as CS cases.

Consider the impact that laboratory testing methods may have on CS case reporting. Consider the impact that clinical diagnostic methods may have on CS case reporting. Estimate what proportion of CS cases may have been missed (through comparison with the

number of pregnant women with syphilis who did not receive treatment). Evaluate what efforts are made to determine the etiology of stillbirth.

Sentinel case-reporting data This should be as for national case reporting. In addition, identify how generalizable sentinel

case reporting data are and whether key subpopulations or geographical areas have been missed.

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Data verification and impact assessments at the national levelCountry: ___________________________________ Date: ________________________________

Description Name of the site/unit: Address:

Types and quantity of staff:

Name of Person Interviewed Position Email Contact number (mobile)

Documents Reviewed Comments

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Checklist

Data collection mechanisms and processes

Yes No Not able to assess

Comments/Justification

There are written national guidelines on what needs to be reported by and to whom, how and when.

There are mechanisms in place for review of the quality of reports received (accuracy, completeness, timeliness).

The data review and collation procedures minimize the risks for double counting and other errors.

There are written procedures to address late, incomplete, inaccurate or missing reports.

There are mechanisms for systematic feedback to the reporting levels on the quality and analysis of their reports.

There are quality controls in place for when data are transferred from one source to another (i.e. from paper to electronic).

There appears to be sufficient staff

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Version date 20 September 2017designated for review, collation and analysis of reports.

Staff has been trained in data management processes and tools.

There has been a national PMTCT impact assessment

Year:

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Version date 20 September 2017Data verification action at the national and sub-national levelPlease name and define country specific “subnational level” (e.g. province, district or health facility)

___________________________________________________________________________

Action Complete

1 Describe and review the central-level aggregation process (paper, electronic).

2 Compare the number of reports received with the expected number of reports over a specified period of time (month, quarter, year).

3 Review the completeness and timeliness of reports received. Identify missing data in reports received.

4 Re-aggregate reported numbers from all intermediate aggregation sites and compare the total to the numbers in the central-level reports.

Include estimated missing data and recalculate national impact and national and sub-national coverage indicators.

5. How are new cases of HIV in children detected? Does the surveillance and monitoring system adequately capture new cases?

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Data quality % Not able to assess Comments

What percentage of monthly/quarterly reports are received at the national or subnational level as of the last quarter? (standard ≥90%)

What percentage of cases reported at the local level appears at the intermediate or central level?

Are recalculated values similar to the reported values?

( ) Yes

( )

No

What can be done to help improve routine M&E?

(Suggestions/comments from interviewed staff)

________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

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Assessment of report on ANC coverage and data completeness – national level

National level

ANC coverage Year Year

N: Number of pregnant women seen in prenatal care services (1)

Source:

D1: Official estimate for number of pregnant women (2)

Source:

D2: United Nations Population Division estimate of live births [UN Pop Division estimate](3)

[A] % coverage of ANC1 (1)/(2) [country estimate]

[B] % coverage of ANC1 (1)/(3) [UN Pop Div estimate]

Other estimates (e.g. population-based surveys)

Comments:

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Assessment of report on ANC coverage and data completeness – subnational level

Sub-national level

ANC coverage Year Year

N: Number of pregnant women seen in prenatal care services (1)

Source:

D: Official estimate for number of pregnant women (2)

Source:

[A] % coverage of ANC1 (1)/(2) [country program estimate]

Other estimates

Comments:

Final assessment of ANC1 coverage

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Version date 20 September 2017Data verification of testing coverage – national level

National level

HIV testing coverage Year Year

N: Number of pregnant women tested for HIV, or with known HIV status (1)

Source:

D: Number of pregnant women seen in antenatal care services (2)

Source:

[A] % coverage of HIV testing among pregnant women at ANC (1)/(2) [country estimate]

[B] % coverage of HIV testing among pregnant women [specify source of total number of pregnant women]

Other sources: Specify (e.g population-based surveys, PMTCT impact assessment/evaluations)

Syphilis testing coverage Year Year

Number of pregnant women tested for syphilis (3)

Source:

[A] % coverage of syphilis testing among pregnant women attending ANC (3)/(2) [country estimate]

[B] % coverage of syphilis testing among pregnant women [specify source of total number of pregnant women]

Comments:

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Assessment of report on testing coverage and completeness – subnational level

Sub-national level

Final assessment of report on TESTING coverage and completeness HIV Syphilis

Number of subnational units performing testing among pregnant women

Number of subnational units reporting test results among pregnant women

% coverage of subnational units reporting test results among pregnant women

% of monthly/quarterly subnational units’ reports received

Does the private sector provide HIV and syphilis testing among pregnant women? ( ) Yes ( ) No What % HIV? What % syphilis%?

