HIV INCIDENCE SURVEILLANCE (HIS)

PROGRAM

HIV INCIDENCE SURVEILLANCE (HIS)

PROGRAM

California Department of Public Health

Office of AIDS

Surveillance Section

HIV Incidence SurveillanceHIV 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

HIV Incidence SurveillanceHIV 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

HIV Incidence SurveillanceHIV Incidence Surveillance

HIV diagnosis (1st positive confidential test) 1st CD4 Count

1st Viral Load Test

1st Drug Resistance test

1st CD4 Count <200 (IMM-AIDS)

AIDS-OI

Death

Measures of HIV morbidity and mortality

HIV Infection

Entry to care Retention in care and viral suppression

Core HIV Surveillance vs. HIV Incidence SurveillanceCore HIV Surveillance vs. HIV Incidence Surveillance

Core Surveillance Incidence 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

HIV Incidence SurveillanceHIV 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

HIV SurveillanceHIV Surveillance

HIV Incidence SurveillanceHIV Incidence SurveillanceResponsible 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

Key Partners in HISKey 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

Key Partners in HISKey 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

Requirements for HIV Incidence Surveillance

Requirements for HIV Incidence Surveillance

Remnant HIV+ Serum Core Surveillance Data

HIV Incidence Estimation

STARHS Testing using Avidity Assay

Diagnosis dateHIV disease statusTTH information

To link these data we need: Laboratory CLIAs, Accession #, and Specimen Date of Collection

Key Data Components Needed for Incidence Surveillance

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

HIV Diagnosis DateHIV Diagnosis Date

• Initial HIV diagnostic specimen or another HIV-related test within 3 months of HIV diagnosis

• The purpose of this element is to determine eligibility of the specimen for STARHS testing

Key Data Components Needed for Incidence Surveillance

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)

HIV Disease StatusHIV Disease Status

HIV diagnosis (1st positive confidential test) 1st CD4 Count

1st Viral Load Test

1st Drug Resistance test

1st CD4 Count <200 (IMM-AIDS)

AIDS-OI

Death

Measures of HIV morbidity and mortality

HIV Infection

Entry to care Retention in care and viral suppression

Key Data Components Needed for Incidence Surveillance

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)

Testing and Treatment History (TTH)

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

Key Data Components Needed for Incidence Surveillance

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)

Laboratory InformationLaboratory Information

• Clinical Laboratory Improvement Amendments (CLIA) Numbers

Specimen Identifiers

• Laboratory-Assigned Accession Number

• Date of Specimen Collection

Key Data Components Needed for Incidence Surveillance

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)

Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS) TestingSerologic 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

Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS) TestingSerologic 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

Local Health Dept

LDET

ACRF (TTH) Other Lab

Reports

OA eHARS

OA HIV Incidence Surveillance

Datafile

CDC(quarterly dataset)

CLIAAccession #Last, First namesDOBGender

CAIncidence Estimate

VRDL & STARHS Lab

Test Lists

Overview HIV IncidenceOverview HIV Incidence

Shipping Remnant SerumShipping Remnant SerumOA asks commercial, private, and public health laboratories to send remnant serum from HIV-positive diagnostic initial and supplemental test such as:

HIV-1/2 Type-Differentiating Immunoassay (e.g. Multispot)

HIV-1 Western blot (WB)

Enzyme Immunoassay (EIA) – (that confirms HIV-positive)

Nucleic Acid Test (NAT)

HIV-1 Immunofluorescence Antibody (IFA) test

Laboratories send remnant serum to the STARHS Laboratory in New York or the Viral & Rickettsial Disease Laboratory (VRDL) in Richmond, CA

Laboratory ProcessLaboratory Process

WB, MS,EIA IFA, VL

VRDL

STARHS LABOA

Specimens sent to VRDL are sent to STARHS

STARHS Results

Shipping ManifestShipping Manifest

Shipping Manifest for VRDL

Shipping ManifestShipping Manifest

Shipping Manifest for STARHS

Contact InformationContact Information 

Contact Information for VRDL: 

Anna Wong Anna.Wong@cdph.ca.gov

(510) 307-8901  

Contact Information for STARHS: 

N’ko Lea Ali-Napo (Lea), nko.ali-napo@health.ny.gov

Important Shipping DatesImportant Shipping Dates

•To meet deadlines CDC key data submissions, OA encourages commercial, private and public health laboratories to participate by sending remnant serum at least twice a year

• April• September

•Laboratories are encouraged to send remnant serum more frequently to STARHS or VRDL

Resources Resources

Standard Operating Procedure for HIV Incidence Surveillance (HIS)

http://www.cdph.ca.gov/programs/aids/Documents/HISSOPProjGuidance.pdf

VRDL Shipping Guidance

http://www.cdph.ca.gov/programs/aids/Documents/OAHISSTARHSShippingGuidelinesPHLs.pdf

STARHS Shipping Guidance

HIV Surveillance Guidelines Vol 1-2 part 1.pdf

HIV Surveillance Guidelines Vol 1-2 part 2.pdf

OA Incidence TeamOA Incidence Team

Jessica Brown Scott MastenHIV Surveillance Laboratory Coordinator HIV Surveillance Section Chief (916) 445-9231 (916) 449-5835Jessica.Brown@cdph.ca.gov Scott.Masten@cdph.ca.gov

Valorie Eckert William Wheeler KC MouaData Management Chief Scientific Information Specialist Data Manager(916) 449-5827 (916)-449-5911 (916)-449-5869Valorie.Eckert@cdph.ca.gov WilliamWheeler@cdph.ca.gov Keur.Moua@cdph.ca.gov

San Francisco Incidence TeamSan Francisco Incidence Team

Tony Buckman, M.S.San Francisco Department of Public Health, Population Health DivisionHIV/AIDS Epidemiology Surveillance Supervisor415-437-6243anthony.buckman@sfdph.org

Jennie ChinApplied Research, Community Health Epidemiology, & Surveillance (ARCHES) BranchPopulation Health DivisionSan Francisco Department of Public Health415.437.6230jennie.cs.chin@sfdph.org

Los Angeles Incidence TeamLos Angeles Incidence Team

Shoshanna Nakelsky, MPHHIV Incidence Surveillance CoordinatorDivision of HIV and STD ProgramsLos Angeles County Department of Public Health 213.351.8154snakelsky@ph.lacounty.gov

Thank You!

Questions?

Thank You!

Questions?

CDC Recommended HIV Lab Testing Algorithm for Serum/Plasma SpecimensCDC Recommended HIV Lab Testing

Algorithm for Serum/Plasma Specimens