Download Towards a Framework for Measuring TA Performance

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
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
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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
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
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
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
Imperative – Moving from this:
PMTCT
Program
ART
Program
Different operational models
Different organizational homes
Different specialized staff
Different facilities
Different data systems and indicators
Imperative – Moving to this:
PMTCT-ART
Program
Shared operational models
Shared organizational homes
Shared specialized staff
Same facilities
Same data systems and indicators
Considerations by Key Components in
the PMTCT-ART Program Cascade
• Known HIV Status
– ART Status at Entry (among HIV+ Pregnant Women)
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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
Already
on ART
ARV/ART Retention and Adherence
(and Change)
ARV/ART
Drug
Initiation
Family Planning
BF
BF
Infant ARV
Infant
ARV
Infant CTX
EID / Testing
Infant ART
HIV Free Survival
HIV
Known
Status
and
Testing
Clinical / Immunologic/Virologic
Assessment
Incidence Reduction
Mortality Reduction
Monitoring HIV+ Pregnant Women and their
HIV-Exposed Infants (simplified)
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
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
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+)
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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
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.
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, 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
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?
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
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
Already
on ART
ARV/ART Retention and Adherence
(and Change)
ARV/ART
Drug
Initiation
Family Planning
BF
BF
?
Infant ARV
Infant
ARV
Infant CTX
EID / Testing
Infant ART
HIV Free Survival
HIV
Known
Status
and
Testing
Clinical / Immunologic/Virologic
Assessment
Incidence Reduction
Mortality Reduction
Monitoring HIV+ Pregnant Women and their
HIV-Exposed Infants (simplified)
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
HIV-Exposed Infants
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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 (motherbaby 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
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
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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
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
Routine Monitoring: Choose Wisely
Level of Data
Collection
Monitoring Tool
Purpose
Quantity
Less
Global
Global summary
indicators
Summary indicators for
global reporting
National
National summary
indicators
Summary indicators for
national reporting and
planning
District
District summary
indicators
Facility
Facility registers, log
books
Clinical team management
of groups of patients, case
review, audits, drug supply
management
Patient
Patient care or record,
longitudinal registers
Individual patient
management
Indicators for district and
national reporting and
planning
More
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
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HIV Prevalence & Incidence
HIV Drug Resistance
Pharmocovigilance
Mortality
• Surveys – Household-based, Immunization Clinics
• Research
Using Program Evaluation
Identify Key Questions:
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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:
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Representative of what? Nation, regions, districts, facilities
Identify Resources:
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Evaluation takes time and skilled staff
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
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
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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
Thank You
Contact Information
Laura Porter ([email protected])
SI Liaisons to PEPFAR PMTCT/Peds TWG
Karin Lane ([email protected])
Rachel Blacher ([email protected])
SI Liaison to PEPFAR Adult Treatment TWG
Joe Barker ([email protected])