Characteristics of private sector:

Are private health sector reports included? ( ) Yes ( ) No ( ) Yes ( ) No

% coverage of testing at sub-national level (provide for both HIV and syphilis)

Numerator: Total number of pregnant women tested or with known status

Denominator: Total number of pregnant women

Final assessment of testing coverage percent for each:

Notes

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Data verification of treatment coverage – national level

National level (and sub-national if estimates of HIV+ pregnant women exist) 0and

HIV treatment coverage Year Year

Number of pregnant women on antiretroviral therapy (ART) (1) Source:

Total Number of HIV-positive pregnant women (2) Source:

Total Number of identified HIV-positive pregnant women (3) Source:

[A] % coverage of ART among HIV positive pregnant women (1)/(2) [country estimate]

[B] % coverage or ART among identified HIV positive pregnant women (1)/(3)

Other sources: e.g. surveys or PMTCT impact assessment

Summarize Data and comment on:

(1) ART retention(2) ART during breastfeeding(3) HIV incidence during pregnancy and

breastfeeding

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Version date 20 September 2017Syphilis treatment coverage Year Year

Number of pregnant women treated for syphilis (1) Source:

Number of syphilis-positive pregnant women diagnosed in ANC (2) Source:

[A] % coverage of syphilis treatment among syphilis positive pregnant women (1)/(2) [country estimate]

Comments: (strengths & weaknesses of data, data sources and others) -_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Assessment of report on treatment coverage and completeness – national and subnational level

National and sub-national level

Final assessment of report on TREATMENT coverage and completeness for HIV and syphilis HIV Syphilis

Number of subnational units providing treatment for pregnant women (a)

Number of subnational units reporting at least one pregnant women testing positive with HIV or SY (b)

Number of subnational units that report treatment for pregnant women (c)

% coverage of subnational units reporting treatment for pregnant women %(c/b)

% of monthly/quarterly subnational units’ reports received

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Version date 20 September 2017Does the private sector provide treatment among pregnant women? If so, around what %:

Are private health sector reports included? ( ) Yes ( ) No ( ) Yes ( ) No

Final assessment of treatment coverage:

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Assessment of impact indicators Year Year

Impact indicators: Target %Numerato

rDenominat

or %Numerat

or Denominator Comments

MTCT rate of HIV <2% at 6 weeks in non-breastfeeding population

OR

< 5% at 18-24months in breastfeeding populations

<2% or < 5% in

breastfeeding

population

Annual rate of new paediatric HIV infections per 100 000 live births ≤50

Annual rate of congenital syphilis per 100 000 live births

≤50

Key monitoring indicators:

Antenatal care coverage ≥95%

HIV testing coverage of pregnant women

≥95%

Syphilis testing coverage of pregnant women

≥95%

ART coverage of HIV-positive ≥95%

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Version date 20 September 2017pregnant women

Treatment coverage of syphilis-positive pregnant women

≥95%

Final assessment of impact targets:

Final MTCT of HIV rate:

List available data, data sources and biases: e.g. national cohort data, research, impact survey

List best estimate, and describe method and rationale:

Child HIV infections due to MTCT per 100 000 live births:



MTCT of syphilis rate:



Congenital syphilis cases per 100 000 live births:

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Version date 20 September 2017List available data, data sources and biases: e.g. national cohort data, research, impact survey


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Data verification and impact assessments at the service delivery levelSite Description

Name of site:

Location: Date: ____/____/____

Type

Primary care clinic Hospital

Other: ______________________________

Public Private

Other:___________________________________

Services provided by the site (check all that apply)

Antenatal care Delivery care Post-delivery care for women

HIV testing (ANC/general) Syphilis testing (ANC/general) Post-delivery care for infants

Syphilis treatment (ANC/general) Antiretroviral therapy Post-delivery care for HIV-exposed infants

Post-delivery care for syphilis-exposed infants

Persons interviewed and documents reviewedPersons interviewed

Name Position Email Tel. number (mobile)

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REVIEW OF RECORDS

Type of records reviewed

Method used to select the records Number of records reviewed

Results and comments

Checklist Data collection mechanisms and processes Yes No Not able to

assessComments

There are written guidelines on what needs to be reported to whom, how and when.

