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

2. 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

3. 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

4. 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

5. 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?

6. 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

7. 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

8. 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.

9. 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?

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

11. 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

12. 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

13. 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?

14. 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

15. 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

16. 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

17. 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

18. 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?

19. 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

20. 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

21. 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

22. 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

23. 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?

24. 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

25. 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

26. 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

27. 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?

28. 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

29. 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 QATB Technical Working Groups OI UTAP

30. COUNTRYLaboratory Points of Contact BotswanaThomas Hearn, DLS/PHPPO Cote d’IvoireAustin Demby, GAP EthiopiaRobert Martin, DLS/PHPPO GuyanaThomas Hearn, DLS/PHPPO HaitiRichard Respess, DASTLR KenyaMark Rayfield, DASTLR MozambiqueAmilcar Tanuri, DASTLR NamibiaAustin Demby, GAP NigeriaMark Rayfield, DASTLR RwandaAustin Demby, GAP South AfricaRon Ballard, DASTLR TanzaniaThomas Hearn, DLS/PHPPO UgandaAustin Demby, GAP ZambiaJohn Ridderhof, DLS/PHPPO CDC Lab Points of Contact by Country

31. 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

32. 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