New In-Home HIV Test Raises Follow-Up Concerns

The FDA recently approved an over-the-counter, in-home HIV testing kit.  (Photo: FDA.gov)

The FDA recently approved an over-the-counter, in-home HIV testing kit. (Photo: FDA.gov)

By Alvin Tran

Beginning this October, Americans will have the opportunity to test themselves for HIV in the comfort and privacy of their own homes. The OraQuick In-Home HIV Test will be the first ever self-administered HIV-test made available for over-the-counter purchase.

The Food and Drug Administration approved the test earlier this week, but it warned the test’s results are a “preliminary” diagnosis, so check-ups are still necessary. Some Bay Area researchers said a key challenge will be ensuring that people actually seek out a confirmation test and additional services from their doctors, regardless of testing positive or negative for the virus.

“The home test is another mechanism for testing but it shouldn’t be [used] in isolation,” said Tracey Packer, the Acting Director of HIV Prevention for the San Francisco Department of Public Health. Packer says that having an in-home HIV test raises the issue of people not getting accurate information.

“They have to know the test may take a while to become positive. It may take several months. If they’ve had a very recent exposure, getting a negative test result is not enough.”

According to the FDA, a positive test does not necessarily mean a person is HIV-positive. The FDA suggests that people who test positive to quickly seek confirmation with their doctors.

People with a negative test should also be wary. A negative test does not mean a person is free from HIV. Susan Buchbinder, MD, the Director of HIV Research Section at the San Francisco Department of Public Health, and a former panel member on the FDA’s advisory committee that recommended OraQuick’s approval, said OraQuick can’t determine if a person has contracted HIV within the past three months.

“If they [test] HIV-negative but may have had recent exposures, they have to know the test may take a while to become positive,” Buchbinder said. “It may take several months. If they’ve had a very recent exposure, getting a negative test result is not enough.”

Regardless of the diagnosis, Buchbinder urges people to quickly seek an additional test to confirm their results with a doctor. She said she is also concerned about how people will perceive their test results, and the potential effects of stigma. “There could be some psychological harm [and] there could be social harm if somebody found out that you were testing and thereby inferred something about you.”

As opposed to being tested at a clinic or in a hospital, Buchbinder said people using in-home HIV test won’t have the benefit of a doctor or health care provider’s counseling services when they get their results.

However, Buchbinder said people do have access to a 24-hour, toll-free number linking them to a supportive services. She added that it may be helpful for people to test with someone they trust, and would feel comfortable being close to, once they get their results.

Though there are concerns, Buchbinder said she believed that the new test has the potential to change people’s risk behaviors. “It has the potential to reduce new infections by getting people who learn that they’re infected into care and treatment, and [reduces] the risk of exposure to HIV-negative individuals,” she said. “[But] we won’t know until we actually see how this rolls out.”

Buchbinder said she also hopes that OraQuick users will share all of their positive and negative experiences. “The more information we get back from the community about what’s working and what’s not working, the better able we are to build services and build programs that can support people,” she said.

The San Francisco Public Health Department is currently working on strategies to figure out the most effective means of using OraQuick in local areas where testing rates are lower and where there is a higher rate of health risk behaviors.

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