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African Society for Laboratory Medicine
Strategic Planning for Scaling Up
HIV Diagnostics for 90/90/90
WHO/UNAIDS MEETING WITH DIAGNOSTIC MANUFACTURERS AND STAKEHOLDERS March 10-11, 2016
Planning and Forecasts
• Strategic diagnostics planning to meet the 90-90-90 goals is increasingly done in Africa
• Quantitative assessment of testing needs by geography, population and over time informs these plans, leading to better forecasts of test commodity demand
Utility of strategic planning for 90-90-90
• HIV testing – Data-based focus on new targeted and community-based
models for testing - e.g. Botswana
• Early infant diagnosis – Strategic deployment of POC EID testing: finding the right
balance between lab-based and POC testing and optimal EID entry points – e.g. Mozambique, Uganda
• Viral load – Strategic implementation plans help coordination of scale-
up and increase visibility of funding or operational gaps – leading to better focus financial and technical assistance resources • E.g. Malawi, Tanzania, Swaziland, Uganda, Zimbabwe
Tools for Viral Load Planning
Evaluation: Time From Diagnosis To CD4 Staging And ART Initiation shows similar results in Uganda
Stakeholder Consultation
Resources and Needs Assessment
Update guidance and algorithms
Impact Analysis
Laboratory networks and systems strengthening
Ensure cost-effectiveness
Monitoring and Evaluation
MoH leadership and Partner coordination
• Set-up TWGs to understand partner roles/responsibilities
• Agree on a coordinated approach
• Assess existing resources (infrastructure, equipment, HR etc.)
• Estimate the cost of integrating viral load into existing ART programs
• Revise national ART-related testing policies, local normative guidance and clinical algorithms
• Understand implications of scaling up VL for the whole health system
• Increase network capacity where needed
• Strengthen laboratory systems to ensure a sustainable scale up
• Lab accreditation
• Consortium procurement, instrument rental agreements, and public-private partnership initiatives with industry, etc
• Rational test deployment
• Perform routine review and evaluation
• Implement improvements and recommendations A
ctiv
itie
s O
bje
ctiv
e Obtain strong commitment
and political will
Leverage existing resources and secure funding
Create a normative framework conducive to VL access
Anticipate and address challenges
Ensure sustainability
Optimized use of available resources
Identify and share best practices
ASLM recommends a framework for viral load implementation
Costing
Diagnostics Implementation Taskforce: Viral Load Toolkit
• VL training tools for clinicians and labs
• Specimen transportation tool
• Laboratory quantification tool
• Viral load costing tool
• Monitoring and Evaluation tool
National viral load scale-up plans: examples
Impact of Viral Load Strategic Planning
• Swaziland: MoH mapped and consolidated viral load resources for single-source procurement to take advantage of lower access pricing
• Zimbabwe: MoH mapped viral load resources and successfully secured for funding to fill the gap
• Tanzania: Planning identified limited immediate viral load funding so resources were focused on vulnerable groups - pregnant women, infants and discordant couples while raising funds to fill the gap
• Malawi: Plan enabled MoH to mobilize early funding for viral load
Impact of Viral Load Strategic Planning
Kenya Zimbabwe
Uganda
Note: this slide only reflects the PCR testing labs used for VL testing in the public sector. This excludes private PCR testing labs or those used for research purposes. Some circle represent multiple labs in the same city
Malawi
Planning for use of DBS: Most of the viral load testing laboratories are in major urban centers…
48% [33% -66%] of all patients1 are at facilities close to centralized labs and can transport samples within 24
hours
Can be accessed
using EDTA whole
blood
1 Data based on facility level ART patient numbers from Kenya, Malawi, Uganda and Zimbabwe
Over 50% of patients are beyond 24 hours sample transport from the testing centers
National viral load policy and planning 2015
0
2
4
6
8
10
12
14
# C
ou
ntr
ies
VL testing innational policy
VL TWGestablished
Nationallyapprovedcurriculum forVL monitoring
Approved and implemented
Approved but not implemented
Not yet approved
In development
None
a. Viral load policy and coordination b. Viral load implementation plan
Tools to expand HIV Testing
WHO normative guidance
Optimizing HTC Approaches to Reach the First 90
Option #1: Identify testing strategies with a higher than average yield (these strategies may be higher cost) • TB Co-Infected • Index Testing
Option #2: Identify testing strategies with lower than average cost (these strategies may have a lower yield) • Mobile • Self-Testing
Pursuing low cost and high yield strategies allows the program to achieve the First 90, while
minimizing financial costs However, it may not be feasible to pursue only the lowest cost per patient identified strategy due to
operational constraints
$0
$100
$200
$300
$400
$500
$600
2014 Cost Per Patient Identified
Optimizing HTC Approaches to Reach the First 90
• The optimized strategy should take account for programmatic capacity and available resources
Using an optimized testing strategy including Index Testing, Door-to-Door, Self-Testing, VTC, and PITC in equal proportions could reduce the total cost of
achieving the First 90 in 2020 by over $3.8M
0% 20% 40% 60% 80% 100%
Identified
Tests
Total Cost
Optimized Approach to Achieving the First 90 MSMSex WorkersIP PITCIndex TestingSelf-testPMTCTVTCMobileCampaignTB Co-infectedPITC
Savings from Optimizing HTC Approaches
$3 826 000
$8 571 000
Total Cost - Optimized
Total Cost - Status Quo
Cost of Status Quo vs. Optimized Strategy to Reach First 90 Over 5 Yrs.
251 280
390 586
Number of Tests - Optimized
Number of Tests - Status Quo
Number of Test to Reach First 90 Over 5 Yrs. - Status Quo vs. Optimized Strategy to
Tools to Expand EID
• WHO 2016 Consolidated Guideline for the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection: Recommendations for a Public Health Approach
0
200
400
600
800
1 000
1 200
1 400
1 600
1 800
2 000
Example: EID Test Demand By Site
Individual Sites (n=2,789)
Number of Tests per Site
per year
<10% of sites account for 50% of patient demand However, to achieve
universal access, we need to reach the “long tail” also
Early Infant Diagnosis testing is highly decentralized
Health technology assessment and diagnostic yield
2015 2013 2014 2016
Alere q Alere
SAMBA VL
DDU/Cambridge
EOSCAPE HIV™ Wave 80
GeneXpert Cepheid
Savanna Viral Load Platform NWGHF
Viral Load Assay with
BART Lumora
*Estimated as of December 2014; timeline and sequence may change. No market launch date set by company. Platforms in red have specific EID assay.
RT CPA HIV-1 Viral Load Ustar
Gene-RADAR Nanobiosm
LYNX HIV p24 Antigen NWGHF
POC HIV EID and viral load products: available and pipeline*
SAMBA EID
DDU/Cambridge
ZIVA™ Cavidi
Truelab PCR Molbio/bigTec
COBAS® Liat™ Analyzer (Iquum)
Daktari™ System
Thank You