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					                                     Safe, Fast and Reliable
                                         A New Generation of HIV Testing




1906 Sunderland Place NW
Washington, DC 20036
P 202.530.8030 F 202.530.8031
www.aidsaction.org




Claudia French, Executive Director
Safe, Fast and Reliable: A New Generation of HIV
Testing was produced by AIDS Action Foundation with
support from the U.S. Department of Health and Human
Services, Centers for Disease Control and Prevention
(CDC). Any opinions expressed herein do not necessarily
reflect the views or policies of the U.S. Department of
Health and Human Services.

AIDS Action is the national voice on AIDS. We are com-
mitted to advocating for people affected by HIV/AIDS
"Until It's Over" --- until no more people become infected
with HIV, until people living with HIV have the care and
support they need, and until a cure is found.

Special thanks to Dr. Bernie Branson of the CDC, and to
Keerthi Gogineni and Michael Isbell, for their invaluable
contributions.
Safe, Fast and Reliable
               A New Generation of HIV Testing


TA B L E           O F      C O N T E N T S




               The State of HIV Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

               Standard (Non-Rapid) HIV Antibody Tests . . . . . . . . . . . . . . . .4

               The Rapid Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

               Accuracy of the Rapid Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

               Issues for Community-Based Organizations . . . . . . . . . . . . . .10

               Impact of Rapid Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

               Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

               Appendix A: The Standard HIV Test vs. the Rapid . . . . . . . . .23

               Appendix B: Positive Predictive
               Value of Rapid HIV Test Combinations . . . . . . . . . . . . . . . . . .24

               Appendix C: Positive Predictive
               Value of a Single Rapid HIV Test Result . . . . . . . . . . . . . . . . . .25

               Appendix D: CDC Guidelines Regarding
               Rapid HIV Tests—Issues for Counselors
               Providing HIV Prevention Counseling . . . . . . . . . . . . . . . . . . .26

               Appendix E: Resources for More Information . . . . . . . . . . . . .32




S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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                                                           The State of HIV Testing

                                                           During the last several years, powerful new drugs
                                                           have emerged for treating HIV disease. These new
                                                           treatments have dramatically reduced AIDS death rates and improved
                                                           the health and well-being of tens of thousands of people with HIV.
“THE     WA I T I N G P E R I O D I S O N E O F T H E
CRUELEST ELEMENTS OF                 HIV     TESTING.      However, not all people with HIV                              infections each year, half of them
IT   I S H AV I N G T O E N D U R E T W O W E E K S
                                                           are benefiting from the treatment                             among young people.
OF HELL.         B E C A U S E O F I T,   PEOPLE
                                                           revolution. AIDS deaths, which
G E T L O S T.    IT IS THE BEST          REASON                                                                         Yet, before people living with
                                                           tumbled 42% in 1997, fell only 20%
F O R E X P E D I T I N G T H I S T E C H N O L O G Y. ”                                                                 HIV/AIDS can begin to maximize
                                                           in 1998. For those who can access
                                                                                                                         the benefits of new treatments
                                                           these treatments and ongoing
Lee Klosinski, AIDS Project Los Angeles                                                                                  and exercise risk reduction, they
                                                           care with a knowledgeable physi-
                                                                                                                         must be aware of their serostatus.
                                                           cian, much of the value of new
                                                                                                                         Too many people cannot take
                                                           treatments has been realized.
                                                                                                                         advantage of treatment opportu-
                                                           Researchers and physicians at the
                                                                                                                         nities or modify their risk behav-
                                                           1999 Conference on Retroviruses
                                                                                                                         iors because they are not even
                                                           and Opportunistic Infections in
                                                                                                                         aware they are HIV positive.
                                                           San Francisco cited the failure of
                                                           drug combinations to help all                                 According to the Centers for Disease
                                                           patients. In spite of these findings,                         Control and Prevention (CDC), near-
                                                           the false notion that promising                               ly 300,000 Americans living with HIV
                                                           therapies are in effect a cure for                            are unaware of their status. As many
                                                           AIDS has helped spawn a frighten-                             as one-third of all HIV-positive peo-
                                                           ing level of complacency. There                               ple in the U.S. do not know they are
                                                           continue to be 40,000 new HIV                                 infected with the virus.


                                                           S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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    Moreover, many of those who get                               There is hope, though, for ensur-                       empowering them                                                  AIDS Action created
    tested learn they are HIV-positive                            ing that virtually everyone who                         to consider critical        U N F O R T U N AT E LY , O V E R    Safe, Fast and
                                                                                                                                                    4 0 % O F T H E N E A R LY T W O
    late in the course of disease —                               seeks HIV testing will get his or her                   treatment options                                                Reliable — A New
                                                                                                                                                     MILLION PEOPLE TESTED
    after the virus has already done                              test results. New rapid HIV tests                       and make safer             E A C H Y E A R I N P U B L I C LY
                                                                                                                                                                                           Generation of HIV
    extensive damage to the immune                                enable providers to offer clients                       decisions. Because        FUNDED COUNSELING AND                  Testing to help
    system. Consequently, many peo-                               pre-test counseling, test results,                      rapid tests are rela-        TESTING SITES NEVER                 navigate the ben-
    ple first learn they are HIV-positive                         and post-test counseling — all in a                     tively inexpensive            RECEIVE THEIR HIV                  efits and chal-
                                                                                                                                                            T E S T R E S U LT S .
    only after they are hospitalized                              single visit. Rapid testing technol-                    and easy to per-                                                 lenges rapid test-
    with an AIDS diagnosis. To care for                           ogy can also save money for test-                       form, they offer the                                             ing poses for com-
    the nearly one million individuals                            ing sites that must otherwise per-                      hope of making testing more                     munity-based organizations and
    living with HIV, the U.S. must first                          form expensive follow-up out-                           accessible by expanding the range               their clients. This guide explores
    ensure that all people who are HIV-                           reach. Such technology will also                        of venues where testing services                current and prospective HIV test-
    positive receive their diagnosis in                           be useful for perinatal and emer-                       are offered. New testing technolo-              ing technology and the issues
    time for treatment to make the                                gency post-exposure antiviral                           gies also save the millions of                  organizations will encounter as
    biggest difference. Furthermore,                              prophylaxis.                                            Americans who test negative each                they seek to incorporate rapid
    the National Institutes of Health                                                                                     year the anxiety and time associated            testing into their HIV testing and
                                                                  The federal government has
    (NIH) has affirmed that early, con-                                                                                   with waiting for their results.                 counseling programs.
                                                                  already licensed one rapid test,
    sistent testing allows for greater
                                                                  and several others are awaiting
    modification of risk behavior.
                                                                  approval. The potential for false
    Unfortunately, over 40% of the                                positives with the use of uncon-
    nearly two million people tested                              firmed rapid test results poses a
    each year in publicly funded coun-                            challenge for testing sites.
    seling and testing sites never
                                                                  However, clear, comprehensive
    receive their HIV test results. In
                                                                  pre/post-test counseling and FDA
    1997 alone, approximately 10,000
                                                                  approval of additional rapid tests
    people, or 30% of those who test-
                                                                  could help ensure that nearly all
    ed positive in publicly funded test-
                                                                  HIV-positive testers receive their
    ing sites, never returned to receive
                                                                  test results without delay —
    this important news.


    S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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    Standard (Non-Rapid) HIV Antibody Tests                                                                               tive for those who
                                                                                                                                                     A RECENT AIDS ACTION
                                                                                                                                                                                            only          FDA-
                                                                                                                          avoid HIV testing                                                 approved home
                                                                                                                                                    SURVEY OF AIDS SERVICE
                                                                                                                          because        they                                               testing kit. The
                                                                                                                                                     O R G A N I Z AT I O N S A C R O S S
    Standard HIV antibody tests, such as enzyme immunoassays                                                              don’t like having        T H E C O U N T R Y F O U N D T H AT
                                                                                                                                                                                            test cost ranges
    (EIA), Western Blots, or immuno-fluorescence assays (IFA), require blood,                                             blood drawn. In a          WA I T I N G T I M E F O R T E S T     from $44 to $55.
    saliva, or urine samples at the testing site. The samples are normally sent                                           Michigan study, a         R E S U LT S A F F E C T S R E T U R N  The user pricks a
                                                                                                                          clinic that began           R AT E S , R E G A R D L E S S O F    finger to collect a
    to an outside laboratory because the standard tests use specialized
                                                                                                                                                   T E S T I N G L O C AT I O N O R H I V
    equipment to evaluate the presence or absence of HIV antibodies.                                                      using a saliva-                                                   dried blood spot
                                                                                                                                                                  S TAT U S .
                                                                                                                          based standard                                                    sample in the
                                                                                                                          test tripled the                                                  home that is then
    The standard HIV test result                                  often experience anxiety during                         number of people tested. An EIA                  sent to a laboratory for process-
    comes from a composite of two                                 the one to two week waiting peri-                       produced by Organon Teknika                      ing. Results are available between
    tests. Specimens for HIV antibody                             od between visits, and many never                       Corporation and a Western Blot                   three to seven business days later.
    testing first undergo a screening                             return for their test results. A                        manufactured by Epitope both                     The convenience and confiden-
    test known as the EIA. If the spec-                           recent AIDS Action survey of AIDS                       screen oral fluid for HIV-1 antibod-             tiality of the Home Access System
    imen tests negative with the EIA,                             service organizations across the                        ies. Researchers have also deter-                have the potential to boost test-
    no further testing is required. If                            country found that waiting time                         mined urine tests accurately                     ing rates overall, but the absence
    the EIA detects HIV antibodies,                               for test results affects return rates,                  screen for HIV-1. Calypte                        of pre- and post-test counseling
    the lab conducts a follow-up con-                             regardless of testing location or                       Biomedical Corporation produces                  raises serious concerns about lost
    firmatory test — either a Western                             HIV status. Consequently, a critical                    EIAs and Western Blots that                      opportunities for support and
    Blot or an IFA. Only after testing                            opportunity for post-test counseling                    screen urine for HIV-1 antibodies.               education. The kit can be pur-
    positive on both the EIA and a                                is lost.                                                                                                 chased over the counter or
    confirmatory test is the specimen                                                                                                                                      ordered directly from the manu-
    verified as HIV positive.
                                                                                                                          Home Tests                                       facturer. Mail delivery takes any-
                                                                  Saliva and Urine Tests                                                                                   where from two days to three
    With the standard test, it normally
                                                                                                                          The Home Access HIV-1 Test
    takes one to two weeks for the lab                            The non-invasive nature of saliva                                                                        weeks, meaning a month may
                                                                                                                          System manufactured by Home
    to return test results to the testing                         and urine tests not only makes                                                                           pass before the client learns of her
                                                                                                                          Access Health Corporation is the
    site. Thus, this test requires a sec-                         them safer alternatives to blood                                                                         or his serostatus.
    ond visit to receive results. Clients                         testing, but also provides incen-


