Monitoring, Evaluation, and Reporting (MER) Guidance (v2.3): PMTCT. Presenter: Jenny Albertini, S/GAC Date: October 2018

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Monitoring, Evaluation, and Reporting (MER) Guidance (v2.3): PMTCT Presenter: Jenny Albertini, S/GAC Date: October 2018

Video Outline Section 1: Overview of the technical area and related indicators Section 2: Indicator changes in MER 2.3 Section 3: Review of numerator, denominator, and disaggregations. Section 4: Overview of guiding narrative questions Section 5: Data quality considerations for reporting and analysis Section 6: Additional Resources and Acknowledgments Please note: FY19 DATIM data entry screens are currently in development. Additional training materials on data entry requirements are forthcoming. 2

Section 1: Overview of the technical area and related indicators

PMTCT Program Goals To keep mothers healthy and alive on ART and prevent HIV transmission from the HIV+ mother to her infant We accomplish this by: Identifying all HIV+ pregnant and breastfeeding (PBF) women Retaining them in care on ART through completion of BF Early identification and linkage of HIV-infected infants to treatment 4

Aligning MER Indicators to the PMTCT Cascade Pregnant & Breastfeeding Women HIV-exposed Infants 5

Aligning MER Indicators to the PMTCT Cascade Pregnant & Breastfeeding Women Maternal Cascade Pregnant women who attend ANC1 Pregnant women with known HIV status at ANC1 HIV+ pregnant women at ANC1 HIV+ pregnant women receiving ART HIV+ pregnant women virally suppressed HIV+ breastfeeding women virally suppressed MER Indicator PMTCT_STAT_D PMTCT_STAT_N PMTCT_STAT_POS PMTCT_ART_N TX_PVLS pregnancy disagg TX_PVLS breastfeeding disagg 6

Aligning MER Indicators to the PMTCT Cascade HIV-Exposed Infant Cascade HIV-exposed infants (Proxy: HIV+ Pregnant & BF women) HIV-exposed infants tested by 2 and 12 months of age HIV-infected infants identified by 2 and 12 months of age HIV-infected infants new on ART HIV-exposed infants uninfected not breastfeeding MER Indicator HIV-exposed Infants PMTCT_STAT_POS + HTS PMTCT Post ANC1: Pregnancy/L&D/BF PMTCT_EID PMTCT_HEI_POS TX_New <1 or PMTCT_HEI_POS_ART PMTCT_FO 7

Overview of PMTCT Indicators Program Area Indicator Code Indicator Name Reporting Frequency Knowing HIV Status On ART Viral Suppression PMTCT_STAT PMTCT_EID PMTCT_ HEI_POS PMTCT_FO PMTCT_ART TX_PVLS (disagg preg/bf) Percentage of pregnant women with known HIV status at antenatal care Percentage of infants born to HIV-positive women who received a first virologic HIV test (sample collected) by 12 months of age. Number of HIV-infected infants identified in the reporting period, whose diagnostic sample was collected by 12 months of age. Percentage of final outcomes among HIV exposed infants registered in a birth cohort. Percentage of HIV-positive pregnant women who received ART to reduce the risk of mother-to-child-transmission (MTCT) during pregnancy Percentage of HIV-positive pregnant and breastfeeding women with a suppressed viral load (<1000 copies/ml) Quarterly Quarterly Quarterly Annual Quarterly Quarterly Reporting Level Facility 8

Overview of PMTCT Indicators: Host Country PMTCT_STAT_ NAT & SUBNAT PMTCT Host Country Indicators Percentage of pregnant women with known HIV status at antenatal care PMTCT_ART_ NAT & SUBNAT Percentage of HIV-positive pregnant women who received ART to reduce the risk of mother-tochild-transmission (MTCT) during pregnancy Annual National & Subnational 9

How to Count PMTCT Indicators Indicator Disaggreagtes How to calculate annual total PMTCT_STAT ANC Register Sum PMTCT_ART ANC or PMTCT Register Sum PMTCT_EID PMTCT_HEI_POS PMTCT_FO Clinical Source: HIV-Exposed Infant Register, Patient Files, EMR Clinical Source: HIV-Exposed Infant Register, Patient Files, EMR, Lab information systems Longitudinal records: HIV-exposed infant registers or facility patient cards Sum Sum Annual indicator Key analytic consideration: For coverage indicators (N&D): Achievement should be evaluated by comparing the numerator and denominator. 10

Section 2: Indicator changes in MER 2.3

What s Changed?: PMTCT_STAT Change Numerator: Removal of separate age-only disaggregate Numerator: Addition of Recent Negative status disaggregate Numerator & Denominator will be auto-summed in DATIM Programmatic Rationale for Change Reduce redundant data entry. Status disaggregates should now be exhaustive. Recent negative was added to account for clients at ANC1 who recently tested negative and are currently ineligible for testing (according to national guidelines) at ANC1. Reduce data entry and improve data quality. V2.2 V2.3 Sole numerator disaggregate 12

