Accelerating access to innovative point of care HIV diagnostics
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Transcript of Accelerating access to innovative point of care HIV diagnostics
Accelerating access to innovative point of care HIV diagnosticsDecade of Diagnostics Satellite SessionWashington, DCJuly 22, 2012
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Agenda
Introduction
Goals and activities of the project
Expected impact
Alignment with other initiatives
Current diagnostic tools are unable to fully meet the need of the continuum of care
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HIV Diagnosis
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Enrollment in HIV care
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Blood draw
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Test performed
Continuum of Care
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Result received
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Clinical consultation
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ART initiation
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Monitoring
Existing systems contribute to: 1. Late ART initiation among adults2. Late ART initiation among infants due to limited access to HIV diagnosis3. Late identification of first-line treatment failure due to limited access to viral load
testing
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2nd line (when necessary
High Loss
High Loss
High Loss
Few Services
Estimates of wastage with conventional diagnostics are significant
Based on weighted average of data from 3 countries1, 46% of CD4 test results were NOT
received by the patient2
(n=12 million tests in 2010)
45.736%
54.264%
Results not receivedResults received
Sources: 1Mozambique: LTFU estimated based on Jani et al (2011); Malawi; MOH Malawi; South Africa: Larson et al (2011); 2Global volumes based on CHAI data;2CHAI data; Assuming ~1,400 tests demanded per year at average health center across 9 African countries; CD4: 5.5 million results not received/$58 million wasted; EID: half estimated 300k tests results not received/$7.5m wasted; 3A Multi-Country Review of HIV Early Infant Diagnosis Service Delivery 2009
Based on an average of 3 countries from a 2009 UNICEF review of EID service delivery,
50% of positive EID test results are NOT received by the patient3
Wastage associated with CD4 and EID tops $60+ million per year and almost 6 million tests where patients do not receive the result3
50%50%Results not receivedResults received
Evaluation: Time From Diagnosis To CD4 Staging And ART Initiation shows similar results in Uganda
POC CD4 increases the number of people initiating ART by cutting LTFU and reducing time to initiation
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Uganda1
• Time to ART initiation: Reduced from 59 to 11 days
Mozambique3
• LTFU: 50% increase in retention from diagnosis to ART initiation
• ART Initiation: 85% increase in ART initiation
Lab-Based CD4 POC CD4
56%
21%
7%
11%
LTFU in Mozambique using POC CD4 vs. Lab-based tests
Before ART Ini-tiation
Before CD4 Results
Malawi2
• PMTCT LTFU: PMTCT initiation during pregnancy increase from 51 to 78%
• Time to CD4 result: time from CD4 blood draw to result reduced from 11 to 0 days
Source: 1MOH Uganda; 2MOH Malawi; 3Jani et al (2010)
Lab-Based CD4 POC CD4
34% 23%
17% 54%
PMTCT Initiation in Malawi using POC CD4 vs. Lab-based tests
After CD4 Results
Before CD4 Results
And there is a lot of unmet need and underserved patients in the market (CD4)
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Unmet NeedConventionalPOC
At estimated current volumes, POC CD4 represents less than 10% of volumes and more than 60% of need is unmet
Tanzania0%
50%
100%
Kenya0%
50%
100%
Mozamb...0%
50%
100%
Zimbabwe0%
50%
100%Malawi
0%
50%
100%
Ethiopia0%
50%
100%
Uganda0%
50%
100%
Total Market0%
25%
50%
75%
100%
Agenda
Introduction
Goals and activities of the project
Expected impact
Alignment with other initiatives
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• Creating and sustaining a healthy competitive market for POC diagnostics where– The most patients have access to diagnostics– There continues to be innovation for increased value– New products can easily enter the market
• Signaling commitment to the POC market through uptake• Growing the demand side of the market
• Accelerating normative guidance on the use of HIV POC diagnostics
• Supporting the entry and uptake of new, quality products
• Achieving substantial public health impact
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CHAI, UNICEF, and UNITAID are together committed to:
Market Preparation
(POC CD4, EID and VL)Catalytic
Implementation(POC CD4 and EID)
Commodity Donation
(POC CD4 and EID)Phase 1
Phase 2a
Phase 2b
In order to achieve the overarching goals, the project will roll out in two phases
