An overview of LIFE-GAP laboratory activities Austin Demby PhD

1. An overview of LIFE-GAP laboratory activities Austin Demby PhD

2. 4,000,000 3,500,000 3,000,000 Highly industrialized countries 2,500,000 North Africa & Middle East Eastern Europe & Central Asia 2,000,000 Sub-Saharan Africa Latin America & the Caribbean 1,500,000 Southern & Eastern Asia 1,000,000 500,000 - 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 Estimated annual number of new HIV infections by region, 1980 to 1999 New infections

3. 25,000,000 20,000,000 Highly industrialized countries North Africa & Middle East 15,000,000 Eastern Europe & Central Asia Sub-Saharan Africa Latin America & the Caribbean 10,000,000 Southern & Eastern Asia 5,000,000 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 Estimated number of people living with HIV/AIDS by region, 1980 to 1999 People living with HIV/AIDS

4. HIV prevalence among pregnant womenin South Africa, 1990 to 1999 25 22.8 22.4 20 17 14.2 15 HIV prevalence (%) 10.4 10 7.6 5 4 2.1 1.7 0.7 0 90 91 92 93 94 95 96 97 98 99 Source: Department of Health, South Africa

5. GAA Program Area -Surveillance and Infrastructure Development • Expanding and strengthening HIV/STI/TB surveillance programs • Strengthening laboratory support for HIV/STD/TB/OI - Surveillance - Diagnosis - Screening for blood safety • Monitoring and evaluation • Strengthening information systems • Training

6. CDC-LIFE Planning and implementation process Technical Strategies Country Program Planning Visits Implementation

7. Most frequently proposed technical strategies

8. Situation analysis in GAP countries Downturn in local economies Management and resource constraints Increased disease burden Institutions diminishing ability to cope

9. Situation Report - laboratory • Loss of trained personnel • Training of lab staff inadequate • Lack of oversight • Training materials not updated • Intermittent supply of reagents • Congested and in some cases unsafe laboratory environment • Health reforms

10. Rationale for GAP support • Strong scientific basis for GAP programs • Biological markers a priority to monitor program successes or failures • Additional work load – GAP programs • Overwhelmed laboratory system (polyvalent lab techs) • Need to create safe work environment

11. Laboratory assessment • National lab assessment a prerequisite for support - lab organization - review recent assessment - current lab activities - communication - reagents, test kits and test algorithms - MoH input - Partners – local and international

12. GAP approach to lab support • Laboratory technical strategy based on best practices • Strong partnership with host nation and regional organizations • Prevention focus with rapid demonstration of success while building long term infrastructure • Rational use of limited USG resources

13. Focus of GAP lab support Balance between: • Supporting quality technical laboratory services at national level –HIV/STI/TB/OI • Supporting the creation/strengthening of PH laboratory systems to support quality testing

14. Laboratory technical support • Strengthen National Reference laboratories: - Quality Reference work – national level (hub for GAA program activities) - Set national standards, guidelines and protocols - Perform QA/QC and national oversight • Support District level laboratory capacity/capability • Advocate Rapid Testing: point-of-service for programs • Training

15. Support for HIV activities • Based on in-country capacity and coverage High priority - Rapid tests with appropriate algorithms - Dried blood spots for surveillance - EIA based serological assays Low priority - Incidence assays - Viral load assays - Monitoring CD4/CD8 cell counts

16. Support for TB activities • Smear microscopy at all levels - diagnosis and monitoring • National surveillance for drug resistance - conventional - molecular

17. Support for STI activities High priority • Evaluation of syndromic management • Basic serology RPR, FTA-ABS, TPHA • Basic microbiology – gram stain Low priority • Molecular methods for diagnosis • Surveillance for STI drug resistance

18. Priorities for Technical capacity building • Proper staff recruitment and retention • Appropriate training and backstopping • Appropriate technology transfer

19. Priorities for physical infrastructure development • Provision of appropriate equipment • Providing reliable reagent supplies • Safe and efficient physical space - water, electricity • Logistics and transportation

20. GAA Laboratory Support Structure Steering Committee Austin Demby – GAP (Chair) Robert Martin – PHPPO Mark Rayfield – NCID Laboratory Technical Review Group CDC/CIOs, Lab Leaders in Africa, WHO-Afro APHL NCID PHPPO Botswana South Africa Mozambique Côte d’Ivoire Senegal Rwanda Ethiopia Nigeria India Kenya Uganda Malawi Zambia Zimbabwe Tanzania

21. GAA Laboratory Support Structure • Technical laboratory support working groups • Surveillance • Rapid tests, VCT and MTCT • TB • STI • QA/QC • Informatics

22. Why a Quality Assurance Workshop? • Matrix of professionals • NCID, PHPPO, NCEH, APHL, WHO, GAP • Varied experience in resource limited countries • Countries looking for strong partnership in a crisis situation • A united US response • Clear unambiguous messages from partners • Results of tests could be life-altering

23. Quality Assurance workshop exit competency • Common understanding of laboratory QA systems • Clear guidelines on the utility of QA in LIFE countries • The added value QA systems bring to the fight against HIV/STI/TB/OI • A plan of action for implementation in GAP programs • - institutional and non-institutional • - priority VCT/MTCT/Surveillance