Background: Data are limited on the female condom's effectiveness against STDs.
Goal: The goal was to compare STD rates between women given small-group education on, and free supplies of, either female or male condoms.
Study Design: Female patients at an STD clinic (n = 1442) were randomly assigned to condom type and followed via medical records for STDs (gonorrhea, chlamydia, early syphilis, or trichomoniasis).
Results: In an intention-to-treat analysis, the odds ratio for a comparison of STD occurrence between the female and male condom groups was 0.75 (95% confidence interval [CI], 0.56-1.01), and it did not change with adjustment. In a second analysis among women returning for subsequent screening, incidence rates for the first new postintervention STD per 100 woman-months of observation were 6.8 in the female condom group and 8.5 in the male condom group (rate ratio = 0.79 [CI, 0.59-1.06]).
Conclusion: Compared with those provided with male condoms alone, women counseled on, and provided with, female condoms fared no worse and experienced a nonsignificant reduction in STDs.
THERE IS AN URGENT NEED for methods that women can use to protect themselves against sexually transmitted disease (STD). The need is particularly critical in the case of human immunodeficiency virus (HIV) because this disease continues to spread among women in the United States and is devastating communities in Africa and Asia. 1 Given the disappointing results from a large clinical trial evaluating the effectiveness of a vaginal preparation containing nonoxynol-9 against HIV, the need to exploit the potential of every available prevention method is even more critical. 2
A host of acceptability studies across numerous populations and settings have shown that the female condom is a realistic alternative to the male condom for STD/HIV protection. 3-10 Other studies have shown it to be a proven contraceptive. 11,12 Yet the female condom is still not fully accepted as providing dual protection equal to that of the male condom against both pregnancy and STD. 13,14 Our objective was to test the hypothesis that women counseled on the use of, and given, female condoms were no more likely than those counseled on the use of, and given, male condoms to present with incident cases of STD.
There are compelling reasons to expect that the female condom will provide protection that is at least equal to that of the male condom. The female condom is a prelubricated polyurethane pouch that, once inserted, lines the vagina and extends outside it to protect the outer labia. The device operates on the same principle as the male condom in that it prevents contact between mucosal surfaces and therefore would be expected to provide a similar degree of protection against STDs. In fact, the female condom has three design advantages over the male condom that may bolster the female condom's method-effectiveness as well as increase the chances that it will be used, thereby enhancing its use-effectiveness.
First, polyurethane can be used with either oil- or water-based lubricants-an important feature, given the continued confusion in the general population about how to properly lubricate latex male condoms. 15-17 Second, the female condom provides more extensive coverage of the female external genitalia than the male condom. Finally, unlike male condom use, the female condom can be used at the initiative of the woman, without the active participation of the male partner. 4
Availability of female condoms remains an issue. Although female condoms cost more than male condoms, there are many public-sector distribution programs that provide the female condom at no or low cost.
The distinction of the latex male condom as the gold standard method for STD prevention was codified early in the AIDS epidemic when, in 1987, the US Food and Drug Administration (FDA) expanded the labeling of male condoms to include protection against STDs, including HIV. 18 Although there has been no randomized trial investigating the effectiveness of the latex male condom in preventing STDs, subsequent observational studies of the male condom have supported expanded labeling for several STDs. 19 A meta-analysis of the male condom in preventing HIV suggests that their effectiveness is 87% (60-96%), with the lower bound emphasizing the importance of consistent and correct use in determining use-effectiveness. 20
In 1993 the FDA classified the female condom as a class III medical device and required labeling that read, If you are not going to use a latex male condom, you can use Reality to help protect yourself and your partner. This labeling placed the female condom in a distinctly inferior position relative to the male condom. Results from in vitro studies conducted before approval by the FDA have shown the female condom to be impermeable to both cytomegalovirus and HIV. 21 Subsequently, three studies have investigated in vivo STD effectiveness. The first, a small observational study investigating the prevention of trichomoniasis, found no infections among women who used the devise consistently, but it lacked the power to detect differences between users and nonusers. 22 Nonrandom assignment in this study also limited inference.
Randomization was achieved in a Thai study where 71 brothels employing 504 sex workers were assigned to either a male-condom-only group or a group instructed to use female condoms if a male condom could not be used. 23 This study did not allow for a direct comparison between a group randomized to male condoms or female condoms only. However, this study did show that the use of the female condom as an alternative to the male condom was associated with a reduced but not statistically lower STD rate, compared with use of the male condom alone (2.81 vs. 3.69 per 100 person-months of observation;P = 0.18). A third, community-level intervention trial conducted in Kenya found no differences in STD incidence between groups provided with male condoms or with both male and female condoms. 33
Thus, data on the effectiveness of the female condom against STDs are limited. Yet it remains impossible to conduct the strongest possible study design: a randomized double-blind trial comparing the female and male condoms. 24 In the current study, we accomplished a study design that combined the random allocation of women to a male condom or to a female condom group and prospectively followed them for incident STDs, with the screening for these outcomes performed with blinding to study group. Unlike the Thai study, we encouraged those in the female condom group to use female condoms consistently, not only when they had failed with the male condom. We tested the hypothesis that women assigned to counseling on use of the female condom were no more likely than those assigned to counseling on use of the male condom to present with incident cases of any of the following four treatable STDs: gonorrhea, chlamydia, early syphilis, and trichomoniasis.