What s Changed?: PMTCT_ART Change Age disaggregates added Programmatic Rationale for Change Align with PMTCT_STAT age disaggregates V2.2 V2.3 13

What s Changed?: PMTCT_EID Change Proxy denominator expanded to include women who test positive post ANC1: Later in pregnancy, L&D, and breastfeeding Programmatic Rationale for Change Provides a more accurate estimate of the total number of HIV-exposed infants. These women are reported under a new HTS modality: PMTCT (Post ANC1: Pregnancy/L&D/BF) Proxy Denominator V2.2: PMTCT_STAT_POS Only HIV+ women identified at ANC1 V2.3: PMTCT_STAT_POS + HTS_TST_POS: PMTCT (Post ANC1: Preg/L&D/BF) HIV+ women identified at ANC1 through breastfeeding 14

What s Changed?: PMTCT_STAT & HTS_TST Change Programmatic Rationale for Change PMTCT_STAT will auto-populate the HTS ANC1-only modality Reduces data entry and aligns HTS ANC1 modality with PMTCT_STAT testing. HTS PMTCT ANC Only modality is now PMTCT ANC1-Only. Aligned PMTCT_STAT and HTS modality for autopopulation. Testing during PMTCT, post ANC1, will be reported under a new HTS modality: PMTCT (Post ANC1: Pregnancy/L&D/BF) A specific modality for re-testing post ANC1 and initial testing at L&D or during breastfeeding. Improves monitoring of retesting and HIV+ pregnant and breastfeeding women. 15

PMTCT HTS Clarification Where should HIV testing of pregnant and breastfeeding women be documented? Newly tested at ANC1 in the reporting period Testing (or retesting of HIV-negative) women in ANC, but POST ANC1 Testing at L&D and during breastfeeding Retesting for verification of positive status prior to initiating ART to reduce misdiagnosis PMTCT_STAT ( HTS modality: ANC1-Only) X HTS_TST modality: PMTCT (Post ANC1: Pregnancy/L&D/BF) X X 16

Section 3: Review of numerator, denominator, and disaggregations

PMTCT_STAT Percentage of pregnant women with known HIV status at antenatal care Numerator: Denominator: Number of pregnant women with known HIV status at first antenatal care visit (ANC1) Number of new ANC clients in reporting period Required Disaggregations: Numerator: Status/Age Denominator: Age Known Positives x Age Newly Tested Positives x Age New Negatives x Age Recent Negatives x Age Key Reporting Clarifications: Only results from ANC1 should be reported under this indicator New disagg: Recent Negative at Entry Women who recently tested HIV negative and are not eligible (according to country clinical guidelines) for another HIV test at ANC1. Expected to be a less utilized disaggregate. 18

PMTCT_ART Percentage of HIV-positive pregnant women who received ART to reduce the risk of mother-to-child-transmission (MTCT) during pregnancy Numerator: Number of HIV-positive pregnant women who received ART Denominator: Number of HIV+ identified pregnant women (PMTCT_STAT_POS) Required Disaggregations: Maternal Regimen Type & Age New on ART x Age Already on Treatment x Age Key Reporting Clarifications: Includes all women on treatment during pregnancy, even if initiated post ANC1 Does not include women who initiate treatment during L&D or breastfeeding Report women where they receive ANC services. If a woman receives her treatment at a different facility she will be counted on TX there but under PMTCT_ART at her ANC facility 19

PMTCT_EID Percentage of infants born to HIV-positive women who received a first virologic HIV test (sample collected) by 12 months of age Numerator: Proxy Denominator: Number of infants who had a first virologic HIV test by 12 months of age during the reporting period HIV+ women identified during pregnancy or breastfeeding [PMTCT_STAT_POS + HTS_POS PMTCT (Post ANC1: Preg/L&D/BF)] Required Disaggregations: Numerator: Infant Test by Age at Sample Collection 0 to <2 months or 2 to 12 months Key Reporting Clarifications: Includes first virologic test only All (1 st ) samples collected during the reporting period should be reported, regardless of result return. 20

PMTCT_HEI_POS Number of HIV-infected infants identified in the reporting period, whose diagnostic sample was collected by 12 months of age. Required Disaggregations: Infant age at virologic sample collection, for positive infants 0 to 2 months of age 2 to 12 months Positive, confirmed initiated ART by age at virologic sample collection 0 to <2 months of age 2 to 12 months Key Reporting Clarifications: Includes ALL infants, regardless of test number, who were found to be HIVpositive by 12 months of age (age at sample collection) 21