    S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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    The Rapid Test                                                                                                        implementation of
                                                                                                                                                                BECAUSE THE RAPID TEST
                                                                                                                                                                                               ing approval from
                                                                                                                          rapid testing is the                                                 the FDA.         Dr.
    Single Use Diagnostic System (SUDS)                                                                                   lack of a second
                                                                                                                                                          DOES NOT REQUIRE
                                                                                                                                                                                               Bernard Branson
                                                                                                                                                    S P E C I A L I Z E D L A B O R AT O R Y
                                                                                                                          FDA-approved              E Q U I P M E N T T O E VA L U AT E
                                                                                                                                                                                               of the CDC recent-
                                                                                                                          rapid test that               THE SAMPLE, IT CAN                     ly presented pre-
    Rapid tests detect HIV antibodies within five to 30                                                                   could be used as a           E A S I LY B E C O N D U C T E D        liminary findings at
    minutes, enabling results to be given during the same visit at which                                                  confirmatory test                         ON SITE.                   an Association of
    the sample is drawn. Because the rapid test does not require specialized                                              instead     of     a                                                 Public       Health
    laboratory equipment to evaluate the sample, it can easily be conducted                                               Western Blot or IFA.                               Laboratories’ conference demon-
    on site.                                                                                                                                                                 strating        that     Determine,
                                                                                                                          In addition to the SUDS test, other
                                                                                                                                                                             Hemastrip, Quix, Unigold, and
                                                                                                                          nations are already using several
    One rapid HIV test — the Single                               Service (USPHS) recommenda-                                                                                Medmira are rapid tests as accu-
                                                                                                                          rapid HIV tests, including some
    Use Diagnostic System for HIV-1                               tions that require confirmation of                                                                         rate as standard EIAs. New York
                                                                                                                          that are saliva based. The CDC is
    (SUDS), manufactured by Abbott                                reactive test results before they                                                                          state’s newborn HIV screening pro-
                                                                                                                          currently evaluating rapid testing
    Diagnostics — has already                                                                                                                                                gram presently relies on uncon-
                                                                  are given to clients. A recent CDC                      in Uganda, Malawi, Botswana, and
    received federal approval from the                                                                                                                                       firmed SUDS results to make post-
                                                                  study determined that if publicly                       South Africa. Clinical trials of non-
    Food and Drug Administration                                                                                                                                             partum treatment decisions, illus-
                                                                  funded testing programs gave                            SUDS rapid tests are also being
    (FDA). The SUDS test is a blood                                                                                                                                          trating the need for expedited
                                                                  clients unconfirmed screening                           conducted in Los Angeles,
    test. There is currently no saliva or                                                                                                                                    FDA approval for additional rapid
                                                                  results from rapid HIV tests, it                        Chicago, and Phoenix. Several
    urine-based rapid test approved                                                                                                                                          tests (S. Kline, personal communi-
                                                                  would substantially increase the                        such products are currently await-
    by the FDA. At present, the SUDS                                                                                                                                         cation, March 2000).
                                                                  number of people receiving posi-
    test is being used primarily in hos-                          tive and negative HIV test results,
    pitals to obtain HIV results imme-                            but also increase those receiving
    diately following needlestick
                                                                  false positive results. However,
    injuries.
                                                                  studies have demonstrated that
    Rapid testing technology has                                  two different rapid tests used in
    been underutilized due in part to                             tandem virtually eliminate false
    United States Public Health                                   positives. A major barrier to the



    S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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    Accuracy of the Rapid Test                                                                                            HIV prevalence —                                              result on the rapid
                                                                                                                          where one in 200         I N A H I G H - P R E VA L E N C E   test probably does
                                                                                                                          people is infected.             AREA — WHERE                  not indicate actual
    Predictive Value of Rapid HIV Test Combinations                                                                       Here, the coun-           ONE IN TEN PEOPLE IS                infection. Indeed,
                                                                                                                                                  INFECTED — A REACTIVE
                                                                                                                          selor will need to                                            a reactive rapid
    The sensitivity and specificity of the rapid HIV test                                                                 help the person
                                                                                                                                                      R E S U LT O N A S I N G L E
                                                                                                                                                                                        test is only 18%
                                                                                                                                                     RAPID TEST PREDICTS
    are just as good as the EIA. As with the EIA, rapid tests are                                                         understand that              INFECTION 96% OF
                                                                                                                                                                                        predictive of infec-
    only screening tests, and a reactive screening test must be confirmed by                                              there is a likeli-                  THE TIME.                 tion in areas with
    a follow-up test. If, as expected, the federal government approves one or                                             hood he or she is                                             such low preva-
    more additional rapid HIV tests in the future, a second rapid test could be                                           uninfected,                                                   lence. Thus, a sin-
    done on site to validate the initial result. Studies by the CDC and others                                            despite having received a reactive           gle rapid test can be most useful in
    have repeatedly documented that combinations of various different rapid                                               test result.                                 emerging and current “hot-spots”
    tests can be as accurate as the current standard EIA and Western Blot/IFA                                                                                          of the epidemic — areas with high
    — virtually 100%. Once the FDA approves a second rapid test, false pos-                                               In low-prevalence areas — where,
                                                                                                                                                                       HIV prevalence — and in targeting
    itive results can be virtually eliminated, unleashing the full potential of                                           say, only one out of every 1,000
                                                                                                                                                                       hard-to-reach populations. See
    rapid testing technology (see Appendix B).                                                                            people is HIV positive — a reactive
                                                                                                                                                                       Appendix C.



    Predictive Value of a Single                                  96% of the time. There, a coun-
    Rapid HIV Test Result                                         selor should tell a person whose
                                                                  test is reactive that he or she is
    The chance that a reactive rapid
                                                                  probably infected, although a
    test result is erroneous depends in
                                                                  small chance exists that the test
    part on the level of HIV infection in
                                                                  result could be false.
    the community in which the test
    occurs. In a high-prevalence area                             By contrast, there is only a 50%
    — where one in 10 people is                                   chance that a reactive result on a
    infected — a reactive result on a                             single rapid test truly indicates
    single rapid test predicts infection                          infection in an area of moderate



    S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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     Issues for Community-Based Organizations                                                                              tests, but CLIA nonetheless                                   tional procedural steps nor a certi-
                                                                                                                           requires institutions that use these                          fied lab technician. These tests
                                                                                                                           diagnostic products to have a lab                             would appear to meet the require-
     Meeting Infrastructure Requirements                                                                                   director and meet certain require-                            ments for a waiver from CLIA.
                                                                                                                           ments regarding lab procedures.
     The feasibility of rapid testing by smaller community                                                                 CLIA certification is required for
                                                                                                                                                                                         Because many smaller community
     organizations may largely depend on which of the rapid tests are                                                      anyone desiring to perform a test
                                                                                                                                                                                         organizations may be unable to
     ultimately approved by the FDA. Although all of the rapid tests current-                                                                                                            hire a lab director and satisfy CLIA
                                                                                                                           of moderate complexity.
     ly under consideration by the FDA are far simpler to administer than stan-                                                                                                          laboratory requirements, approval
     dard antibody tests, some are more complicated than others.                                                           The various newer rapid tests that                            of one or more moderate-com-
                                                                                                                           are in clinical trials or awaiting fed-                       plexity tests might not be suffi-
                                                                                                                           eral approval include both moder-                             cient to enable such organizations
     The sophistication of laboratory                              that are waived from any certifica-
                                                                                                                           ate-complexity tests and those                                to provide rapid testing services.
     infrastructure required for institu-                          tion requirement. To be waived,
                                                                                                                           that could probably be eligible for                           Waived tests, by definition, are
     tions to perform a diagnostic test                            the test must use unprocessed
                                                                                                                           a CLIA waiver. One group of                                   simple to perform, and approval
     depends on how the test is classi-                            specimens (e.g., pure blood or
                                                                                                                           unapproved rapid tests, for exam-                             of these might well facilitate the
     fied under the federal Clinical                               saliva), require no procedural step
                                                                                                                           ple, uses flow-through devices                                development of many new venues
     Laboratory Improvement Act                                    beyond adding the specimen to
                                                                                                                           that require lab technicians to add                           for rapid community-based HIV
     (CLIA). CLIA established three cate-                          the testing device, and have a
                                                                                                                           reagents at various steps in the                              testing services.         However,
     gories for diagnostic tests. High-                            clear, well-defined end point (e.g.,
                                                                                                                           testing process. Because these                                although some rapid tests may be
     complexity tests — such as the EIA                            positive or negative). Home tests,
                                                                                                                           tests have additional procedural
     and Western Blot — demand elab-                               urine dipstick tests, and the like                                                                                    waived from CLIA certification,
                                                                                                                           steps beyond simply adding the
     orate laboratory equipment and                                are all simple tests that are waived                                                                                  community-based organizations
                                                                                                                           specimen to the device, they
     adherence to rather complicated                               from CLIA’s requirements.                                                                                             will still need to implement meas-
                                                                                                                           would be classified as moderate-
     procedures. To perform high-com-                                                                                                                                                    ures for quality assurance and pro-
                                                                   Between the opposite poles of                           complexity tests and would
     plexity tests such as the standard                                                                                                                                                  ficiency testing. Local health
                                                                   high-complexity and waived tests                        require a laboratory.
     HIV antibody test, labs must be cer-                                                                                                                                                departments can offer communi-
                                                                   are tests of moderate complexity.
     tified under CLIA’s requirements.                                                                                     Other rapid tests awaiting                                    ty-based organizations technical
                                                                   The SUDS test fits in this category.
     At the opposite end of the CLIA                               These tests are less difficult to                       approval, by contrast, use a simple                           assistance to ensure sites are out-
     spectrum are low-complexity tests                             administer than high-complexity                         dipstick that requires neither addi-                          fitted with well-trained personnel.


