1. Lessons from Practice in HIV Scale-Up IAS Education Programme ICASA 2008 Debrework Zewdie Director Global AIDS Program The World Bank Dakar, Senegal December 2, 2008

2. Overview  Historical context of scale up of treatment in Africa  Current challenges to further expansion and sustainability  Operational research garners evidence to ensure sustainability – examples  Role of donors and partners to coordinate and support research and to promote learning  Conclusion

3. Number of people receiving antiretroviral drugs in low- and middle-income countries 2002−2007 Source: Data provided by UNAIDS & WHO, 2008. end- 2002 end- 2004 end- 2003 end- 2005 0.4 0.8 1.2 1.6 2.2 2.8 Millions Year 2.4 2.6 3.0 0.0 0.2 0.6 1.0 1.4 1.8 2.0 end- 2007 end- 2006 North Africa and the Middle East Eastern Europe & Central Asia East, South and South-East Asia Latin America and the Caribbean Sub-Saharan Africa 5.2

4. Total annual resources available for AIDS 1986–2007 [i] 1996-2005 data: Extracted from 2006 Report on the Global AIDS Epidemic (UNAIDS, 2006); [ii] 1986-1993 data: Mann.&. Tarantola, 1996 Notes: [1] 1986-2000 figures are for international funds only; [2] Domestic funds are included from 2001 onwards 0 1000 2000 3000 4000 5000 6000 7000 8000 9000 US$ million 292 1623 8.3 billion Signing of Declaration of Commitment on HIV/AIDS, UNGASS 1996199719981999200020012002200320042005198619871990199119921993 Less than US$ 1 million 59 212 World Bank MAP launch Global Fund PEPFAR 257 UNAID S Gates Foundation 20062007 10 000 8.9 billion 10 billion 7.1 Source: UNAIDS & WHO unpublished estimates, 2007

5. Bilateral & multilateral resources available for HIV-related programmes in 2006 G Source: UNAIDS analysis based on OECD/DAC online database (last visited on May 6, 2008), Resource availability UNAIDS 2005, Funders Concerned About AIDS (FCAA), European HIV/AIDS Funders Group (EFG) for Philanthropic sector Bilateral disbursements to HIV-related programmes in 2006 (OECD/DAC statistics) Global resources available for HIV- related programmes in 2006 (US$ Billions) 2 5 8 6 7 0 1 3 4 9 10 UN (2%) GFATM (7%) Foundations (11%) Bilaterals (33%) Domestic Public and Private (46%) EC (0.5%) Canada 2% Belgium 1% Netherlands 3% Other DAC country members 1% Sweden 3% Spain 1% Norway 2% Australia 2% Germany 2% Ireland 3% United Kingdom 9% United States 71% (US$ Billions) Global resources available: US$8.9 BillionPercentage out of the total bilateral disbursements Total Bilateral disbursements 2006: US$ 2.9 Billion The organizational disbursements are different than commitments or obligations, as well as different from in-country expenditures

6. Current challenges (1)

7. The Face of Treatment is Changing…  Dr. Mari Kitahata at Univ. of Washington recently compared patients who started ART with a CD4 below 350 cells/mm 3 to those started between 350-500 cells/mm 3. The later initiators had a 71% increased risk of death (relative hazard of 1.7; C.I. 1.4 – 2.1).  Reported on October 27 2008 at Interscience Conference on Antimicrobial Agents and Chemotherapy; will appear in Journal of Infectious Disease Dec. 2008  Used 22 U.S. and Canadian cohorts; 8374 “healthy” HIV patients from the International Epidemiology Databases to Evaluate AIDS  Studies are ongoing comparing starting with CD4 > 500 with starting CD 4 = 350 - 500 cells/mm 3. Current challenges (2) Attribution: Dr. Jon Simon, Boston University

8. Other Major Challenges  Funding increases cannot be infinite, donor dependence makes these unpredictable  Late enrollment and early mortality  Treatment failure and the expense of second line therapy  Limited integration with other treatment services (especially TB)

9. The role of research in sustaining HIV Treatment programs  Discovery of better drugs  Understanding our epidemics  Operational Research  Cost-effectiveness research

