Introduction to the STARHS in the HIV Event System

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Introduction to theSTARHS in the HIV Event
System VARHS Update

• Marianne OConnor MPH, MT
• STARHS Coordinator
• Mary-Grace Brandt, PhD, MPH
• VARHS Coordinator
• HIV, STD and Bloodborne Infections Surveillance
  Section
• Bureau of Epidemiology
• Michigan Department of Community Health

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This presentation will cover

• An introduction to STARHS
• Testing and treatment history information for HIV
  Event System and for revised HIV/AIDS case report
  form
• A review of VARHS
• Free baseline genotype offered under the VARHS
  protocol

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STARHS

• Serologic
• Testing
• Algorithm for
• Recent
• HIV
• Seroconversion

• STARHS National effort to estimate HIV
  incidence (rates of recent infection)
• STARHS is now part of routine HIV surveillance in
  Michigan

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HIV Incidence Surveillance in the United States
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STARHS Involves 2 Efforts

• 1. Incidence test on left-over serum
• 2. Answers to a few testing and treatment history
  questions

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STARHS Incidence Test

• Test indicates whether infection is likely to
  have occurred in the last 6 months
• Results Recent or Long-Standing
• Test performed on left-over serum after EIA
  screen and Western blot confirmation
• May also be performed on left-over viral loads,
  CD4s, but not on oral specimens at present
• Done on newly-reported cases over the age of 12,
  regardless of stage of disease

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Testing/Treatment History Questions

• HIV testing and treatment history has
• been reduced to 4 areas
• 1. Date of first positive HIV test
• 2. Date of last negative HIV test
• 3. Number of HIV tests in the 2 years
• before the first positive HIV test
• 4. Antiretroviral medication information

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Testing/Treatment History Questions

• HIV testing and treatment history information is
  needed for all newly reported cases in Michigan,
  regardless
• Of specimen type used to diagnose the client (ie,
  needed with Orasure diagnoses etc.)
• Of stage of disease (HIV or AIDS)

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Why Testing/Treatment History?

• To make inferences about the the incidence of HIV
  in general population from data based on the
  subgroup that tested, we need
• 1. Incidence test result data
• Testing history information which is used to
  determine testing patterns etc. giving rise to
  calculations using statistical weights to
  estimate HIV incidence rates in the overall
  population

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Importance of Incidence Data

• Monitor the epidemic more effectively
• Identify priority populations for prevention and
  intervention in real time
• Plan, implement and evaluate prevention programs
• Plan how to best allocate resources target
  populations at highest risk
• Incidence estimates are CDCs highest priority
  for HIV surveillance

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Importance of Incidence Data

• Incidence data will define the HIV epidemic by
• Who is getting recently infected- by sex, age,
  race
• How they are getting recently infected (the
  modes of transmission)
• Location of recent infections state, region and
  county

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Incidence Test Results are Not Returned to Client
or Physician

• The test is for surveillance use only it is not
  FDA approved for diagnostic or clinical use
• False positive and false negative results do
  occur with the test. On a population basis, they
  cancel each other out
• Allows incidence estimates for groups

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Consent Not Required

• Unlike an earlier version of the STARHS protocol,
  informed consent is not required for this
  additional incidence test, beyond the initial
  consent for HIV testing
• The incidence test is part of routine surveillance

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Role of CTR Sites and PCRS Staff

• Ask testing and treatment history (TTH) questions
  during counseling
• CTR add questions to intake form or ask during
  post-test session
• CTR enter TTH information on revised HIV/AIDS
  case report form
• Enter TTH information on STARHS pages in HIV
  Event System CTR and PCRS modules

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Testing/Treatment History Questionnaires Available
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Testing/Treatment History Questionnaires Available
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STARHS in HIV Event System (HES)

• STARHS Testing/Treatment History pages will
  launch in the HES for positive clients in both
  the CTR and PCRS modules
• Confidential testers only not anonymous testers
• Orasure testers are included as well as serum
  testers
• Counseling, Testing and Referral (CTR) data entry
  
• Partner Counseling and Referral Services (PCRS)
  data entry

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HIV Event SystemPartner Elicitation Screen
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HIV Event System STARHSQuestions Answered?
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Were STARHS TTH questions answered for this
client?

