1. HIV INCIDENCE SURVEILLANCE (HIS) PROGRAM California Department of Public Health Office of AIDS Surveillance Section

2. HIV Incidence Surveillance Background - Core and Incidence HIV Surveillance Key Partners and Responsibilities Key Requirements and Data Components Management and Shipping Processes for STARHS tests Contact information

3. HIV Incidence Surveillance HIV/AIDS Core Surveillance: All people diagnosed and reported Used to calculate: New reported/diagnosed cases Prevalence (people living with HIV) HIV Incidence Surveillance: Used to estimate new infections within a given year, including those that: Test early Test late Are undiagnosed

4. Core HIV Surveillance vs. HIV Incidence Surveillance Core SurveillanceIncidence Surveillance Measures HIV Prevalence New diagnoses People living with HIV HIV Incidence New infections Data collected Demographic information HIV risk exposures HIV laboratory results & specimen identifiers (CLIA; Accession numbers) AIDS indicators HIV testing and treatment history (TTH) Medications to treat or prevent HIV (ART) Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS) test result from remnant blood specimen

5. HIV Surveillance

6. HIV Incidence Surveillance Incidence Surveillance allows us to: Estimate total new infections in California Estimate the number of HIV positive people who are unaware of their infection Identify emerging demographic or geographic groups where infections are increasing Better inform and guide prevention and care activities and resource allocation Develop new HIV interventions and approaches to prevention

7. HIV Incidence Surveillance

8. Responsible Parties The California Department of Public Health, Office of AIDS (OA) is responsible for maintaining the HIV Incidence Surveillance (HIS) program within the California Project Area (CPA) San Francisco and Los Angeles Counties run the HIS programs in their jurisdictions Activities of an Effective HIS Program Identify probable new cases of HIV infection Ascertain corresponding remnant serum specimens for those cases Send those serum specimens sent for STARHS testing Receive results of the STARHS tests that establish whether the HIV infections were indeed new Manage data, including STARHS results Incorporate the test for STARHS into the incidence estimation algorithm to calculate the number of new infections within a specified region

9. Key Partners in HIS Health Care Providers : –Document patient medical records include testing and treatment histories (TTH) –Facilitate completion of HIV/AIDS case report forms Local Health Departments –Collect core surveillance variables and testing and treatment histories (TTH) from providers and through medical record reviews –Accurately record specimen CLIA and Accession Numbers

10. Key Partners in HIS Laboratories: –Coordinates transportation of sera to CDC- designated lab for STARHS testing Office of AIDS –Identify qualifying cases and specimen –Raise awareness and interest –Provide technical support and monitoring –Manage data and transfers to CDC –Complete California incidence estimation

11. Requirements for HIV Incidence Surveillance Remnant HIV+ SerumCore Surveillance Data HIV Incidence Estimation STARHS Testing using Avidity Assay Diagnosis date HIV disease status TTH information To link these data we need: Laboratory CLIAs, Accession #, and Specimen Date of Collection

12. Key Data Components Needed for Incidence Surveillance HIV diagnosis date HIV disease status (HIV or AIDS) Testing and Treatment History (TTH) Laboratory Information Clinical Laboratory Improvement Amendments (CLIA) Numbers Laboratory-Assigned Accession Number Date of Specimen Collection Test results of the serologic testing algorithm for recent HIV seroconversion (STARHS) Core Surveillance Data

13. HIV Diagnosis Date Initial HIV diagnostic specimen or another HIV- related test within 90 days of HIV diagnosis The purpose of this element is to determine eligibility of the specimen for STARHS testing

14. Key Data Components Needed for Incidence Surveillance HIV diagnosis date HIV disease status (HIV or AIDS) Testing and Treatment History (TTH) Laboratory Information Clinical Laboratory Improvement Amendments (CLIA) Numbers Laboratory-Assigned Accession Number Date of Specimen Collection Test results of the serologic testing algorithm for recent HIV seroconversion (STARHS)

15. HIV Disease Status

16. Key Data Components Needed for Incidence Surveillance HIV diagnosis date HIV disease status (HIV or AIDS) Testing and Treatment History (TTH) Laboratory Information Clinical Laboratory Improvement Amendments (CLIA) Numbers Laboratory-Assigned Accession Number Date of Specimen Collection Test results of the serologic testing algorithm for recent HIV seroconversion (STARHS)

17. Testing and Treatment History (TTH) TTH data collection is to obtain the most accurate information available to characterize a person’s HIV testing and treatment history TTH information is collected by local health jurisdiction (LHJ) staff through various reporting methods (e.g., patient interview, medical record review, or passive case reporting) These data are recorded in the TTH section on the Adult Case Reporting Form (ACRF) and then sent to OA

