PEPFAR Plansfor Initiating ART andProviding Laboratory

Services

Tedd V. Ellerbrock, MD, FACOGGlobal AIDS Program

Centers for Disease Control and Prevention

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

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

PEPFAR Plans for Initiating ARTand 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

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?

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

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

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.

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?

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

Next 5 Years

0

100,000

200,000

300,000

400,000

500,000

600,000

2004 2005 2006 2007 2008

Year

No.

of H

IV-i

nfec

ted

Per

sons

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

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

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?

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

Need to address issues related to: Clinical careDrugs and health

commoditiesLaboratory supportTraining Community mobilizationMonitoring and evaluation

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 diagnosticsHematologyChemistriesCD4+ countsViral loads

Diagnosis of OIs Diagnosis of malariaDiagnosis of TBDiagnosis of STIsPediatric HIV diagnostics

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

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

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?

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

Essential Laboratory Servicesfor the First Year of PEPFAR

(in order of priority)

1) HIV diagnostics2) Diagnosis of TB 3) Diagnosis of malaria 4) CD4+ counts5) Chemistries

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

Essential Laboratory Services for Large Urban Hospitalsduring the First Year of

PEPFAR

1) HIV diagnostics2) Diagnosis of TB 3) Diagnosis of malaria 4) CD4+ counts

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

1) HIV diagnostics2) Diagnosis of TB 3) Diagnosis of malaria

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

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?

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 diagnosticsHematologyChemistriesCD4+ countsViral loads

Diagnosis of OIs Diagnosis of malariaDiagnosis of TBDiagnosis of STIsPediatric HIV diagnostics

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

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

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?

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

GAP Laboratory Support StructureSteering Committee

T. Mastro, S. Wiktor, A.Demby, P. Crippen – GAPR. Martin, T. Hearn, J. Ridderhof – PHPPO

M. Rayfield, J. Kaplan, R. Ballard, S. McDougal – DASTLRYvette 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 GroupsOI

UTAPUTAP

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

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