# Presentation: 358592

## PEPFAR Plansfor Initiating ART andProviding Laboratory Services Tedd V. Ellerbrock, MD, FACOGGlobal AIDS ProgramCenters for Disease Control and Prevention 

**Notes:**
Thank you all for coming.  I’m sorry we can’t see you, but it’s nice to talk with everyone.
We are proposing to initiate an antiretroviral treatment program.
This pilot initiative will be carried out by: The Kenya Ministry of Health, The St Mary’s Mission Hospital, Kibera Community Self Help Program, otherwise known as KICOSHEP, the Kenya medical Research Institute and CDC

## Goals of PEPFAR

- During a 5-year period, the goals of PEPFAR are
- To treat at least 2 million HIV-infected people with antiretroviral therapy (ART)
- To prevent 7 million new HIV infections, which             is about 60% of the projected new infections in the 14 participating countries
- To care for 10 million HIV-affected individuals and AIDS orphans

**Notes:**
It is a well-known fact that ARVs lead to reductions in mortality and morbidity arising from HIV infection. 
In Kenya the HIV prevalence is estimated at 13% in adults aged 15- 49 years, with approximately 500 – 700 people dying daily of AIDS. 
Despite this, ARVs are available to few people, mainly in the private sector due primarily to cost implications and complexity of ARV regimens.  
As cost of AIDS treatment continues declining, there is potential for these therapies to become more accessible and it is therefore an important time to expand national capacity for safe and effective use of antiretroviral therapy in Kenya. 

## Goals of PEPFAR

- During a 5-year period, the goals of PEPFAR are:
- To treat at least 2 million HIV-infected people with antiretroviral therapy (ART)
- To prevent 7 million new HIV infections, which             is about 60% of the projected new infections in the 14 participating countries
- To care for 10 million HIV-affected individuals and AIDS orphans

**Notes:**
It is a well-known fact that ARVs lead to reductions in mortality and morbidity arising from HIV infection. 
In Kenya the HIV prevalence is estimated at 13% in adults aged 15- 49 years, with approximately 500 – 700 people dying daily of AIDS. 
Despite this, ARVs are available to few people, mainly in the private sector due primarily to cost implications and complexity of ARV regimens.  
As cost of AIDS treatment continues declining, there is potential for these therapies to become more accessible and it is therefore an important time to expand national capacity for safe and effective use of antiretroviral therapy in Kenya. 

## PEPFAR Plans for Initiating ARTand Providing Laboratory Services

- If we plan to initiate ART and provide lab services for 2 million HIV-infected persons, we need to address several important questions and develop a consensus about what are the best answers to these questions

**Notes:**
Thank you all for coming.  I’m sorry we can’t see you, but it’s nice to talk with everyone.
We are proposing to initiate an antiretroviral treatment program.
This pilot initiative will be carried out by: The Kenya Ministry of Health, The St Mary’s Mission Hospital, Kibera Community Self Help Program, otherwise known as KICOSHEP, the Kenya medical Research Institute and CDC

##  Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                     Question #1
- 	What are the major factors that will determine how many HIV- infected persons will be treated through PEPFAR?

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Major Factors that will Determine How Many HIV- infected Persons will be Treated through PEPFAR 

- Goal of PEPFAR – treat at least 2 million with ART
- Funding of PEPFAR – $10 billion over 5 years
- Need – 20 million HIV-infected persons live in the 14 PEPFAR countries and at least 3 million (15%) of these qualify for ART
- Feasibility – if we receive the funding, determining how many persons we can feasibly treat with ART will probably not be an option because those who are not treated are at risk of serious illness and death

**Notes:**
Thank you all for coming.  I’m sorry we can’t see you, but it’s nice to talk with everyone.
We are proposing to initiate an antiretroviral treatment program.
This pilot initiative will be carried out by: The Kenya Ministry of Health, The St Mary’s Mission Hospital, Kibera Community Self Help Program, otherwise known as KICOSHEP, the Kenya medical Research Institute and CDC

## Major Factors that will Determine How Many HIV- infected Persons will be Treated through PEPFAR 

- Goal of PEPFAR – treat at least 2 million with ART
- Funding of PEPFAR – $10 billion over 5 years
- Need – 20 million HIV-infected persons live in the 14 PEPFAR countries and at least 3 million (15%) of these qualify for ART
- Feasibility – if we receive the funding, determining how many persons we can feasibly treat with ART will _probably not be an option_ because those who are not treated are at risk of serious illness and death

**Notes:**
Thank you all for coming.  I’m sorry we can’t see you, but it’s nice to talk with everyone.
We are proposing to initiate an antiretroviral treatment program.
This pilot initiative will be carried out by: The Kenya Ministry of Health, The St Mary’s Mission Hospital, Kibera Community Self Help Program, otherwise known as KICOSHEP, the Kenya medical Research Institute and CDC

##  Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                         Question #1
- 	What are the major factors that will determine how many HIV- infected persons will be treated through PEPFAR?
-                                      Response
- 	The major factors that will determine how many persons will be treated through PEPFAR are probably the goals of PEPFAR, the funding for PEPFAR, and the need for ART; stating that a goal is not feasible may not be an option.

