THE POWER OF PUBLICPRIVATE PARTNERSHIPS IN EARLY INFANT DIAGNOSIS

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THE POWER OF PUBLIC/PRIVATE PARTNERSHIPS IN EARLY
INFANT DIAGNOSIS
Roche Molecular Diagnostic Symposium August 2008
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Agenda

• Introduction to Clinton Foundation
• Case study Implementing Early Infant Diagnosis
• Outcomes

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Background Clinton Foundation Mission
The Clinton Foundation works to strengthen the
capacity of people in the United States and
throughout the world to meet the challenges of
global interdependence.

• The mission is pursued through programs and
  partnerships in a variety of areas.
• The Clinton HIV/AIDS Initiative (CHAI) is the
  oldest and largest of the Foundations many
  programs and has been the template for several
  other programs.

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Background CHAI Mission and Objectives
To bring high-quality care and treatment to
people living with HIV/AIDS, and to improve
healthcare systems in resource-poor countries.
Mission

• To be effective, programs must
• combine prevention, care, and treatment
• be integrated into public health infrastructure
• have strong in-country political and policy
  support
• be viewed as urgent, not as business as usual

Philosophy

• Ability to mobilize political will (donor and
  host governments)
• Combine business and clinical expertise in
  operational planning and ongoing implementation
  support
• Change economics of care and treatment

Unique Value-Add
To accelerate patient enrollment and to improve
the quality and continuity of HIV/AIDS care and
treatment in resource-poor settings.
Goals
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Overview How CHAI Works

• At the invitation of local governments, CHAI
  supports developing countries to reach their
  HIV/AIDS care and treatment targets by
• Facilitating access to affordable drugs and
  diagnostics and
• Providing technical assistance that combines
  distinctive business/analytics competency with
  clinical expertise.
• CHAI pursues its mission through three strategic
  program areas
• Applying business principles to lower the cost
  of, and increase access to, essential drugs and
  diagnostics
• Partnering with governments to address
  bottlenecks in healthcare systems and
• Pioneering models to catalyze access for
  hard-to-reach populations.

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How CHAI Works (2)
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CHAI has been working for 6 years to help
governments make best use of available resources,
to save as many lives as possible
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CHAI has supported treatment scale-up through its
work with 18 manufacturers and more than 65
countries
22 partner countries 25 of people on treatment
in developing countries 69 total consortium
countries 90 of people on treatment
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CHAI Laboratory Services
1. Diagnostic Test Agreements

• Initially CHAI focused on reducing the cost of
  care and treatment, as it was identified as one
  of the primary barriers to access
• As a result, CHAI negotiated with suppliers to
  bring down cost of ARVs and diagnostics
• Diagnostic test agreements to date include CD4,
  viral load, DNA PCR and rapid tests

2. Laboratory Technical Assistance (TA)

• Despite available funds and better market prices,
  there are still barriers to scaling-up care and
  treatment
• Many partners are providing site-level support,
  but few are working closely with governments to
  build management capacity
• CHAI priority is to fill gaps, which often fall
  in the area of operational planning and
  implementation, systems development and program
  management
• CHAI aims to remain strategic in TA offering,
  building capacity within national systems

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What are the needs beyond the tests?

• Scale-up of ARVs has meant significant and
  growing demand for testing services
• Laboratory needs often not considered until after
  ARVs arrive
• Little/no experience with specialized testing
  (CD4/VL/DNA PCR)
• Labs often require basic equipment and
  infrastructure upgrades
• Laboratory management systems at central level
  underdeveloped
• Lack of coordination among individual labs,
  donors, technical assistance partners, government
• Many partners providing site-level support, but
  few are working closely with governments to build
  management capacity

Testing networks that are high-cost and
unreliable, which can limit a countrys ability
to take advantage of lower cost diagnostics.
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In other words, SYSTEMS development is needed for
laboratories
GOAL
Quick, reliable, high quality, cost-effective,
scalable and uniformly accessible/equitable
testing services that meet the needs of medical
services diagnostics, surveillance and regulatory
requirements
Requires TA in areas including Management and
Planning Human Resources Procurement and Supply
Chain Management Laboratory Networks Laboratory
Infrastructure Training Quality Management
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Agenda