There are clear instructions on how to complete the data collection and reporting tools.

The data collection and reporting tools appear to be used consistently at the site.

The data collection and reporting tools include the core data elements to monitor the EMTCT targets.

The data collection and reporting tools minimize the risks for double counting and other errors.

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Version date 20 September 2017There are quality controls in place for when data are transferred from one source to another (i.e. from paper to electronic.

Patient records are maintained according to national and international confidentiality guidelines.

There appears to be sufficient staff designated for data entry and reporting.

Staff has been trained in data management processes and tools.

Data quality Yes No Not able to assess

Comments

Congenital syphilis case definitions are accurate and consistently applied.

Maternal syphilis case definitions are accurate and consistently applied.

Pediatric HIV case definitions are accurate and consistently applied.

Maternal HIV case definitions are accurate and consistently applied.

Stillbirths attributable to syphilis are recorded and reported.

Clinical Record Review Percent

What % of expected or estimated ANC patients has attended the site over the past year? (standard ≥95%)

What % of reviewed ANC patient cards or registers indicates syphilis testing? (standard ≥95%)

What % of reviewed ANC patient cards or records indicates HIV testing? (standard ≥95%)

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Version date 20 September 2017What % of reviewed cards or records from syphilis-seropositive pregnant women indicates syphilis treatment? (standard ≥95%)

What % of reviewed cards or records from HIV-positive pregnant women indicates HIV treatment? (standard ≥95%)

In what % of CS cases are case investigation or other reliable source documents available? (standard ≥95%)

In what % of cases was there consistency between recorded and reported CS cases? (standard ≥95%)

What % of syphilis-exposed infants has been diagnosed? (standard ≥95%)

In your opinion, what are major challenges with M&E of EMTCT?

What can be done to improve routine M&E of EMTCT?

Data verification of testing coverage – service delivery level

Service delivery level

HIV testing coverage Year Year Year

Number of pregnant women tested for HIV or with known status (1)

Source(s):

Also list multiple data and data sources to triangulate

Number of pregnant women seen in prenatal care services (2)

Source(s):

% coverage of HIV testing among pregnant women (1)/(2)

Syphilis testing coverage Year Year Year26


Number of pregnant women tested for syphilis (3)

Source:

Also list multiple data and data sources to triangulate

% coverage of syphilis testing among pregnant women (3)/(2)

Comments:

Data verification of treatment coverage – service delivery level

Service delivery level

HIV treatment coverage Year Year Year

Number of pregnant women on ART (1)

Source:

Number of identified HIV-positive pregnant women (2)

Source:

% coverage of ART among HIV positive pregnant women (1)/(2)

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Version date 20 September 2017Syphilis treatment coverage Year Year Year

Number of pregnant women treated for syphilis (1)

Source:

Number of syphilis-positive pregnant women (2)

Source:

% coverage of syphilis treatment among HIV positive pregnant women (1)/(2)

Comments:

Data verification actions at the service delivery level

Action Complete

1 Verify syphilis testing of pregnant women on a sample of patient records.

2 Verify that the locally used CS case definition is in line with the national definition.

3 Review the existence and completeness of case investigation or other documents to assess consistency of process for final diagnosis of CS cases.

4 Verify if stillbirths are included in the reported number and how stillbirth cases are diagnosed (syphilis status of mother, autopsy, etc.).

