Workshop on ART in Pregnancy, Breastfeeding , and Beyond

1. Workshop on ART in Pregnancy, Breastfeeding, and Beyond Key Considerations in Monitoring & EvaluationAs We Move to Options A, B,B+ Laura PorterCDC-AtlantaJune 19, 2012

2. Same Old Challenges • Under-resourced, large numbers of ANCs • Services span different facilities (ANC, L&D) • Persistent (and large?) data quality challenges • How to classify different ARV prophylaxis • Double-counting (overestimation) of HIV+ pregnant women on ARVs • Events occur in community (e.g. home births) • Following mother-infant pairs • What happens to infants? (ARV, CTX, EID, ART) • Cohort measures require longitudinal monitoring

3. Different Cohorts Form the Basis of Different Indicators PREGNANCY COHORT FOR HIV+ PREGNANT WOMEN Pregnancy – HIV Test – ARV – Birth -- BF ART COHORT FOR HIV+ PREGNANT WOMEN ART Initiation --- Retention BIRTH COHORT FOR HIV EXPOSED INFANTS Birth – BF -- ARV-- EID--- ART ART COHORT FOR HIV+ INFANTS ART Initiation – Retention

4. Different Cohorts Form the Basis of Different Indicators (already on ART) PREGNANCY COHORT FOR HIV+ PREGNANT WOMEN Pregnancy – HIV Test – ARV– Birth -- BF ART COHORT FOR HIV+ PREGNANT WOMEN ART Initiation --- Retention BIRTH COHORT FOR HIV EXPOSED INFANTS Birth – BF -- ARV-- EID--- ART ART COHORT FOR HIV+ INFANTS ART Initiation – Retention

5. And, Some New(ish) Challenges • How to count (women receiving ARVs) in any period when don’t know at initiation to classify as prophylaxis or treatment, with possibility of change over time • In Option B ‘there is no initial distinction between treatment and prophylaxis’ – WHO Update • Option B - May stop drugs or “change” to treatment depending on result of eligibility assessment • Monitoring of retention and adherence • Option A requires measurement of retention and adherence (for the infant) • Both Option B and Option B+ require measurement of retention and adherence

6. Imperative – Moving from this: PMTCT Program Different operational models Different organizational homes Different specialized staff Different facilities Different data systems and indicators ART Program

7. Imperative – Moving to this: Shared operational models Shared organizational homes Shared specialized staff Same facilities Same data systems and indicators PMTCT-ART Program

8. Considerations by Key Components in the PMTCT-ART Program Cascade • Known HIV Status • ART Status at Entry (among HIV+ Pregnant Women) • ARV/ART Initiation (or Continuation) • Clinical, Immunologic, VirologicAssessment • ARV/ART Retention and Adherence • Retention of Mother-Baby Pair in Program • Pregnant HIV+ Woman – ANC, Birth, ART/ARVs, CTX, family planning, ongoing care and treatment • Exposed infant – Birth, BF, ARVs, EID + results, CTX, final definitive diagnosis, ART (if needed) • Impact

9. Monitoring HIV+ Pregnant Women and their HIV-Exposed Infants (simplified) HIV Known Status and Testing Already on ART Clinical / Immunologic/Virologic Assessment ARV/ART Retention and Adherence (and Change) Incidence Reduction Mortality Reduction ARV/ART Drug Initiation Family Planning BF BF Infant ARV Infant ARV HIV Free Survival Infant CTX EID / Testing Infant ART

10. Known HIV Status Indicator: Number of pregnant women tested who received their results. Disaggregation: Known HIV+ at entry. Disaggregation: HIV test result: Positive, Negative, Unknown. • Must disaggregate known HIV+ pregnant women at entry from those HIV- or HIV status unknown • Challenge with repeat testing during same pregnancy at same facility and at ANC vs. L&D • Must consider whether to count from ANC or L&D or both and how to de-duplicate • Must consider how to verify reported numbersthrough routine DQ assurance, periodic DQ assessments

11. ART Status at Entry Indicator: Number of pregnant women, known HIV+ at entry Disaggregation: On ART, not on ART at entry • Must assess ART status among pregnant women known HIV+ at entry • On ART • Not on ART • Assessed for eligibility and not started • Not assessed for eligibility • Must distinguish those already on ART who become pregnant (continue on ART) vs. those HIV+ pregnant newly initiating ART during pregnancy

