SFAF Testimony Regarding At-Home HIV Test Kits

November 3, 2005

Today, the Blood Products Safety Advisory Committee is considering criteria that the U.S. Food and Drug Administration (FDA) should use when evaluating applications for over-the-counter (OTC) home-use rapid HIV test kits. We appreciate the opportunity to provide comments on this critical issue.

First, let me explain that the San Francisco AIDS Foundation generally supports the availability of at-home HIV rapid test kits. We believe that the availability of such a product could play a key role in increasing access to HIV testing and in helping many Americans more rapidly determine their HIV status. According to the federal Centers for Disease Control and Prevention, it is estimated that 25-30% of the estimated 1.1 million Americans living with HIV are not aware that they are infected. We must continue to develop innovative and creative approaches that will significantly reduce the number of people in our country who are unaware that they are HIV-positive. At-home HIV test kits should be a part of this larger effort.

In particular, home-use HIV test kits could be especially helpful and useful for individuals who are uncomfortable seeking an HIV test at a physician's office or HIV testing clinic but who desire speedy test results and prefer the privacy and anonymity of testing at home. They could also be used by those who feel they do not have the time to spend waiting at a physician's office or HIV testing clinic and would be far more likely to get tested if they could get speedy HIV test results at home.

We do recognize that potential misuses of this product--such as a person somehow coercing or forcing a spouse or sexual partner to take such a test or an individual attempting to gather a sample from someone else to be tested without his or her consent--pose significant concerns. We believe, however, that the benefits of such a product outweigh these risks.

That all being said, we also believe that the FDA needs to apply rigorous criteria in reviewing such products to ensure that they are as effective as possible and do not produce negative health outcomes for those who purchase and use the product. Specifically, we recommend that the committee support the following criteria:

1. The kits must ensure that those who purchase and use the product are able to easily and correctly interpret the results. It is critical that the person taking the test is able to easily understand the results and has ample and easily accessible information that helps him/her understand what the results mean. The fact that a negative test result could still mean the person is actually infected (because of the window period between infection and the creation of antibodies) must be clearly explained in language that is easily understood. Similarly, the remote chance that test results could be inaccurate needs to be explained in clear terms that will be understood by all who use the product.
2. The companies who sell these products must ensure that individuals who test positive have immediate access to emotional support and counseling. For many individuals, testing positive for HIV can create significant emotional distress. Individuals who find out they are HIV-infected should have 24-hour phone access to trained emotional support counselors who can assist them with dealing with the array of reactions they may have.
3. Individuals who use the product must have an easy and reliable mechanism to obtain referrals to HIV treatment and prevention services in their local community. It is critical that people who opt to use a home-use HIV test kit be able to quickly link to HIV programs in their local area. Those who test positive should be able to quickly identify resources in their area that will assist them in getting a confirmatory test and to obtain HIV care, treatment and support. Those who test negative or have inconclusive results should also be able to easily get information about organizations they can turn to for additional information about HIV/AIDS.
4. The product should include information about the risks posed by other sexually transmitted diseases and about how to prevent the spread of both HIV and other STDs. If a consumer is concerned enough to buy an at-home HIV test because they believe they may be at risk for HIV, they may also be at risk for other STDs. We believe the manufacturer has a responsibility to help educate consumers about this potential risk and to provide clear and comprehensive information about how individuals can best protect themselves from getting HIV or other STDs.
5. This information and these resources should be made available in a variety of languages. In order to be effective, as many individuals as possible must be able to understand what their results mean and where they can receive additional support and referrals. At a minimum, materials, emotional support and referrals should be made available in Spanish.
6. These test kits must be priced appropriately to ensure maximum utilization and benefit. If at-home test kits are expensive, they will be used by a much smaller segment of the population and our goals of helping more Americans identify their HIV-status will be undermined. Especially given the disproportionate impact of HIV on those with lower incomes, it is critical that these products be priced to ensure that as many people at risk for HIV have access to them as possible.

We sincerely appreciate the opportunity to speak on these important issues. The San Francisco AIDS Foundation hopes to work with the FDA and the United States Health and Human Services Agency to ensure that these products are made available in the near future and that the criteria we have outlined are met.