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Funding needs for HIV is expected to grow significantlyFunding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocolsPhase 1 will occur before a product becomes available and Phase 2 once it reaches the market
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Phase 1: Market Preparation• Engage with suppliers to
accelerate market entry and negotiate pricing
• Support regulatory approvals and policy adoption by facilitating evaluations
• Conduct operational research to support normative guidance on the impact, cost-effectiveness, and appropriate use of POC
• Support national planning processes for POC
Example: Regulatory and policy barriers to market entry
6-18 months 6-12 Months 6-12 Months
On-going scale-upFirst phase implementation
ProcurementplanningTo 1st Supply
Registration& Evaluation
3-5 Years
Rollout of new products in general, and new diagnostics in particular, is slow
2 months 2 Months 3 Months
Example: Uganda (POC CD4)
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The project will facilitate each step in this process to support regulatory approvals
Began writing protocol – Sept 2010
Protocol approved – Nov 2010
Pilot began – January 2011
Product and scale-up approved – April 2011
Illustrative
Funding needs for HIV is expected to grow significantlyFunding needs for HIV is expected to grow significantlyMany countries already adopting emerging products in treatment protocolsPhase 1 will occur before a product becomes available and Phase 2 once it reaches the market
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Phase 1: Market Preparation• Engage with suppliers to
accelerate market entry and negotiate pricing
• Support regulatory approvals and policy adoption by facilitating evaluations
• Conduct operational research to support normative guidance on the impact, cost-effectiveness, and appropriate use of POC
• Support national planning processes for POC
Phase 2a: Commodity Donation • Donation (half of estimated need) and
consolidation of demand through a single procurement system
• Leveraging volumes to negotiate ceiling prices
Phase 2b: Catalytic Implementation• Product agnostic implementation
systems, planning and support for uptake (training, etc)
• Coordination and collaboration with other initiatives
• Responsibly transition procurement and operations support for lasting impact
Example: Product agnostic implementation
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Product Selection
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Procurement/ Tendering
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Operator Training
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QA/QC
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Patient Flow
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Data management
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Data Analysis
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Mentoring/supervision
In order for POC testing to be effective, new systems for implementation must be created. These can be product agnostic.
• Objective selection criteria
• Exclusion criteria to determine eligibility
• Volume discounts and leasing
• Service and maintenance
• Standardized sample collection
• Systems training on clinic workflow
• Participation in global EQA schemes
• Daily internal controls
• Timing of ART and OI treatment
• Patient movement through services
• Open data systems to manage devices
• Data transmitted remotely by modem
• Tracking volumes for forecasting
• Program mgmt with real time data
• Regular site level follow up
• Problem solving w/ real-time data
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Agenda
Introduction
Goals and activities of the project
Expected impact
Alignment with other initiatives
Components necessary for smooth, rapid uptake of new diagnostics
Uptake
Normative
Evidence
CostRegulatory
OperationsPolicy
Speedy, transparent pathways for quality
diagnostics
Strong, swift normative
support for high quality, impactful
products
National policy approval and
inclusion in planningand programming
processes
Evidence determining
quality and impactof new
diagnostics
Cost-effectiveness and cost-impact data
to guide investment In new testing
systems
Guidance on appropriate use
alongside existing diagnostics
infrastructure
POC will upend current limitations on HIV care and treatment
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1
HIV Diagnosis
2
Enrollment in HIV care
3
Blood draw
4
Test performed
Continuum of Care
5
Result received
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Clinical consultation
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ART initiation
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Monitoring
Point of care will expand access to actionable results, reduce loss and improve patient outcomes.