10. Operational Research in Treatment Programs  Evidence is vital for good strategic planning  Research can be an engine of excellence and capacity building  Research for activism and ownership  Clinical research – an essential tool to support programs

11. The Sydney Declaration “ Ten per cent of all resources dedicated to HIV programming should be used for research towards optimizing interventions utilized and health outcomes achieved ”

12.  Optimizing Treatment approaches and effectiveness  Integration of services  Greater understanding of social, political and cultural barriers  Integration of new therapies, technologies and guidelines  Sustainability. success and cost effectiveness Priority Research Needs

13. Treatment Acceleration Project (1)  Goal – pilot strategies for strengthening countries’ capacity to scale-up care and treatment programs that are efficient, affordable and equitable  Piloted in Ghana, Burkina Faso and Mozambique, 2004-2008  3 components:  Test approaches to scaling-up AIDS care and treatment  Strengthen institutional capacity for AIDS care and treatment  Facilitate regional learning  Technical support from WHO, UNECA (UN Economic Commission on Africa)

14.  The TAP included a strong operational research / learning component, with regular meetings to share findings and resolve common challenges  Impact evaluations explored:  Factors that affect adherence  Impact of increased treatment access on prevention and risk behavior of patients, family members, and society  Impact of ART on individual and family well-being (health expenditures, assets, incomes, life expectancy, poverty, living standards, childrens’ schooling & nutrition  Impact of AIDS funding on quality and access to other health services (facililty and patient surveys) Treatment Acceleration Project (2)

15. Addressing Knowledge Gaps in the Public Health Approach to Delivering Antiretroviral Therapy and Care  Two day consultation, March 2008 convened by WHO and cosponsored by IAS, World Bank and GFATM  Clinicians, community advocates, programme managers, researchers, donors and normative agency representatives  To identify gaps in policy relevant and operational research, barriers and opportunities: ART, non-ART care, Lab Services and Health Systems  Emphasis on Treatment through the Public Health Approach

16. WHO Consultation Research Gaps - ART  When is the optimal time to initiate treatment?  What are the most effective strategies for improving adherence and the durability of first-line regimens?  When is the optimal time for switching to second-line regimens?  What role should laboratory monitoring play in clinical management?  What is the potential impact of new drugs/drug classes on first and second-line regimens?  What is the impact of ART and other care/treatment interventions on preventing HIV transmission?  Delivering care and treatment to special populations, such as injecting drug users  Pediatric ART  Integration of TB and HIV treatment programs

17. WHO Consultation Research Gaps - Health Systems  Optimal service delivery approaches for HIV treatment and care interventions  What is the impact of HIV ART care and treatment on the overall health care system?  How can the public health approach to delivering HIV interventions strengthen health care systems?  What costing, and cost-effectiveness analyses, are required to inform the optimal preventive and therapeutic service delivery strategies?

18. WHO Consultation Research Gaps - Challenges  Lack of political commitment  Weak links between researchers and policymakers to help set a policy-relevant research agenda  Lack of funding  The lack of adequately trained staff with research expertise  Poor physical research infrastructure  Slow adoption and implementation of new technologies

19. WHO Consultation Research Gaps - Opportunities  Invest in building research capacity (human resources and infrastructure)  Strengthen health information systems to capture information that will be used for decision-making;  Consider developing regional "centres of excellence" to foster and support regional and national research;  Expand north/south and south/south research collaboration and networks  Strengthen links between researchers and policymakers, possibly with a national coordinating body, to help set a policy- relevant research agenda  Invest in community engagement -- define and support a role for the community in designing and implementing research;  Strengthen coordination between granting agencies and HIV programmes.

20. WHO Consultation Partner Commitments WHO, World Bank, GFATM, IAS agreed to advocate for:  Funding and implementation of Operations Research  Collaboration with countries to encourage greater investment in policy-relevant research  Collaboration with international agencies and countries to develop the research capacity of low- and middle-income countries and to use the results of this research  Contribute resources in co-sponsoring a session on research in Mexico and a follow-up summit in Vancouver in Feb 2009

21. Conclusion  Treatment sustainability is not assured  Evidence is essential to preserve and expand our gains and operational research can provide this evidence  Research – especially operational research, which uses tools from epidemiological, social and clinical research – can deliver this evidence, but requires substantially increased support

22. Thank you