# Presentation: 789834

## Building Laboratory Capacity in Support of HIV/AIDS Care Programs in Resource-limited Countries

**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
- Robert Martin, DrPH
- Director, Division of Laboratory Systems

## CDC Global AIDS Program Mission

- GAP helps resource-constrained countries:
- prevent HIV infection
- improve treatment, care, and support for people living with HIV
- build capacity/infrastructure to address the global HIV/AIDS pandemic
- GAP provides its assistance directly through CDC staff and through partnerships with governments, communities, and national and international institutions

## GAP Budget History

**Notes:**
GAP’s budget for FY03 is flat – with the exception of $40M appropriated specifically for PMTCT, for the President’s mother-to-child initiative.  USAID received $750M specifically for HIV/AIDS programs, and up to $100M for PMTCT.  

## HIV/AIDS Burden: Year-End 2002

- Total estimated HIV-infected population worldwide:  42 million, 95% in the developing world
- Total HIV burden in GAP countries:	37million
-  **>**90% of all HIV-infected persons live in countries that have a CDC Global AIDS Program presence

- Source: UNAIDS,  December 2002

**Notes:**
UNAIDS recently released new estimates of worldwide HIV infection, revising the estimate of those infected upwards to 42 million.  At this point, they have not released country-specific numbers, so we cannot estimate accurately the burden in GAP countries, however, a simple ratio would indicate that it will be approximately 37 million, or 92.5%.

## GAP Countries 2003

**Brazil**

**Haiti**

**Senegal**

**Côte d’Ivoire**

**Guyana**

**South Africa**

**Botswana**

**Namibia**

**Zimbabwe**

**Zambia**

**Angola**

**Rwanda**

**Nigeria**

**Ethiopia**

**Kenya**

**Tanzania**

**Mozambique**

**Malawi**

**Uganda**

**India**

**D.R. Congo**

**China**

**Thailand**

**Vietnam**

**Cambodia**

**Notes:**
At the end of calendar year 2002, GAP was working in 25 countries around the globe, shown here – including 17 in Africa, 5 in Asia and 3 in the Caribbean and South America.  We do not anticipate adding additional bilateral countries in 2003 – but that is subject to direction from those higher in the administration.  There is significant interest and concern about the countries in the former Soviet Union as well as other nations with burgeoning epidemics.  We feel that we’re at our carrying capacity with the fiscal and human resources available to us now – but we may have to find ways to stretch those resources even further.  

## President’s Emergency Plan for AIDS Relief

**Prevent 7 million new infections (60 percent of the projected new infections)** *Large-scale prevention efforts, including voluntary testing and counseling. The availability of treatment will enhance prevention efforts by providing an incentive for individuals to be tested. *
**Treat 2 million HIV-infected people **** ***First global effort to provide advanced antiretroviral treatment on a large scale in the poorest, most afflicted countries.*
**Care for 10 million HIV-infected individuals and AIDS orphans**  *Range of care, including support for AIDS orphans. *

**Notes:**
$15B over 5 years, including $10B new money

PMTCT initiative seen as a model for this effort; same 14 countries:
In Africa:
Botswana
Cote d’Ivoire
Ethiopia
Kenya
Mozambique
Namibia
Nigeria
Rwanda
South Africa
Tanzania
Uganda
Zambia and, 
in the Caribbean,
Guyana
Haiti

## Designated Countries in the President’s PMTCT Initiative

_**Africa**_
- Botswana
- Côte d’Ivoire
- Ethiopia
- Kenya
- Mozambique
- Namibia
- Nigeria
- Rwanda

- South Africa
- Tanzania
- Uganda
- Zambia
_**Caribbean**_
- Guyana
- Haiti
-  *and* Regional efforts through CAREC (Trinidad)
_**Southeast Asia**_
- 15.  Vietnam

**Notes:**
The Administration selected these 14 countries based on 
the burden of HIV/AIDS, particularly as indicated by ANC data, 
the level of infrastructure to support targeted efforts to prevent mother-to-child HIV transmission, 
the individual country governments’ commitment to preventing HIV and treating those infected.

