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The Longest Week
Health Department Inaction Makes Gay Men Wait for HIV Results
by Ric Kasini Kadour
The
Vermont Department of Health is blocking gay men's access to a powerful,
new HIV prevention tool.
In November 2002, The Food and Drug Administration
approved OraQuick, an HIV anti-bodies test that uses a finger-prick of
blood to screen a person for HIV in about twenty minutes. An even less
invasive version that uses saliva was approved in March of this year.
Traditional HIV testing requires someone to go to a testing site, give
a sample of blood or saliva, then return at a future date to receive their
results. Over one third of people tested this way do not return, and thus
never discover their sero-status. The anxiety of waiting one to three
weeks to hear the results is a deterrent for gay men and others getting
tested.
The new rapid test changes all that. Nearly
all the results are delivered the same day, removing a significant testing
and prevention barrier for gay men and other at-risk populations.
But even though credible sources support
the accuracy of the test, and the kits are being offered free, along with
training, and even though AIDS service organizations want the test and
its own policies offer a mandate, VDH has yet to formally consider the
Oraquick test.
Fast Results Mean More Tests
OraQuick is quickly becoming the preferred
HIV testing tool across the United States. One clinic in Seattle claims
that of the 400 gay men given the option of rapid results during a four-month
period, all but two chose rapid testing. The clinic also reports a dramatic
increase in the number of gay men getting tested.
"Men opted for the rapid test primarily because of the anxiety of
waiting," said Fred Swanson, Executive Director of Gay City Health
Project.
"All of it [the waiting time]
is spent idling over what the result will be. It's a week of not knowing.
Even for guys who consistently protect themselves and make great decisions,
there's the possibility in the back of their mind," explained Swanson.
"There's the not knowing for the week and feeling disconnected from
information that's vital to living their life."
"New technology has always been important
at slowing the rate of HIV infection in the community," said Christopher
Kaufman, Executive Director of the R.U.1.2? Community Center, which offers
HIV testing to gay and bisexual men in partnership with Vermont CARES.
"We at R.U.1.2? would certainly support
rapid testing because it reduces the barriers gay men face at getting
tested and getting their results," he added.
Why Not in Vermont?
Despite FDA approval and promising increases
in testing numbers elsewhere, rapid testing is not expected to be available
in Vermont anytime soon. Even with a mandate from its own HIV-prevention
policies, the Vermont Department of Health (VDH) has not assessed the
new test. Furthermore, the reasons cited for not making the test available
are contradicted by the Centers for Disease Control and Prevention, the
Food and Drug Administration, and Orasure Technologies, the makers of
the test.
"The testing sites that we pay for
do not use OraQuick," declared Susanna Weller, Acting Director of
the Vermont Department of Health AIDS Program.
With traditional HIV testing now sponsored
by VDH, a person would go to a clinic and give a sample of a blood or
saliva. The sample would be sent to the Vermont Department of Health Lab
and tested. One to three weeks later the person would be notified by the
testing site staff to return, and a test counselor would give the person
his or her results. The long lag time between test and result is where
nearly a third of the people tested are lost to the system when they don't
show up for their results, even though the testing site is paid for doing
the test by the Vermont Department of Health only when the results are
delivered.
Rapid testing removes the need for people
to come back to a clinic for results by eliminating the time and expense
of involving the Vermont Department of Health's lab. Nearly all of the
results are delivered 20-30 minutes after the test is administered.
Rapid HIV testing has the potential to dramatically
increase the number of people who know their HIV status. Because the test
kit itself is self-contained, it has the added benefit of being portable.
Across the nation, outreach workers are taking rapid HIV tests to places
where people at high-risk for HIV congregate and performing HIV tests.
So, will the new test be available in Vermont anytime soon?
"I doubt it," said Weller. "OraQuick
works best in places with a high concentration of HIV. In Vermont, we
predict that 50 percent of our preliminary positives would be false given
the HIV prevalence for the population of Vermont."
"I'm stunned they have that opinion,"
said Ron Spair, Executive Vice-President of Orasure Technologies. "The
CDC recommends this test because of its significant positive predictive
value."
