HIV INCIDENCE SURVEILLANCE (HIS) PROGRAM California Department of Public Health Office of AIDS...
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Transcript of HIV INCIDENCE SURVEILLANCE (HIS) PROGRAM California Department of Public Health Office of AIDS...
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 [email protected]
(510) 307-8901
Contact Information for STARHS:
N’ko Lea Ali-Napo (Lea), [email protected]
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) [email protected] [email protected]
Valorie Eckert William Wheeler KC MouaData Management Chief Scientific Information Specialist Data Manager(916) 449-5827 (916)-449-5911 (916)[email protected] [email protected] [email protected]
San Francisco Incidence TeamSan Francisco Incidence Team
Tony Buckman, M.S.San Francisco Department of Public Health, Population Health DivisionHIV/AIDS Epidemiology Surveillance [email protected]
Jennie ChinApplied Research, Community Health Epidemiology, & Surveillance (ARCHES) BranchPopulation Health DivisionSan Francisco Department of Public [email protected]
Los Angeles Incidence TeamLos Angeles Incidence Team
Shoshanna Nakelsky, MPHHIV Incidence Surveillance CoordinatorDivision of HIV and STD ProgramsLos Angeles County Department of Public Health [email protected]
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