12. ARV/ART Initiation • Indicator: Number of HIV+ pregnant women receiving ARVs • Disaggregation: Regimen • sdNVP(with or without AZT/3TC tail) • Maternal AZT Prophylaxis (Option A) • Triple ARV Prophylaxis (Option B) • ART (Option B+) • How to distinguish 3ARV from ART in Option B? • Count when? Initiated at ANC, later at ANC, at L&D? • Count which regimen? First or most recent (most efficacious) • How to de-duplicate across pregnancy and facilities • How to count the special case of initiating at L&D • Must consider how to verify reported numbers through routine data quality assurance, periodic data quality assessments • What if we can only verify 50% of reported results? • I.e. Overestimating PMTCT ARV numbers

13. What to count as SD-NVP? Count SD-NVP if: • It is the ONLY option provided to a patient either antenatally or at L&D (this includes use of a tail*) Do NOT count SD-NVP if: • NVP is provided as part of Option A antenatally or • An HIV+ women is initiated on Option A, B, or B+ at labor and delivery *The tail is used to prevent NVP resistance. It does not alter risk of transmission and therefore does not constitute a different regimen.

14. Clinical, Immunologic, VirologicAssessment Indicator: Number of HIV‐positive pregnant women assessed (for ART eligibility) through either clinical staging (using WHO clinical staging criteria) or CD4 testing Disaggregation (proposed):Number of women with CD4 less than 350 among women assessed for eligibility Disaggregation (alternative): Distribution of women by CD4 count categories (e.g less than 200, 200-349, 350+) • Eligibility assessment not required to start 3ARV in Option B or to start ART in Option B+ • Nonetheless, want baseline measures (stage, CD4, VL) to compare health status over time? • Timing of assessment – when after ARV/ART begins? • Need to document timing of assessment relative to ARV initiation and relative to perinatal status? • Guidelines unclear on using assessment to stop 3ARV

15. ARV/ART Retention Indicator (Proposed): Among women initiated on ART (or 3ARV), number who are still alive and on ART (or 3ARV) at 6, 12, 18, 24 months Disaggregation (Optional): Month or trimester of initiation (?) • Best to make comparable to ART cohort measures • OK to combine 3ARV and ART into one cohort (?) • Special case of 3ARV stop for ART ineligible – expect stops with 3ARV in Option B • What is right retention interval for 3ARV? • Relative to ARV Initiation • Relative to Pregnancy and Birth • Need 30-,60-,90-day retention?

16. ARV/ART Retention PREGNANCY COHORT FOR HIV+ PREGNANT WOMEN Pregnancy – HIV Test – ARV – Birth -- BF ART COHORT FOR HIV+ PREGNANT WOMEN ART Initiation --- Retention 3ARV/ ART COHORT FOR HIV+ PREGNANT WOMEN 3ARV Initiation - Retention – CD4 - (Stop) 3ARV/ ART COHORT FOR HIV+ PREGNANT WOMEN 3ARV Initiation - Retention – CD4 - ART

17. ARV/ART Adherence Indicator (Proposed): Among HIV+ pregnant women retained on ART (or 3ARV) at 3,6 months, what percent have undetectable viral load • Consequences of non-adherence substantial • Optimal measure of adherence is viral load • Consider getting viral load among periodic, sample at selected facilities • E.g. AIDSRelief 15% QI approach • Other measures of adherence practical but suboptimal • ARV pick-ups (6/6, 12/12) • Missed appointments • Pill counts

18. Monitoring HIV+ Pregnant Women and their HIV-Exposed Infants (simplified) HIV Known Status and Testing Already on ART Clinical / Immunologic/Virologic Assessment ARV/ART Retention and Adherence (and Change) Incidence Reduction Mortality Reduction ARV/ART Drug Initiation Family Planning BF BF ? Infant ARV Infant ARV HIV Free Survival Infant CTX EID / Testing Infant ART

19. HIV-Exposed Infants Indicator: Percentage of HIV-exposed infants receiving ARV prophylaxis to reduce the risk of early mother-to-child transmission in the first 6 weeks Indicator: Percentage of HIV-exposed infants who are exclusively breastfeeding, replacement feeding or mixed feeding at DPT3 visit Indicator: Percentage of HIV-exposed infants who are breastfed provided with ARVs (either mother or infant) to reduce the risk of HIV transmission during the breastfeeding period Indicator: Percentage of HIV-exposed infants who are started on Cotrimoxazoleprophylaxis within 2 months of birth Indicator: Percentage of HIV-exposed infants receiving a virological test for HIV within 2 months of birth (results received?) Indicator: Percentage of HIV-infected children aged 0–1 who are receiving ART