## Major GAP Activities

- HIV Prevention Programs
- 	Including behavior change (abstinence, delay, risk reduction), voluntary counseling and testing, prevent/treat other sexually transmitted infections, prevent mother-to-child transmission, blood safety
- HIV/AIDS Treatment and Care Programs
- 	Including diagnosis, prophylaxis and treating opportunistic infections, tuberculosis and HIV/AIDS, and operational research related to developing program models, standards and guidelines
- Program Infrastructure
- 	Including surveillance, operational research, informatics, training, laboratory support and monitoring and evaluation

## CDC GAP Program Model

**CDC GAP Program Model**

**  ****Surveillance**
- HIV surveillance
- Behavioral surveys

**Primary Prevention**

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

|  |  | Interventions |
| --- | --- | --- |
|  |  |  Testing and Counseling
 BCC
 STI prevention/care
 Workplace/union 
 Post-exposure   prophylaxis
 Condom promotion
 School-based |
|  |  | - PMTCT |
|  |  |  Interventions for IDUs
 Blood system    interventions
 Post-exposure   prophylaxis |

- - **Laboratory**
- - Information systems

- - Monitoring and evaluation
- - Training

**Capacity and Infrastructure Strengthening**

**Notes:**
Capacity-building and infrastructure-strengthening are essential to accomplishing all other GAP programmatic elements.  These two components under gird all other activities.

## 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

- APHL

- GAP country-specific lab liaison team

- Laboratory Technical Advisory Group
- CDC/CIOs, Lab Leaders in GAP countries, WHO

- DASTLR

- PHPPO

-           GAP country

- STI

- Lab
- Sys

- Dx
- Surv

- Dx
- Care

- QA

- TB

- Technical Working
- Groups

- OI

- UTAP

- UTAP

## 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
**NRL ****	**	National Reference Serology Laboratory
**APHL**    	 Public Health Laboratory        				Assessments, long term twinning  				partnerships, lab management training – (CoAg)
**ASCP   ****	**Training materials development - (CoAg/Contract)
**UTAP **    	Technology transfer and long term 				partnership – (CoAg)
**WHO **** ****	**Regional/international leadership and 			coordination - (CoAg)

**Notes:**
Incredible talent pool spread across centers
Interested in doing or were already doing international work
Individual partnership development
Mutual trust knowing we are all working for a common cause

## Operationalizing Laboratory Technical Support

- Strengthen National Reference laboratories:
-          - Quality Reference work – national level
-              (hub for GAP program activities)
-         - Set national standards, guidelines and protocols
-         - Perform QA/QC and national oversight
- Support District level laboratory capacity/capability
- Rapid Testing: point-of-service for programs
- Training - national, regional and international

**Notes:**
Support National Reference Laboratories to retain technical staff and to assure minimum standards.
Since no basic research is anticipated, advocate a change in role to:
                  - Reference work for HIV/TB/STI drug resistance
                  - Test kit evaluation and validation
                  - Supervisory national QA role to assure quality of testing
                  - Supervisory national QC and proficiency testing
Rapid HIV tests to support GAA program areas.
Assure minimum standards for TB diagnosis and monitoring - basic smear microscopy and periodic culture to monitor resistance
Rapid tests for STI
Possible cooperative agreement with APHL to foster linking laboratories in Africa with sister laboratories in the United States

## Implementation of Laboratory Capacity Strengthening in CambodiaApril 2003

## Mission/Scope of Work

- Assess resources, capabilities and needs of laboratories in Phnom Penh and eight provinces.
- Recommend improvements for public health laboratory infrastructure supporting HIV/AIDS and OI’s.
- Prepare implementation plan to carry out recommendations.

## Recommendations - National Level (3)

- Quality Management / Quality Assurance
- Development and improve the quality of training and supervision
- Determine the Ministry of Health’s responsibility in maintaining and assuring the integrity of laboratory equipment

## Implementation Steps

- Coordinate a National meeting to develop a national strategy for improving the quality of laboratory testing

## Developing the Agenda for the Establishment of a National Network of Health Laboratories

- Phnom Penh, Cambodia
- September 3-4, 2003

## Quality Assurance Group

- MoH establish a single laboratory quality assurance body through Sub-committee action.