     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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     Costs of Rapid Testing                                        the positive and negative controls.                     testing services.                                               test counseling in
                                                                   For most clinics, though, batching                      Forty percent of          THE COST EFFECTIVENESS                accordance with
     The EIA costs approximately $2
                                                                   reduces the benefits of rapid test-                     AIDS        service        O F R A P I D T E S T I N G M AY     CDC guidelines
     per test. However, the cost rises to                                                                                                              ENABLE AIDS SERVICE
                                                                   ing because it requires the person                      organizations sur-                                              (see Appendix D).
     about $6 for a negative test result                                                                                                               O R G A N I Z AT I O N S W I T H
                                                                   being tested to wait until enough                       veyed by AIDS                                                   The client can
     and $51 (including confirmatory                                                                                                                   SMALLER BUDGETS TO
                                                                   specimens are available.                                Action did not             OFFER HIV COUNSELING
                                                                                                                                                                                           continue        to
     tests) for a positive result when
                                                                                                                           offer HIV testing          AND TESTING SERVICES.                receive counseling
     accounting for laboratory expens-                             The newer rapid tests may cost as
                                                                                                                           and counseling.                                                 while waiting for
     es associated with processing.                                little as $2 each. Thus running two
                                                                                                                           The organizations                                               the test results.
     These costs are realized from the                             rapid tests will cost $4 versus the
                                                                                                                           most likely to offer on-site services           When the unconfirmed test results
     economy of running a large num-                               $6 per test cost of the EIA for a
                                                                                                                           are those with larger annual budg-              are disclosed, the counselor
     ber of tests in a central laboratory.                         negative test result. The issue of
                                                                                                                           ets (73% of those with budgets                  should make sure the person
     Unfortunately, much of the current                            batching should be minimized
                                                                                                                           over $2 million) and larger preven-             understands what the test results
     cost of testing is wasted if the per-                         once federal approval is given for
                                                                                                                           tion budgets (77% of those with                 mean and provide additional
     son tested never learns the results.                          some of the newer rapid testing
                                                                                                                           budgets over $300,000).                         information, assistance, linkages,
                                                                   technologies. Some tests require
     At approximately $7.50 each, the                                                                                                                                      or referrals based on the client’s
                                                                   that only a positive and negative
     currently available SUDS test costs                                                                                                                                   individual needs.
                                                                   control be run each day or for
     more than the EIA. SUDS requires                                                                                      Counseling Considerations
                                                                   each technician’s shift, rather than                                                                                  For the person who tests HIV
     both a positive and negative con-
                                                                   each time the test is administered.                     Counseling is central to the HIV                              positive, effective counseling
     trol for each test, which brings the
                                                                   For people who come to the clinic                       testing experience. Regardless of                             includes, at the very least, the pro-
     total cost of a negative result to
                                                                   for testing, this means that their                      the mode of testing, every person                             vision of accurate, comprehensi-
     $22.50 per test. Testing sites in
                                                                   test can be performed immediately,                      who learns his or her HIV status                              ble information on available med-
     Columbus, Indianapolis, and
                                                                   without waiting for enough tests                        needs accurate, sensitive, cultural-                          ical and support services.
     Phoenix have found that client
                                                                   to form a batch.                                        ly appropriate counseling to                                  Optimally, the testing center
     requests for the SUDS test have
                                                                                                                           understand the meaning and                                    would take proactive steps to con-
     increased despite the cheaper EIA                             The cost effectiveness of rapid
                                                                                                                           implications of the test result.                              nect the person who tests positive
     alternative. Moreover, clinics can                            testing may enable AIDS service
                                                                                                                                                                                         with a primary care provider or
     reduce the per-test cost by run-                              organizations with smaller budg-                        The person who presents for test-
                                                                                                                                                                                         case manager.
     ning several tests as a batch with                            ets to offer HIV counseling and                         ing should receive extensive pre-


     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
14                                                                                                                                                                                                                                               15




     The rapid test presents at least                              counselor can use the return of a                       Impact of Rapid Testing
     two challenges for community-                                 reactive rapid test result to ease
     based testing sites. First, a reac-                           the news that this confirmatory
     tive result on a single rapid test                            test result may be positive.                            Field Evaluation
     has a somewhat higher chance of
     being false than a confirmed posi-                            It is often perceived that rapid                        CDC undertook a field evaluation of the SUDS
     tive result on the standard test.                             testing will pose a logistical chal-                    product in 1993 at two sites in Dallas County, Texas to learn more
     Thus, the counselor will need to                              lenge to effective counseling. Use                      about the rapid test. The enzyme-linked immunosorbent assay (ELISA)
     clearly explain the meaning of a                              of the rapid HIV test might require                     was used at an anonymous test clinic and a sexually transmitted diseases
     positive test result and the                                  some testing sites to alter or                          (STD) clinic for approximately three months; the rapid test was then used
     chances that it could be incorrect.                           change at least some of their serv-                     for a similar period, and the results of both compared.
                                                                   ices and the way those services
     Clearly, it will be necessary during                                                                                  At the anonymous test clinic, 14%                             received their results, the same
                                                                   are delivered. As with the current
     pre-test counseling to explain the                                                                                    of all positive testers (three out of                         could be said for only 3% (one out
                                                                   test, the rapid test will require a
     nature and limitations of the rapid                                                                                   22) who tested positive using the                             of 31) of positive rapid testers. A
                                                                   follow-up appointment for the dis-
     test about to be administered.                                                                                        standard protocol never received                              notable 97% of HIV-positive indi-
                                                                   closure of confirmed test results. It
     During post-test counseling, par-                                                                                     their test results. By contrast,                              viduals who rapid tested actually
     ticular care will need to be taken in                         would still be possible to make
                                                                                                                           100% (30) of those who tested                                 learned their results — a marked
     helping the person with a reactive                            available on-site case manage-
                                                                                                                           positive using the rapid test actu-                           improvement over the standard
     test understand the test result.                              ment for people returning to                                                                                          HIV test. In order to inform the
                                                                                                                           ally received their positive test
     Extra effort is likely to be required                         receive the results of their confir-                                                                                  34% (10 out of 29) who tested pos-
                                                                                                                           results. The percentage of individ-
     in helping reactive testers cope                              matory tests, so that the person                                                                                      itive on the standard test but did
                                                                                                                           uals testing HIV negative who
     with the stress of waiting for the                            testing positive can receive imme-                                                                                    not return for their results, public
                                                                                                                           received their test results
     return of their confirmatory test,                            diate practical assistance with                                                                                       health workers had to perform
                                                                                                                           increased from 95% to 99% with
     which may take two weeks. The                                 benefits, health care, and the like.                                                                                  time-consuming, expensive out-
                                                                                                                           use of the rapid test.
                                                                                                                                                                                         reach. Among individuals testing
                                                                                                                           The results were even starker in                              HIV negative in STD clinics, the
                                                                                                                           the STD clinic. Whereas 21% (six                              percentage obtaining their test
                                                                                                                           out of 29) of those testing positive                          results rose from 30% on the stan-
                                                                                                                           on the standard test never                                    dard test to 93% on the rapid test.

     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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     Making Testing                                                neighborhood-centered          pro-                     Implications for                                                      such testing, the
                                                                   grams, bars, or street fairs as well                                                          RECENT CDC-SPONSORED            anonymous option
     More Accessible                                                                                                       Anonymous
                                                                                                                                                      R E S E A R C H F O U N D T H AT
                                                                   as needle exchange, street, and                         Testing                                                               is not always acces-
     Whereas current tests normally                                                                                                                 H I V- P O S I T I V E I N D I V I D U A L S
                                                                   mobile     outreach      programs.                                                                                            sible. Whether a
                                                                                                                                                    WHO ARE TESTED ANONY-
     require affiliation with a laboratory                                                                                 The CDC strongly
                                                                   Springfield, Illinois began a pilot                                                M O U S LY T E N D T O L E A R N           community-based
     and adherence to often-compli-                                                                                        encourages states
                                                                   mobile testing program that pro-                                                 O F T H E I R I N F E C T I O N AT A         organization can
     cated administrative regulations,                                                                                     and localities to
                                                                   vides rapid HIV testing for people                                                M U C H E A R L I E R S TA G E O F          perform anony-
     rapid testing is easier to adminis-                                                                                   provide the option           DISEASE THAN THOSE
                                                                   who do not have transportation                                                                                                mous testing is
     ter. With appropriate certification,                                                                                  of     anonymous          T E S T E D C O N F I D E N T I A L LY .
                                                                   and for those who feel uncomfort-                                                                                             normally governed
     community-based testing sites                                                                                         testing for people
                                                                   able in a clinic setting (D.Hunt,                                                                                             by state regula-
     that use this new technology can                                                                                      who wish to learn
                                                                   personal communication, March                                                                             tions. Many states restrict the
     evaluate HIV-tests “in-house.”                                                                                        their HIV status. Recent CDC-
                                                                   2000). Rapid HIV testing can be                                                                           anonymous option solely to public
     FDA approval of low-complexity                                                                                        sponsored research found that
                                                                   made available in non-medical                                                                             testing sites. The clear evidence of
     rapid tests means many communi-                                                                                       HIV-positive individuals who are
                                                                   settings with which people are                                                                            the public health benefits of anony-
     ty-based programs that may not                                                                                        tested anonymously tend to learn
                                                                   familiar and comfortable and                                                                              mous testing, when combined with
     currently perform HIV antibody                                                                                        of their infection at a much earlier
                                                                   therefore more likely to consent to                                                                       the obvious advantages of
     testing — such as community cen-                                                                                      stage of disease than those tested
                                                                   voluntary testing.                                                                                        enabling more people at risk of
     ters, YMCAs, or meals-on-wheels                                                                                       confidentially.
                                                                                                                                                                             infection to learn their serostatus,
     programs — might now be able to                               Rapid       testing     technology
                                                                                                                           There is no reason to believe that                provides local programs with a
     integrate HIV testing into the                                deployed in emergency rooms
                                                                                                                           rapid testing will make anony-                    powerful argument for expansion
     range of services they offer their                            could also play an important role
                                                                                                                           mous testing less accessible. It                  of anonymous testing to communi-
     clients.                                                      in detecting HIV early through vol-
                                                                                                                           merely reflects a technological                   ty-based settings. Rapid tests make
                                                                   untary screening. In 1994 and
     Thus, in addition to increasing the                                                                                   change in the way testing is per-                 this possible.
                                                                   1995, hospital and surgical
     number of people who actually                                                                                         formed. Like the current test,
                                                                   patients accounted for the highest
     receive their HIV test results, rapid                                                                                 rapid testing can be performed
                                                                   percentage of patients not receiv-
     testing could also expand and                                                                                         anonymously or confidentially.                                Discrimination
                                                                   ing their test results.
     diversify the range of venues in
                                                                                                                           Unfortunately, some states do not                             Unfortunately, experience has
     which testing takes place. It
                                                                                                                           currently permit anonymous test-                              shown HIV testing can be used as
     invites greater use of testing by
                                                                                                                           ing, and even in states that allow                            a vehicle for discrimination.


