Evaluation and Implementation of Rapid HIV Tests in African Countries

1. Evaluation and implementation of rapid HIV tests: the experience in eleven African countries Dr. Stefan Wiktor Chief, Surveillance and Infrastructure Development Branch Global AIDS Program CDC/HHS

2. Adults and children estimated to be living with HIV/AIDS - 2004 Eastern Europe & Central Asia 1.2 – 1.8 million Western Europe 520 000 – 680 000 North America 790 000 – 1.2 million East Asia & Pacific 700 000 – 1.3 million North Africa & Middle East 470 000 – 730 000 South & South-East Asia 4.6 – 8.2 million Caribbean 350 000 – 590 000 Sub-Saharan Africa 25.0 – 28.2 million Latin America 1.3 – 1.9 million Australia & New Zealand 12 000 – 18 000 Total: 34 – 46 million

3. World Bank Multi-country AIDS Program (MAP)

4. President’s Emergency Plan for AIDS Relief • Announced January 28, 2003 • 15 focus countries • Goals: • Prevent 7 million new HIV infections • Treat 2 million HIV-infected people • Provide care for 10 million HIV-infected people and AIDS orphans • Overall budget for global AIDS: $15 billion over 5 years ($10 billion new money, including $1billion for Global Fund)

5. President’s Emergency Plan for AIDS Relief15 Focus Countries Ethiopia Uganda Haiti Kenya Guyana Rwanda Côte d’Ivoire Tanzania Nigeria Zambia Vietnam added 7/04 Namibia Mozambique Botswana South Africa

6. The role of HIV testing to meet the goals of the Emergency Plan • Massive scale-up of testing capacity needed: 30-100 million persons tested • Broad range of testing sites with personnel of varying levels of training/experience • Lack of infrastructure or environment for quality assurance • CDC-GAP focus on expanding access to HIV testing with focus on rapid tests

7. Emergency Plan strategy to improve access and quality of rapid HIV testing • Facilitate procurement • Develop guidelines • Strengthen/develop national reference laboratory • Advocacy • Renovations, equipment • Technical assistance • External quality assurance • Provide training – WHO/CDC rapid HIV test curriculum

8. HIV testing is expanding rapidly(Number of HIV tests performed in CDC/GAP supported programs)

9. HIV testing is expanding rapidly(Number of CDC/GAP supported sites qualified to perform HIV testing)

10. WHO-AFRO/HHS- CDC/APHL Guidelines For Appropriate Evaluations of HIV Testing Technologies in Africa

11. Steps to in-country rapid HIV test evaluation and implementation Serum panel: Collect, characterize, store National Reference Lab Phase I Evaluate tests, select 2-or-3 test algorithm Pilot testing algorithm in testing sites Point-of- service site Phase II EQA and ongoing monitoring of testing National Reference Lab/ Point of service site Phase III

12. Ethiopia Uganda Kenya Senegal Rwanda Côte d’Ivoire Tanzania Angola Namibia Mozambique Botswana Evaluation and implementation of rapid HIV tests in 11 African countries • Country contacts identified – working group created • Questionnaire administered concerning evaluations: • Process • Results • Implementation

13. Determine Delta HIV ½ Doublecheck Genie II Hema-Strip Hexagon HIV Spot ImmunComb Instant CHEK InstantScreen Rapid MultiSpot Oraquick Sero-Strip Swift Stat-Pak UniGold Virocheck Rapid HIV tests evaluated

14. Phase I evaluations • Conducted in national reference or hospital laboratories • Serum panels created: • Median 506 samples (range 51-2000) • Median HIV prevalence 38% (range 14-78%) • Median duration 6 months (range 2-26 months) • Results: • Median sensitivity >99% for 12 tests • Median specificity >99% for 14 tests

15. Median sensitivity of rapid HIV tests in evaluations conducted in central reference laboratories in 11 African countries # of evals: 11 11 10 10 6 3 3 2 2

16. Median specificity of rapid HIV tests in evaluations conducted in central reference laboratories in 11 African countries # of evals: 11 11 10 10 6 3 3 2 2

17. Phase II evaluations • Conducted in variety of settings (VCT, blood donation centers, hospitals) • Whole-blood samples; on-site testing with repeat testing at reference laboratory • Median 566 samples (range 209-3,791) • Results comparable to Phase I evaluations

18. Phase III: status of rapid HIV test implementation • National algorithm selected in 10 countries: • Serial algorithm - 6 countries • Parallel algorithm - 4 countries • Screening: Determine and Unigold – 7 countries • Tie-breaker or retesting • External quality assurance – 6 countries • Site visits • Retesting of specimens at reference laboratory • External proficiency testing (Zimbabwe)

19. Phase III: Status of rapid test implementation, 2003

20. External quality assurance: comparison of results of on-site rapid HIV testing with central laboratory EIA/WB testing

21. Conclusions • Testing needs are huge • HIV testing is scaling up rapidly • HIV rapid tests work • Testing is conducted in variety of sites by persons with varying levels of experience • Quality assurance: a major and growing challenge

22. Acknowledgements:Rapid HIV Test Evaluation Working Group Co-ordinating group K. Bond, B. Branson, P. Crippen, A. Demby, T. Diaz, M. Downer, G. Gershy-Damet , T. Granade, T. Hearn, K. Lewis, T. Merlin, D. Plate M. Rayfield, R. Respess J. Ridderhof A. Tanuri, S. Wiktor In-country Collaborators Angola: C. Fernandes, F. da Silva, M. Francisco, F. del Castillo, J. Cox Botswana: T. Roels, L. Povinelli, P. Kilmarx Ethiopia: B. Tegbaru, A. Geyed, M. Fekadu, J. Mengistu, T. Wuhib Ivory Coast: C. Maurice, A. Tehe, D. Yavo Kenya: J. Nyamongo, N. Achola, K. Mandaliya, P. Tukei, L. Marum, K. DeCock Mozambique:A. Barreto, S. Stakteas, K. Marsh, A. Vergara Namibia: C. Weiss, H. Kaura, T. Kenyon Rwanda: P. Rugimbanya, E. Rusanganwa, J. Hanson, V. Koscelnik Senegal: M. Gueye, S. Mboup, C. Murrill Tanzania: E. Lyamuya, Y. Ipuge, C. Kagoma, C. Scott Zimbabwe: J. Mudzori, Z. Ziyambi, K. Mutasa, E. Burke, M. St. Louis