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Info on HIV/AIDS:
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TTY: 206-296-4843
Toll-free: 800-678-1595
Administration:
206-296-4649
HIV/STD Testing
HIV/STD Hotline:
206-205-7837 or
Toll-free: 800-678-1595
9:00 am to 4:00 pm
Monday - Friday for
testing information, resources and referrals
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HIV/AIDS Program
Variant, Atypical, and Resistant HIV Surveillance Project
Frequently Asked Questions (FAQ)
Click on a question below to reveal and hide its answer.
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1.
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What is VARHS?
VARHS is the national HIV drug resistance and HIV subtype surveillance system that was rolled out after the pilot (ARVDRT or Antiretroviral Drug Resistance Testing) demonstrated the feasibility and utility of surveillance. VARHS is an acronym for Variant, Atypical, and Resistant HIV Surveillance.
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2.
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Which areas participate in VARHS as part of HIV incidence surveillance?
As of June 1, 2005, 16 areas are funded by the Centers for Disease Control and Prevention (CDC) to participate in VARHS in conjunction with HIV incidence surveillance: Chicago, Indiana, Louisiana, Massachusetts, Michigan, Mississippi, New Jersey, New York City, New York state, North Carolina, Pennsylvania, South Carolina, Texas, Virginia, Washington DC, and Washington state.
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3.
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Can areas that are not participating in HIV incidence surveillance still participate in VARHS?
Any state or city health department performing HIV surveillance can participate in VARHS if their methods have been approved by CDC and if they are able to send HIV diagnostic specimens meeting VARHS criteria for HIV drug resistance (HIVDR) testing. HIVDR testing will be performed at no cost to the health department under a CDC contract with Stanford University Laboratories.
Except for support for HIVDR testing in the laboratory funded by the CDC contract, no funding is currently available to support specimen handling, processing, and shipping or data management for VARHS in non-HIS states.
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4.
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What are VARHS specimens?
VARHS uses remnant sera from blood drawn for HIV diagnostic purposes from persons newly diagnosed with HIV at participating diagnostic and clinical centers. Aliquots are not labeled as VARHS specimens until basic diagnostic and clinical testing has been completed.
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5.
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Does VARHS require informed consent?
VARHS received a non-research determination in August 2004 and was designated by that determination as a part of routine HIV surveillance. As a routine public health surveillance activity, VARHS is not a research project and does not require informed consent.
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6.
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What are the criteria for diagnostic and clinical centers to participate in VARHS?
A diagnostic or clinical center can participate in VARHS if remnant specimens will generally be available from all persons newly diagnosed with HIV in the center. If specimens are only available from a subgroup then the site cannot participate in VARHS.
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7.
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What are the eligibility criteria for VARHS?
- Remnant specimens are eligible for HIV drug resistance testing in VARHS from individuals who have:
- a confirmed positive HIV test, and
- a new HIV diagnosis (no previously reported “positive” HIV test, or no previous HIV diagnosis more than 3 months before the blood draw providing the specimen), and
- no known history of antiretroviral drug treatment, and
- no previous specimen successfully tested for HIV drug resistance as part of VARHS or the ARVDRT project.
- Specimens from persons diagnosed with AIDS at the time of, or shortly after their HIV diagnosis are eligible for resistance testing if all the above criteria are fulfilled. An AIDS diagnosis is not an exclusion criterion.
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8.
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What about groups that are often excluded from research projects, such as children under the age of 18, mentally incompetent persons, and prisoners? Are these groups eligible for VARHS and ARVDRT?
Remnant specimens from newly diagnosed children less than 18 years of age, persons who are mentally incompetent, and prisoners for whom HIV testing is voluntary or part of routine HIV surveillance are eligible. Their inclusion is encouraged since their providers can receive a potentially beneficial clinical result.
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9.
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Can individuals who have anonymous HIV tests be included in VARHS?
No, anonymously tested individuals are not currently eligible for VARHS.
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10.
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Is Institutional Review Board (IRB) approval needed for an area to start HIV drug resistance and subtype surveillance?
Because HIV drug resistance and subtype surveillance has a federal non-research determination designating it a routine public health surveillance activity, neither CDC nor local IRB approval is required prior to implementation.
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11.
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Are HIV drug resistance and subtype results returned to participants?
- Results are not returned directly to participants, but health departments must provide a mechanism by which participants can designate a provider, either when they return for HIV diagnostic results or at a later time when they go into care, to receive the results.
- Hard copy “provider friendly” reports are returned from the HIV drug resistance testing laboratory to the health department, which in turns sends an individual’s report to his or her designated provider, or holds the result for a specified period until a provider is designated.
- If an individual’s HIV test was performed at a facility that provides clinical services, health departments may return the HIV drug resistance result to that facility, where it becomes part of the medical record and can be forwarded to a provider as part of a medical records release.
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12.
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How are VARHS specimens tested for HIV drug resistance testing?
- Two types of HIV drug resistance testing are commonly available in the US. Genotypic testing, or genotyping, evaluates genetic information in the relevant portions of the HIV genome and detects the presence of mutations known to be associated with resistance to one or more HIV drugs. Phenotypic testing, or phenotyping, evaluates the drug concentration necessary to stop the HIV in the specimen from reproducing itself, and compares that to the amount needed to prevent drug-susceptible HIV from reproducing itself.
- Standard genotypic testing is performed for all VARHS specimens. If back-up specimens are available, phenotypic testing and additional HIV drug resistance testing may also be performed on specimens with drug resistance mutations and other mutations of interest.
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13.
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Which laboratories provide HIV drug resistance testing for VARHS, ARVDRT, and ARVDRT/DFS?
- The majority of areas collaborating with CDC for HIV drug resistance testing of specimens either as part of routine HIV surveillance or research have their specimens tested at the Stanford University Laboratories, which operates under a contract with CDC for this purpose.
- Genotyping may also be performed at a local genotyping laboratory for health departments that received funding for this purpose under some program announcements, or in areas that have non-CDC resources for this purpose.
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14.
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How large a remnant specimen is required for VARHS?
One ml of serum should be sent for HIV drug resistance testing to Stanford or the local laboratory.
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15.
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How quickly are results returned from the HIV drug resistance testing laboratory?
Laboratories providing HIV drug resistance testing for VARHS are required to return results no more than one month from receipt of specimens in the laboratory.
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16.
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What information is collected for HIV drug resistance surveillance and how?
- No extra demographic and clinical information is collected for VARHS.
- Specimen tracking data, most importantly the date of the blood draw, the time of blood draw (within a six hour range), and the date and time of specimen freezing, are collected.
- HIV incidence (STARHS) results, if available, are also collected.
- A local database allows recording of basic data that are recorded for local logistics, eligibility checking, and other routine public health surveillance activity. This information is not sent to the CDC.
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17.
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How is privacy maintained for electronic files sent from the HIV drug resistance (HIVDR) testing laboratory to a health department?
Participating health departments are required to purchase PGP encryption software with at least 128-bit encryption, which requires keys be exchanged between the health department and the HIVDR testing laboratory before HIVDR data can be sent from the laboratory to the health department.
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