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Evaluation of the effects of a female condom on the female lower genital tract.

The purposes of this study were to determine if use of the female condom (Reality) was traumatic to the vaginal mucosa and/or vulvar skin and to determine its effect on resident vaginal bacterial flora. Thirty subjects were randomly assigned to utilize the female condom or diaphragm during the study period. Initially and during 3 follow-up visits, each subject underwent colposcopic examination of the vagina, cervix, and vulva with photographic record, and qualitative fungal, aerobic and anaerobic cultures of the vagina. The two groups were compared with respect to the frequency of abnormal physical findings determined by both macroscopic and colposcopic examination. Visits were compared within each contraceptive group with respect to changes in resident vaginal flora. There was no evidence of significant trauma associated with the use of either contraceptive device during the study period. The resident vaginal flora did not significantly change during the three follow-up visits in patients using the female condom. In diaphragm users, lactobacilli were less frequently isolated at the third (14/15 vs 6/15, P = 0.008) and fourth (14/15 vs 7/15, P = 0.039) follow-up visits when compared to the initial visit. In addition, aerobic gram-negative rods were more frequently isolated during the fourth visit (1/15 vs 9/15, P = 0.021) when compared to the first visit. We conclude that neither the female condom (Reality) nor the diaphragm is associated with trauma to the lower genital tract. Subjects using the diaphragm undergo a significant change in vaginal bacterial flora, becoming more likely to be colonized with coliform microorganisms and less likely to maintain lactobacilli colonization.

Adult

Teaching about the female condom.

Reality female condoms became available for over-the-counter purchase in the fall of 1994. Because the female condom is a new sexual barrier device, women need to learn how to use it correctly. Health care providers must also be knowledgeable about the correct use of the female condom so that they can teach women how to use it as a barrier method. To facilitate learning about the female condom, a curriculum was developed that included a quiz on knowledge about the female condom. Content validity was established through a content validity index completed by six content experts. This quiz was used to evaluate educational sessions offered to 42 persons in an urban college setting and 18 women in a community setting. The article describes the female condom along with the curriculum that was developed to teach its correct use and the reactions of potential users of the female condom.

Adult

[Current status of the female condom in Africa].

The female condom was developed in the 1980s. It is a contraceptive device used by women that protects against both pregnancy and sexually-transmitted diseases (STDs) including HIV infection. Two studies have investigated the contraceptive effectiveness of the female condom, and it was found to be as effective as other barrier methods. It has been shown to be effective against STD and HIV transmission in vitro but there is only limited evidence of its efficacy in vivo. No serious local side effects or allergies have been reported and the female condom can be used with any type of lubricant, spermicidal cream or foam. The female condom is the only device other than the male condom that has been shown to prevent HIV transmission. The female condom has been marketed in 13 countries since the summer of 1996. Most of these countries are industrialized and the selling price in these countries is too high for developing countries. Sub-Saharan Africa has very high prevalence rates for HIV infection, at least 30% of the general population in Eastern and Central regions. The epidemic is also spreading fast in some parts of the Western region. In Ivory Coast for example, 12 to 15% of pregnant women are infected. African women are subordinate to men in many aspects of their lives, politically, educationally, socially and sexually. This sexual inequality makes them highly vulnerable to STDs, including HIV, and unwanted pregnancies. This paper reviews 10 of the 15 studies carried out in sub-Saharan African countries between 1990 and 1996 and compiled by the World Health Organization. Recruitment methods, education of subjects, methodology and assessment of acceptability differed between studies. Despite these limitations, most studies concluded that the women who participated in the trials generally found the female condom acceptable. Acceptability was established quicker among prostitutes than among other women and men found the female condom less acceptable than did women. However, the sample size is too small to draw any firm conclusions. Commercial sex workers in the studies reviewed were very interested in this new method because it gave them an additional method of safer protection during sex. However, they were occasionally faced with difficult negotiations with some clients, refusal to use the female condom and sexual violence. Reuse of the device was reported in four studies, but the term reuse is seldom defined. In cases where it was defined, the frequency of reuse, with washing of the device, accounted for no more than 1% of the total number of uses. The acceptability of the female condom among women other than prostitutes faces two obstacles, the reaction of the woman's regular partner and attitudes to the device itself (appearance, difficulties or uneasiness concerning its use). However, some women liked it because it provided dual protection against pregnancy and STDs and sexual pleasure. The moderate level of acceptability to male partners may be overestimated because women whose partners disliked the device would be more likely to discontinue its use. The studies of acceptability reviewed here show that use of the female condom in Africa is realistic and that it provides women with more independent protection. Initial negative perceptions of the device are often replaced with a more positive reaction after several uses. The experience gained with use reduces the technical problems. We need to overcome the stereotypes, simplifications and strong opinions that threaten to damage the acceptance of this new method and efforts to encourage women to adopt it. However, we still require further clinical data on the effectiveness of the female condom at preventing pregnancy and HIV transmission. Availability of the female condom is improving in Africa. Pilot marketing studies were launched in 1996 in Guinea, Zambia, South Africa, followed by Uganda and Tanzania. There are local initiatives in Ivory Coast and Zimbabwe. (ABSTRACT TRUNC