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                        Question #2
- 	If we initiate ART for 2 million persons during the next 5 years, how many persons should we start on ART during the first year of PEPFAR?

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Number of HIV-infected Persons Who Need to be Started on ART Annually during the Next 5 Years

## Number of HIV-infected Persons Who Need to be Started on ART Annually during the Next 5 Years

-    200,000 – during the first year
-    300,000 – during the second year
-    400,000 – during the third year
-    500,000 – during the fourth year
-    600,000 – during the fifth year
- 2,000,000 – total during 5 years

**Notes:**
It is a well-known fact that ARVs lead to reductions in mortality and morbidity arising from HIV infection. 
In Kenya the HIV prevalence is estimated at 13% in adults aged 15- 49 years, with approximately 500 – 700 people dying daily of AIDS. 
Despite this, ARVs are available to few people, mainly in the private sector due primarily to cost implications and complexity of ARV regimens.  
As cost of AIDS treatment continues declining, there is potential for these therapies to become more accessible and it is therefore an important time to expand national capacity for safe and effective use of antiretroviral therapy in Kenya. 

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                          Question #2
- 	If we initiate ART for 2 million persons during the next 5 years, how many persons should we start on ART during the first year of PEPFAR?
-                                       Response
- 	If we initiate ART for 2 million persons during the next 5 years, we estimate that about 200,000 will have to be started on ART during the first year of PEPFAR

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                        Question #3
- 	How can we initiate ART for 200,000 HIV-infected persons during the first year of PEPFAR?

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Plan for Initiating ART for 200,000 Persons during First Year of PEPFAR 

- Need to address issues related to:
- Clinical care
- Drugs and health commodities
- Laboratory support
- Training
- Community mobilization
- Monitoring and evaluation

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Plan for Initiating ART for 200,000 Persons during First Year of PEPFAR 

- 	     For laboratory support, we need to decide
- 	     which of the following services we can provide:
- HIV diagnostics
- Hematology
- Chemistries
- CD4+ counts
- Viral loads

- Diagnosis of OIs
- Diagnosis of malaria
- Diagnosis of TB
- Diagnosis of STIs
- Pediatric HIV diagnostics

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Plan for Initiating ART for 200,000 Persons during First Year of PEPFAR 

- 	For each laboratory service, we need to need to address issues related to:
- Training
- Infrastructure
- Equipment and supplies
- Quality assurance
- Information systems

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                           Question #3
- 	How can we initiate ART for 200,000 HIV-infected persons during the first year of PEPFAR?
-                                        Response
- 	To initiate ART for 200,000 HIV-infected persons during the first year of PEPFAR, we will probably have to provide only essential laboratory services in at least some settings

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                         Question #4
- 	What laboratory services are essential for initiating ART for 200,000 persons during the first year of PEPFAR?

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Plan for Initiating ART for 200,000 Persons during First Year of PEPFAR 

- Essential Laboratory Services
- for the First Year of PEPFAR
- (in order of priority)
- HIV diagnostics
- Diagnosis of TB
- Diagnosis of malaria
- CD4+ counts
- Chemistries

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Plan for Initiating ART for 200,000 Persons during First Year of PEPFAR 

- Essential Laboratory Services
- for Large Urban Hospitals
- during the First Year of PEPFAR
- HIV diagnostics
- Diagnosis of TB
- Diagnosis of malaria
- CD4+ counts

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Plan for Initiating ART for 200,000 Persons during First Year of PEPFAR 

- Essential Laboratory Services
- for District Hospitals
- during the First Year of PEPFAR
- HIV diagnostics
- Diagnosis of TB
- Diagnosis of malaria

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                         Question #4
- 	What laboratory services are essential for initiating ART for 200,000 persons during the first year of PEPFAR?
-                                     Response
- 	In some settings, diagnostics for HIV, TB, and malaria may be the only laboratory services that we can provide during the first year of PEPFAR

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                    Question #5
- 	How can we develop a strategic plan for laboratory services during the first year of PEPFAR?

