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Excellent healthcare – locally delivered
Integration of
ARV toxicity surveillance into
HIV monitoring and evaluation
Technical review meeting of country experiences in ARV toxicity surveillance: sharing preliminary results and lessons
learnt, identifying solutions 7 - 8 November 2013, Geneva
Outline
1. Consolidated strategic information guide for HIV in the health sector, to be released July 2014 2. Integrating Toxicity Monitoring into M&E Systems
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Consolidated HIV Strategic Information Guide
2014 Consolidated HIV SI Guide
Type date
Why consolidation?
WHO, 2005 ART M&E guide
WHO, 2009 TB/HIV M&E guide
WHO, 2011
HTC M&E guide
WHO, 2012
PMTCT
Impact Measurement Guide
WHO, 2013 PWID Target setting guide
WHO/UNAIDS, 2013 HIV surveillance bundle
UNAIDS/WHO/ UNICEF, 2012 GARPR core indicators
WHO, 2013 3 ILPMS WHO, 2011
PSM M&E guide
WHO, 2012 Drug resistance Surveillance, M&E
GFATM, 2011 M&E Toolkit
PEPFAR, 2013 MER Guide
WHO/UNAIDS, 2010 Estimating the size of populations most at risk to HIV
WHO, 2010 Health Systems Monitoring
Type date
2014 Consolidated HIV SI Guide
• “All you need to know to manage your health sector HIV programme”
• Organized along the cascade of HIV care, also includes surveillance, M&E, impact, HIVDR, toxicity monitoring, systems strengthening
Consolidated HIV SI Guide
for the Health Sector
2014
Over 30 existing guides!
“All you need to know to manage your HIV health sector response” Chapter 1: Introduction Chapter 2: Indicators (and data elements)
i. Methods ii. Utility for programme improvement
Section 3: SI systems Emphasize essential components of generating Health sector HIV data
3ILPMS: Three Interlinked Patient Monitoring System (set of generic tools-patient cards, registers, reporting forms)
will also be updated and linked to the SI guide
Structure and content
Integrating Toxicity Monitoring into M&E Systems
2014 Consolidated HIV SI Guide
Toxicity Monitoring in SI Guide • Recommend Toxicity Monitoring as Key
component of Strategic Information for HIV programme.
• Especially as ART is scaled up and more people start ART earlier and longer on a wide scale, implementation of toxicity monitoring is critical for HIV programmes to monitor safety.
• Need to address how best to implement the toxicity monitoring system in a given country.
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Toxicity Monitoring – M&E • How can we implement TM beyond special
studies in sentinel sites
• Can we integrate selected components of TM within routine monitoring systems?
• Integrating it into routine M&E systems means potentially more data (more or all sites) but may also lead to more variability in quality of data and interpretation of reported data.
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Generic Tools
1. HIV Patient Card – one card/file per individual 2. ART Register – summary of key variable to facilitate data aggregation and reporting
3. Reporting Forms
1. Cohort Reporting From 2. Cross-sectional Reporting From 3. Toxicity Monitoring form??
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HIV Care Card - 1
Sociodemographic Variables
Prior ARVs ARV start date ARV regimen
Treatment Substitution or Interruption and WHY, including toxicity/side effects as a possible reason
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Potential side effects
OIs or other problems
Reasons for poor adherence, including toxicity
HIV Care Card - 2
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ART Register – 1: for selected data to aggregate and report
No specific adverse event
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ART Register - 2
Generic Tools
1. HIV Patient Card – one card/file per individual 2. ART Register – summary of key variable to facilitate data aggregation and reporting
3. Reporting Forms
1. Cohort Reporting From 2. Cross-sectional Reporting From 3. Toxicity Monitoring form??
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Reporting Forms
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ART Cohort Reporting Form: Report on a group of patients’ status at time x after initation
Out of all patients who started ART in a given month , what was there status 12 m later: - On ART (1st line, 2nd line) - Stopped - Died - Lost No reason, no link to molecule
On 1st Line Regimen
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Cross sectional reporting form
On 1st Line Regimen
On 2nd Line Regimen
What to report up for toxicity monitoring? Specific TM reporting form
Using routine data
• Routine reporting from facilities – Paper-based system: simple and small set of data
reported up monthly or quarterly – Electronic system: core set of data for toxicity
monitoring categorized for routine reporting
• Retrospective data extraction, based on: – Various inclusion/exclusion criteria – Various disaggregation or target population of
interest 18
Integration with M&E Pros
• More data from larger number of facilities and patients.
• Potentially more representative characterization of toxicities
• Potentially saves cost with less resource-intensive approach compared to research/special studies
Cons
• Reporting on adverse events (and serious adverse events) may be more under-reported.
• Training and supervision may not be as rigorous as research/pilot/sentinel sites.
• Diagnostic capacity • Less detailed information
available. • No incentive(?) but more
work load • Data interpretation?
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Issues to Consider • What adverse reactions are worth collecting
routinely everywhere? • Minimum set of data elements - adverse events
to be recorded in patient cards and reported up • Criteria/conditions to make this work
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Is it worth it? TM Data Collected through routine monitoring system (benefit)
≥ Effort and Resources required to report extra TM related data (cost)
Indicators for TM Possible indicators:
• % of treatment discontinuation or substitution due to ARV toxicity
• % of life-threatening illness* and death due to ARV toxicity
* Life-threatening illness defined as a serious drug reaction , together with death, hospitalization, disability, and congenital anomalies.
Currently, WHO generic routine registers collect treatment discontinuation and deaths by ART start cohort. Can consider including in the cross-sectional form or a TM-specific reporting form (which can also include other drugs).
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Thank you
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