Africa

Female condoms.

Early versions of a female condom were available in the 1920s and 1960s, but they were little used and soon forgotten. It took the arrival of AIDS, and the urgent need for a wider range of female-controlled barrier techniques, to rekindle scientific interest in this method. In the 1980s, three groups in Europe and the USA began development of new female condom designs, comprising 'Femidom (Reality)', the 'Bikini Condom', and 'Women's Choice'. Apart from differences in their physical design, Femidom differs from the others in that it is made of a polyurethane membrane, which has several advantages over latex. Of the three, Femidom is the most advanced in terms of development and clinical testing, and it is the only one to have reached the marketing stage. Laboratory studies and clinical trials suggest that its contraceptive efficacy is similar to that documented for the male condom, though a direct comparison is not possible because no comparative clinical trials have, as yet, been undertaken. Reported 'typical-use' pregnancy rates range from 12.4 to 22.2% at 6 months of use in the USA and Latin America, respectively, while a study in the UK observed a rate of 15% at 12 months. As with all barrier methods, most failures appear to be associated with poor compliance or incorrect use. 'Perfect-use' pregnancy rates were substantially lower, indicating that Femidom can be very effective, if used consistently and correctly. Evidence for Femidom's effectiveness to protect against transmission of sexual disease-causing organisms, including HIV, is still very limited and based largely on laboratory studies. Whilst, in theory, the condom should confer reliable protection, its efficacy in clinical use will depend upon correct and consistent use and upon the product's ability to maintain an effective physical barrier throughout penetrative intercourse. In this respect, the results of recent and ongoing clinical studies are expected with much interest. How valuable Femidom will prove to be, in terms of sexual health and contraception, will also depend largely on its long-term user-acceptability. As is generally the case with new methods, initial public interest in Femidom is expected to be high, as was documented in numerous surveys, and there undoubtedly exists a sub-group of women who view the product as their most appropriate contraceptive/sexually transmitted disease prevention option. However, more information on the product's acceptability, based on continuation rates, as is usually applied to other contraceptive techniques, is urgently needed to permit a more reliable assessment of Femidom's position among current methods. The arrival of a female condom represents a welcome addition to the range of female-controlled barrier contraceptives and, because of its numerous potential advantages over the male condom, may play an important role in the prevention of unwanted pregnancy and sexually transmitted diseases.

Single-Use Internal Condom

Female condom acceptability among sex workers in Costa Rica.