• You must click Yes or state a reason in the
  space provided as to why testing and treatment
  history questions were not answered.

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HIV Event System STARHSQuestions NOT Answered
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HIV Event System STARHSQuestions Answered
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HIV Event System STARHS Testing/Treatment
Questionnaire
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HES Testing Treatment HistoryInstructions
1. DATE OF INTERVIEW Use date client filled out
questionnaire or verbally answered the questions.
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HES Testing Treatment HistoryInstructions

• 2. DATE OF POSITIVE TEST USED FOR THIS ACTIVITY
• Use the specimen collection date of the current
  positive
• HIV test that you are counseling.

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HES Testing Treatment HistoryInstructions

• 3. WHEN IS THE FIRST TIME THE CLIENT EVER TESTED
  POSITIVE FOR HIV?
• This date is usually the month and year of the
  same date as in
• answer 2, unless the client has tested positive
  previously.
• The answer is per patient history you do not
  need to see documentation of a
• previous positive test result.

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HES Testing Treatment HistoryInstructions
4. HAS THE CLIENT EVER HAD A NEGATIVE HIV TEST?
IF YES a. Enter the date of the last
negative HIV test. This is by patient report
you do not need to see a negative lab report.
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HES Testing Treatment HistoryInstructions

• 4b. Enter the number of tests in the 2 years
  before the first positive test. Include the
  first positive test in the count.

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HES Testing Treatment HistoryInstructions

• Number of tests in 2 years before first positive
  test
• This question is often misinterpreted
• Enter only the number of negative tests in the 2
  years before the first positive test AND include
  the first positive test in the count
• See examples to follow

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HES Testing Treatment HistoryInstructions

• Number of tests in 2 years before first positive
  test
• If client tested negative 5 times in his/her
  lifetime but tested negative once in the 2 years
  before the first positive test
• 1 (first positive) 1 ( prior tests) 2 TOTAL

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HES Testing Treatment HistoryInstructions

• Number of tests in 2 years before first positive
  test
• If client never tested before the first positive
  test, then he/she has 0 prior tests in the last 2
  years
• 1 (first positive) 0 ( prior tests) 1 TOTAL

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HIV Event System STARHS Testing/Treatment
History
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HIV Event System STARHS Testing/Treatment
History
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HES Testing Treatment HistoryMedication Chart
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HIV Event System STARHS Testing/Treatment
History
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DCH Form 1355 Revised Adult HIV/AIDS Case
Report Form
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DCH Form 1355 Revised AdultHIV/AIDS Case Report
Form

• Section VIII. Testing and Treatment History

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HIV Event SystemPCRS Data Entry top
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HIV Event SystemPCRS Data Entry bottom
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HIV Event System PCRSPartner Elicitation Screen
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HIV Event System PCRSSTARHS Implementation
screen
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Thank you for your assistance in collecting HIV
testing and treatment information!

• For any questions or concerns,
• please contact
• Marianne OConnor. MPH, MT (ASCP)
• HIV Incidence Surveillance Coordinator
• Email OconnorMF_at_michigan.gov
• Phone [phone]

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VARHS

• VARHS National effort to estimate the frequency
  of HIV drug resistance and variant/atypical (non
  subgroup B) strains
• VARHS is now part of routine HIV surveillance

• Variant
• Atypical
• Resistant
• HIV
• Surveillance

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VARHS - Public Health Benefits

• Determine the distribution of viral genotypes
  among individuals newly diagnosed with HIV
• Evaluate the effectiveness of risk reduction
  interventions among treated (Are people on ARVDT
  transmitting HIV)
• Influence vaccine studies if prevalence of HIV-1
  non-B subtypes is increasing
• Impact treatment guidelines if resistance is
  found to associate with certain HIV subtypes

