Imagine that you fear you may have a life-threatening disease. Imagine now that this disease is almost always contracted through sexual activity or illicit drug use. Imagine that the stigma attached to this disease is so great that you fear running into someone you know at the doctor's office or wherever you can go to get the test. Would you be more likely to present yourself at a crowded public health clinic to take a diagnostic test, or would you be happier to just take the test in the privacy of your own home?
The FDA is considering whether it will allow the marketing of OraQuick, an HIV test that requires a simple swab of the gums and can give results in just twenty minutes, as an over-the-counter product for at-home use. More than a million people in the United States are infected with HIV, and a disturbing 250,000 of them, it is estimated, do not know it. Experts have long claimed that the only way to stem the tide of the pandemic is to do widespread testing -- so that those who have the disease can seek treatment and refrain from behaviors that may spread the virus to others. Encouraging people to go in for testing is challenging enough, but even when they have been tested, encouraging people to return to clinics for test results that may take a week or more is a big obstacle (in New York City, for example, 32% of those who test positive by a traditional blood test never return to hear the results). An over-the-counter test would help people who are unable or unwilling to go to a doctor's office to learn their HIV status.
But FDA officials and AIDS advocates have long insisted that the test should only be available in doctors' offices and clinics where professional counseling is available. The concern is an understandable one -- a positive diagnosis could be so overwhelming that a patient might attempt suicide. However, it is difficult to imagine that the absence of a fifteen-minute session with a counselor (who may be working on a volunteer basis with no clinical credentials whatsoever) would drastically affect the chance that such a tragedy would occur. This is not to say that counseling is not important -- it is -- but it should not be the policy of the FDA to prevent people from knowing their HIV status without the agency's help.
It is important that the makers of OraQuick, if they are permitted to sell their product over the counter, take several steps to ensure that the role of the counselor is incorporated in the test kit. First, the company should provide twenty-four-hour professional hotline counseling, the telephone number of which should be prominently displayed in the instructions. The counselors could provide information about treatment options as well as referrals to social and medical services. Second, the instructions for the test itself must be easy to read, bilingual (at least), and otherwise foolproof. Finally, the test kit must contain information about the potential for false positive and false negative results and must emphasize that for certainty's sake consumers should have the test repeated by a clinician. It is also important that consumers be made aware that the test may not be able to detect the presence of the virus for as long as a month after infection.
The OraQuick test is not without its limitations, and fears that at-home testing may lead some people to panic are valid -- things to consider in refining and improving such kits. However, the potential of this product to prevent new infections and encourage people to seek treatment is so great that these concerns should not be barriers to approval.
Mara Burney is a research associate at the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).