Home Testing for HIV -- Reading the Lines in Do-It-Yourself Test

The OraQuick HIV home test breaks barriers and could expand HIV testing.

December 13, 2012, 11:03 AM

Dec. 18, 2012 — -- Dan Nainan had never heard of a home test for HIV until a prospective girlfriend insisted that he take one. Apparently, she didn't trust him.

"I'm not some sleaze bag, but she's really suspicious," said Nainan, 31, who works as a comedian. "I'm like, 'Come on, you're kidding me.'"

The test became a sticking point in their budding relationship. "I didn't feel I had anything to be worried about," Nainan said, "but she didn't want to proceed."

He finally gave in and took the test his girlfriend foisted on him, certain he'd test negative. He swabbed his gums -- the test works on saliva -- put the test swab in a test tube and waited as his girlfriend grilled him about his sexual history.

"It was a bit uncomfortable," Nainan said.

Ten tense minutes passed as he watched a deep-pink line appear slowly in a tiny window on the testing device. He prayed it wouldn't be joined by a second line signaling a positive result, and wondered what he'd do if it did emerge.

"I felt like I was taking a pregnancy test," Nainan said.

Do-it-yourself home testing for HIV, the virus that causes AIDS, has arrived.

The OraQuick In-Home HIV Test -- the only one approved for over-the-counter use by the Food and Drug Administration that captures testing and results in one sitting -- hit drug-store shelves two months ago. An earlier HIV home test -- called Home Access -- required a user to prick a finger with a spring-loaded lancet, collect a drop of blood on a test card, mail it to a lab and call in one to seven days for the results.

"This was actually quite easy and painless," Nainan said of the OraQuick test. "It's so much better than what you used to have to do."

Aimed at those who might have avoided getting tested in the past either out of, fear, stigma, worries over confidentiality or inconvenience, the new home test has been hailed as a breakthrough.

"It's hard not to be fully enthusiastic about the test," said Dr. Myron Cohen, director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. "Everything we do to increase testing has to have some degree of benefit. By identifying and treating people early, we preserve normal life span and excellent health and reduce contagion."

But the new home test, which sells for about $40 and can also be bought online, has generated its share of hand-wringing, too.

"We generally like this thing," said Dan Tietz, executive director of the research and advocacy group AIDS Community Research Initiative of America, or ACRIA. "It decreases some of the barriers to testing. It kind of puts HIV in front of people, but there's a bunch of cautions."

For one, there's what Tietz called the "freaking out by themselves problem" -- for the first time, there's no live counselor present -- not even a voice over the phone -- to deliver the results, offer support and make referrals.

Nainan tested negative for HIV, as he expected he would. Despite some sweat as he waited out the 20 minutes staring at the test window, "I really wasn't nervous," he said.

But for home-testers less certain of their HIV status, or who receive an unexpected result, the do-it-yourself route could be overwhelming, Tietz said. "I think about a young person with very little experience with the health care system who might pick up this test," he added.

Tony Martinez, 40, who works in New York's fashion district, took the home test as an "experiment." "If I didn't know I wasn't HIV positive, the test would be a different ballgame. I put myself back many years ago when I went to a clinic and took the test and was terrified. [The home test] was a lot of steps. I don't think I would have followed the directions in that [terrified] state. Am I really going to read the manual "What Your Results Mean" if the test is positive? It's like asking someone to read a drivers' ed manual after an accident."

In lieu of an in-person counselor, OraSure Technologies, which makes the OraQuick test that the FDA approved in July -- has set up a toll-free 24/7 customer support center with bilingual reps (English-Spanish). They're not certified counselors but have been trained to answer questions about HIV/AIDS, explain how the test works and what the results mean. They can also hook up callers to counseling and care, using the CDC National Prevention Information Network and the HIV Medicine Association, and can also transfer callers directly to a health care professional or agency, said Ron Ticho, senior vice president for corporate communications at OraSure.

"Our representatives go through more than 160 hours of training," Ticho said. Test kits come with instructions, warnings and precautions. Home-testers can find the same test information on OraSure's website, along with the same referral databases the call center uses.

But handing concerns about HIV over to a toll-free number has raised questions.

Much is made of the fact that without a counselor present, even with warnings on the box and inserts and brochures written for a seventh- to eighth-grade reading level, home-testers might not understand that, as with all HIV tests, regardless of the testing method, a positive result is preliminary and needs to be confirmed by a more specific test given at an HIV test site.

This is especially worrying with the home test because although the OraQuick test is the same rapid test that medical professionals have used at testing sites since 2004, it loses some of its accuracy in the hands of consumers: The percentage of results that will be accurately positive drops from 99.3 at a testing site to 92.9 when do-it yourselvers test themselves at home: This means that about one person in 12 could get a false negative.

Another stumbling block is the "window period" -- the time it takes, usually 12 weeks, for the body to develop the antibodies the test detects after exposure to HIV, giving some people a "false sense of safety" that they're HIV negative when they are in fact HIV positive and at their most contagious.

"That's always a huge, really important piece of counseling," said Barbara Adler, manager of HIV counseling and testing at the AIDS Alliance Project at the University of California at San Francisco, where the first HIV test was given 27 years ago.

But, Adler said, sometimes people who received a preliminary positive result didn't return for the results from the confirming test.

"So I don't know if sitting with another human being when they're getting a result is going to help that. I think the person who wants the physical presence of someone else probably won't do the home test.

"There's reasons, though, for wanting to test alone in your home. While the stigma is not like it was 30 years ago," Adler said, "it's still there and can be heavy. It's a disease around sex, or around needle use. Who wants to talk about those things? It's not like we're talking about cholesterol, or something you got because you ate certain foods or got too much sun."

OraSure emphasizes that its HIV home test is simply an additional option to the testing already available -- which often comes free -- at public health clinics, community service organizations and doctors' offices.

"We know that there's a lot of individuals who should be getting tested but aren't, and this is another opportunity for them to do so," OraSure's Ticho said. "Is it the right option for everyone? Probably not."

Nevertheless, with an HIV diagnosis no longer sounding a death knell, it could be a test whose time has come.

"The tide has really turned on HIV testing," said Dr. Rochelle Walensky, co-director of the Medical Practice Evaluation Center and an AIDS researcher at Massachusetts General Hospital in Boston.

"It's a lot more streamlined, and there's not a lot of counseling required now. Treatment is available, and there's a lot of literature that says that life expectancy is up to near normal if people engage in care early and take care of themselves.

"There are cancers, and many, many other diseases that have far worse outcomes than HIV that people deal with on their own without a lot of counseling."

Of the 1.2 million Americans living with HIV in the United States, the Centers for Disease Control and Prevention estimates that 20 percent don't even know that they're infected and account for more than half of the 50,000 new infections a year in the United States.

Whether people most at risk -- African-American gay-bisexual men, especially those between the ages of 13 and 24, according to the CDC -- will have the money and motivation to go to the drug store and pay $40 for the home test is another question, Walensky said.

Even if they have the $40 to spend on an HIV home test, many won't be able to buy it anyway, because the OraQuick home test cannot be sold to anyone younger than 17, and requires ID.

"Any availability of any test anywhere is a good thing," Walensky said. "Whether this is going to be an epidemic game-changer is where I have to opt out."

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