     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
18                                                                                                                                                                                                                                               19




     Surreptitious use of rapid testing                            Potential National Impact                               According to the CDC, if rapid test-                          Like any new technology, rapid
     conceivably could invite discrimi-                            of Rapid Testing                                        ing had been available, it would                              testing poses challenges. But the
     nation in a variety of settings.                                                                                      have resulted in the receipt of test                          potential it offers to revolutionize
                                                                   The impact on the national epi-
     Rapid HIV tests also could                                                                                            results by nearly 30,000 HIV-positive                         testing and prevention campaigns
                                                                   demic could be enormous were
     increase the likelihood of testing                                                                                    people between 1995 and 1997.                                 — to ensure that millions of
                                                                   rapid tests routinely utilized. The
     without consent, for example                                                                                                                                                        Americans receive their HIV test
                                                                   convenience of rapid testing tech-
     mandatory testing of pregnant                                                                                                                                                       results — is truly promising. Rapid
                                                                   nologies may be key to reaching
     women and/or newborns. Rapid                                                                                          On the Horizon                                                testing technology revitalizes the
                                                                   the nearly 300,000 Americans who
     tests could make it easier to force                                                                                                                                                 critical message of early, consis-
                                                                   do not know they are HIV positive.                      Rapid testing technology fills the
     incarcerated individuals, alleged                                                                                                                                                   tent testing. The opportunity to
                                                                   Whereas only two out of three                           critical information gap that hin-
     criminals, and patients to be test-                                                                                                                                                 make HIV testing available in com-
                                                                   people testing HIV positive in STD                      ders the decision-making capacity
     ed when security personnel, crime                                                                                                                                                   munity venues facilitates outreach
                                                                   clinics currently return for their                      of clients who are HIV positive and
     victims, or providers are exposed                                                                                                                                                   to individuals who might other-
                                                                   results, rapid testing provides 97%                     negative as well as those who
     to bodily fluids. Finally, rapid tests                                                                                                                                              wise be apprehensive of AIDS
                                                                   of all positive testers with their test                 need to make urgent treatment
     could aggravate concerns about                                                                                                                                                      service organizations or health
                                                                   results. In STD clinics, the number                     decisions perinatally, post-partum,
     confidentiality and consent that                                                                                                                                                    clinics. Community-based organi-
                                                                   of HIV-positive individuals who                         or after occupational exposure.
     may arise with private or public                                                                                                                                                    zations can promptly assuage the
                                                                   would receive their test results                        The CDC is developing an
     screening for benefits or services.                                                                                                                                                 anxiety of clients who test nega-
                                                                   without costly outreach would be                        expanded access program to help
                                                                                                                                                                                         tive and offer immediate support
     In virtually all situations, such dis-                        43% greater with the rapid test                         meet these needs while ensuring
                                                                                                                                                                                         and services for those who test
     crimination would be illegal under                            than with the current standard test.                    that rapid testing technology is
                                                                                                                                                                                         positive. With FDA approval of
     current statutes such as the                                                                                          thoroughly “road-tested.” An
                                                                   With rapid testing, the number of                                                                                     additional invasive and non-inva-
     Americans With Disabilities Act.                                                                                      expanded access program would
                                                                   HIV-positive people receiving                                                                                         sive rapid HIV tests, there is
     Preventing such transgressions,                                                                                       enable community-based organi-
                                                                   results could be 32% greater in                                                                                       tremendous potential to reduce
     however, will require vigilance by                                                                                    zations to offer rapid tests await-
                                                                   drug treatment settings, 18%                                                                                          the number of new infections and
     community advocates and by all                                                                                        ing approval from the FDA while
                                                                   greater in HIV counseling and test-                                                                                   to draw hundreds of thousands of
     levels of government to ensure                                                                                        simultaneously gathering data to
                                                                   ing sites, 26% greater in family                                                                                      HIV-positive Americans into a sys-
     that the clear benefits of rapid                                                                                      expedite the approval process.
                                                                   planning clinics, and 33% greater in                                                                                  tem of care and support.
     testing are not diluted by illegal
                                                                   other publicly funded testing sites.
     acts of discrimination.


     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
20                                                                                                                                                                                                                                               21


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     Altman, L.K. (2000, February 8).                              CDC. (2000, June). CDC points
                                                                                                                           and/or HIV-2 in human sera                                    hivkits.html.
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     AIDS. The New York Times, D1.                                 Testing Day and knowledge of
                                                                   serostatus [webpage]. Retrieved
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                                                                   from the World Wide Web:
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                                                                   www.cdc.gov/hiv/nhtd/nhtdpr.pdf.
                                                                                                                           Studies
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     and hepatitis tests [webpage].                                CDC. (1998, August 31). Rapid                           Branson, B., Woehrle, T.,                                     Giles, R.E., Perry, K.R., & Parry,
     Retrieved from the World Wide                                 HIV testing [webpage].                                  Fridlund, C., Granade, T., &                                  J.V. (1999). Simple/rapid test
     Web: www.fda.gov/cber/                                        Retrieved from the World Wide                           Hall, L. (2000). Accuracy of                                  devices for anti-HIV screening:
     products/testkits.htm.                                        Web: www.cdc.gov/hiv/pubs/rt.htm.                       newer whole-blood rapid tests                                 Do they come up to the mark?
                                                                                                                           for HIV antibody. Program and                                 Journal of Medical Virology,
     Centers for Disease Control and                               Cimons, M. (2000, June 14).                             Abstracts, Human Retrovirus                                   59(1), 104-109.
     Prevention (CDC). (1998, March                                FDA blamed for holding up                               Testing Committee, Association
     27). Rapid HIV tests: Issues for                              rapid AIDS tests. Los Angeles                                                                                         Kassler, W. J., Dillon, B.A.,
                                                                                                                           of Public Health Laboratories
     counselors providing HIV pre-                                 Times, 10.                                                                                                            Haley, C., et al. (1997). On-site,
                                                                                                                           Conference.
     vention counseling [webpage].                                                                                                                                                       rapid HIV testing with same-day
     Retrieved from the World Wide                                 French, N., Mpiirwe, B.,                                Branson, B. (1998). Home                                      results and counseling. AIDS, 11,
     Web: www.cdc.gov/hiv/pubs/rt/                                 Namara, A.H., & Kyalo, G.                               sample collection tests for                                   1045-51.
     rapidct.htm.                                                  (1997). HIV testing strategies at                       HIV infection. Journal of the
                                                                   a community clinic in Uganda                                                                                          Kelen, G.D., Shahan, J.B., &
                                                                                                                           American Medical Association,
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                                                                                                                           280(19), 1699-1701.
     HIV tests: Issues for laboratori-                                                                                                                                                   department-based HIV screen-
     ans [webpage]. Retrieved from                                 Mphuka, S., Mazuwa, B.,                                 CDC. (1998). Update: HIV coun-                                ing and counseling: Experience
     the World Wide Web:                                           Muyinda, G., et al. (1998).                             seling and testing using rapid                                with rapid and standard sero-
     www.cdc.gov/hiv/pubs/rt/                                      Evaluation of the introduction of                       tests — United States, 1995.                                  logic testing. Annals of
     rapidfs.htm.                                                  low-cost HIV testing technolo-                          Morbidity and Mortality Weekly                                Emergency Medicine, 33(2),
                                                                   gies into rural hospitals in                            Report, 47(11), 211-215.                                      147-55.
     CDC. (1998, March 27). Rapid                                  Zambia. International
     HIV tests: Questions/answers                                  Conference on AIDS, 12:799                              CDC. (1998). HIV testing -–                                   Lake Snell Perry & Associates.
     [webpage]. Retrieved from the                                 (abstract no. 42133).                                   United States, 1996. Morbidity                                (2000). AIDS Action’s prevention
     World Wide Web: www.cdc.gov/                                                                                          and Mortality Weekly Report,                                  survey: Analysis of a mail survey
     hiv/pubs/rt/rapidqas.htm.                                     Rodgers, L. (1999, April 13).                           48(3), 52.                                                    of AIDS service organizations.
                                                                   Mobile unit will make HIV test-                                                                                       Washington, DC: AIDS Action
     CDC. (1998, August 31). Using                                 ing available to more residents.                        CDC. (1999, August 30). New                                   Foundation.
     rapid testing in HIV counseling                               The State Journal-Register, 9.                          data show continued decline in
     and testing programs [web-                                                                                            AIDS deaths [press release].                                  Randall, L., Pope, R.S., Ives, E.,
     page]. Retrieved from the World                               World Health Organization.                              Retrieved from the World Wide                                 Lapinski, M. et al. (1998). New
     Wide Web: www.cdc.gov/hiv/                                    (undated). HIV test kits:                               Web: www.cdc.gov/od/oc/                                       testing technologies to enhance
     pubs/rt/index.htm.                                            Comparative evaluation of the                           media/pressrel/r990831.htm.                                   HIV prevention: Evaluation of


