Box 3.1 The Female Condom
An estimated 3 million women worldwide have HIV infection, and AIDS has become the leading cause of death among women between the ages of 20 and 40 years in major cities throughout sub-Saharan Africa, Western Europe, and the Americas (Chin, 1990; Hankins and Handley, 1992). In the United States, women still represent a small percentage of all AIDS cases; however, their proportion is growing (CDC, 1993a). While the sharing of injection equipment had been the primary risk factor for HIV infection among women in the United States, current epidemiologic data indicate that sexual activity has now surpassed needle sharing as the leading risk factor for AIDS among women. There are indications that many of the traditional HIV prevention and intervention programs have not had a major impact in reducing highrisk sexual behavior among women (Sorensen et al., 1991; Weissman and National AIDS Research Consortium, 1991). To date, the most common and effective risk reduction method is condom use. But many woman at risk report not using them, a situation resulting from a variety of factors, including socioeconomic circumstances, sex roles in the street drug culture, and fear that mistrust, rejection, and even violence will result if they suggest that their partners use condoms (Padian, 1988; Schilling, El-Bassel, Gilbert, et al., 1991; Valdiserri, Arena, Proctor, et al., 1989).
There are few woman-controlled methods of sexual risk reduction, and what is available is not effective in preventing HIV infection. For example, both the effectiveness and the side effects of spermicides have raised questions about their feasibility as an HIV risk reduction technique (Stein, 1992). Sponges and diaphragms are promoted as HIV risk reduction mechanisms because they reduce the incidence of sexually transmitted diseases (Rosenberg and Gollub, 1992), but neither has actually been tested to determine whether it reduces risk of HIV infection.
However, a new device called the "female condom," may potentially address this need. The first female condom, made of rubber with a steel coil rim, was introduced in the 1920s (British Journal of Family Planning, 1992). It was not until the late 1980s, however, that a more acceptable device was developed—the Femidom™ female condom, which has been commercially available in the United Kingdom since September 1992 and received FDA approval in the United States in 1993. In the United States, the female condom has been marketed since January 2, 1994 by Wisconsin Pharmacal Company under the name of Reality™. The design combines features of the male condom and the diaphragm (Bounds, 1989). The Reality™ female condom is a polyurethane sheath with a flexible inner ring that secures the condom against the cervix and an outer ring that prevents the condom from entering the vaginal canal. Various tests