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2nd line (when necessary
POC CD4/EID
POC VL
POC CD4/EID
POC CD4/EID
Same day testing to CD4 resultSame day EID to ART initiation
• Healthy, competitive market with multiple competing products in each product class (CD4, EID, VL)
• Improved patient outcomes from earlier ART/2L initiation and decreased LTFU
• Regulatory and policy approvals for a range of products in focus countries • Research to support appropriate deployment and implementation systems• Improved market intelligence and encouragement for new suppliers to
invest in POC according to approved norms• Coordinated response among governments and partners for sustainable
gains
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Expected outcomes
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Agenda
Introduction
Goals and activities of the project
Expected impact
Alignment with other initiatives
Limited access to HIV diagnostics has been highlighted as a priority in the Treatment 2.0 Framework
Five priority work areas have been highlighted in the Treatment 2.0 framework
The Treatment 2.0 Framework for Action: Catalysing the Next Phase of Treatment, Care and Support, http://data.unaids.org/pub/Outlook/2010/20100713_outlook_treatment2_0_en.pdf
Priority work area 2: Provide Access to Point-of-Care and Other Simplified Diagnostics and Monitoring Tools
MSF UNITAID Project alignment
MSF aims to show if and how simplified testing can work in remote and resource-limited settings and to provide an evidence base for the range of products, or combination of products, to use in which contexts (e.g. lab vs clinic, urban vs rural)
Synergy:• Evidence on the efficiency and use of diagnostics – alignment on OR
questions• Access to CHAI/UNICEF procurement agreements • Sharing work on implementation systems• Using evidence to determine appropriate deployment and integration
with existing diagnostics
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Implementation of CD4 and Viral Load Testing in decentralised remote and resource-limited settings in
MSF-supported HIV programmes:Operational Research Priorities
Dr Tom Ellman,SAMU
MSF South Africa
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Monitoring ‘Lazarus’ was easy…
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This is more tricky...
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Across programmes: 2% of treated patients are on 2nd-line ARTIn South Africa (Khayelitsha), where routine virological monitoring is available: 12% on 2nd-line after 5 years
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The patient, their bodily fluids, the health worker, the tests and test results
Patient Sample Test
Result in LabResult with
Health worker
Result with Patient
Something Useful Happens...
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Rise of the PoC
Reduce risk of not testing, of death or of loss to follow-up
• HIV testing• CD4 screening pre-ART• Early Infant Diagnosis• Tuberculosis
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Rise of the PoC
Reduce risk of not testing, of death or of loss to follow-up
• HIV testing• CD4 screening pre-ART• Early Infant Diagnosis• Tuberculosis
Reduce risk of not testing, not receiving result, not acting on result
• 3 or 6 month Viral load• Routine viral load• Before TDF switch• At delivery
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Operational Research Framework1. Policy and Research landscape review2. Descriptive cohort and Cross-sectional studies
• Cohort/cascade outcomes,• Prevalence of failure and 2nd line• Prevalence of VL ranges in treated patients including
threshholds• Prevalence of genotypic resistance
3. Impact and costs of VL v CD4 monitoring strategies4. Validation and costing of tools and approaches
• Improved lab-based options• PoC tools• Mhealth tools• Adherence support
5. Comparison of different algorithms using validated tools6. M&E
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Comparison of multiple strategies
Overview of outputs
Lesotho Malawi T Mozambique S. Africa Zimbabwe Swaziland Malawi C UgandaPoint of care CD4 PI MA ✓ ✓ ✓ ✓ ✓
Partec miniPOC ✓Daktari ✓Zyomyx ✓ ✓
Lab-based viral load bioMerieux (DBS) ✓ ✓ ✓Biocentric ✓Roche (DBS) ✓pooled testing ✓ ✓ ✓ ✓
Simplified viral load GeneXpert ✓ ✓SAMBA ✓ ✓Alere ✓ ✓ ✓Liat ✓
EID SAMBA/Biocentric ✓ ✓ ✓Viral load alone ✓ ✓ ✓Viral load + CD4 ✓ ✓ ✓ ✓mHealth for reporting ✓ ✓ ✓
head-to-head comparison
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In conclusion…
• Partnership of implementers, researchers and modellers, and policy makers
• Define tools, strategies , and policies
• Reduce costs• Guarantee the funding
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Thanks!