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发帖数: 29846 | 1 $661,858 Federal Study: Will 'Rapid HIV Home Test' Reduce HIV Infection
Among Gays?
January 13, 2015 - 11:54 AM
By Melanie Hunter
Plaintiffs Moudi Sbeity, right, and his partner Derek Kitcheny. (AP Photo/
Rick Bowmer)
(CNSNews.com) – The National Institutes of Health has awarded $661,858 to
the New York State Psychiatric Institute to study whether the use of rapid
home HIV tests will reduce sexual risk behavior in “men who have sex with
men” and “transgender women.”
According to the grant abstract, men who have sex with men or MSM “are the
only CDC-defined risk group in the US in which new HIV infections have been
increasing steadily since the 1990s.”
“This study focuses on HIV-uninfected men and transgender women who have
sex with men, with special emphasis on ethnic minority individuals, who have
more than one sexual partner and never or seldom use condoms,” the grant
said.
“Statistics about HIV among male-to-female transgender women (TGW) are
often unavailable but it is known that HIV prevalence in this population is
high, and the 2011 Institute of Medicine Consensus Report called for much
needed research among transgender populations,” the grant said.
“Alternatives to condom use are needed for individuals who cannot or will
not use condoms,” it said.
Researchers will study one such alternative to condom use: rapid HIV home
tests (HT).
The study “seeks to demonstrate that these individuals will have fewer
occasions of risky sex if they use a rapid HIV home test (HT) to determine
if their sexual partners are infected with HIV (although the test does not
detect very recent infections).
It also seeks to show that “having easy access to HT, including an
affordable price, is crucial so that people can use it to test potential
sexual partners; this is important because this procedure may become a brand
new approach to HIV-prevention, leading to fewer new infections and a
decrease in healthcare costs,” the grant said.
“This 5-year randomized controlled trial will target mainly, but not
exclusively, ethnic minority men and TGW who have sex with men, are HIV-
uninfected and non-monogamous, never or seldom use condoms, and have a
history of serodiscordant UAI,” the grant said.
Serodiscordant UAI is when one partner is infected with HIV and the other is
not.
On July 3, 2012, the Food and Drug Administration approved the OraQuick in-
home HIV test that does not require sending in a sample to a lab for
analysis. The kit involves swabbing the upper and lower gums for an oral
fluid sample with the test device and placing the sample in a tube with a
developing solution. After a 20-40 minute waiting period, one line means the
sample has tested negative for HIV, and two lines indicate it tested
positive for HIV.
Follow-up confirmatory testing is needed for those who receive a positive
result. Also, a false negative result is possible for those who were exposed
to the HIV virus in the past three months.
“The test is not reliable at detecting HIV infection until at least three
months after infection,” the FDA said on its website. It also advised that
people “should not interpret a negative test to indicate that engaging in
high risk behavior is safe.”
Researchers will recruit and pre-screen about 600 people in New York City
and San Juan, Puerto Rico – two cities with high HIV prevalence. Only 300
participants, however, are expected to be eligible to enroll in the trial
after screening at the first visit, due to the “stringent eligibility
criteria.”
Participants will then be “randomized” and assigned to one of two groups.
“Group A participants will receive an HT intervention orientating them to
effective ways of using HT to screen sexual partners and will be supplied
with HT kits to use with sexual partners over 6 months.”
“Group B participants will receive neither the HT intervention nor supply
of kits, and we will monitor whether they avail themselves of HT kits
through purchase or other means,” the grant said. “Both groups will
receive risk-reduction counseling.”
“All participants’ behavior will be monitored for 6 months through daily
brief SMS reports,” it said.
CNSNews.com contacted the project leader, Alex Carballo-Dieguez, and asked:
“Will your study include an explanation that a negative result does not
mean that the ‘individual is definitely not infected with HIV, particularly
when exposure may have been within the previous three months,’ as
indicated by the FDA on its website page about the OraQuick In-home HIV test?
“Will it address the risk one takes when engaging in unprotected sex even
after a negative result from such a test and the false sense of security the
negative result may give?” CNSNews.com asked.
“You mentioned that Group A and B participants will receive risk-reduction
counseling. Will that counseling include the FDA's warning that even getting
a negative result using at-home HIV tests does not guarantee that the
person is not infected with HIV, especially if that person was infected in
the past 3 months?” CNSNews.com added.
Carballo-Deiguez responded by referring CNSNews.com to a study similar to
the one in question.
“It will probably respond to many of your questions,” Carballo-Deiguez
wrote. “As you will see, we only recruit people who seldom or never use
condoms and who have multiple partners. We not only extensively explain the
window period and the limitations of the test but we even test the
participants understanding of this window period. If they don’t understand
it, they are not eligible to participate in the study.”
A paper on the aforementioned study published in 2012, titled, “Use of a
Rapid HIV Home Test Prevents HIV Exposure in a High Risk Sample of Men Who
Have Sex With Men,” explained the “window period.”
“A caveat is that OraQuick is an antibody test; therefore, an HIV-infected
individual may appear uninfected until anti-bodies are generated. The window
period of antibody tests lasts 25 days on average and in some cases as long
as 8 weeks,” the paper said. “Thus, despite the high sensitivity and
specificity of OraQuick, using it to screen sexual partners still would not
completely eliminate risk.”
The project and budget start date is listed as July 1, 2014 and is expected
to end on June 30, 2019. The budget end date is listed as June 30, 2015. |
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