This study measured short-term female condom acceptability among 51 female sex workers in San José, Costa Rica. Each woman was trained in use of the female condom and was asked to use the device if clients refused to use male condoms during a 2-week study period (male condoms were also distributed). Two follow-up visits with short interviews were scheduled, including questions on general reaction to the female condom by the participants and their clients, ease and comfort of use, and preferences for male or female devices. At the first follow-up visit, 51% of the women reported they "liked the female condom very much" and 45% reported they "liked it somewhat." Similar results were reported after the second follow-up phase. Sixty-seven percent of the participants preferred the female condom over the male condom, and, according to the the women, over half of their clients liked the female condom "very much" or "somewhat." The most common problems during the first phase were difficulty to insert (61%) and discomfort (43%). However, during the second study phase a reduction in these problems (22% and 25%, respectively) and other use-related problems were noted. Although this new method is not yet available throughout Costa Rica, these results should encourage sexually transmitted diseases and HIV service organizations to make this method accessible to women.

Acquired Immunodeficiency Syndrome

Acceptability of the female condom among STD clinic patients.

This study examines the acceptability of the female condom among African American and Latino patients from two inner-city sexually transmitted disease (STD) clinics through focus group discussions. Prior to the initial focus group sessions, 90% (n = 90) had heard about the female condom, 8% (n = 8) had seen it, and 2% (n = 2) had used it. Among the 41 participants (22 males and 19 females) attending a second focus group session, 85.4% (n = 35) had used the female condom at least once. Female study participants who had previous experience inserting a barrier contraceptive device, such as a diaphragm, indicated that they felt more comfortable inserting the female condom than those who had never used such a device. Male participants indicated that they were more comfortable using the female condom with their steady partners than with casual partners, whereas female participants indicated no such distinctions. These and other study findings suggest that need to promote and expand the use of the female condom as a device that protects women from STD transmissions including HIV and AIDS.

Acquired Immunodeficiency Syndrome

Heterosexual men's attitudes toward the female condom.

This article addresses heterosexual men's familiarity with the female condom and their attitudes toward this barrier method. Qualitative interviews were conducted with 71 ethnically diverse and heterosexually active men who were recruited in sexually transmitted disease (STD) clinics or through word of mouth in communities with high HIV/STD seroprevalence in New York City during fall 1994 to fall 1995. Only one man reported previous experience with the female condom. The large majority of men had no or limited knowledge of the female condom. Men's reactions to learning about this method ranged from positive to negative, although most men reported willingness to have sex with a partner who wanted to use the female condom. Positive reactions included: endorsement of a woman-controlled condom and her right to use it, the potential for enhancing one's sexual pleasure, and an eagerness to have a new sexual experience. Negative reactions centered on the "strangeness" and "bigness" of the female condom, concerns about prevention efficacy, and concerns about reductions in sexual pleasure. Our findings highlight the need for HIV prevention programs that target heterosexual men and promote the use of the female condom.

Adult

Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia.

BACKGROUND: Few studies have measured female condom use for more than a 6-month period or among persons at high risk of STD. OBJECTIVE: To measure long-term use of the female condom among couples at high risk of HIV infection and to evaluate the effect of female condom use on unprotected coital acts. STUDY DESIGN: Ninety-nine Zambian couples with symptomatic sexually transmitted diseases (STD) received female condoms, male condoms, and spermicides and were counseled to use either condom plus spermicide for each coital act. Couples were followed up at 3-, 6-, and 12-month visits. Barrier contraceptive use was measured prospectively by coital log. RESULTS: Among the 99 couples enrolled, 51, 38, and 30 couples were successfully followed up for 3, 6, and 12 months, respectively. Female condoms were reportedly used in 24%, 27%, and 23% of coital acts and by 86%, 79%, and 67% of the returning couples during each time interval. Higher-level female condom users used male condoms less often but had fewer unprotected coital acts (5% vs. 14%; p < 0.05) than lower-level female condom users. CONCLUSION: A majority of couples at high risk of HIV infection used the female condom in conjunction with other barrier methods over a 1-year period. The addition of female condoms accompanied by appropriate counseling to the barrier method mix may reduce unprotected sex among couples at high-risk of HIV infection.