## Declaration of Commitment

- The Ministry of Health, Kingdom of Cambodia, the Health Directors of the Provinces, and the U.S. Global AIDS Program have participated in the first national meeting of the Cambodian National Laboratory Network.  The purpose of the meeting was to develop an agenda for the establishment of the national network through participation of all appropriate levels of the Cambodian government and the U.S. Global AIDS Program.
- The undersigned are committed to:
- 	Establishing the Cambodian National Laboratory Network (CNLN)
- 	Developing and participating in a national laboratory quality assurance program
- 	Continuation and assurance of the impact of the CNLN through organization of workshops and meetings on specific topics, such as:
- 		Networking
- 		Management and Leadership Skills
- 		Quality Assurance, Quality Control and Quality Improvement
- 		Laboratory Procedures and Methods Updates
- 		Equipment Management/Maintenance
- 		Inventory Management
- The undersigned are committed to pursuing the recommendations of the workgroup deliberations at this meeting for the purpose of making quality laboratory testing a priority for addressing the HIV/AIDS epidemic and other significant public health needs in the Kingdom of Cambodia.

## Building Laboratory Quality Systems:         A Route to Reliable Laboratory DataJuly 2004 

**Workshop Goals**

**Occurrence Management**

**Information Management**

## Building Laboratory Quality Systems Workshop Participants

**Laboratory leadership from Cambodia (Laboratory Directors, Ministries of Health, Quality Assurance specialists)**
**Participants from China, Vietnam, Thailand**
**Association of Public Health Laboratories**
**Australia National Reference Laboratory**
**CDC Global AIDS Program**

## Workshop Goals

**Describe the framework for a quality system**
**Provide information on how to address essential elements of the Quality System including: organizational responsibilities, specimen management, quality control, personnel management, documentation and record keeping, equipment management, external quality assessments, and information management **

## Workshop Goals

**Develop common approaches for implementing  national programs **
**Provide a forum for exchange of experiences in efforts to promote, establish, and implement a quality laboratory system in GAP-supported countries**
**Provide participants with materials for training others **

## Workgroup Sessions

- Divide participants into six workgroups
- Each workgroup will have two facilitators
- Two tasks for workgroups
- How to develop a plan for a quality laboratory system and present (Thursday)
- Develop a national quality system plan and present (Friday)

## Scheme for Group  Work

**1**

**2**

**3**

**4**

**5**

**6**

**Group**

**Topic 1**

**Topic 4**

**Topic 5**

**Topic 2**

**Topic 6**

**Topic 3**

**Topics**

## How To Develop a Plan

- Gathering information
- What is quality of laboratory testing in Cambodia?
- What problems might prevent implementing a quality system?
- What are the current strengths that can be built on (what’s good, what’s bad)?

## How to Develop a Plan

- Getting Support
- Is a national system important and how do you tell others?
- How do you get support from national and local leadership?

## How to Develop a Plan

- Communications
- How do you get people involved (national and local)?
- Laboratory staff
- Customers

## How to Develop a Plan

- Assessment of Laboratory
- Have assessments been conducted and what are results?
- How would you get more information if  you need it?
- What quality system essentials are already being addressed?

## How to Develop a Plan

- Authorities and Responsibilities
- Who will have overall responsibility for planning and implementation?
- Who has authority for laboratory policy (national and local)?
- Are there laws or regulations that address laboratory practices?

## How to Develop a Plan

- Measuring Success
- Is the plan working?
- How would you know?

## Making the Plan

- Identify and include stakeholders (who are your customers)
- Establish goals and objectives
- Identify activities
- Determine resource needs
- Assign responsibility
- Develop a timeline
- Develop mechanism for evaluation, monitoring and continuous improvement.

## Ongoing Rating of the Sessions

- Session				Date
- Rate    5   -   1 ( all I expected – not what I expected)
- I am learning new information
- I am understanding the information
- I hear the information
- I can use the information in my work

## Thailand

- Collaboration and partnership are key...skillful project management is essential

- Vietnam

- Cambodia