Charu Sabharwal, MD MPH Medical Director Epidemiology and Field Services Program

1. Concordance of HIV surveillance and medical record data: What do CD4 and viral loads not tell us about linkage to HIV care? Charu Sabharwal, MD MPH Medical Director Epidemiology and Field Services Program Bureau of HIV/AIDS Prevention and Control NYC Department of Health

2. Acknowledgements • Sarah Braunstein • Rebekkah Robbins • Colin Shepard • HIV Epidemiology and Field Services Program

3. Background

4. National HIV/AIDS Strategy • NHAS (July, 2010) - first comprehensive roadmap • Amore coordinated response to the HIV epidemic • Primary Goals for 2015: • Reduce infections • Increase access to care • Reduce health disparities

5. HIV Continuum of Care Das, MoupaliPrevention of HIV Acquisition: Behavioral, Biomedical, and Other Interventions. Medscape 2012

6. Monitoring HIV Care – CD4/VL • HIV Care = outpatient HIV visit with provider authorized to prescribe ART1 • Clinical monitoring/treatment guidelines2 • Traditionally, 1st CD4/VL at initial HIV care visit • CD4/VL: every 3-6 months;  frequency after ART initiation • CD4/VLs proxy for HIV care [HIV care visits not reported] • Since 2004, CSTE encouraged all states (59 jurisdictions) to report allCD4 and VLs3[New York2005] • Limited comprehensive evaluation of the validity of surveillance data as proxy of HIV care 1Health Resources and Services Administration. The HIV/AIDS Program: HAB Performance Measures Group 1. In; 2009. 2DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. In; 2012. 3 CSTE Position statement 04-ID-07

7. Measuring linkage to care • Surveillance traditionally measures linkage by a single event: 1streported CD4/VL on/after HIV diagnosis date • Accuracy of 1st CD4/VL1,2 drawn prior to referral to HIV care. For example, at the time of • Confirmatory testing after + rapid/point-of-care test • Inpatient diagnosis: CD4 impacts treatment decision • In New York City: routinemedical record (MR) abstraction for linkage to care is not feasible • 3,500 diagnosing providers; 3,000+ HIV cases yearly • Timely linkage – entry into care within 3 months of diagnosis. Local3 and national measure 1 BertolliA. et al The Open AIDS Journal 2012,6:131-141. 2Keller et al. J Acquir Immune DeficSyndr2013. 3New York City HIV/AIDS Surveillance Slide Sets. http://www.nyc.gov/html/doh/html/data/epi-surveillance.shtml

8. New York City’s Care Validation Study • Validate CD4 and VL tests for persons living with HIV (PLWH) in NYC as proxy measure for HIV care in the first year after diagnosis 1° Objective – evaluate the correspondence between a patients 1st CD4/VL on/after HIV diagnosis and linkage HIV care

9. Purpose Validate 1st lab test (CD4/VL) from the diagnosing facility as measure of timely linkage toHIV care • Hypothesis: early post-diagnostic lab tests within first 2 weeks arepart of diagnostic work-up and not an actual linkage event

10. Methods Methods

11. Study population selection: New York City HIV Registry • Selected high-volume HIV diagnosing sites with co-located care (n=24) • Patients with new, confirmed HIV diagnosis in 2009 reported the Registry • Patients who had to linked to care at the same diagnosing facility within 12 months as per the Registry • PLEASE NOTE – Even though Surveillance does not require linkage to care at the same site of diagnosis, we did in order to conduct this validation study

12. Figure 1: Final study population 3,536 new, confirmed HIV diagnoses among > 13 years in NYC in 2009 1,263 (36%) patients reported from high-volume (> 20 diagnoses) co-located HIV care sites 947 (75%) patients had 1st CD4/VL reported from co-located site within 12 months of diagnosis eligible for medical record (MR) abstractions 165 (17%) excluded: MR unavailable 782 (83%) patients Registry (1st CD/VL) and MR (care visit) data

13. Data Analysis

14. Analytic population (n=782) Linkage within 12 months, per Registry NO YES HIV care visit confirmed by MR No medical visit group Medical visit group • Compared the subgroups based on: • Key demographic characteristics (age, gender, risk) • Proportion concurrently diagnosed with HIV/AIDS(AIDS within 31 days of HIV diagnosis – local definition) • Proportion diagnosed on inpatient service • Proportion that died within 12 months of diagnosis

15. Timely linkage to HIV care • Compared the proportion who linked to HIV care within 3 months of diagnosis (timely) by Registry (1st CD/VL) vs. MR (care visit)

16. Do 1st reported CD4/VLs indicate timely linkage to HIV care? • Compared subgroups: • Median time to 1st lab per the Registry • Proportion of 1st labs in 0-7 days and 0-14 days • Calculated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of Registry data in correctly classifying patients’ true timely linkage to care status based on the 1st CD/VL within: • 0-91 days (no labs excluded: National standard) • 8-91 days (excluded labs from 0-7 days) • 15-91 days (excluded labs from 0-14 days)

17. RESULTS

18. Figure 2: Linkage to care (n=782)Registry vs. MR No Medical visit 20% (n=157) 1st CD4/VL 100% (n=782) Medical visit 80% (n=625)

19. Table 1: Demographics/clinical outcomes

20. Figure 3: Inpatient diagnoses No medical visit Medical visit

21. Figure 4: Mortality outcomes:Deaths within 12 months of HIV diagnosis

22. Timely Linkage to Care

23. Figure 5: Timely linkage to careRegistry vs. MR 97% 1st CD4/VL (proxy measure): 0-91 days 75% True linkage event (HIV care visit): 0-91 days

24. Are labs within the early post-diagnostic period indicative of timely linkage to care? Timely linkage

25. Figure 6: Median time (days) to linkage based on 1st CD4/VL, by subgroups No medical visit 1 day (IQR 0-5 days) p <0.001 Medical visit

26. Figure 7: Proportion of 1st labs in the early post-diagnostic period, by subgroups p <0.001 p <0.001 19% 31% No medical visit No medical visit Medical visit Medical visit

27. Figure 8: Performance of Registry data 99% 0-91 days 8-91 days 15-91 days

28. Refinement of NYC’s timely linkage to care indicator

29. Figure 9: Final study population: Refining timely linkage to care No lag applied Lag applied

30. Figure 10: New York City’s refined Timely linkage to care indicator No lag No lag Lag Lag

31. Conclusions • First population-based study to validate the use of HIV Surveillance’s proxy measure of timely linkage to care • Substantial misclassification of timely linkage in the early post-diagnostic period • NYC DOHMH implemented a refined definition of timely linkage to care (labs 8-91 days after diagnosis) • HIV labs in 1st 7 days  not indicative of linkage • Surveillance data overestimated linkage for older persons, non-traditional HIV risk transmission, and those who died soon after diagnosis

32. Limitations • Selection of provider • A portion had a CD4/VL at an alternate provider which may be the linkage to care visit –DID NOT validate if these patients EVER linked • Oversampled the acute care setting • Selection of study population • Due to the complexities of HIV laboratory reporting, the 1st lab may have been misclassified to the incorrect provider

33. Future directions • Exploration of surveillance-based retention in care measures vs. medical abstraction data • All care visits at diagnosing provider during first 12 months immediately following diagnosis • In depth exploration of mortality within 12 months of HIV diagnosis

34. Thank you! cjain@health.nyc.gov