     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
22                                                                                                                                                                                                                                                 23


     oral mucosal transudate-based                                 Stetler, H.C., Granade, T.C.,                           Appendix A:
     HIV testing. International                                    Nunez, C.A., et al. (1997). Field
                                                                                                                           The Standard HIV Test vs. the Rapid Test
     Conference on AIDS, 12:868                                    evaluation of rapid HIV serolog-
     (abstract no. 43106).                                         ic tests for screening and con-
                                                                   firming HIV-1 infection in
     Randall, L.M., et al. (1999).                                 Honduras. AIDS, 11, 369-75.                                                                      Standard Test                                   Rapid Test
     Effectiveness of oral mucosal
     transudate HIV testing: Findings                              Tao, G., Branson, B., Kassler, W.,                         Type of Test                            EIA (Enzyme                             SUDS (Single Use
     from Michigan’s evaluation.                                   & Cohen, R. (1999). Rates of                                                                      Immunoassay)                             Diagnostic System)
     Proceedings of the Centers for                                receiving HIV test results: Data
     Disease Control and Prevention                                from the U.S. National Health                              Detects                               HIV Antibodies                              HIV Antibodies
     1999 National HIV Prevention                                  Interview Survey for 1994 and
     Conference (abstract no. 690).                                1995. Journal of Acquired                                  Confirmatory Test                      If reactive,                                If reactive,
                                                                                                                                                                  Western Blot or IFA                         Western Blot or IFA
                                                                   Immune Deficiency Syndromes,
     Spielberg, F., Golbaum, G.,                                   22, 395-400.
     Branson, B., & Wood, B. (1999).                                                                                          Waiting Period for                       1-2 weeks                                    5-30 minutes
     Acceptance of alternate HIV                                   Urnovitz, H.B., Sturge, J.C.,                              Test Results
     counseling and testing strate-                                Gottfried, T.D., & Murphy, W.H.
                                                                                                                              Number of Visits                                    2                                   1 or 2*
     gies. Proceedings of the                                      (1999). Urine antibody tests:
     Centers for Disease Control and                               New insights into the dynamics                             Cost**                                             $6.00                                    $22.50
     Prevention 1999 National HIV                                  of HIV-1 infection. Clinical
     Prevention Conference (abstract                               Chemistry, 45(9), 1602-1613.
     no. 420).                                                                                                                Testing Site                            Centralized                          Potential for any site to
                                                                                                                                                                      laboratories                       provide HIV testing services
     Spielberg, F., Golbaum, G.,
     Branson, B., & Wood, B. (1999).                                                                                          Counseling Issues                   Possibility that HIV+                     More likely to link those
     “By all means necessary:” HIV                                                                                                                                 individual will not                       who test + w/services
     counseling and testing prefer-                                                                                                                              return for test results                    & counseling regarding
     ences among individuals at high                                                                                                                                                                            risk reduction
     risk. Proceedings of the Centers
     for Disease Control and                                                                                                                                        Outreach costs                            Greater chance for
     Prevention 1999 National HIV                                                                                                                                                                               false positives
     Prevention Conference (abstract
                                                                                                                                                               Ability for case-manager                    Need for available on-site
     421).
                                                                                                                                                                  to prearrange for                          case management
                                                                                                                                                               post-test + counseling


                                                                                                                           *One visit for a negative result and a second visit for a positive result.
                                                                                                                           **Total cost of a negative result. The cost of a negative rapid test result could drop to $4
                                                                                                                           with FDA approval of the newer rapid tests.




     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :    A   N E W   G E N E R A T I O N   O F    H I V   T E S T I N G
24                                                                                                                                                                                                                                                 25


     Appendix B:                                                                                                            Appendix C:
     Positive Predictive Value of Rapid HIV Test Combinations                                                               Positive Predictive Value of a Single Rapid HIV Test Result

        Positive Predictive Value of HIV Tests for Screening and Confirmation                                                              Positive Predictive Value of HIV Tests in Populations with
          of HIV Infection in Populations with Low HIV Prevalence (1.5%)*                                                                                  Differing HIV Prevalence*


                                                                               Predictive
                                 Combination**                                     Value                                                                HIV                                           Predictive
                                     Abbott EIA + Gen Svs EIA                         100%                                                              Prevalence                                        Value
                                     Abbott EIA + HIVCHEK                             100%                                                                  10%                                                96%
                                     Abbott EIA + Genie                               100%                                                                  5%                                                 91%
                                     Abbott EIA + Retrocell                           100%                                                                  2%                                                 80%
                                     Retrocell + HIVCHEK                              100%                                                                  1%                                                 67%
                                     Retrocell + Genie                                100%                                                                  0.5%                                               50%
                                     HIVCHEK + Genie                                  100%                                                                  0.3%                                               38%
                                                                                                                                                            0.1%                                               18%

        * Calculated for test with sensitivity 77-100%, specificity 99.6-100%
        ** Stetler et al., AIDS 1997 (cited in Branson, 2000)                                                                  * Calculated for test with sensitivity 99.9%, specificity 99.6%



        The above table demonstrates that the use of two screening tests —
        either rapid tests or EIAs — is comparable to the presently approved                                                   The one currently available FDA-licensed rapid HIV antibody test has a
        protocol of an EIA and Western Blot to confirm positive results. For                                                   sensitivity of 99.9% and a specificity of 99.6%. This means, for example,
        example, if 1,000 people were tested with any of the last three combina-                                               if 1,000 people were tested with this rapid HIV test, an STD clinic with an
                                                                                                                               HIV prevalence of 10% would expect to see 100 true positives and four
        tions of rapid HIV tests, an STD clinic with an HIV prevalence of 1.5%
                                                                                                                               false positives, for a positive predictive value of 96% for the HIV rapid test
        would expect to see 100 true positives and 0 false positives, for a posi-
                                                                                                                               result (i.e. 96% of the persons with a positive test result would be truly
        tive predictive value of 100% for the HIV rapid test results (i.e.100% of                                              positive). Use of the same test on 1,000 clients in a family planning clinic
        those with a positive test result would be truly positive).                                                            with an HIV prevalence of 0.4% would yield four true positives and four
                                                                                                                               false positive results, for a positive predictive value of 50% for the HIV
        Abbott EIA and Gen Sys EIA are both standard HIV screening tests.                                                      rapid test result (four of the eight individuals with reactive test results
        Retrocell, HIVCHEK, and Genie are all rapid screening tests that are not                                               would be truly positive).
        authorized for use in the U.S. Abbott, which produced Retrocell, is now
        developing a different rapid test called Determine. Ortho-McNeil pro-
        duced HIVChek. Genie is now known as Multispot and is produced by
        BioRad.




     S A F E   ,   F A S T   A N D    R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D    R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
26                                                                                                                                                                                                                                               27


     Appendix D:                                                                                                           Counseling should still include a                             every reactive rapid test must be
                                                                                                                           personalized client risk assess-                              confirmed by a supplemental test
     CDC Guidelines Regarding Rapid HIV Tests —                                                                            ment and should be interactive.                               (either Western blot or an immuno-
     Issues for Counselors Providing HIV Prevention Counseling                                                             Special attention should be given                             fluorescence assay [IFA]), as is done
                                                                                                                                                                                                                             (3)
                                                                                                                           to the ongoing behaviors and cir-                             currently for EIA-positive results.
                                                                                                                           cumstances that place the client at                           However, studies have shown that
     Why Provide Rapid HIV Testing?                                What Are Considerations for                             risk of acquiring or transmitting                             an assessment of behavioral risk
                                                                   HIV Prevention Counseling with                          HIV infection.                                                factors can substantially improve
     Rapid HIV tests provide opportu-
                                                                   Rapid HIV Tests?                                                                                                      the predictive value of an HIV
     nities for persons to learn their HIV
                                                                                                                           Clinical studies have demonstrat-
     antibody test results on the day                              Rapid HIV testing will change how                                                                                     screening test. That is, a reactive
                                                                                                                           ed that the sensitivity and the
     they are tested. Use of rapid HIV                             and when HIV prevention counsel-                                                                                      test for an individual with risk
                                                                                                                           specificity of rapid HIV tests are
     tests can substantially increase the                          ing is delivered. Counseling might                                                                                    behavior(s) is more likely to repre-
                                                                                                                           comparable to those of the
     number of uninfected persons                                  increase from one session per client                                                                                  sent a true positive than is a reac-
                                                                                                                           enzyme immunoassays (EIAs) cur-
     who learn their HIV status.                                   (HIV risk assessment) to two ses-                                                                                     tive test for an individual with no
                                                                                                                           rently used for screening. The
     Furthermore, HIV-infected per-                                sions (HIV risk assessment and test                                                                                   identifiable risks for HIV. (See
                                                                                                                           negative predictive value of
     sons may learn their status sooner.                           results) per client in a single day.                                                                                  Appendix: Positive Predictive Value
                                                                                                                           screening tests is high at the HIV
                                                                                                                                                                                         for Rapid HIV Tests.)
     Approximately 2.0 to 2.5 million                              Experience to date in counseling                        prevalence observed in most U.S.
     tests are conducted annually in                               clients tested with the rapid HIV                       testing settings. Thus, a negative                            Each clinic will need to establish
     publicly funded counseling and                                test comes from several public                          rapid HIV test result means that                              its own policy to guide counselors
     testing (CT) programs. In 1996,                               health clinics in the United States                     the client is negative for HIV anti-                          in the correct interpretation of
     only 41% of these were performed                              that have instituted their routine                      body and need not return for a                                reactive rapid HIV test results.
     for persons who said they had not                             use. Techniques developed for                           second visit.                                                 These policies will need to take
     been tested before. However,                                  counseling clients receiving rapid                                                                                    into consideration the proportion
                                                                                                                           The content of the prevention
     many persons do not return for                                test results have been published.                                                                                     of reactive rapid-test results that
                                                                                                                           counseling session before provid-
     their test results: 26% of persons                            (1)
                                                                       Additional counseling guidance                                    (2)                                             may be false-positive. This pro-
                                                                                                                           ing a reactive test result will have
     who tested HIV-positive during                                is being developed in collabora-                                                                                      portion will differ, as it depends on
                                                                                                                           to be tailored to each person,
     1996 and 33% of persons who                                   tion with CDC’s prevention part-                                                                                      the prevalence of HIV infection
                                                                                                                           because it involves both an under-
     tested HIV-negative did not                                   ners as we acquire more experi-                                                                                       among the clients tested. Staff of
                                                                                                                           standing of the technical aspects of
     return. (HIV CT Client Record                                 ence with rapid HIV tests. In the                                                                                     each clinic should develop sug-
                                                                                                                           screening tests and an assessment
     Report, 1996 U.S. Total; CDC,                                 interim, the information here can                                                                                     gested language for counselors to
                                                                                                                           of each client’s behavioral risk for
     unpublished data.) The use of                                 help staff as they begin to provide                                                                                   use when explaining the results of
                                                                                                                           HIV infection. Because the positive
     rapid HIV testing can help resolve                            prevention counseling to clients                                                                                      reactive rapid HIV tests.
                                                                                                                           predictive value of a test is low in
     this problem, because it enables                              who are receiving same-day
                                                                                                                           populations with low prevalence,
     persons to learn their HIV status                             results from rapid HIV tests.
     on the day they are tested.
     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
28                                                                                                                                                                                                                                               29