20. HIV-Exposed Infants • Not as much emphasis given to measurement of infant ARV (NVP within 72 hrs, NVP for 6 weeks, beyond…) • Indicators haven’t kept up with program change • Information collected in different service sites, including U5 / immunization clinics • Infant data depends on mother engagement (mother-baby pair follow-up) • Most indicators not required for reporting • “Within 2 months of birth” optimal but may not occur then (EID, CTX initiation) - hard to tell progress if occurs later • EID indicator doesn’t include results returned

21. Family Planning and Partner Testing Indicator: Percentage of women of reproductive age attending HIV care and treatment services with unmet needfor family planning Indicator: Percentage of pregnant women attending antenatal care whose male partner was tested for HIV • Critical to eMTCT and AIDS Free Generation • Requires special linkages and integrated services • Look to successful country models (e.g. Rwanda) • FP - Included in universe of PLHIV services but monitoring each component is challenging • Additional tools and indicators under consideration • WHO guidance on M&E of HIV Testing & Counseling http://whqlibdoc.who.int/publications/2011/9789241501347_eng.pdf • Collected locally but often not aggregated, reported

22. Capacity and Performance Indicator: Percentage of health facilities that provide antenatal care services with both HIV testing and antiretroviral drugs for the prevention of mother-to-child transmission on site (UA) Indicator: Percentage of health facilities that provide virological testing services (e.g. PCR) for infant diagnosis, on site or from dried blood spots Indicator: Percentage of HIV service delivery points prepared (with stocks and trained provider) to provide at least three family planning methods Indicator: Percentage of districts with CD4 testing services • Don’t ignore capacity development, assessment readiness, and monitoring (facility, district) • Use tools already developed • Monitor regularly as part of supportive supervision

23. Routine Monitoring: Choose Wisely Level of Data Collection Monitoring Tool Purpose Quantity Global National District Facility Patient Global summary indicators National summary indicators District summary indicators Facility registers, log books Patient care or record, longitudinal registers Summary indicators for global reporting Summary indicators for national reporting and planning Indicators for district and national reporting and planning Clinical team management of groups of patients, case review, audits, drug supply management Individual patient management Less More

24. Different Methods for Different Data • Routine Monitoring • ‘Enhanced’ Monitoring (need for all or just some?) • Use of innovative technology • Selected sentinel sites, sampling (districts, sites, patients) • Program Evaluation and Implementation Science • Process, Outcome, Impact • Demonstration or pilot projects • What can go to scale in public health approach? • Surveillance • HIV Prevalence & Incidence • HIV Drug Resistance • Pharmocovigilance • Mortality • Surveys – Household-based, Immunization Clinics • Research

25. Using Program Evaluation Identify Key Questions: • E.g. Among those initiated on ART (or 3ARV), what percent are still alive and on ART (or 3 ARV) at 30, 60, 90 days and 6, 12, 18, 24 months? • E.g. Among those retained for 30,60,90 days on ART (or 3ARV), what percent have undetectable viral load? Identify Design: E.g. Retrospective Cohort: Are data in records / registers and can be abstracted and linked? E.g. Prospective Cohort: Must data be collected across settings? Identify Sample: • Representative of what? Nation, regions, districts, facilities Identify Resources: • Evaluation takes time and skilled staff

26. Measuring Effectiveness Indicator: Percentage of infants born to HIV-infected women who are infected – estimated transmission rate • Recommend standardized approaches developed to assess impact of PMTCT • Methods • Modelling • Immunization clinic survey (and follow-up) • Cohort/follow-up data • Analysis of EID and HIV testing data. • Each approach has strengths and limitations • Not all methods are suitable for all settings Reference: WHO. Measuring the impact of national PMTCT programmes: a short guide on methods. 2012

27. Practical Considerations: Do What Works • Be selective about required indicators • Plan systems thoughtfully • Move to unique ID wherever possible • Enterprise architecture, standards, and interoperability • With evidence about relative performance, rationalize from many partner systems to few • Use technology strategically • Attend to staffing – sufficient numbers, specific skills • Provide supportive supervision • Assess quality of data • Use data to inform and improve program (CQI) • Consider evaluation, surveillance, and research

28. Thank You Contact Information Laura Porter (lporter@cdc.gov) SI Liaisons to PEPFAR PMTCT/Peds TWG Karin Lane (kalane@usaid.gov) Rachel Blacher (rblacher@cdc.gov) SI Liaison to PEPFAR Adult Treatment TWG Joe Barker (jbarker1@cdc.gov)