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VARHS - Individual Benefits

• Provide reassurance to individuals whose strains
  are fully susceptible to drugs
• Support strategies to optimize treatment in
  individuals with resistant strains
• Capture mutations before they become undetectable
  (within the 2 year window following infection),
  providing treatment insight otherwise lost
• Provide a potential benefit to individuals who do
  not have financial resources to acquire genotyping

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VARHS - Overview

• CDC funded initiatives Michigan is one of 22
  funded sites
• Genotypes all newly diagnosed named HIV cases at
  State Health Department Lab in Lansing
• - Returns results to clinicians for FREE
• - Over 75 of all individuals in Michigan testing
  today are offered this service and more are being
  recruited

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VARHS - Eligibility

• Newly diagnosed via a confidential lab/case
  report
• No antiretroviral drug history
• Any stage in disease process
• gt12 years of age

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VARHS - Specimen Collection

• VARHS requires 1mL of diagnostic serum (making
  the total requested for diagnostic testing 3mL)
• Specimens should be centrifuged refrigerated
  quickly
• Serum should be poured into polystyrene tubes and
  mailed (US mail - no special handling) within 24
  hours from blood draw accompanied by an MDCH Test
  Request Form

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VARHS - Specimen Collection

• MDCH provides (FREE of charge)
• polystyrene tubes for collected serum
• MDCH test request forms to accompany serum to the
  diagnostic lab
• Mailing tubes with labels

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VARHS - No Informed Consent

• VARHS protocol has cleared CDC IRB with a
  non-research determination (waives consent) and
  was exempted from local MDCH IRB review
• Consent is waived because
• - VARHS presents minimum risk
• No extra draw, little additional volume
• No additional information collected
• - VARHS provides information
• Individuals can specify clinicians to receive
  results

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VARHS - Support to Sites

• VARHS Project Summary Sheets are available to all
  sites submitting specimens for HIV testing to the
  MDCH regional labs
• A powerpoint (or similar) presentation can be
  scheduled for a CTR site upon request
• MDCH has a wide variety of information from
  non-profit, governmental, and pharmaceutical
  sources that present topics ranging from drug
  therapy to drug resistance and resistance testing
  that are available upon CTR site request

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VARHS Results to Date

• We have successfully genotyped over 750 specimens
• 65 specimens have failed to amplify for various
  (sometimes unknown) reasons
• Nearly 1 in 7 individuals have been found to be
  resistant to at least 1 drug class slightly
  higher than national averages
• Approximately 70 specimens have been identified
  as variant or atypical strains (A, A/E, C, D, AG,
  G or other recombinants)

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Summary of what is requested from CTR sites for
STARHS and VARHS

• Include a few extra testing history questions
  into an intake form at your site
• Test and report clients with name, unless they
  request anonymous testing
• Test client with blood specimen unless
  blood-drawing capability doesnt exist or client
  does not want blood drawn
• When blood specimen is drawn, draw enough to
  provide 3 ml serum, to allow enough sera for both
  incidence test and genotype
• When any client is found to be HIV positive,
  include testing/treatment history information on
  the STARHS page of HES system and on the revised
  Adult HIV/AIDS report form

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Summary of what is requested of PCRS Staff

• Consider any partner who is tested for HIV as a
  potentially eligible for STARHS and VARHS test
  by name and draw enough blood to yield 3ml serum
  when possible
• Ask index clients and partners testing and
  treatment history questions during partner
  counseling
• Enter testing/treatment history information
  collected from each index client and partner into
  the HES system STARHS page

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Thank you for your assistance in this important
effort!

• For any questions or concerns regarding VARHS
  please contact
• Mary-Grace Brandt PhD, MPH
• HIV VARHS Coordinator
• Email BrandtMG_at_michigan.gov
• Phone [phone]