     Should We Provide Client-                                     Providing Prevention                                       explaining rapid test results,                                 rapid test results, some clients
     Centered Prevention                                           Counseling with Rapid Testing                              especially if the rapid test                                   with recent risk exposures will
     Counseling with Rapid Testing?                                                                                           should be reactive.                                            need to be retested after suffi-
                                                                   General Considerations
                                                                                                                                                                                             cient time has elapsed since
     Yes. CDC is currently revising its                                                                                    • be used as an opportunity to
                                                                   After learning the test results,                                                                                          their most recent risk exposure
     guidance for HIV counseling, test-                                                                                      help the client develop a realis-
                                                                   many HIV-negative clients may not                                                                                         in order to verify that they are
     ing, and referral to incorporate new                                                                                    tic and incremental plan for
                                                                   receive counseling beyond that                                                                                            HIV negative.
     information about counseling as                                                                                         reducing risk, regardless of the
                                                                   provided with their test results,
     well as new developments in test-                                                                                       client’s HIV test result.
                                                                   and clients who receive reactive
     ing technology. HIV prevention                                                                                                                                                      Communicating Reactive
                                                                   screening test results may be too
     counseling should follow the con-                                                                                                                                                   Rapid HIV Test Results
                                                                   worried to focus on developing a                        Communicating Negative
     cepts of client-centered counseling                                                                                                                                                 One of the more challenging
                                        (4)
                                                                   personalized risk reduction plan.                       Rapid HIV Test Results
     currently recommended by CDC.                                                                                                                                                       counseling issues posed by the
                                                                   Therefore,     the     counseling                       Counselors communicating nega-
                                                                                                                                                                                         introduction of rapid HIV tests is
     • The focus of the counseling                                 received by the client before test-                     tive rapid HIV test results should
                                                                                                                                                                                         providing reactive rapid HIV test
       session is on developing pre-                               ing takes place at a crucial inter-                     do the following:
                                                                                                                                                                                         results to clients without the bene-
       vention goals and strategies                                vention point.
                                                                                                                           • review the protective behaviors                             fit of a same- day confirmatory
       with the client, rather than
                                                                   Counseling before rapid HIV test-                         that have helped the client                                 test. Currently, confirmatory tests
       simply providing information.
                                                                   ing should                                                avoid infection with HIV and                                results are usually not available for
     • All prevention counseling should                                                                                      reinforce the client’s plan to                              1 to 2 weeks.
                                                                   • ensure that the client is aware
       be “client-centered.” Counseling                                                                                      remain uninfected.
                                                                     that rapid testing is being used                                                                                    Counselors providing reactive
       should be interactive, allowing
                                                                     and that he or she can receive                        • ensure that the client is aware                             rapid HIV test results should do
       the counselor to recognize and
                                                                     test results during this visit.                         that, as is true of any antibody                            the following:
       respond to each client’s needs.
                                                                                                                             test, the negative HIV test result
                                                                   • include an explanation of a                                                                                         • Explain the meaning of the
     • HIV counseling should result in                                                                                       may be unreliable when risk
                                                                     reactive screening test result,                                                                                       reactive screening test result
       a realistic and incremental per-                                                                                      exposure has been very recent.
                                                                     and a statement about the                                                                                             and communicate the likelihood
       sonalized plan for the client to                                                                                      Specifically, the client needs to
                                                                     necessity for a waiting period of                                                                                     of HIV infection.
       reduce his or her risk of                                                                                             be informed that after a person
                                                                     1 to 2 weeks for the confirmato-
       acquiring or transmitting HIV.                                                                                        is infected with HIV, it takes time                             The phrase the counselor
                                                                     ry test result.
                                                                                                                             (average, 25 days) before anti-                                 chooses when providing the
     • Quality assurance must be in
                                                                   • help the client specify behaviors                       bodies develop that can be                                      test result should be simple. For
       place to ensure that appropri-
                                                                     that place him or her at risk for                       detected by the test.                                           example, a counselor may say,
       ate, competent, and sensitive
                                                                     HIV. It is useful to explain that
       methods are used for risk                                                                                           • Although most persons who are                                   Your first screening test came
                                                                     understanding the risk behav-
       assessments, counseling, and                                                                                          tested can rely on their negative                               back reactive.
                                                                     iors of clients is important in
       referral of clients.
     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
30                                                                                                                                                                                                                                               31


          Counselors may use the follow-                               ... likely to be infected                                firmed), give options for sup-                               result of the confirmatory test.
          ing language to emphasize the                                                                                         port, and make psychosocial
                                                                       ...a good chance of being infected                                                                                • If the confirmatory test result is
          importance of a confirmatory                                                                                          referrals.
                                                                                                                                                                                           positive, help with partner noti-
          test, especially in settings that                        Other phrases can be used when
                                                                                                                           • Verify the client’s locating infor-                           fication and make medical refer-
          have low HIV prevalence and                              the counselor wishes to convey
                                                                                                                             mation, so that it will be possi-                             rals, after discussing these with
          thus a high proportion of false-                         that the reactive rapid HIV test
                                                                                                                             ble to contact the client if he or                            the client and obtaining the
          positive screening test results                          result probably means the client is
                                                                                                                             she does not return for the                                   client’s cooperation.
          (true of many family planning                            truly infected:
          clinics):
                                                                       ... probably infected
     • There is a possibility you are HIV
                                                                       ...very likely (or highly likely)
       infected, but we won’t know for
                                                                       infected.
       sure until we get the results
       from your confirmatory test.                                    ...a very good chance of being
                                                                       infected.
     or
                                                                   • Do not initiate partner notifica-
     • We need to verify this result with
                                                                     tion or provide medical refer-
       a follow-up test.
                                                                     rals, but advise the client to
          Or counselors may use phrases                              adopt behaviors to prevent HIV
          that convey a higher likelihood                            transmission (i.e., to act as if he
          of infection. These phrases                                or she is HIV infected) until the
          require skill and good judg-                               reactive rapid test result has                        References for Appendix D
          ment. The counselor will need                              been confirmed.
                                                                                                                           1.     Kassler WJ, Dillon BA, Haley C, et al. On-site rapid HIV testing with same day
          to explain the test result on the                                                                                       results and counseling. AIDS 1997;11:1045-51.
                                                                   • Schedule a return visit for confir-
          basis of the prevalence of HIV
                                                                     matory test results, explaining                       2.     “Reactive rapid test” as used in this paper means a repeatedly reactive
          infection in their clinic, and from                                                                                     rapid test, i.e., the same test was performed twice and was reactive both
                                                                     that the confirmatory test is
          the assessment of the client’s                                                                                          times.
                                                                     important but that it cannot be
          risks that was made during the
                                            (5)                      done in one day.                                      3.     Centers for Disease Control. Interpretation and use of the Western blot
          prevention counseling session.                                                                                          assay for serodiagnosis of human immunodeficiency virus type 1 infections.
                                                                   • Discuss whether and how to dis-                              MMWR 1989; 38(suppl 7): S4-S6.
          Several phrases can be used
                                                                     close the results of the reactive                     4.     Centers for Disease Control and Prevention. HIV counseling, testing and
          when the counselor is less cer-
                                                                     rapid test to partners and other                             referral - standards and guidelines. Atlanta: CDC, May 1994.
          tain whether the reactive rapid
                                                                     persons important to the client                       5.     Centers for Disease Control and Prevention. Technical guidance on HIV
          HIV test result means the client
                                                                     (before the test result is con-                              counseling. MMWR 1993; 42: (RR-2).
          is truly infected:


     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
32                                                                                                                                                                                                                                                 33


     Appendix E:
     Resources for More Information


     • Centers for Disease Control and Prevention                                                                           • U.S. Food and Drug Administration

                   For more information on rapid HIV testing and HIV prevention                                                           FDA Center for Biologics Evaluation and Research (CBER)
                   counseling, agencies or jurisdictions receiving HIV prevention funds                                                   Licensed / Approved HIV Tests Website:
                   should contact their CDC project officer. Others should contact:                                                       http://www.fda.gov/cber/products/testkits.htm

                   Kay E. Lawton, RN, MN
                   Deputy Chief, Prevention Services Research Branch
                   Division of HIV/AIDS Prevention — Surveillance and Epidemiology                                          • World Health Organization
                   NCHSTP, CDC
                                                                                                                                          For information on HIV test kits commercially available for use in
                   1600 Clifton Road, E-46
                                                                                                                                          other nations: http://www.who.int/pht/blood_safety/hivkits.html
                   Atlanta, GA 30333
                   (404) 639-6131phone
                   (404) 639-2029 fax
                   kel1@cdc.gov

                   For information on referrals to counseling and testing sites, contact:
                   CDC National AIDS Hotline
                   (English) 800-342-2437
                   (Spanish) 800-344-7432
                   (TTY) 800-243-7889

                   For information on CDC-sponsored training
                   for performing HIV testing, contact:
                   National Laboratory Training Network
                   (telephone) 770-488-7811
                   CDC Division of HIV/AIDS Prevention Website:
                   http://www.cdc.gov/hiv/dhap.htm

                   CDC Division of HIV/AIDS Rapid Testing Website:
                   http://www.cdc.gov/hiv/pubs/rt.htm


