Today, the San Francisco AIDS Foundation provided public comment at the Blood Products Safety Advisory Committee, which is making recommendations to the U.S. Food and Drug Administration on criteria that should be used when evaluating applications for over-the-counter home-use HIV test kits. A copy of the testimony provided by the San Francisco AIDS Foundation at today's meeting can be found at www.sfaf.org/policy/reporting/otc_testimony.html.

If at-home HIV test kits are able to meet certain criteria and standards, the San Francisco AIDS Foundation is supportive of bringing these products to market. The federal Centers for Disease Control and Prevention estimates that 25-30% of the estimated 1.1 million Americans living with HIV are not aware that they are infected and new approaches are needed to improve these figures. If ultimately developed and approved, such test kits would allow individuals to test themselves at home and get quick results about their HIV status.

"We must continue to develop innovative and creative approaches that will significantly increase the number of people in our country who know that they are HIV-positive; at-home HIV test kits should be a part of this larger effort," explained Mark Cloutier, the AIDS Foundation's executive director. "These kits have the potential to increase HIV testing among those who want speedy results but prefer to do this in the privacy of their own homes or without the time-sink of visiting a physician's office or an HIV testing center."

The AIDS Foundation urged, however, that rigorous criteria must be established that will ensure that these at-home test kits are as effective as possible and do not produce negative health outcomes for those who purchase and use the product. In particular, the Foundation recommended criteria to ensure that:

1. those who utilize the tests are able to correctly interpret the results;
2. individuals who test positive have access to trained emotional support counselors;
3. individuals who use the product have an easy and reliable mechanism to obtain referrals to HIV treatment and prevention services in their local community; and
4. the product is priced appropriately to ensure maximum utilization and benefit.

"The adoption of these criteria is absolutely essential to ensuring that those who use at-home HIV test kits have the information and resources necessary to benefit from this new approach," said Ernest Hopkins, the San Francisco AIDS Foundation's director of federal affairs who provided testimony at today's advisory committee meeting. "We need to minimize the potential risks associated with such a product by ensuring the most easily understandable information about interpreting the results as well as appropriate linkages to emotional support and community-based referrals."

For additional information about HIV or for referrals to HIV/AIDS programs and services in California, individuals are encouraged to contact the California HIV/AIDS Hotline at 800-367-AIDS.