In early July, the United States Food and Drug Administration made a monumental stride in the fight against human immunodeficiency virus (HIV) by approving the first over-the-counter test. The test—named OraQuick, which was made available by the Pennsylvania-based company OraSure Technologies—allows individuals to perform the test at home using a mouth swab.

Drexel’s School of Public Health Dean Marla Gold said that studies show among those infected with HIV in the United States, approximately 200,000 people—or one out of five infected—do not know their HIV status. This in turn, serves as fuel, which when coupled with risky behaviors such as unprotected sex or intravenous drug abuse, leads to some 50,000 newly HIV-infected persons in the U.S. annually.

Gold talked to DrexelNow about the new test and how it could affect the trajectory of the HIV/AIDS epidemic.

What is it about the newly approved HIV home test that is causing some to call it a "game changer"?

This is the first home HIV test that provides test results in [as many as] 40 minutes. Previous “home” tests allowed you to collect a blood sample at home and mail it in to get test results by phone. OraQuick involves swabbing your gums and then, similar to a home pregnancy test, waiting 20 to 40 minutes to see results on an area of the test stick.

In the clinical setting, HIV testing has a “gold standard” that involves a preliminary test, and if that is positive, a confirmatory test [is administered] to be certain. When you receive positive results in a doctor’s office, that result has already been confirmed. In addition, a good clinician will do full pre- and post-test counseling, providing important information to the patient concerning what the test does and does not mean as well as ensuring linkage to health care services as needed.

What are the advantages of the option of an at-home test as opposed to tests at a clinic or doctor's office? Are there any disadvantages?

The home HIV test is essentially one more tool in the testing toolbox. The good news is that those who don’t know their HIV status because they dread going to a health care setting for their test results will soon be able to buy the test at the drug store—around October 2012, [the cost is] not known yet—and perform it in the privacy of their home. Ideally, this will encourage more testing, diagnose more infection and encourage more people get into care. Proper care for an HIV-infected individual can extend their life by many decades and also makes transmission of their HIV infection less likely as their virus falls under control of good medications.

However, the home test is akin to the currently used “screening” test, not the confirmatory test. Therefore, some positive results will occur among people who in fact, are HIV negative. All people with a positive home HIV test result must undergo confirmatory testing. This means the person will need to seek health care [through] their provider or a clinic and wait for another test—certainly a stressful waiting time.

It has been said that the home test does not come with a home health care provider. There is no one in the box to tell you what the test means before you do it, nor what the results mean once you are holding them in your hand. There is a 24-hour hotline to call for you to talk with a professional. Then, it’s up to you to get yourself to a health care provider for the needed next steps.

If your test is negative, that is not a license to go have unprotected sex. A negative test is a strong reminder about HIV prevention and what steps you need to take—condom use, for example—to protect yourself from infection and from other STDs.

Thinking long term, what kind of effect could the new at-home test have on the spread of HIV?

It’s not possible to say at this time what impact the availability of a home HIV test will have on individual HIV infection, nor on the overall epidemic. Certainly, the ideal hope is that more people will get tested, more people with infection will get into care, less disease will be spread and more people who test negative will remain negative. The home test is another tool, but the bottom line is the same: Know your HIV status, get tested, and be safe.

For more information and access to free condoms in Philadelphia, check out www.takecontrolphilly.org and http://hivtest.cdc.gov.