Adult

Prevention of vaginal trichomoniasis by compliant use of the female condom.

BACKGROUND: Several case-control studies suggest that the male condom protects women against some sexually transmitted diseases. The female condom is the first barrier device under the woman's control that may be effective in the prevention of sexually transmitted diseases. GOAL OF THIS STUDY: To determine if appropriate use of the female condom decreased the rate of recurrent vaginal trichomoniasis in previously diagnosed and treated women. STUDY DESIGN: One hundred and four sexually active women with vaginal trichomoniasis were treated with metronidazole and assigned to a group using the female condom or a control group during a 45-day period of continued sexual activity. Fifty women served as controls, and 54 women were assigned to use the female condom. RESULTS: Only 20 women used the female condom each time they had sexual intercourse. Reinfection with trichomonas occurred in 7/50 (14%) controls, in 5/34 (14.7%) noncompliant users, and in 0/20 compliant users of the female condom. CONCLUSION: The compliant use of the female condom is effective in preventing recurrent vaginal trichomoniasis.

Adult

Preliminary comparison of the polyurethane female condom with the latex male condom in Kenya.

This paper summarizes acceptability data published to date on the innovative female condom, and presents an additional study comparing the acceptability of the female condom and the latex male condom in a sample of low risk women attending private obstetrician/ gynaecologists' clinics in Nairobi, Kenya. Eighty-four percent of all subjects who completed interviewer-assisted questionnaires reported that they liked using the female condom, and more than two-thirds of all the women liked the female condom as much or better than the male condom. Fifty-five percent of the women would use the device in future if it were available. The least liked features were that the device was too large for easy insertion, messy to handle, and reduced sensation. Use became easier and more comfortable with experience. The most liked features were that the device made sex more enjoyable, protected against sexually transmitted diseases and pregnancy, and was under the woman's control. Male partner response was slightly less favourable, and sometimes resulted in women's noncompliance or discontinuation of use, despite the fact that such a device is supposed to empower women. This study provides preliminary data indicating that the female condom is a fairly acceptable method for some Kenyan couples, but recommends further research into safety, cost-effectiveness and hindrances to acceptability.

Adult

Acceptability of female condom use among women exchanging street sex in New York City.

Greater access to alternative female-initiated barrier methods, such as the female condom, is needed among women exchanging street sex. This study describes knowledge of and experience with the female condom among 101 women exchanging sex for money and drugs on the streets of New York City, and examines the acceptability of female condom use as an alternative barrier method for HIV/STD prevention among this population. Female condom use among this sample of sex workers was found to be related to having a regular sexual partner, living with someone who is a drug or alcohol abuser, not being homeless, using alcohol or intravenous heroin, having heard of the device, and having discussed the device with other women or with a regular sexual partner. Despite decreased acceptability post-use, most sex workers indicated an intention for future female condom use.

Adult

Perceptions and acceptability of the female condom [Femidom] amongst commercial sex workers in the Songkla province, Thailand.

In a prospective descriptive study on the perceptions and acceptability of the female condom in a group of Thai commercial sex workers (CSWs) in the Songkla province, we invited CSWs from selected brothels to participate. Those who used the female condom were interviewed after one week and 16 weeks of use. Focus group discussions were also conducted at the end of the study period to obtain additional information. The group comprised 56 CSWs. Only 34% of them had heard of the female condom prior to this study and none had ever used one. A high proportion of CSWs reported positive experiences and perceptions. There were no significant changes in perceptions and experiences during the study. Eighty per cent of participants said they were satisfied with the female condom and would use it again in the future and would recommend it to their friends. However, the female condom was used in only 29% of the total number of sexual acts reported, and 98% of CSWs said they would prefer to use a male condom for sex work. Many of the women were concerned that the physical appearance of the condom would reduce its acceptability to their clients. This was the most frequently cited reason for not using the female condom in the future. While a promising device, the female condom must also become more acceptable to men if it is to enable women to be in control of their own protection from pregnancy and STD/HIV.