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Version date 20 September 20175 Compare recorded cases with reported cases to determine consistency

6 Compare reported number of pregnant women tested for HIV with total number of pregnant women seen at the site.

7 Verify patient records to determine the timing of initiation of ANC and number of ANC visits.

8 Compare the registered number of HIV-exposed infants with registered number of HIV-positive pregnant women.

9 Verify if the process for infant diagnosis is in line with international guidelines.

10 Check how record is kept on HIV-exposed infants until final diagnosis.

11 Compare the recorded number of HIV-positive infants with the reported number.

12 Compare the registered number of HIV-exposed infants with the registered number of infants with a final diagnosis.

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Summary overview of data verification by indicator

Quick reference guide to impact indicators including recommended program data review actions and verification criteria

Indicator Numerator/ denominator

Actions Locations Verification criteria

1.1 Annual rate of reported cases of congenital syphilis per 100 000 live births

Number of reported cases of congenital syphilis (CS) according to the national case definition in the defined year

o Verify syphilis testing of pregnant women on sample of patient records

o Verify that local CS case definition is in line with national definition

o Review the existence and completeness of case investigation or other documents to assess consistency of process for final diagnosis of CS cases

o Verify if stillbirths are included in the reported number and how stillbirth cases are diagnosed (syphilis status of mother, autopsy, etc.)

o Compare reported number of live births with vital statistics and trends over past years

o Compare recorded cases with reported cases to determine consistency

o ANC sites (primary care and/or specialized sites/hospitals)

o Delivery sites and registers

o Stillbirth registers

o Paediatric care sites (hospitals/ambulator

o ≥95% of patient records indicate syphilis testing

o ≥95% of records of seropositive syphilis women indicate adequate treatment

o CS case definitions are accurate and consistent with international guidelines

o Process for diagnosis of CS is consistent

o Case investigation or other reliable source documents are available for ≥95% of CS cases

o Stillbirths attributable to syphilis are included in numerator

o ≥95% consistency between

Estimated number of live births in the same time frame

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Version date 20 September 2017Indicator Numerator/

denominatorActions Locations Verification criteria

y) recorded cases and reported cases

Reported rate of mother-to-child transmission of HIV: percentage of infants born to mothers living with HIV, who tested positive for HIV

Number of infants born to HIV-positive mothers, in a defined calendar year, who were diagnosed as positive

o Compare registered number of HIV-exposed infants with expected number

o Verify if process for infant diagnosis is in line with international guidelines

o Compare number of HIV-exposed infants with number of infants with final diagnosis

o Compare recorded number of HIV-positive infants with reported number

Paediatric care sites (hospitals/ambulatory)

o HIV infant diagnosis procedures are in line with international guidelines

o ≥95% of the estimated number of exposed infants have been diagnosed

o Case investigation or other reliable source documents are available for ≥95% of paediatric HIV cases

Reported number of infants born to HIV-positive mothers within a defined calendar year, with definitive diagnosis (HIV positive and negative)

o Compare reported number of exposed infants to reported number of HIV+ pregnant women

o Verify if coverage of HIV testing of pregnant women is 95% or higher (compare reported number of pregnant women tested to estimated number of pregnancies/live births)

Annual rate of reported cases of mother-to-child transmission of HIV per 1000 live births

Number of children born in a defined calendar year to mothers living with HIV, who were diagnosed as positive

o Same as above

Same as above

Same as above

Estimated number of live births within the same defined calendar year

o Compare reported number of live births with vital statistics and trends over past years

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Coverage indicators Indicator Numerator/


Percentage of pregnant women attended by skilled health personnel during prenatal period

Number of pregnant women who have received prenatal care by trained health workers during any given year, disaggregated by number of visits: at least one visit; four or more visits

o Review/check data collection forms and mechanisms to describe and assess the data collection system

o Compare number ofpregnant women seen with anticipated/estimated number of pregnant women to be served (if these data are available)

o Verify patient records to determine number of ANC visits

o Calculate number of pregnant women with four or more visits

o Compare ANC coverage from programme records with population-based surveys, if available (e.g. Demographic and Health Surveys [DHS], Multiple Indicator Cluster Survey [MICS])

ANC service delivery sites

o ≥95% of anticipated ANC patients seen

o Quality of ANC: percentage of ANC patients who attended four or more visits

Estimated number of pregnant women OR number of live births over the past 12 months

o Compare the estimated number of pregnant women with vital statistics and international estimates to determine reliability of the denominator used

