Challenges to female condom integration into condom programming.

Condoms are a highly effective means of preventing human immunode® ciency virus (HIV) transmission and their use is increasing in many parts of the world. Currently, the only widely-available effective method to prevent the heterosexual transmission of HIV is the use of male condoms. However, even where HIV prevalence is high, as is the case in some developing countries, condom promotion projects, involving constant condom availability and regular counselling, have been unable to attain levels of use above 70% except in limited targeted populations1,2. The world’s ® rst female condom (Reality, Femidom, and Femy are all registered names for the female condom) became available to the public in 1992. For ® ve years prior to its introduction in 1992 and continuing since then, clinical studies have been conducted to evaluate ef® cacy, acceptability and safety. The studies have satis® ed ef® cacy, safety, and acceptability standards established by government regulatory bodies including the United States Food and Drug Administration (FDA), and the product has received the European CE mark. Additional studies addressing operational issues, such as introduction strategies, education,marketing and distribution programmes, are increasing trial, acceptance and availability of the female condom, particularly to at-risk populations. The female condom extends the choice of contraceptive methods available and provides signi® cant protection from the risk of pregnancy and infection with sexually transmitted diseases (STDs). Most women andmen participating in the clinical studies report that the female condom is acceptable and allows them to practise safer sex that is sensitive and pleasurable. Data from studies around the world have highlighted the need for female-controlled prevention methods. Non-consensual sex, fear of violence, economic dependence, and inability to negotiate male condom use restrict prevention options for many women3. Although the female condom requires male cooperation, it does not require male initiative. Most importantly, use of the female condom reduces the number of unprotected acts of sexual intercourse, thereby decreasing the risk of pregnancy and increasing protection against transmission of STDs, including HIV. AIDS is now a leading cause of death among women in developing countries4. Women at all ages are biologically at higher risk than men for contracting HIV5. The majority of these infections are transmitted through vaginal intercourse; the presence of other STD infections can substantially increase women’s chances of becoming infected with HIV6. The design of the female condom offers an extra measure of safety to women that the male condom does not. Because the outer ring of the female condom partially covers the external genitalia7, the female condom may be particularly bene® cial in preventing infections caused by genital ulcer pathogens, such as herpes and chancroid. Furthermore, the female condom covers the vaginal mucosa, and thus may provide better protection from STDs than diaphragms, sponges, and caps that cover the cervical mucosa only8. In vitro studies have shown that the female condom provides an effective barrier to passage of microorganisms including HIV9,10. The female condom blocked passage of a bacteriophage smaller than hepatitis B, the smallest virus known to cause an STD, and one-quarter the size of HIV. One study of STD reinfection rates in 104 sexually active women with documented trichomonas and/or chlamydia infection demonstrated that none of the 54 participants who consistently used the female condom were reinfected. Non-compliant users and the control group had trichomonas reinfection rates of 14.7% and 14%, respectively. Three non-compliant users were reinfected with chlamydia11. In a study of Thai sex workers12 randomly allocated to receive either male or female condoms, there was a 25% reduction in the geometric mean incidence rate of STDs in the sex establishments using the female condom compared with those using the male condom (2.81/1000 vs. 3.69/100 women-weeks). Using an acceptable statistical model and extrapolating from failure rates for correct and consistent use, calculations estimate a 97.1% reduction in the risk of HIV infection for each act of intercourse with correct use of the female condom13. International Journal of STD & AIDS 2002; 13: 444± 448