Bioethicist sees promise in home HIV test, but raises serious questions
The FDA is considering whether to approve the use of an at-home HIV test. But, as a bioethicist points out, the test doesn't come with counseling for people who test positive or negative and it's only 93 percent accurate.
An advisory panel to the Food and Drug Administration this week unanimously recommended the approval of the first-ever, rapid, over-the-counter, completely in-home HIV test.
Though the FDA has approved other HIV test kits designed for at-home use in the past, those tests required a blood sample that must be sent in to a laboratory for development. The new kit — called the OraQuick In-Home HIV Test — requires a mouth swab and a 20-minute wait for results.
It’s estimated that approximately one-fifth of the 1.2 million HIV carriers in the United States are unaware of their infection. Advocates of OraQuick say the test would provide a new and powerful tool in the battle against HIV.
Art Caplan, a professor of bioethics at the University of Pennsylvania, says there are a lot of people who are reluctant to go and be tested. He says there's a stigma that keeps people in the dark.
"Overall, we have way too many people who don't know they're infected and they account, people think, for about 70 percent of the new infections each year," Caplan said. "Presumably, if you know you're infected, you'll change your behavior. You'll cut back on the number of new cases."
But while the test, in Caplan's mind, is ultimately a good thing, he says there are serious ethical holes in the test itself.
"One problem is accuracy. This test is probably 93 percent accurate. Now that's pretty good, but it means, if you're going test 50,000 people, then roughly (3,500) are going to come out thinking 'I had a negative result and I'm OK, or I had a positive result and I'm infected, when they're not.' So we have right away an accuracy issue," Caplan said. "The test, when you do it at home, doesn't get you into a conversation with somebody about the accuracy of that test. Putting it simply, you need to follow up a positive, early, quick-test result with a blood test that is just as easy to do, but is going to go into a lab and has more accuracy."
The other problem, Caplan said, is that when you get an HIV test, you need to have someone who knows you and can "yell at you" about the risky things you've been doing that have led to the test.
"I get a negative test and I'm OK and I think I can keep doing my risky things," Caplan said. "Risky sexual behavior, risky use of needles. I'm dodging this bullet. Maybe next month, you won't be so lucky."
In short, there's no counseling that comes along with the home counseling. He compares it to a bathroom scale. While a scale can tell you how you're doing in terms of your weight, but to actually make a chance, you need to make changes, which often requires outside help.
This is the same thing, he said.
"Testing, that's great. But I would say how about a $25 rebate if you call the 1-800 number and let them give you the explanation and the speech about how to cut back on your risk," Caplan said.
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