False positives are the primary explanation
given for not making the test available in Vermont. VDH has been successful
at convincing a number of community leaders that the test is bad or ineffective
in Vermont.
"VDH is currently training us to deliver
the [traditional] oral testing and they are reticent to train us in the
finger stick test because of the number of false positives," said
Peter Jacobsen, Director of Prevention at Vermont CARES.
VDH claims it is basing its assessment of
the test on a statistic called the Positive Predictive Value, an estimate
of the number of positive test results that would be false given the rate
of HIV in any given population. The problem with the VDH's logic is that
the HIV sero-prevalence for everybody living in the state of Vermont and
the HIV sero-prevalence of Vermont's gay men are widely differing values.
Approximately one of a thousand Vermonters
is HIV-positive, compared to perhaps one of every 16 gay men in Vermont.
(Incidentally, VDH refuses to state publicly an official rate of HIV for
gay men in Vermont. The rate referred to here is the 'middle of the road'
value for the rate of HIV when looking at the aggregate of surveys of
Vermont gay men that ask their HIV status.) At this level of HIV sero-prevalence,
only 2-4 percent of positive results would be false, resulting in the
test being accurate 99.6 percent of the time, a level of accuracy on par
with that of other available tests.
Ultimately, however, pointing to the accuracy
of the test is a smokescreen. There is not much difference in the accuracy
of OraQuick compared to traditional, lab-based testing.
A study published by the CDC in January
2004 concluded OraQuick "produced substantially fewer false-positive
results than traditional lab-based HIV tests." Documents from the
Food and Drug Administration state the test "provides screening results
with over 99 percent accuracy."
"Rapid testing tools are widely accepted
by the CDC," said Karlie Stanton, spokesperson for the CDC's National
Center of HIV, STD, TB Prevention, who expressed 'shock' that a public
health official would make such a claim of an FDA approved test.
A slightly more believable claim is the
cost of implementing the new test, but even this explanation does not
pan out.
"Cost definitely plays a part, because
it's not only the test but the test counselors and quality assurance.
The CDC has not made any funds available to make it happen," said
Weller.
In fact, the CDC is giving away test kits
and actively training test providers.
"To date, the CDC has purchased and
distributed 500,000 finger stick rapid tests and trained more than 475
people at twenty regional training sessions," said Stanton. "Ten
to 15 additional trainings are planned this year."
The primary issue appears to be the willingness
of VDH to offer the test.
"I wouldn't say it's not on the radar,"
said Bill Apao, VDH Director of Surveillance. "We absolutely see
the importance of a rapid test. It's not that we don't want to do it,
we don't want to cut the legs out from under our outreach workers."
But organizations who employ those outreach workers
can't wait for the test.
"I knew the CDC was pushing the rapid testing,
and we'd love to be part of it," said Vermont CARES's Jacobsen. "We're
willing to send our staff to training using general donations."
"We would certainly support rapid testing
because it reduces the barriers gay men face at getting tested and getting
their results," said R.U.1.2?'s Kaufman.
Perhaps the real issue in not offering the
test is VDH's lack of awareness of what's important to gay men.
"The Department of Health does have the community's
best interest at heart, but they don't always have accurate information
about what the community needs and what it's like for the average gay
man who is concerned about HIV," said Kaufman. "It would be
great if the Health Department could listen more carefully to men who
are at risk – which is not necessarily those who participate in
the community planning group."
The VDH Comprehensive HIV Prevention Plan governs
prevention activities of the state's AIDS program. Twice it directs public
health officials to "consider and evaluate the adoption of rapid
testing technologies to increase the likelihood that people who access
antibody testing will receive accurate results in the most timely manner
possible."
When asked if VDH had assessed the impact the
test would have on people getting tested for HIV in Vermont, performed
a cost/benefit analysis of providing the test, or documented the cost
of training HIV test counselors, Apao's response was "Nothing formal."
In the meantime, gay men wait.
Ric Kasini Kadour is a gay men's health advocate and freelance writer
living in Shoreham.