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