Percentage of pregnant women whose first ANC visit

Number of pregnant women who had their first ANC check-up with trained health workers before 20 gestational weeks, during

o Review/check data collection forms and mechanisms to describe and assess the data collection system.

o Review patient cards to determine gestational

o Information system able to generate data sufficiently disaggregated to determine the quality of ANC

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occurred before 20 weeks gestational age

any given year age at first ANC visit Note: while this indicator is not a core coverage indicator for validation, it is recommended to include this in the assessment, considering the critical importance of early ANC enrolment for EMTCT

Estimated number of pregnant women/number of live births over the past 12 months

o Compare the estimated number of pregnant women with vital statistics (number of live births) and international estimates to determine reliability of the denominator used

Percentage of pregnant women tested for HIV who received their results during pregnancy, childbirth, or the postpartum period

Number of pregnant women with a known HIV status, who were tested for HIV and received their results during pregnancy, childbirth, or the postpartum period (<72 hours after birth), including those who had previously tested positive for HIV during the past 12 months

o Review/check data collection forms and mechanisms to assess the data collection system

o Review ANC HIV testing procedureso Review ANC patient cards to verify

documentation of HIV testingo Compare total number of ANC patients with total

reported number of ANC patients tested for HIVo Review HIV testing procedures at delivery siteso Review source documents at delivery sites for

HIV testing and HIV status of patients

o ANC sites

o Delivery sites

o Post-delivery care sites

o ≥95% of ANC patient cards indicate HIV testing

o ANC HIV testing algorithm used is in line with international recommendations

o ≥95% of delivery site source documents (patient cards, registers) indicate HIV testing or known HIV status

Estimated number of pregnant women over the past 12 months

o Compare estimated, recorded and reported numbers of pregnant women for consistency.

Percentage of pregnant women tested for syphilis during pregnancy

Number of pregnant women tested for syphilis during pregnancy over the past 12 months, total and before 20 weeks

o Review/check data collection forms and mechanisms to assess the data collection system

o Review ANC syphilis testing procedureso Review ANC patient cards to verify

documentation of syphilis testingo Compare total numbers of ANC patients with total

reported number of ANC patients tested for

o ANC sites

o Delivery sites

o ≥95% of ANC patient cards indicate syphilis testing

o ANC syphilis testing algorithms used are in line with international recommendations

o ≥95% of delivery site source

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(total and before 20 weeks)

syphiliso Review syphilis testing procedures at delivery

siteso Review source documents at delivery sites for

syphilis testing and test results of patients

documents (patient cards, registers) indicate syphilis testing or known syphilis status

Number of pregnant women seen in ANC services during the past 12 months

o Compare estimated, recorded and reported numbers of pregnant women for consistency

Percentage of syphilis-seropositive pregnant women who were appropriately treated

Number of pregnant women who tested positive for syphilis during pregnancy and who received appropriate treatment

o Review/check data collection forms and mechanisms to describe and assess the data collection system

o Review ANC syphilis treatment procedureso Review ANC patient cards to verify

documentation of syphilis treatment

o ANC sites

o Delivery sites

o ≥95% of ANC patient cards from syphilis-seropositive pregnant women indicate syphilis treatment

o ANC syphilis treatment protocol is in line with international recommendationsNumber of pregnant

women who tested positive for syphilis during pregnancy

o Compare total recorded numbers of syphilis-seropositive pregnant women with total reported number

Percentage of HIV-positive pregnant women who received ART to reduce the risk of MTCT

Number of HIV-positive pregnant women who received ART during the past month to reduce the risk of MTCT

o Review/check data collection forms and mechanisms to describe and assess the data collection system.

o Review ANC ART protocols.

o Review ANC ART cards to verify retention in care.

o ANC sites

o Delivery sites

o ART sites

o ≥95% of ANC patient cards from HIV-positive pregnant women indicate treatment

o ANC HIV treatment protocols are in line with international recommendations

o > 95% of ANC patients are retained in care until deliveryEstimated number, over

the past 12 months, of o Review ANC patient cards to verify

documentation of ART

34



HIV-positive pregnant women o Review ANC ART cards to verify retention in care

Percentage of infants born to HIV-positive women who were tested to determine their HIV status

