At-home HIV testing: Educating patients
Counseling patients about FDA's first at-home HIV test
In July 2012, FDA approved the first oral HIV home test kit for use by adults 17 years and older. The OraQuick In-Home HIV Test from OraSure uses a gum swab from the patient’s mouth and provides results within 20 minutes, so that patients can quickly learn their HIV status in the privacy of their own homes.
FDA predicted that the availability of the OraQuick In-Home HIV test will contribute to public health by helping more infected patients become aware of their HIV status, thereby reducing transmission of the virus. The agency noted that the test is targeted toward people who would otherwise not be tested, such as those who fear a lack of privacy and confidentiality by the provider and those with busy lifestyles.
Preference and performance
In a study of 478 patients comparing OraQuick with a traditional blood test, most patients preferred the oral swab for HIV testing (91% vs. 9%, P < 0.05). In addition, studies have shown that less than 54% of patients who take nonrapid tests in professional settings actually follow up with their providers to receive the results. In stark contrast, 93.3% and 98.9% of patients who take a rapid test in a provider’s office or at home, respectively, receive the results.
Another advantage of this OTC HIV test is its performance. OraQuick was able to correctly identify 99.9% of HIV-negative patients and 91.67% of HIV-positive patients, compared with laboratory testing. This translated to a 99.9% specificity and 91.67% sensitivity for the test.
Education on appropriate use
Educate patients on the appropriate use of OraQuick to ensure that they obtain accurate results. Tell patients that the test is designed to detect HIV infection if used 3 months after the risk event. It takes 3 months for the body to build up antibodies to the virus, so if testing is done too soon, it may not work.
Once patients are ready to use the test, encourage them to read all of the directions in the kit and information on the back of the outer carton box. Give patients detailed instructions on how to use the test (i.e., role of the test tube, test stick, and performance of the swab) and how to interpret the results.
Explain to patients the difference between the “C” line (control) and the “T” line (test). If both lines are present after 20 minutes, this indicates that the test is positive. Inform patients that this result does not mean that they definitely have HIV, however. It means that further testing its needed to confirm their HIV status, as a false-positive result is possible.
Additional educational points include the following:
- Do not drink or use oral care products such as toothpaste, mouthwash, or whitening strips for 30 minutes before starting the test.
- Remove any dental products (e.g., dentures) that may cover the gums before starting the test.
- Use a timer or watch to tell when 20 to 40 minutes have passed.
- Have access to a phone to speak directly to a support person if needed.
Since patients use this test in their homes, access to support services is important for patients who have questions about HIV or the test itself, as well as for those whose results are positive. OraSure provides a 24/7 bilingual (English and Spanish) support center that can help patients in all of these areas; the center can be reached at 866-436-6527. The center is staffed with representatives trained in accordance with CDC’s guidelines for HIV counseling, testing, and referrals. In addition, the center provides referrals for follow-up support and care near the patient’s home.
Patients can also use other resources, including the CDC National Prevention Information Network () and the HIV Medicine Association (). Refer patients to these organizations for additional information about HIV and AIDS.
The ease of availability of this new at-home HIV test is as a major advance in HIV screening and public health. Proper education of patients on use of the test and appropriate follow-up will lead to accurate diagnosis of more patients and earlier care, thus helping to reduce transmission of the virus.