     S A F E   ,    F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,    F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
34                                                                                                                                                                                                                                                     35

     AIDS Action’s Contributing Organizations
     (AIDS Action board members in bold)




     Action for a Better Community - Action Front                        AIDS Service Center, Pasadena, CA                       Association of Schools of Public Health,                      Community AIDS Network - Ohio, Akron, OH
         Center, Rochester, NY                                           AIDS Service for the Monadnock Region, Keene, NH            Washington, DC                                            Community Care HIV/AIDS Program, Ukiah, CA
     ADAP Working Group, Washington, DC                                  AIDS Services Center Coalition, Inc., Louisville, KY    Association of State and Territorial Health                   Community Health Awareness Group, Detroit, MI
     Advocates For Youth, Washington, DC                                 AIDS Services Foundation Orange County,                     Officials, Washington, DC                                 Community Health Law Project, Bloomfield, NJ
     African Services Committee, Inc., New York, NY                          Irvine, CA                                          Aunt Bee’s Laundry, Los Angeles, CA                           Community Healthcare Network Inc., New York, NY
     African-American AIDS Support Services and                          AIDS Services of Dallas, Dallas, TX                     Bailey House, Inc., New York, NY                              Community Prescription Services, Inc., New York, NY
         Survival Institute, Inglewood, CA                               AIDS Services of North Texas, Inc., Denton, TX          Bering Omega Community Services, Houston, TX                  Community Research Initiative, Brookline, MA
     AID Atlanta, Atlanta, GA                                            AIDS Survival Project, Atlanta, GA                      Berks AIDS Network, Reading, PA                               Comprehensive AIDS Program of Palm Beach
     AIDS Action Committee of Massachusetts,                             AIDS Task Force of Alabama, Birmingham, AL              Better Existence With HIV, Evanston, IL                           County, Inc., Belle Glade, FL
         Boston, MA                                                      AIDS Task Force Ft. Wayne, Fort Wayne, IN               Bienestar Health Services, Inc., Los Angeles, CA              Comprehensive AIDS Resource Education, Long
     AIDS Administration - Maryland Department of                        AIDS Taskforce of Greater Cleveland, Cleveland,         Billy De Frank Lesbian and Gay Community Center,                  Beach, CA
         Health and Mental Hygiene, Baltimore, MD                            OH                                                      San Jose, CA                                              Comprehensive Substance Abuse Program,
     AIDS Alliance for Children, Youth & Families,                       AIDS Vaccine Advocacy Coalition, Washington, DC         Boulder County AIDS Project, Boulder, CO                          Virginia Beach, VA
         Washington, DC                                                  AIDS Volunteers of Cincinnati, Cincinnati, OH           Broward House, Inc., Fort Lauderdale, FL                      Connecticut AIDS Residence Coalition, Hartford, CT
     AIDS ARMS, Inc., Dallas, TX                                         AIDS Walk Kansas City, Kansas City, MO                  CAEAR Coalition, Washington, DC                               Connecticut Positive Action Coalition, Hartford, CT
     AIDS Care Ocean State, Providence, RI                               AIDSCARE, Inc., Chicago, IL                             Cambridge Cares About AIDS, Inc., Cambridge, MA               County of Los Angeles, Los Angeles, CA
     AIDS Community Alliance, Lancaster, PA                              AIDServe Indiana, Inc., Indianapolis, IN                Caracole, Inc., Cincinnati, OH                                CRI-Help, Inc., North Hollywood, CA
     AIDS Community Services of Western New York,                        Albany Medical Center AIDS Program, Albany, NY          CARES, Kalamazoo, MI                                          D.C. Comprehensive AIDS Resource and Education
         Inc., Buffalo, NY                                               All Souls AIDS Task Force, New York, NY                 Catholic Charities of The Archdiocese of San                      Consortium, Washington, DC
     AIDS Consortium of Southeast Michigan, Detroit, MI                  Allan Guttmacher Institute, New York, NY                    Francisco, San Francisco, CA                              Damien Ministries, Inc., Washington, DC
     AIDS Council of Northeastern New York, Inc.,                        American Academy of Family Physicians,                  Catholic Charities USA, Alexandria, VA                        David’s House of Compassion, Toledo, OH
         Albany, NY                                                          Washington, DC                                      CBAF, Inc., Corpus Christi, TX                                Delaware HIV Consortium, Wilmington, DE
     AIDS Council of Western Virginia, Roanoke, VA                       American Academy of Pediatrics, Washington, DC          Center for AIDS Research Education and Services,              Department of Health and Mental Hygiene,
     AIDS Delaware, Wilmington, DE                                       American Association for World Health,                      Sacramento, CA                                                Baltimore, MD
     AIDS Education Training Centers                                         Washington, DC                                      Center for Community Alternatives, New York, NY               Desert AIDS Project, Inc., Palm Springs, CA
     AIDS Foundation Miami Valley, Dayton, OH                            American Civil Liberties Union, Inc., Washington, DC    Center for Health Policy Development, Inc.,                   Doorways, Interfaith Residence, St. Louis, MO
     AIDS Foundation of Chicago, Chicago, IL                             American Dental Education Association,                      San Antonio, TX                                           Douglas County AIDS Project, Lawrence, KS
     AIDS Healthcare Foundation, Los Angeles, CA                             Washington, DC                                      Center For Women Policy Studies, Washington, DC               Drug Policy Foundation, Washington, DC
     AIDS Help, Inc., Key West, FL                                       American Federation of State, County and                Central Florida AIDS Unified Resources, Inc.,                 Economic Opportunity Family Health Center, Inc.,
     AIDS Housing Corporation, Boston, MA                                    Municipal Employees, Washington, DC                     Orlando, FL                                                   Miami Springs, FL
     AIDS Legal Referral Panel, San Francisco, CA                        American Foundation for AIDS Research,                  Central Ohio HIV Consortium, Columbus, OH                     Elizabeth Glaser Pediatric AIDS Foundation,
     AIDS Network, Madison, WI                                               Washington, DC                                      Central Ohio Ryan White Consortium,                               Washington, DC
     AIDS Network of Western New York, Buffalo, NY                       American Friends Service Committee, Washington, DC          Columbus, OH                                              Emory University School of Medicine - Southeast
     AIDS Nutrition Services Alliance, Washington, DC                    American Lung Association, Washington, DC               Chase-Brexton Health Services, Inc., Baltimore, MD                AIDS ETC, Atlanta, GA
     AIDS Outreach Center, Fort Worth, TX                                American Nurses Association, Washington, DC             Chicken Soup Brigade, Seattle, WA                             Episcopal Church, Washington, DC
     AIDS Partnership Michigan, Detroit, MI                              American Psychiatric Association, Washington, DC        City of Chicago Department of Public Health,                  Escambia AIDS Services and Education,
     AIDS Project Arizona, Phoenix, AZ                                   American Psychological Association, Washington, DC          Chicago, IL                                                   Pensacola, FL
     AIDS Project Los Angeles, Los Angeles, CA                           American Public Health Association,                     City of Chicago Office of City Comptroller, Chicago, IL       Exponents, Inc.- Arrive Project, New York, NY
     AIDS Project Rhode Island, Providence, RI                               Washington, DC                                      City of Los Angeles - AIDS Coordinator’s Office, Los          Family Care Agency, Inc., Reseda, CA
     AIDS Project Worcester, Worcester, MA                               American Red Cross, Washington, DC                          Angeles, CA                                               Fenway Community Health Center, Boston, MA
     AIDS Project, Inc., Portland, ME                                    American Social Health Association, Washington, DC      Clark and Associates Advocacy, Detroit, MI                    Florida AIDS Action Council, Inc., North Miami, FL
     AIDS Research Alliance, West Hollywood, CA                          Amigos Volunteers in Education and Services,            Coastal Bend AIDS Foundation, Inc., Corpus                    Florida AIDS Consortium
     AIDS Resource Alliance, Inc., Orlando, FL                               Inc, Houston, TX                                        Christi, TX                                               Food & Friends, Inc., Washington, DC
     AIDS Resource Center of Wisconsin, Milwaukee, WI                    Asian & Pacific Islander Coalition on HIV/AIDS,         Colorado AIDS Project, Denver, CO                             Food for Thought / Sonoma County AIDS Food Bank,
     AIDS Resources Information & Services, San Jose, CA                     Inc., New York, NY                                  Columbia University School of Public Health - New                 Forestville, CA
     AIDS Response Seacoast, Portsmouth, NH                              Association of Maternal and Child Health                    York/Virgin Islands AIDS ETC, New York, NY                Fraternity House, Inc., Escondido, CA
     AIDS Rochester, Inc., Rochester, NY                                     Programs, Washington, DC                            Columbus AIDS Task Force, Columbus, OH                        Funders Concerned About AIDS, New York, NY
     AIDS Service Agency of North Carolina, Raleigh, NC                  Association of Nurses in AIDS Care, Reston, VA          Community Action Against Addiction, Cleveland, OH             Gay Men’s Health Crisis, New York, NY

     S A F E   ,   F A S T    A N D        R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
36                                                                                                                                                                                                                                               37




