ICAP Data Dissemination Meeting September 21, 2010 Charon Gwynn

1. Overview of ICAP Laboratory Data Collection Initiatives ICAP Data Dissemination Meeting September 21, 2010 Charon Gwynn

2. Background • ICAP supports >500 clinical testing laboratories • Routine data collection on the number and type of HIV-related testing being performed, and assessments of laboratory infrastructure can help ensure high quality and effective lab programs • Laboratory data collection can be used to demonstrate health system strengthening

3. Data collection initiatives • Routinely Collected Laboratory Indicators • Laboratory PFaCTS • CD4 Database

4. PEPFAR definition of clinical laboratory testing • laboratory that has the capacity (i.e. infrastructure, dedicated lab personnel, and equipment) to: • Perform testing for the diagnosis of HIV infection with either rapid test, EIA or molecular methods; and, • Perform clinical laboratory tests in any of the following areas: • Hematology • Clinical chemistry • Serology • Microbiology • HIV/AIDS care and treatment monitoring with CD4 testing or HIV viral loads, • TB diagnostic and identification • Malaria infection diagnosis • OI diagnosis

5. Routinely Collected Laboratory Indicators

6. Lab indicators • Measure the extent to which laboratory services are expanding to support HIV/AIDS care and treatment services as well as health system strengthening • Indicators aligned with the Next Generation PEPFAR Indicators • Rolled out April-June 2010

7. ICAP-NY Laboratory Indicators • Number of ICAP-supported laboratories with capacity to perform clinical laboratory testing* • Number of laboratories that are accredited according to national or international standards* • Number of laboratories participating in external quality assurance/proficiency testing (EQA/PT) for CD4 testing • Number of laboratories participating in external quality assurance/proficiency testing  (EQA/PT) for HIV rapid-testing • Number of laboratories participating in external quality assurance/proficiency testing  (EQA/PT) performed for AFB smear microscopy • Number of HIV simple rapid tests conducted • Number of HIV enzyme immunoassay (EIA) tests conducted • Number of PCR tests conducted for infant HIV diagnosis • Number of CD4 count tests conducted • Number of CD4 percentage tests conducted • Number of HIV viral load tests conducted • Number of smear tests (AFB) conducted • Number of TB culture tests conducted • Number of TB drug susceptibility tests (DST) conducted • Number of malaria smear tests conducted • Number of syphilis tests conducted • Number of ALT tests conducted • Number of creatinine tests conducted • Number of hematology (CBC) tests conducted • Number of laboratorians who successfully completed an in-service training program* Disaggregated by testing done for HIV positive versus HIV negative and unknown patients * PEPFAR Next Generation Indicator

8. Supported and Reported Facilities as of April-June 2010

9. Proportion of care and treatment sites with clinical laboratories N=60 N=69 N=157 N=62 N=33 N=127 N=2 N=47

10. # sites= 9 128 21 17 4 5 4 6 33 33 33 33 56 44 43 51 100 98 *CI and KN did not report AFB, TZ did not report CD4 count or CD4%

11. Number of Other HIV-related Tests Conducted, April- June 2010* # sites= 13 13 12 1 6 4 4 5 33 33 56 54 51 50 53 100 *KN did not report any other HIV related test. Nigeria only reported LFT and hematology, Tanzania reported syphilis.

12. Labs conducting EQA among those reporting HIV-related tests, April-June 2010* (%) 56 *Among countries reporting EQA testing

17. Next steps • Analyze trends over time • Add lab indicators to routinely generated master slide set • Use routinely collected data with other lab data sources (eg, lab PFaCTS) to evaluate the type of services offered and improve quality

18. Laboratory PFaCTS

19. Lab PFaCTS • Facility level survey to capture information on • infrastructure and equipment • quality assurance activities • supply and procurement chain management • human resources • Information will be used together with new laboratory indicators for program planning purposes

20. Distributed Sept 2009 to Laboratory Advisors Piloted in 51 non-randomly selected sites in 6 countries 39 questions in eight sections General Information Testing Services & Testing Equipment Laboratory Testing Network Protocols, Procedures & Quality Assurance Data Collection/Reporting Systems Physical Infrastructure & Equipment Maintenance Supply Inventory & Procurement Human Resources & Training Pilot survey design

21. Pilot sample

22. Type of support provided N=51

23. Available tests by site type N = 4 N = 4 N = 18 N = 25

24. Quality Assurance/Quality Control for select HIV-related tests (N=48) (N=5) (N=35) (N=24)

25. Rapid test QA/QC – type and frequency (n=37) QA/QC Measure

26. CD4 count QA/QC – type and frequency (n=31)

27. Reasons for supply shortages (N=42)

28. Supply shortages per year (N=39)

29. Power outage frequency

30. Availability of backup generators by outage frequency N=7 N=13 N=17 N=1

31. Lessons learned • Problems highlighted during pilot • Missing data Solution  Offline Computer-based module • Inaccurate data Solution  New question order and computer-based skip pattern • New responses/questions • Responses commonly written in on paper pilot survey • Impact of ICAP support on system strengthening

32. Next Steps • Finalize computer data entry module • Launch data collection – Lab Advisors to complete most of data collection • Analyze data and disseminate results to country teams

33. CD4 Database

34. Why an electronic CD4 database? • CD4 counts provide important clinical information used for HIV care and treatment • Reporting CD4 testing capacity to assess progress toward program goals • Monitoring test kit usage can be used for supply forecasting • Electronic systems allow for standardization of data collection and enhancement of data quality • Many sites have capacity for simple Access database

35. Components of the CD4 database Data Elements • Patient demographic information • ART status and follow-up CD4 measures • CD4 count and % results • testing technician and health center information Key Functionality • Searchable by patient • Automated data quality checks of CD4 test results • Tools to monitor CD4 testing kit inventory Automated Reporting • Reports of CD4 counts for specific time period and health center • Highlighting of low CD4 values for potential physician follow-up

36. Pilot of CD4 database • Piloted database at 4 labs in Kenya in early 2010 • Support for database provided by ICAP staff

37. Tests entered into database during pilot

38. Gender by site, CD4 database pilot N=2170 N=947 N=2003 N=979

39. Age by site, CD4 database pilot N=2170 N=947 N=2003 N=979

40. Patient ART status by site N=2170 N=947 N=2003 N=979

41. Reason for CD4 test by site

42. CD4 value among patients with CD4 test results N=2153 N=947 N=1999 N=910

43. Next steps • Database has been updated to accommodate additional tests (e.g., viral load, blood chemistry, etc) specified by user • Country implementation • Provide updated version to Kenya and potentially expand to additional sites • Database to be piloted in Tanzania this year • Available as a tool for country teams, however database is most effective as a jointly clinical and M&E activity • Eventually explore possibility of combining with other electronic databases

44. Summary • Availability of quality laboratory testing is integral to provision of HIV-related services • New laboratory data collection initiatives are important part of larger effort to capture information necessary to inform programs

45. Acknowledgements • Country Lab and M&E teams http://www.mericap.columbia.edu/dashboard.php?dashboard_type=lab&country_id=0&reset=1 • Amilcar Tanuri, Luis Felipe Gonzalez, Stephania Koblavi, Jessica Justman, Allison Goldberg • Annie Kao, Suzue Saito, M&E Liaisons