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Strategic Plan for Laboratory Services during the First Year of PEPFAR 

- 	     	For the services listed below, we could suggest 	objectives for each of 2 types of clinical settings 	(for example, for large urban and district 	hospitals) and make recommendations about 	how best to achieve these objectives:
- HIV diagnostics
- Hematology
- Chemistries
- CD4+ counts
- Viral loads

- Diagnosis of OIs
- Diagnosis of malaria
- Diagnosis of TB
- Diagnosis of STIs
- Pediatric HIV diagnostics

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Strategic Plan for Laboratory Services during the First Year of PEPFAR 

- During this meeting, the work groups could develop first year objectives for 2-3 services for 2 types of clinical settings and make recommendations about how best to achieve these objectives
- The objectives and recommendations could be reviewed and discussed during the work group presentations on the second day of the meeting
- After the meeting, the objectives and recommendations could be compiled into a strategic plan for providing laboratory services during the first year of PEPFAR

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                                    Question #5
- 	How can we develop a strategic plan for laboratory services  during the first year of PEPFAR?
-                                    Response
- 	We can use the work groups during this meeting to develop a strategic plan for laboratory services during the first year of PEPFAR

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                    Question #6
- 	How can we help to implement a strategic plan for laboratory services during the first year of PEPFAR?

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Strategic Plan for Laboratory Services during the First Year of PEPFAR 

- By March 31, 2004, USG staff in each PEPFAR country has been asked to submit a country plan for the first year of PEPFAR
- In consultation with in-country USG staff, we could organize a lab team to assist each PEPFAR country prepare the country plan for laboratory sevices for the first year of PEPFAR
- The lab teams could use the strategic lab plan for the first year, developed initially at this meeting, as guidance when preparing the country plans

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## 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

## CDC Lab Points of Contact by Country

| COUNTRY | Laboratory Points of Contact |
| --- | --- |
|  |  |
| Botswana | Thomas Hearn, DLS/PHPPO |
| Cote d’Ivoire | Austin Demby, GAP |
| Ethiopia | Robert Martin, DLS/PHPPO |
| Guyana | Thomas Hearn, DLS/PHPPO |
| Haiti | Richard Respess, DASTLR |
| Kenya | Mark Rayfield, DASTLR |
| Mozambique | Amilcar Tanuri, DASTLR |
| Namibia | Austin Demby, GAP |
| Nigeria | Mark Rayfield, DASTLR |
| Rwanda | Austin Demby, GAP |
| South Africa | Ron Ballard, DASTLR |
| Tanzania | Thomas Hearn, DLS/PHPPO |
| Uganda | Austin Demby, GAP |
| Zambia | John Ridderhof, DLS/PHPPO |

- CDC Lab Points of Contact by Country

## Questions that Need to be Answered to Initiate ART for 2 Million Persons

-                        Question #6
- 	How can we help to implement a strategic plan for laboratory services during the first year of PEPFAR?
-                                   Response
- 	We can help implement a strategic plan for laboratory services during the first year of PEPFAR by using lab teams to help countries prepare their country plans for the first year during January – March 2004

**Notes:**
The objectives of this pilot initiative are:
To develop and evaluate practical and locally appropriate ways of delivering ARVs
To enhance country capacity to provide ARVs in Kenya by developing training materials for health care personnel and community health workers, provide expertise and experience, and to demonstrate how to procure, store, and ensure uninterrupted supply of antiretroviral drugs.
And thirdly, to attract and absorb additional donor resources for AIDS treatment programs

## Summary

- To treat at least 2 million HIV-infected people with ART during 5 years, we will probably need to initiate ART for about 200,000 persons during the first year of PEPFAR
- To initiate ART for 200,000 persons during the first year, we need to develop plans for providing laboratory services during the first year of PEPFAR
- This meeting offers a unique opportunity to begin preparing a strategic laboratory plan that can be used to prepare country plans for the first year of PEPFAR

**Notes:**
It is a well-known fact that ARVs lead to reductions in mortality and morbidity arising from HIV infection. 
In Kenya the HIV prevalence is estimated at 13% in adults aged 15- 49 years, with approximately 500 – 700 people dying daily of AIDS. 
Despite this, ARVs are available to few people, mainly in the private sector due primarily to cost implications and complexity of ARV regimens.  
As cost of AIDS treatment continues declining, there is potential for these therapies to become more accessible and it is therefore an important time to expand national capacity for safe and effective use of antiretroviral therapy in Kenya.