PMTCT_FO Percentage of final outcomes among HIV-exposed infants in a birth cohort Numerator: Number of HIV-exposed infants at 18-24 months of age disaggregated by outcome type. Denominator: Number of HIV-exposed infants who were born 24 months prior to the reporting period and registered in the birth cohort. Required Disaggregations: Numerator: Outcome Type HIV-infected HIV-uninfected HIV-final status unknown Died without status known 22

Definitions of Disaggregates: PMTCT_FO Outcome Type: HIV-infected: HIV-exposed infants identified any point during follow-up. HIV-uninfected: HIV-exposed infants with a documented negative antibody test at their 18-month visit or post breastfeeding (at least 6 weeks post breastfeeding) HIV final status unknown: Sum of the following disaggregates (not reported in DATIM but should be documented at site level) In care but no test done Lost to follow-up Transferred out Died without status known: HIV-exposed infants documented to have died without confirmation of HIV-infection between 0 and 18 months. 23

Key Reporting Considerations: PMTCT_FO Not all infants are exactly 18 months at their 18-month appointment. This indicator is intending to capture data at the time the child goes to their 18-month visit but the child may in fact be 18-24 months of age. HIV-exposed infants who are HIV infected and later confirmed to have died or transferred out during follow-up are still counted under HIV infected and not died or transferred out. All infants should be assigned an outcome but only one outcome If breastfeeding lasts past 24 months, consider documenting final status unknown FY19 Reporting Timeline Guide Reporting Month (FY19) Birth Month (FY17) FY 2019 (Report results for the entire 12-month reporting period for these indicators at the Q4 reporting cycle) OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP 24

What non-traditional PMTCT indicators capture Pregnant and Breastfeeding data? Indicator Disaggregation(s) Reporting Frequency TX_NEW TX_PVLS HTS_TST PMTCT (ANC1-Only) modality HTS_TST PMTCT (Post ANC1: Pregnancy/L&D/BF) modality Breastfeeding (Pregnancy Captured in PMTCT_ART) Pregnancy; Breastfeeding Quarterly Quarterly Quarterly Quarterly HTS_RECENT Pregnancy Quarterly 25

Pulling it together in visuals

Trend analysis examples 27

Additional analysis to consider 28

Additional analysis to consider HIV+ mothers enrolled in PMTCT 580,572 Total HIV Exposed Infants (HEI)??? HIV+ mothers not enrolled in PMTCT??? 7% MTCT* Total HIV+ infections of HEI at birth HIV+ infants in PMTCT 40,640 HIV+ infants not enrolled in PMTCT??? 35% MTCT* Leaky PMTCT cascade Results not returned to patient/caregiver HIV+ infants not enrolled in PMTCT cascade HIV+ infants identified via PMTCT 14,172 HIV+ infants likely to be LTFU 26,468 HIV+ infants not likely to be identified??? 29

Let s flip the cascade and review missed opportunities instead 30

Section 4: Overview of guiding narrative questions

Guiding Narrative Questions Narratives provide programmatic context to reported results and demonstrate that results have been analyzed and any notable challenges or trends are described and responded to. All PMTCT indicators: Provide context for poor coverage performance by geographic area, age, or IP, including planned remedial actions Describe any reporting/data collection challenges and known data quality issues PMTCT_ART: Describe activities related to ensuring retention through the breastfeeding period. If able, describe retention rates among pregnant women continuing or starting ART as of ANC1. Explain any differences in PMTCT_ART coverage among newly identified HIV positive women initiating ART compared to known positives already on ART. 32

Guiding Narrative Questions by Indicator EID: Provide additional monitoring data related to: turn-around time of virologic test results back to the facility and results returned to caregiver HEI_POS: Define data source Describe linkage rates by age and SNU, including any remediation activities to improve linkage. PMTCT_FO: Define data source Provide status of cohort monitoring (by IP if relevant) for HEI and HIV+ mothers *Reference indicator reference sheets for complete indicator-specific questions* 33

Section 5: Data quality considerations for reporting and analysis

Data Quality Checks All Review outliers (>100% and significantly <100% coverage) PMTCT_STAT N<D (total & by age band) <10, possible data entry error PMTCT_ART N<D (total & by age band) Note: N includes women initiated at any ANC visit, but D limited to ANC1; Identification and initiation may occur in different quarters PMTCT_EID Compare N & D. See indicator reference sheet for considerations PMTCT_HEI_POS If EID reported, HEI_POS reported PMTCT_FO N=D 35

Section 6: Additional Resources and Acknowledgments

Additional Resource 37

Acknowledgments Country teams for all of their PMTCT work and feedback on MER indicators Interagency PMTCT teams for their dedicated discussions and feedback on how best to monitor our PMTCT programs Kristine Clark for her leadership, inspiring patience, and sense of humor during the MER Refresh process 38

Thank you