• Introduction to Clinton Foundation
• Case study Implementing Early Infant Diagnosis
• Outcomes

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Case Study Implementation of DNA PCR Testing

• In 2007, CHAI was named the implementing partner
  for a pediatric initiative funded by UNITAID.
• The UNITAID pediatric initiative covers more than
  30 countries in the developing world.
• As part of the initiative, CHAI partnered with
  Roche Diagnostics to provide a comprehensive
  package of products for the diagnosis of HIV in
  infants lt18 months of age.
• However, establishing early infant diagnostic
  (EID) capacity in resource-poor settings faces
  certain barriers.

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Case Study Implementation of DNA PCR Testing

• What are the barriers to establishing EID?
• Requires additional infrastructure or equipment
• Reagents are expensive
• Infant diagnosis methods are technologically
  complex
• To support testing, it is necessary to procure
  multiple supplies from many sources
• Follow-up through pediatric care and treatment is
  not widely available
• There is frequently a lack of infant testing
  policies and national infant diagnosis algorithms
• There is frequently a lack of sample referral
  systems

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CHAIs Approach to EID

• As a result of these barriers, CHAI tried to take
  a comprehensive approach to supporting EID by

• Working upstream and collaborating with suppliers
  to look at procurement challenges and identify
  novel solutions find a turn-key solution
• Taking a holistic approach to programmatic
  implementation to assist governments in meeting
  demand for the service
• Signing MOUs with governments and work at the
  national level to develop public systems and
• Filling gaps and collaborate with partners to the
  greatest extent possible.

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CHAIs Approach to EID

• Initially, CHAI worked with Roche Diagnostics to
  reach an agreement on improved pricing for DNA
  PCR test reagents.
• Then, CHAI and Roche worked together to create a
  turn-key solution to provide all additional
  products needed for DNA PCR testing
• Dried Blood Spot (DBS) collection devices
• General laboratory consumables
• Instruments
• The result was the design and delivery of various
  bundles of commodities for EID.

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DNA PCR Laboratory Instrument Bundles

• Creation of Laboratory Instrument Bundles
• Establishing and maintaining a DNA PCR laboratory
  typically requires the procurement of equipment
  and supplies from multiple manufacturers.
• CHAI worked with Roche South Africa to develop
  product bundles that simplify this process
• Roche assisted with provision of
  service/maintenance.
• Quantity and quality of supplies in each bundle
  is based on experience and validated by
  specialists, including those at CHAI and Roche.
• Roche has the responsibility of setting up the
  laboratories (turn-key solution)
• Three laboratory bundle options, depending on
  degree of automation

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Collection Supply Bundles for DNA PCR
DBS and Whole Blood Collection Bundles All
products required for sample collection are
bundled into a small box, simplifying procurement
and reducing supply chain risks

• Bundles available for DBS and whole blood
  collection
• Specifications and ratios determined through
  collaboration with Ministries of Health,
  clinicians, partner organizations, and Roche
• High- and Low-Prevalence Bundles available

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DNA PCR Laboratory Supplies
Laboratory Consumable Bundles Complete testing
supplies bundled together for similar convenience
at the laboratory
Laboratory Reagents CHAI has worked closely with
governments and suppliers to provide the
necessary reagents

• CHAI will support the assay of the countrys
  choice, so long as it complies with international
  standards
• Over 90 of countries are using the Roche
  qualitative HIV DNA PCR Assay
• CHAI has negotiated price reductions, varying by
  country from 30-50

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Programmatic Support for EID
CHAI recognized that price reductions and a
turn-key solution to commodities for EID were not
sufficient alone to accelerate the implementation
of this much needed technology.
Therefore, CHAI took a comprehensive approach to
programmatic implementation of EID to assist
governments in meeting the demand for service. In
collaboration with other in-country partners,
e.g., the U.S. CDC, Baylor University, ICAP,
UNICEF and others, this work has included a range
of technical assistance.
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Main Programmatic Areas Addressed When
Establishing Early Infant Diagnosis
Strategy and Planning