18. Testing and Treatment History (TTH) 1. 2. 3. 4. 5. 6. 7. 8. MM/DD/YYYY 1,2,3, …

19. Key Data Components Needed for Incidence Surveillance HIV diagnosis date HIV disease status (HIV or AIDS) Testing and Treatment History (TTH) Laboratory Information Clinical Laboratory Improvement Amendments (CLIA) Numbers Laboratory-Assigned Accession Number Date of Specimen Collection Test results of the serologic testing algorithm for recent HIV seroconversion (STARHS)

20. Laboratory Information Clinical Laboratory Improvement Amendments (CLIA) Numbers All laboratories certified to perform testing on human specimens have a CLIA number that uniquely identifies the laboratory. Laboratory-Assigned Accession Number Laboratory-assigned accession numbers are tracking or inventory numbers found on laboratory reports and specimen vials that are used to track specimens and link them to patients Date of Specimen Collection The date of specimen collection is the date the specimen was drawn for the HIV-related test.

21. Recording Lab Information Adult Case Report Form (ACRF)

22. Recording Lab Information

24. Key Data Components Needed for Incidence Surveillance HIV diagnosis date HIV disease status (HIV or AIDS) Testing and Treatment History (TTH) Laboratory Information Clinical Laboratory Improvement Amendments (CLIA) Numbers Laboratory-Assigned Accession Number Date of Specimen Collection Test results of the serologic testing algorithm for recent HIV seroconversion (STARHS)

25. Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS) Testing The last component of Incidence is the Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS) results Laboratory test used for STARHS –BED HIV-1 Capture Enzyme Immunoassay (BED assay) –Bio-Rad HIV O ELISA (Bio-Rad Avidity assay) STARHS testing is conducted by CDC funded laboratory known as the Wadsworth Laboratory in New York

26. Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS) Testing Results of the test for recent infection are obtained by: –Locating and determining the disposition of remnant specimens –Preparing VRDL & STARHS lab eligibility lists –Transporting remnant HIV-positive specimens to the STARHS Laboratory –Testing the specimens, and reporting the results back to the HIS jurisdiction

27. Local Health Dept LDET ACRF (TTH) Other Lab Reports OA eHARS OA HIV Incidence Surveillance Datafile CDC (quarterly dataset) CLIA Accession # Last, First names DOB Gender CA Incidence Estimate VRDL & STARHS Lab Test Lists Overview HIV Incidence

28. Shipping Remnant Serum OA asks commercial, private, and public health laboratories to send remnant serum from ALL HIV-positive diagnostic initial and supplemental tests. Laboratories send specimens that are collected within 90 days of HIV diagnoses. Laboratories send remnant serum to the STARHS Laboratory in New York or the Viral & Rickettsial Disease Laboratory (VRDL) in Richmond, CA

29. Resources Standard Operating Procedure for HIV Incidence Surveillance (HIS) http://www.cdph.ca.gov/programs/aids/Documents/HISSOPProjGuidance.pdf Guide to Accession Number Identification from Common Laboratories http://www.cdph.ca.gov/programs/aids/Documents/GuideToAccessionNumberId entificationFromCommonLaboratories2.pdf CDC Revised Surveillance Case Definition for HIV Infection — United States, 2014-Morbidity and Mortality Weekly Report (MMWR) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm

30. OA Incidence Team Jessica Brown Scott Masten HIV Surveillance Laboratory Coordinator HIV Surveillance Section Chief (916) 445-9231 (916) 449-5835 Jessica.Brown@cdph.ca.govJessica.Brown@cdph.ca.gov Scott.Masten@cdph.ca.govScott.Masten@cdph.ca.gov Valorie Eckert William Wheeler KC Moua Data Management Chief Scientific Information Specialist Data Manager (916) 449-5827 (916)-449-5911 (916)-449-5869 Valorie.Eckert@cdph.ca.govValorie.Eckert@cdph.ca.gov WilliamWheeler@cdph.ca.gov Keur.Moua@cdph.ca.govWilliamWheeler@cdph.ca.govKeur.Moua@cdph.ca.gov

31. San Francisco Incidence Team Tony Buckman, M.S. San Francisco Department of Public Health, Population Health Division HIV/AIDS Epidemiology Surveillance Supervisor 415-437-6243 anthony.buckman@sfdph.org Jennie Chin Applied Research, Community Health Epidemiology, & Surveillance (ARCHES) Branch Population Health Division San Francisco Department of Public Health 415.437.6230 jennie.cs.chin@sfdph.org

32. Los Angeles Incidence Team Shoshanna Nakelsky, MPH HIV Incidence Surveillance Coordinator Division of HIV and STD Programs Los Angeles County Department of Public Health (213)-351-8154 snakelsky@ph.lacounty.gov

33. Thank You! Questions?

34. CDC Recommended HIV Lab Testing Algorithm for Serum/Plasma Specimens