1. Early Infant Diagnosis Data Collection, Management, and Analysis for Program Monitoring Presented by William Jimbo MD, MPH PMTCT Advisor CDC/BOTSWANA Early Infant Diagnosis Meeting 13 th May, 2010, Arusha, Tanzania

3. Overview of talk Botswana and the EID program System for EID data collection, management, and analysis Data and lessons learned from the data –About EID –About PMTCT –About Cotrimoxazole and infant ART Gaps/weaknesses in data system Next steps

4. Background: HIV in Botswana’s pregnant women Overall 33.7% of pregnant women infected (2007) Approximately 14,000 HIV-infected women deliver per year HIV testing coverage >95% PMTCT or ART drug coverage 90% 20% of HIV-infected pregnant women now on ART before pregnancy

5. Early Infant Diagnosis Botswana policy largely matches WHO recommendations: –Infants tested with DNA PCR on dried blood spots (DBS) collected at routine health visits, ideally at 6- week postnatal visit –Infants testing positive receive ART immediately –Infants testing negative retested 6 wks after weaning if breastfed, otherwise negative status confirmed by rapid test at 18 months –Positive tests confirmed with a second PCR, but ART start not delayed while awaiting result –Not using rapid testing before PCR after 9 months (deviation from guidelines)

6. History of EID program Piloted Jun-Dec 2005 Pilot very successful National rollout Nov 2006-April 2007 Dedicated training teams visited each district for 1-3 weeks, classroom and hands-on training Supervisory followup visits to many sites 2008-2009

7. Botswana EID data Detailed data on each patient collected from beginning of the program Data has been used to –Describe HIV transmission rates –Describe EID program coverage –Identify strengths and weaknesses in early infant followup and care Still some important gaps –Data we can’t or don’t collect –Capacity for regular analysis

8. Data collection Data collected about each infant on lab requisition form –Age, reason for test, inpatient/outpatient –Dates of collection, testing –PMTCT interventions, feeding method DBS card and lab form travel from health facility to the district laboratory by government courier

9. Data flow – District Lab to Reference Lab District lab receives forms, DBS in envelope with checklist that contains the names of all the forms and samples in the envelope Lab confirms that all names on checklist match forms and DBS cards, signs check list and retains copy Lab sends forms, DBS, check list to reference lab by government courier

10. Data flow- Reference Lab Lab point of receipt checks: –Names on checklist match forms and DBS cards –DBS quality –Rejects those that don’t match or are poor quality Accepted and rejected samples entered into lab computer system with basic demographic data (name, age, date) –Rejected samples are immediately canceled, result of “rejected’ is printed out –Samples to be tested receive 3 barcode stickers and specimen number Stickers go on EID form, DBS card, sample tube (used in DBS processing)

11. Data flow – Reference Lab After PCR test run –Results are first written on PCR assay map, entered into lab computer system Second technician confirms data entry Result slips printed and put in mailbox for district of origin –If positive or indeterminate result, additional spots are tested from the same card before entering result If indeterminate, result entered, new sample requested If lab database is down, results will be entered by hand on to lab requisition form –Form photocopied, photocopy stored for entry at later date, while original is sent to mail box for collection

12. Data flow – Lab to Clinic to Patient When district courier returns to lab to drop off next batch of DBS, picks up results, and takes them to the district central office –Responsibility for returning of results differs by districts Example – PMTCT focal person –In some cases, health facility staff may have to follow up on results on their own and pick them up at the district office –Patients instructed to return after 4 weeks

13. Data flow – lab to program managers Requisition forms (sometimes without HIV results) sent to reference lab in capital Forms given to contract data management organization Data double-entered into database system HIV test results merged in periodically from lab database using specimen number as link Data can be exported to essentially any software for analysis

14. Data Flow - weaknesses Lab form version control –Minor changes in 2006, 2007, 2009 – not all clinics have updated form –Handwritten forms when no photocopier Lab computer is down frequently –Specimens not entered before test –Results not entered Forms without sitecode/sitename never return to clinics, needs to be verified at district lab level Thousands of 2009 forms from one reference lab never sent to capital for data entry – not realized for a year

