LIFE Initiative

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Building Laboratory Capacity in Support of
HIV/AIDS Care Programs in Resource-limited
Countries
Laboratory Support for the Global AIDS Program
Organization and Response Strategy Austin Demby,
PhD Laboratory Team Leader
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History of Laboratory Interaction With Programs
(1)

• Communications Difficulties
• - Programs with lab components developed and
  implemented without input from lab staff (budget,
  procurement, training, implementation,
  evaluation)
• Laboratory out of touch with program needs

3
History of Laboratory Interaction With Programs
(2)

• Effects
• Lab component are often one of the weakest links
  in programs
• Problems discovered in the middle of or at the
  end of programs
• Solution
• True partnership (mutual respect, joint program
  planning, implementation, and evaluation)

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Why a Retreat 1

• Changing climate in support of HIV/AIDS
  interventions in resource-limited countries
• Unprecedented increase in resources
• USG (HHS, DOD, USAID), Global fund, World Bank
  MAP funds, multilateral (e.g.WHO, EU) and
  bilateral funds (e.g. DFID), private sector (e.g.
  Gates Foundation and other major charities)
• Expansion of interventions with major underlying
  laboratory components

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Why a Retreat 2

• Reminder that laboratory partners could bring
  added value to HIV/AIDS interventions when
• Lessons learnt are shared with providers and
  end-users (Surv, STI, TB)
• Clarity of the needs and expectations from both
  providers and end-users
• Adequate attention and resources are allocated to
  laboratory services
• A clear roadmap for the provision of quality
  laboratory services is developed with input from
  providers and end-users

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Retreat Objectives (1)

• Primary Objective
• To develop an implementation plan for
  strengthening
• laboratory capacity in support of HIV/AIDS care
• programs in resource-limited countries.
• Develop a clear strategy for introducing and
  supporting quality basic laboratory services in a
  timely manner
• To review and prioritize the spectrum of
  laboratory technologies available to adequately
  respond to the different components of HIV/AIDS
  care and prevention programs
• To develop a clear strategy for rapid scale-up of
  laboratory support to programs as they expand
  services.

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Retreat Objectives (2)

• Secondary Objectives
• Build Constituencies, Coalitions and Networks
• Build support and advocacy for appropriate use of
  laboratory services as HIV/AIDS programs expand

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Laboratory Service With Consumer in Mind
Consistently accurate and reliable test
result Consistently accurate and reliable
monitoring
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GAP Countries 2003
China
India
Haiti
Vietnam
Nigeria
Senegal
Ethiopia
Guyana
Cambodia
Thailand
Côte dIvoire
Uganda
D.R. Congo
Kenya
Rwanda
Angola
Tanzania
Zambia
Zimbabwe
Brazil
Namibia
Malawi
Botswana
Mozambique
South Africa
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CDC GAP Program Model

• Surveillance
• HIV surveillance
• Behavioral surveys

• Primary Prevention

• Care and Treatment
• - Palliative care
• - Treatment of OIs
• - TB treatment
• - Use of ARVs

Capacity and Infrastructure Strengthening

- Laboratory - Information systems
- Monitoring and evaluation - Training
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GAP countries with ongoing lab activities
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Laboratory Mandate and Strategy for Implementation

• Mandate
• Provide direct quality support to GAP programs
• Provide lab systems infrastructure a platform
  to support expanded national programs
• Strategy
• Assure minimal standards are met before high-end
  requests are filled
• Ensure service has impact at point-of-care
• Service is timely and responds to the epidemic

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Major challenge to implementing the mandate

• Balance between
• Supporting direct quality technical laboratory
  services for HIV/STI/TB/OI
• Supporting the creation/strengthening of PH
  laboratory systems to support quality testing
• Effect
• Rapid impact
• At the same time building long-term national
  capacity for sustainable support of programs.

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Organizational Model for Response

• Partnership Matrix
• GAP US-based Coordination
• PHPPO Lab systems, QA, training (MOU)
• DASTLR Wet bench technology transfer (MOU)
• NCEH Dried Blood Spot Technology
• APHL Public Health Laboratory
  Assessments, long term twinning
  partnerships, lab management training (CoAg)
• UTAP - Technology transfer and long term
  partnership (CoAg)
• WHO Regional/international leadership and
  coordination - (CoAg)

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GAP Laboratory Support Structure
Steering Committee T. Mastro, S. Wiktor, A.Demby,
P. Crippen GAP R. Martin, T. Hearn, J.
Ridderhof PHPPO M. Rayfield, J. Kaplan, R.
Ballard, S. McDougal DASTLR Yvette Benjamin -
APHL
Laboratory Technical Advisory Group CDC/CIOs, Lab
Leaders in GAP countries, WHO
UTAP
UTAP
APHL
DASTLR
PHPPO
Technical Working Groups
Lab Sys
STI
Dx Surv
Dx Care
QA
TB
OI
GAP country-specific lab liaison team
GAP country
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Approach 1

• A. Regional
• Regional organizations with overarching
  responsibilities that guide policies
• e.g. WHO-Geneva, WHO-Afro, PAHO, CAREC
• Establishing laboratory networks
• Developing and sharing common documents and
  products (Guidelines, training products
  videos/posters etc.)
• Joint training programs (e.g. Guyana, Uganda,
  Botswana)

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Approach 2

• B. National
• Ministry of Health the principal GAP partner
• Direct support to GAP programs
• e.g. Quality lab support to surveillance
• Protocol development and/or review
• Training, implementation and External Quality
  Assurance
• Building / rebuilding national or local
  laboratory systems with strong links to GAP
  programs (planning, construction, equipment
  procurement, training)

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Operationalizing Laboratory Technical Support

• Strengthen National Reference laboratories
• - Quality Reference work national
  level
• - Set national standards, guidelines and
  protocols
• - Perform QA/QC and national oversight
• Support District level laboratory
  capacity/capability
  
• Testing point-of-service for programs
• Training - national, regional and international

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Reality on the Ground - 1

• Wide range of competencies
• Loss, sub-optimal distribution of trained
  personnel (very centralized)
• Major training needs for critical lab staff
• Intermittent supply of reagents
• Congested and in some cases unsafe laboratory
  environment
• Fear that additional work load overwhelms weak
  laboratory system

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Reality on the Ground - 2

• Islands of excellence
• Government / public leaders
• Institutions
• Programs with lab component
• Key in-country laboratory personnel
• The need however for supporting comprehensive
  national programs

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Range of Laboratory InfrastructureNational
Reference Laboratory

• Burundi National Institute of Public Health a
  potential for national laboratory training and
  oversight
• Substantial investment

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Range of Laboratory Infrastructure Sub-district
Level Laboratory
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Range of Laboratory Infrastructure Rural Primary
Health Care Laboratory
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A Major Question for Laboratory Services

• Who has responsibility for assuring the
  quality of testing throughout the service?

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Quote of the Week

• Poor quality test results are worse than no test
  results
• 
  Building
  Laboratory Quality Systems
• 
  A Route to reliable laboratory
  data
• 
  Gabarone, Botswana. August 2003

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Critical Success Factors for Laboratory Support
to HIV/AIDS Programs

• Leadership from laboratory service providers and
  end-users
• In-country capacity to absorb technical support
  and expand services
• Appropriate training with a focus on systems
  development
• A deliberate system for assuring the quality of
  test results

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The Future

• Partners present at the retreat have unique
  expertise, proven track records, and experience
  in implementing well thought out programs with
  strong laboratory components in developing
  countries
• Over the years effective partnerships between
  public and private institutions have been
  developed in support of lab-based programs
• Retreat provides an opportunity to shape a common
  road map for future lab support