Adolescent

Short-term acceptability of the female condom among staff and patients at a New York City Hospital.

An acceptability study of the female condom undertaken at New York's Harlem Hospital between August 1993 and February 1994 enrolled 52 women aged 18-57, 41 of whom (79%) used the female condom at least once. Of these, one-half used the female condom at least three times and 40% used it once; on average, women used it 2.4 times. Two-thirds of users liked the female condom either very much or somewhat, 20% were neutral and 15% stated that they did not like it. One-half of the women reported that their partner liked the device, while 17% said he felt neutral about it and approximately one-quarter said he disliked it. Seventy-three percent of respondents and 44% of their partners preferred the female condom to the male condom.

Adult

User acceptability of a female condom (Reality) in Shanghai.

Thirty married couples evaluated the Reality female condom on questionnaires about its acceptability for 300 acts of coitus (10 per couple). An analysis of the summary questionnaires showed: 90% of couples considered the female condom an acceptable method and 87% felt it was a good contraceptive device; the majority of couples (87%) found it easy to use; and 80% of females and 73% of males reported that, in comparison with the male condom, the effect on sexual pleasure was either improved or no different. A little more than half of the couples (55%) preferred it to male condoms. To look at the learning curve effect, an additional analysis was completed by pooling the first 5 applications of each user and comparing the results with the pooled results of the second 5 uses. All the findings suggest that a certain proportion of couples of childbearing age will choose the Reality female condom for contraception if it enters into the Chinese market. As a new contraceptive barrier device, the female condom may require a certain amount of education and awareness before it will be fully recognized as an important option to help prevent pregnancy as well as sexually transmitted infections.

Adult

Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial.

BACKGROUND: The male condom is the most effective barrier method available for protection against sexually transmitted diseases (STDs), including HIV infection. There is an urgent need to develop and evaluate other prevention methods, such as the female condom. This study estimated the additional protection against STDs offered to sex workers by giving them the option of using the female condom when clients refused to use a male condom. METHODS: Sex establishments in four cities in Thailand were randomized into two study groups: one in which sex workers were instructed to use male condoms consistently (male condom group); and one in which sex workers had the option of using the female condom if clients refused or were not able to use male condoms (male/female condom group). Randomization was done by sex establishments, and not by individuals, to minimize sharing of female condoms across study groups. The proportion of unprotected sexual acts (defined as sexual acts in which condoms were not used, tore, or slipped in or out) and incidence rate of STDs (gonorrhoea, chlamydial infection, trichomoniasis and genital ulcer disease) were measured over a 24-week period and compared between the two study groups. FINDINGS: Results are available from 34 sex establishments (249 women) in the male/female condom group, and 37 sex establishments (255 women) in the male condom group. Condom use was very high in both groups (97.9 and 97.3 % of all sexual acts, respectively, P > 0.05). Male condom use was lower in the male/female condom group when compared with the male condom group (88.2 and 97.5%, respectively, P < 0.001). However, this reduction in male condom use was counterbalanced by the use of female condoms in 12.0% of all sexual acts in the male/female condom group, contributing to a 17% reduction in the proportion of unprotected sexual acts in this group when compared to the male condom group (5.9 versus 7.1%, respectively, P = 0.16). Female condom use was sustained over the entire study period. There was also a 24% reduction in the weighted geometric mean incidence rate of STDs in the sex establishments of the male/female condom group compared to the male condom group (2.81 versus 3.69 per 100 person-weeks, P = 0.18).

Adolescent

The female condom (Femidom)--a study of user acceptability.