     Genesis House, Chicago, IL                                    Louisiana State University Health Sciences Center       National Health Care for the Homeless Council,                Project Response, Inc., Melbourne, FL
     Georgia AIDS Coalition, Snellville, GA                           - Delta Region AIDS ETC, New Orleans, LA                Nashville, TN                                              PWA Coalition of Broward County,
     God’s Love We Deliver, New York, NY                           Low Country AIDS Services, Charleston, SC               National Health Law Program - DC, Washington, DC                  Fort Lauderdale, FL
     Good Samaritan Project, Kansas City, MO                       Maricopa Integrated Health System, Phoenix, AZ          National Hospice and Palliative Care Organization,            Regional HIV/AIDS Consortium, Charlotte, NC
     Government of the District of Columbia,                       Marin Treatment Center, Inc., San Rafael, CA               Inc., Alexandria, VA                                       Religious Action Center of Reform Judaism,
         Washington, DC                                            Maui AIDS Foundation, Wailuku, HI                       National Mental Health Association, Alexandria, VA                Washington, DC
     Gregory House Programs, Honolulu, HI                          Medical and Health Research Association of New          National Minority AIDS Council, Washington, DC                Research & Policy Reform Center, Inc.,
     Gulf Coast Jewish Family Services, Inc.,                         York City, New York, NY                              National Native American AIDS Prevention Center,                  Washington, DC
         Clearwater, FL                                            Metrolina AIDS Project, Inc., Charlotte, NC                Oakland, CA                                                River Region Human Services, Inc., Jacksonville, FL
     H.C.C., Washington, DC                                        Metropolitan AIDS Neighborhood Nutrition Alliance       National Rural Health Association, Kansas City, MO            Saint Joseph’s Mercy Care Services, Atlanta, GA
     Harlem Congregations for Community                               (MANNA), Philadelphia, PA                            Nebraska AIDS Project, Omaha, NE                              San Diego County Department of Health - Office of
         Improvement,                                              Metropolitan Charities, Inc., St. Petersburg, FL        New Mexico AIDS Services, Inc., Albuquerque, NM                   AIDS Coordination, San Diego, CA
         New York, NY                                              Metropolitan Housing and CDC, Inc., Washington,         New York AIDS Coalition, New York, NY                         San Francisco Department of Public Health,
     Harlem Directors Group, New York, NY                             NC                                                   New York City AIDS Housing Network, New York, NY                  San Francisco, CA
     Health Education Resource Organization,                       Metropolitan Residential Services, Columbus, OH         New York City Department of Health, New York, NY              SAVE, Inc., Kansas City, MO
         Baltimore, MD                                             Minnesota AIDS Project, Minneapolis, MN                 New York Planning Council, New York, NY                       Service Employees International Union,
     Health Horizons of East Texas, Inc.,                          Mobile AIDS Support Services, Mobile, AL                New York State Department of Health - AIDS                        Washington, DC
         Nacogdoches, TX                                           Montrose Clinic, Houston, TX                               Institute, Albany, NY                                      Service To AIDS Victims Endowment Foundation,
     Hemophilia Association of New Jersey, East                    Mothers’ Voices Inc., New York, NY                      NO/AIDS Task Force, New Orleans, LA                               Kansas City, MO
         Brunswick, NJ                                             Mountain States Regional Hemophilia &                   North Central District AIDS Coalition,                        Simon House, Detroit, MI
     Hetrick-Martin Institute, New York, NY                           Thrombosis Center - University of Colorado              Lock Haven, PA                                             South Jersey AIDS Alliance, Atlantic City, NJ
     HIV Law Project, Inc., New York, NY                              Health Sciences Center                               North Coast HIV/AIDS Coalition,                               Southern Arizona AIDS Foundation, Tucson, AZ
     HIV/AIDS Center of Virginia Commonwealth                      Multi-County Community Development Corporation,            Cleveland Heights, OH                                      Southern Colorado AIDS Project, Colorado Springs, CO
         University, Richmond, VA                                     Saugerties, NY                                       North Jersey Community Research Initiative,                   Southern Tier AIDS Program, Johnson City, NY
     HIV/AIDS Resource Center, Ypsilanti, MI                       Nashville CARES, Nashville, TN                             Newark, NJ                                                 Spokane AIDS Network, Spokane, WA
     HIV/AIDS Services, Inc., Grand Rapids, MI                     National AIDS Fund, Washington, DC                      Northeast Valley Health Corp., Panorama City, CA              Springfield AIDS Resource Association,
     Home Nursing Agency Community Services - AIDS                 National Alliance of State and Territorial AIDS         Northwest AIDS Foundation, Seattle, WA                            Springfield, IL
         Intervention Project, Altoona, PA                            Directors, Washington, DC                            Ohio AIDS Coalition, Columbus, OH                             St. Louis Effort For AIDS, Saint Louis, MO
     Howard University - National Minority AIDS ETC,               National Association of Alcoholism & Drug Abuse         Ohio Department of Health, Columbus, OH                       State of Alaska Department of Health and Social
         Washington, DC                                               Counselors, Arlington, VA                            Outer Cape Health Services, Inc., Truro, MA                       Services, Anchorage, AK
     Human Rights Campaign, Washington, DC                         National Association of Children’s Hospitals, Inc.,     Parkland Health & Hospital System - Texas and                 Staten Island AIDS Task Force, Staten Island, NY
     Hyacinth AIDS Foundation, New Brunswick, NJ                      Alexandria, VA                                          Oklahoma AIDS ETC                                          Tapestry Health Systems, Northampton, MA
     Institute for Health Policy Studies, San Francisco, CA        National Association of Community Health Centers,       Peabody House, Inc., Portland, ME                             Tarrant County AIDS Interfaith Network, Inc.,
     International AIDS Vaccine Initiative, New York, NY              Inc., Washington, DC                                 Pediatric and Family HIV/AIDS Project - Catholic                  Fort Worth, TX
     Inter-Tribal Council of Arizona, Inc., Phoenix, AZ            National Association of People with AIDS,                  Charities Diocese of Fort Worth, Inc., Fort Worth,         Tarzana Treatment Center, Inc., Tarzana, CA
     John XXIII AIDS Ministry, Monterey, CA                           Washington, DC                                          TX                                                         The AIDS Council of Greater Kansas City,
     Johns Hopkins School of Medicine - National AIDS              National Association of Protection & Advocacy           People With AIDS Coalition of Houston, Houston, TX                Kansas City, MO
         ETC Resource Center, Baltimore, MD                           Systems, Washington, DC                              Persad Center, Inc., Pittsburgh, PA                           The American Dietetic Association, Chicago, IL
     Justice Resource Institute, Boston, MA                        National Association of Public Hospitals & Health       Philadelphia Health Management Corporation,                   The Assistance Fund, Houston, TX
     Kentuckiana People With AIDS Coalition, Inc., Kevil,             Systems, Washington, DC                                 Philadelphia, PA                                           The Cascade AIDS Project, Inc., Portland, OR
         KY                                                        National Association of Social Workers - NY State       Phoenix Body Positive, Inc., Phoenix, AZ                      The Center for AIDS, Houston, TX
     L.A. Gay & Lesbian Center, Los Angeles, CA                       Chapter, Albany, NY                                  Piedmont Consortium, Durham, NC                               The City of New York - Mayor’s Office, City Hall,
     Lansing Area AIDS Network, East Lansing, MI                   National Catholic AIDS Network, San Francisco, CA       Pierce County AIDS Foundation, Tacoma, WA                         New York, NY
     Latino Family Services, Inc., Detroit, MI                     National Council of Negro Women Empowerment             Pima County AIDS Program, Tucson, AZ                          The CORE Center, Chicago, IL
     Legal Action Center, New York, NY                                Program, New Orleans, LA                             Plan International, Arlington, VA                             The Damien Center, Indianapolis, IN
     Life Force: Women Fighting AIDS, Inc., Brooklyn, NY           National Episcopal AIDS Coalition, Washington, DC       Planned Parenthood Federation of America, Inc.,               The Free Medical Clinic of Greater Cleveland,
     Los Angeles County Health Department, Los                     National Gay And Lesbian Task Force Policy                 Washington, DC                                                 Cleveland, OH
         Angeles, CA                                                  Institute, Washington, DC

     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G   S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G
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     The Hektoen Institute for Medical Research, L.L.C.,           University of Colorado Health Sciences Center -
         Chicago, IL                                                  Mountain Plains AIDS ETC, Aurora, CO
     The Henry J. Kaiser Family Foundation, Menlo Park, CA         University of Illinois at Chicago - Midwest AIDS
     The Irene Diamond Fund, Inc., New York, NY                       ETC, Chicago, IL
     The Jewish Healthcare Foundation, Pittsburgh, PA              University of Kansas School of Medicine AIDS ETC,
     The Momentum AIDS Project, Inc., New York, NY                    Wichita, KS
     The Names Project Foundation, San Francisco, CA               University of Massachusetts - New England AIDS
     The Pittsburgh AIDS Task Force, Inc., Pittsburgh, PA             ETC, Brookline, MA
     The Salvation Army - Social Services/AIDS                     University of Medicine and Dentistry of New Jersey
         Ministries, Hartford, CT                                     - New Jersey AIDS ETC, Newark, NJ
     The San Francisco AIDS Foundation, San Francisco, CA          University of Pittsburgh - Pennsylvania/Mid
     The Serra Project, Los Angeles, CA                               Atlantic AIDS ETC, Pittsburgh, PA
     The Sharing Community, Inc., Yonkers, NY                      University of Washington - Northwest AIDS ETC,
     The Society for the Advancement of Women’s                       Seattle, WA
         Health Research, Washington, DC                           University of Wyoming, Laramie, WY
     The Stewart B. McKinney Foundation, Inc.,                     Urban Coalition for HIV/AIDS Prevention Services
         Fairfield, CT                                             Us Helping Us...People Into Living, Inc.,
     Therapeutic Communities of America, Washington, DC               Washington, DC
     Tidewater AIDS Crisis Task Force, Norfolk, VA                 Victory House, Boston, MA
     Title II Community AIDS National Network,                     WAM Foundation, Inc., Houston, TX
         Washington, DC                                            Wayne State University - Great Lakes to Tennessee
     Treatment Action Group, New York, NY                             Valley AIDS ETC, Detroit, MI
     Triangle AIDS Network, Beaumont, TX                           We The People living with AIDS/HIV, Philadelphia, PA
     United Communities AIDS Network, Olympia, WA                  Wellness House of Michigan, Detroit, MI
     United Jewish Appeal - Federation of Jewish                   Western Colorado AIDS Project, Grand Junction, CO
         Philanthropies of New York, Inc., New York, NY            Western North Carolina Community Health Services
     Universidad de Puerto Rico - Puerto Rico AIDS ETC,               Inc., Asheville, NC
         San Juan, PR                                              Westside Community Mental Health Center, Inc.,
     University of California San Francisco AIDS Health               San Francisco, CA
         Project, San Francisco, CA                                Whitman-Walker Clinic, Inc., Washington, DC
     University of California San Francisco - Pacific              William F. Ryan Community Health Center, New
         AIDS ETC, San Francisco, CA                                  York, NY




     S A F E   ,   F A S T   A N D   R E L I A B L E   :   A   N E W   G E N E R A T I O N   O F   H I V   T E S T I N G

				
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