16. Infant diagnosis database Data thoroughly analyzed twice with assistance from CDC-Atlanta –May 2008 –January 2010 Capacity being developed for regular analysis by MOH staff Overall clean, with low rates of missing data No unique identifiers for infants –Serious national problem for infant followup –Removing duplicates very complex, based on name, DOB, clinic (done manually once, algorithm now being created in Access)

17. Overview of test results (2006-2008 data) Total records18889 No result885 (4.7%) Results Positive676 (3.8%) Negative17308 (96.2%)

21. Positive PCR results by reason for testing Reason for testing Number (% of total) Number HIV infected Percent HIV infected First test for healthy infant of HIV-positive mother 13284 (94%)3632.7 First test for sick baby 518 (3.7%)11221.4 Repeat test 6 weeks after weaning from breast 9111.1 Repeat because of problem with first test 287 (2%)124.2 Repeat to confirm result 43 (0.3%)49.3

23. Lessons learned from the EID data EID program –Lab turnaround time very long early in the program; improved to about 2 weeks –1/3 of all HIV-exposed infants born in the country were tested at <8 wks old in 2006-8 (increased to 50% in 2009) –Tests are appropriately coming from all levels of health system (health posts to hospitals) –Most tests being done are routine tests for healthy HIV-exposed babies

24. MotherBaby Percent MTCT Variable name Short AZT Long AZTSDNVP HAART During HAART BeforeAZTNVPFormula NO PMTCT 24% NO mat AZT 13% SHORT AZT ONLY 1.9% SHORT AZT + NVP 5.1% Long AZTONLY 2.5% Long AZT+BNVP 2.1% Long AZT+MNVP 3.3% Mat HAART during preg 1.9% Mat HAART B4 preg 0.9% TOTAL 2.6% Rates of HIV infection at <2 months, by PMTCT regimen received

25. PMTCT program –HIV transmission rates among TESTED infants are low and match expected rates based on drug regimens given to mothers and babies –These data used to calculate overall transmission rates among ALL HIV-exposed infants in Botswana (infants who didn’t receive PMTCT are under-represented in the dataset, so calculation is required to show true transmission rate) Lessons learned from the EID data

26. Cotrimoxazole Percent of infants receiving cotrimoxazole at time of HIV test CTX status0-8 weeks 9-12 weeks 13-24 weeks 6-12 months 13-18 months None5.86.16.38.515.6 Already taking32.570.775.976.724.2 Starting today61.422.816.512.44.1 Completed 1 year55

28. DOES IT WORK? Results of follow up of infected infants in F/town in 2007

29. Lessons learned from the EID data Cotrimoxazole –Excellent coverage ART for infected infants –Very poor coverage as of last analysis (repeat analysis ongoing) –Data displayed here is not the most accurate way of assessing this, but does indicate that there is a problem

30. Gaps/weaknesses in data system No data on rate and timeliness of returning results to clinics and families –Widely reported that this is a problem, but not quantified –Ultimate measure of EID program success –Cannot be collected from this lab-based dataset –Can be assessed during supervisory visits to clinics or reported from clinics, but currently no system for this Lack of unique identifiers is a data weakness –Manual/algorithm-based de-duplication is subject to error –Since all positive PCRs should be repeated, risk of over-reporting transmission rate

31. Next steps Get missing 2009 forms and repeat the analysis System being created for regular, standardized reports produced by MOH More supervisory visits (with assessment of result return issues) Work on unique identifier issue Conversion of PMTCT data to electronic system, allowing tracking of infants across different parts of the system including ART

32. Acknowledgements PMTCT and M&E Team - MOH Botswana Esther Machakaire - CDC Botswana Tracy Creek - CDC Atlanta Helen Dale - CDC Atlanta Rachel Blacher - CDC Atlanta

33. Thank you Asante sana