The FDA approved the first home blood sample HIV collection test kit and HIV telephone counseling service on May 14. Marketed by Direct Access Diagnostics under the trade name "Confide," the test kit and counseling service are initially limited to Texas and Florida. A retail marketing program has been launched in Texas and an (800) number provided for residents of both states. A national marketing program is expected to be rolled out in early 1997.
The approval came after several years of sometimes bitter and acrimonious relations between the former management of Direct Access Diagnostics and the FDA, marked by a lawsuit by the Johnson & Johnson Company against the FDA, and the subsequent resignation of the company's former CEO Elliott Millenson.
The AIDS community was strongly divided over the Confide program, primarily over the program's use of telephone counseling. Some AIDS organizations have condemned telephone counseling as potentially harmful to some people who test positive and who, without face-to-face counseling, might attempt suicide. Others, including the International Association of Physicians in AIDS Care, have reviewed the Confide counseling program and found it as effective as, and sometimes superior to, some of the HIV counseling currently offered.
IAPAC has pressed for approval of home HIV testing, which could remove the often serious obstacles faced by many who wish to get an HIV test. For example, there is strong anecdotal evidence that individuals in rural communities are afraid of going to local physicians for testing, and will not travel to test sites in major cities. And city dwellers worried about a lack of confidentiality may not seek out test sites. But the overriding reason for our association's support was that this testing option could save lives.
Unfortunately, much of the continuing opposition to home HIV testing comes from public health and AIDS agencies who receive funding for such testing and counseling. While I can appreciate the concern of experienced counselors over the risks of not having face-to-face counseling, we must realize that it is the individual's right to choose not to have this counseling, and to assume any risk that may result from this choice. All of us involved with people at risk for or with HIV need to support and fight for the right of each individual to make his or her own testing and treatment decisions.
While the Direct Access Diagnostics management team is largely responsible for the long-awaited Confide approval, credit for mobilizing a major part of the AIDS community in support of home testing goes to Bruce Decker. Bruce died last November before his work could come to fruition. He focused his indefatigable efforts toward the Confide approval through the Direct Access Diagnostics Community Advisory Board which he organized and headed, and on which several IAPAC trustees have the privilege of serving.
The advisory board had a major impact on Direct Access Diagnostics' sensitive marketing plans to reach the diverse group of people at risk for HIV/AIDS. The advisory committee also convinced the company to distribute test kits to some of the people at risk who might not be able to afford them. And it was Bruce's dogged efforts that convinced the company to establish the Confide Fund, supported by sales of the kit, which will be used to support AIDS organizations nationally. But Bruce's most imporant legacy will be seen in the lives that can be saved by the wide implementation of this new technology.