OBJECTIVE: To determine the acceptability of the female condom (Femidom). DESIGN: Questionnaire survey following the use of the Femidom during sexual intercourse. SETTING: Groote Schuur and Somerset Hospitals, Cape Town. PARTICIPANTS: Nurses, secretaries, doctors and domestic staff of Groote Schuur and Somerset Hospitals who volunteered-61 women were recruited, 8 did not use any female condoms, and 1 did not return. Many women refused, mainly because of the unaesthetic appearance of the Femidom and the fact that they had to continue using their regular contraceptive and they did not think their partners would co-operate. OUTCOME MEASURES: Sexual responsivity compared with that without Femidom; acceptability of the method; women's and their partners' enjoyment of using the method; comparison with the male condom; awareness of HIV-AIDS and protective measures that can be used. RESULTS: Of the 52 participants, 23 used all 10 Femidoms issued to them. Thirteen women and 18 of their partners did not enjoy using the method and 9 had problems with it. Sex with the Femidom was the same or better in 51.9%. The Femidom was unacceptable in 32.7%, acceptable in 52% and very acceptable in 13.4%. Compared with the male condom, 50% of women and 44.2% of men considered the Femidom as good or better. Of the 61 women, 59 had heard of AIDS, and awareness of protective measures was good. CONCLUSION: There was resistance to accepting the Femidom, mainly because of its unaesthetic appearance and because women were participating for altruistic reasons. Acceptance and ease of application improved with use. Comments regarding problems and subjects' and their partners' enjoyment varied from extremely positive to extremely negative; 65.4% considered sex using the Femidom acceptable or very acceptable. It is important to inform and obtain co-operation from the male partner. The female condom has been developed as an alternative for women to use if their partners refuse or dislike using male condoms. Perfect use of the Femidom may reduce the annual risk of acquiring HIV by more than 90% in women who are sexually active with an infected male. The efficacy of the female condom has been described as equal to that of the diaphragm. The Femidom will increase the range of choices of contraceptives and prophylactic methods available for protective sex. It should become accepted as a method of contraception and an adjunct to other contraceptive methods as a prophylactic against sexually transmitted diseases and AIDS, particularly in relationships that are not mutually monogamous.

Adult

Comparative contraceptive efficacy of the female condom and other barrier methods.

Because the research design for the clinical trial establishing the contraceptive efficacy of the female condom--a six-month life-table probability of failure of 15% (12% in the United States vs. 22% in Latin America)--did not include randomization with another method of contraception, no definite conclusion about its comparative efficacy is possible. Comparisons using other female barrier methods as historical controls, however, provide evidence that, among women in the United States, the contraceptive efficacy of the female condom during typical use is not significantly different from that of the diaphragm, the sponge or the cervical cap. The six-month probability of failure during perfect use of the female condom is 2.6% among U.S. women, similar to rates for the diaphragm and the cervical cap but significantly lower than that for the sponge. Meaningful comparisons with the male condom are not possible because of the lack of data from carefully controlled prospective clinical trials. Extrapolations from the results on contraceptive efficacy suggest that perfect use of the female condom may reduce the annual risk of acquiring the human immunodeficiency virus by more than 90% among women who have intercourse twice weekly with an infected male.

Clinical Trials as Topic

Commentary: the new female condom--item 1 on a women's AIDS prevention agenda.

A US Food and Drug Administration (FDA) advisory panel has recommended that the female condom Reality be approved for contraception and acquired immunodeficiency syndrome (AIDS) prevention. Final FDA approval will mark the first official recognition of a woman-controlled method for protection against sexually transmitted disease. A female condom allows women to use just one method to respond to the twin anxieties of AIDS and unwanted pregnancy. In those couples in which the man refuses to wear a male condom, the availability of a female condom makes protection possible for the first time. Although the female condom has some advantages over the male condom--greater comfort for some women and men and nonreliance on male arousal--general population experience with the device is needed to achieve regular widespread use and hence effectiveness at population levels. The FDA still lags behind in responding to women's needs for information on AIDS and sexually transmitted disease.

Acquired Immunodeficiency Syndrome