• Policy decisions such as service entry points and
  referral
• Establishment of early infant diagnosis algorithm
• Timeline for implementation and rollout

Laboratory Setup

• Infrastructure
• Equipment and Supplies

• Human Resources
• Quality Control

Training

• Training participants
• Trainers
• Content

• Training rollout strategy and timeline

Sample Referral Network

• Transport routes between clinic and testing labs
• Transport modes (e.g. courier, facility vehicle,
  public transport)
• Data management, including return of results

Procurement and Supply Chain Management

• List of products to procure
• Forecasting
• Ordering and inventory management

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Guidelines, Training Partnerships, and Laboratory
Support

• Guideline and Policy Support
• Lesotho CHAI assisted to write guidelines for
  early infant diagnosis
• Tanzania Seconded staff, supported and
  coordinated meetings
• Laboratory Technician Secondment and Training
• Zimbabwe CHAI seconded technicians, Roche to
  deliver training
• Mozambique CHAI seconded technicians, Roche
  delivered training
• China CHAI seconded technicians, Roche delivered
  training
• Coordination of Sample Collection Trainings /
  Logistical and Programmatic Support
• Lesotho collaboration with Ministry of Health,
  CDC, Baylor and NICD
• Swaziland collaboration with Ministry of Health,
  ICAP, Baylor, and UNICEF
• Kenya CHAI supports logistics, CDC and partners
  deliver the training
• Mozambique CHAI providing logistical support and
  funding
• China support for the central lab to conduct
  trainings at 14 provincial CDC labs around the
  country
• Delivery of Sample Collection Training
• Tanzania TOT in Mtwara and Lindi
• Caribbean Sample collection training for several
  islands
• India Several thousand health care workers
  trained

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Sample Transportation
Design and implementation of sample
transportation networks fit into the broader
framework of a countrys laboratory referral
system. CHAI has supported this process in
several ways

• Assess existing sample transport networks
• Determine routes, segments, mechanisms
• Courier negotiations
• Programmatic support
• Monitor and track service providers
• Forecast volumes from collection sites
• Map against capacity at reference laboratories
• Analyze the impact of different sample
  transportation scenarios
• Examples of country work include
• Cameroon
• Dominican Republic
• Kenya
• Mali

• Mozambique
• Tanzania
• Uganda
• Zimbabwe

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Sample Referral Systems Data Management

• Country Example

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Agenda

• Introduction to Clinton Foundation
• Case study Implementing Early Infant Diagnosis
• Outcomes

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Outcomes of EID Intervention
Overall, the results of the collective work on
EID under the pediatric initiative have been
significant Approximately 100,000 DNA PCR tests
were conducted in 2007 across resource-poor
settings, excluding RSA, and that number doubles
if RSA is included. DBS infant blood samples were
collected at approximately 1,400 sites in 2007
across major countries. Excluding RSA, it is
expected that approximately 185,000 to 200,000
DNA PCR tests will be conducted in 2008 with
blood collected from approximately 2,000 or more
sites.

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Challenges Remain
Despite the overall success of EID over the last
year, challenges remain. These include Continuing
to build on the momentum of 2007 Improving loss
to follow-up following diagnosis, which has a
number of dimensions One focus in this regard
will be improving turnaround time from blood
collection at community sites to return of test
results to the patient.

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Example - Kenya DNA PCR Network
Packaging
1 day
4 days (shipping done once a week)
Sample Collection
2 Week turnaround to receipt of results
ART/PMTCT centre
Securicor Samples
Testing lab
1 day
1 day
5 days (lab testing)
CDC/KEMRI-Kisumu CDC/KEMRI-Nairobi KEMRI-Kilifi KE
MRI/WRP-Kericho
SecuricorResults
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The pediatric program, in partnership with
UNITAID and other partners, doubled the number of
children on treatment in 33 countries in 2007
Available resources
60m
35m
3m
Price of peds ARVs
567
196
60
Infant diagnosis sites
1,400
lt200
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Thank you