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 scaleup 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
Objective Activities Evaluation: Time From Diagnosis To CD4 Staging And ART Initiation shows similar results in ASLM recommends a framework for viral load implementation Uganda Stakeholder Consultation Resources and Needs Assessment Update guidance and algorithms Impact Analysis Laboratory networks and systems strengthening Ensure costeffectivenes s Monitoring and Evaluation MoH leadership and Partner coordination Costing Set-up TWGs to understand partner roles/responsibil ities 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 improvemen ts and recommenda tions 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
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
Impact of Viral Load Strategic Planning 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
Planning for use of DBS: Most of the viral load testing laboratories are in major urban centers 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 Kenya Zimbabwe Uganda Malawi
Over 50% of patients are beyond 24 hours sample transport from the testing centers 48% [33% -66%] of all patients 1 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
# Countries National viral load policy and planning 2015 a. Viral load policy and coordination b. Viral load implementation plan 14 12 VL testing in national policy 10 8 6 VL TWG established 4 2 0 Nationally approved curriculum for VL monitoring Approved and implemented Approved but not implemented Not yet approved In development None
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 $600 $500 $400 $300 $200 $100 $0 2014 Cost Per Patient Identified 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
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 Optimized Approach to Achieving the First 90 Total Cost Tests Identified 0% 20% 40% 60% 80% 100% MSM Sex Workers IP PITC Index Testing Self-test PMTCT VTC Mobile Campaign TB Co-infected PITC
Savings from Optimizing HTC Approaches Cost of Status Quo vs. Optimized Strategy to Reach First 90 Over 5 Yrs. Total Cost - Status Quo $8 571 000 Total Cost - Optimized $3 826 000 Number of Test to Reach First 90 Over 5 Yrs. - Status Quo vs. Optimized Strategy to Number of Tests - Status Quo 390 586 Number of Tests - Optimized 251 280
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
Early Infant Diagnosis testing is highly decentralized Number of Tests per Site per year Example: EID Test Demand By Site 2 000 1 800 1 600 1 400 1 200 1 000 <10% of sites account for 50% of patient demand However, to achieve universal access, we need to reach the long tail also 800 600 400 200 0 Individual Sites (n=2,789)
Health technology assessment and diagnostic yield
POC HIV EID and viral load products: available and pipeline* Alere q Alere EOSCAPE HIV Wave 80 RT CPA HIV-1 Viral Load Ustar SAMBA VL DDU/Cambridge GeneXpert Cepheid Truelab PCR Molbio/bigTec Savanna Viral Load Platform NWGHF Gene-RADAR Nanobiosm ZIVA Cavidi Daktari System SAMBA EID DDU/Cambridge LYNX HIV p24 Antigen NWGHF Viral Load Assay with BART Lumora COBAS Liat Analyzer (Iquum) 2015 2013 2014 2016 *Estimated as of December 2014; timeline and sequence may change. Platforms in red have specific EID assay. No market launch date set by company.
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