1. Workshop on ART in Pregnancy, Breastfeeding, and Beyond
Key Considerations in Monitoring & Evaluation As We Move to Options A, B,B+ Laura Porter CDC-Atlanta June 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
ART
Program
Different operational models Different organizational homes Different specialized staff Different facilities Different data systems and indicators

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

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, Virologic Assessment
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 numbers through 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 How to distinguish 3ARV from ART in Option B?
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: Do NOT 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, Virologic Assessment
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, , 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 Best to make comparable to ART cohort measures
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 – HIV Test – ARV – Birth -- BF
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 Consequences of non-adherence substantial
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 Cotrimoxazole prophylaxis 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 need for 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
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
SI Liaisons to PEPFAR PMTCT/Peds TWG
Karin Lane
Rachel Blacher
SI Liaison to PEPFAR Adult Treatment TWG
Joe Barker