Number of infants born over the past 12 months to HIV-positive women who were tested for HIV through:

- viral load or qualitative polymerase chain reaction (PCR) test during the first 2 months

- viral load or qualitative PCR test after 2 months

o Compare registered number of HIV-exposed infants with expected number

o Verify if process for infant diagnosis is in line with international guidelines

o Compare number of HIV-exposed infants with number of infants with final diagnosis

o Compare recorded number of HIV-positive infants with reported number

o Explore/discuss the profile of HIV-exposed infants lost to follow up and what their outcome may be

Paediatric care sites (hospitals/ambulatory)

o HIV infant diagnosis procedures are in line with international guidelines

o ≥95% of the estimated number of exposed infants have been diagnosed

o Case investigation or other reliable source documents are available for ≥95% of paediatric HIV cases

Estimated number of HIV-positive pregnant women who gave birth over the past 12 months

o Compare reported number of exposed infants to reported number of HIV-positive pregnant women

o Verify if coverage of HIV testing of pregnant women is 95% or higher (compare reported number of pregnant women tested to estimated number of pregnancies/live births)

35


Required tables for country and/or RVC/RVT reports

Table 1. EMTCT of HIV and syphilis impact (for 1 year) and process indicators (for 2 years) include data sources for numerator and denominator, and add any other comments to help understand and interpret data source.

Impact indicators

Target current yearnumerator/denominator

past yearnumerator/denominator

Data sources

HIV MTCT rate by birth cohort

<2% OR <5% for BF countries

N/A

Annual rate of new paediatric HIV infections per 100,000

< 50

N/A

Annual rate of congenital syphilis cases per 100,000 live births

< 50N/A

ANC1 coverage >95%

HIV testing coverage of pregnant women >95%

36


Syphilis testing coverage of pregnant women

>95%

ART coverage of HIV positive pregnant women

>90 or >95%

Treatment coverage of syphilis positive women

>95%

Table 2. Achievements of lowest performing subnational unit. Include data sources for numerator and denominator, and add any other comments to help understand and interpret data sources

Impact indicators

Target Year 1numerator/denominator

Year 2numerator/denominator

Data sources

HIV MTCT rate by birth cohort

<2% OR <5% for BF countries

N/A

Annual rate of new paediatric HIV infections

< 50N/A

37

Version date 20 September 2017per 100,000

Annual rate of congenital syphilis cases per 100,000 live births

< 50

N/A

ANC1 coverage >95%

HIV testing coverage of pregnant women >95%

Syphilis testing coverage of pregnant women >95%

ART coverage of HIV positive pregnant women

>95%

Treatment coverage of syphilis positive women >95%

Table 3. Overall summary of HIV exposed and infected infants

# of exposed # of exposed # HIV infected # HIV # with missing

38

Version date 20 September 2017infants infants with

final infection status

uninfected or unknown HIV status

Table 4. For countries with large numbers of HIV exposed and infected infants

# with 1 PCR (+)

# with > 2 PCR (+)

# with >1 PCR (+)

# Ab+@ 18m

# with Ab+@ 18m

Comments

Table 5. For HIV exposed and Uninfected infants

# with 1 PCR (+) and subsequent negative testing

# with 1 PCR (-)

# with >2 PCR (-)

# with 1 PCR (-)

and Ab(- ) @ 18 months

# with AB (-) @ 18 months

Table 6. Syphilis data table

39

Version date 20 September 2017Year (include numerator and denominator

Year (include numerator and denominator

Prevalence of syphilis pregnant women

(#pregnant female syphilis cases/#pregnant women tested)

Number of CS cases

Number of CS stillbirths

Number of CS live births

Number of CS cases to untreated mothers

Number of CS cases to mother treated late in pregnancy (less than 30 days prior to delivery)

40


Table 7. Data table for Congenital Syphilis for RVT Case Review/Report - Line-listed case report

Case Number Congenital syphilis

(LB or SB) Mother tested in pregnancy?

Yes/No

Mother treated less than 30 days prior to delivery?

Yes/No

Infant treated?

Yes/No

Case notes to assess prevention breakthrough

41