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PubMed1991

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↗
PubMed1997

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↗
PubMed2000

Male-condom and female-condom use among women after counseling in a risk-reduction hierarchy for STD prevention.

BACKGROUND: A concern with hierarchy messages, which promote male condoms and female-controlled barrier methods along a prevention continuum, is that they may discourage condom use. GOAL: To measure male-condom and female-condom use among women who received hierarchy counseling and compare this with women counseled about condoms only. STUDY DESIGN: Three observational cohorts that correspond to prevention message received were assembled, and consisted of female sexually transmitted disease clinic patients who were counseled about male condoms, female condoms, or a hierarchy message. The hierarchy message promoted male and female condoms, the diaphragm and cervical cap, spermicides, and withdrawal, in descending order of effectiveness against sexually transmitted diseases. After counseling, women were interviewed and returned for follow-up visits at 2 weeks, 4 months, and 6 months. The outcome was the mean proportion of male condom- or female condom-protected coital acts at each follow-up visit in the hierarchy cohort. The outcome was dichotomized as high (> or = 70% of coital acts protected) or low (< 70%), and generalized estimating equations were used to compare observed follow-up condom use with baseline within the hierarchy cohort and observed follow-up condom use between cohorts. It was assumed that condom use in persons not present at 6 months was equal to baseline levels, and condom use estimates were calculated for each full cohort that was initially enrolled.

Cohort Studies↗
PubMed2000

The female condom.

BACKGROUND: The female condom has been available in numerous countries for some years. It was launched in Australia on March 8th, 2000 and is an important addition to the range of barrier contraceptives. OBJECTIVE: This article aims to provide an overview of the female condom to enable GPs and nurse practitioners to advise clients and provide information about its use. DISCUSSION: The female condom is an effective form of contraception. When used correctly it has a failure rate of about 5%, which compares favourably with other forms of barrier contraception. It is important that users are instructed on insertion, in particular the need to guide the penis into the condom. Evidence shows that it reduces the incidence of sexually transmitted infections. There may also be additional benefit in reducing wart virus and herpes transmission, as there is greater protection to the vulva and the base of the penis, when compared with the male condom. The female condom has high user acceptability, and offers advantages in terms of sensitivity and also ease of use by men with erectile dysfunction. It is the only barrier protection under a woman's control, giving protection to the vagina and vulva as well as the cervix.

Australia↗
PubMedDate not supplied

[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↗
PubMed2000

Factors associated with female condom use among HIV-seropositive women.

Female condoms are an effective option for preventing sexually transmitted diseases (STDs), including HIV transmission. Little is known, however, about female condom use in women living with HIV/AIDS. Ninety HIV-positive women completed measures of demographic characteristics, exposure and use of female condoms, attitudes toward female and male condoms, sexual behaviours, and substance use. Most women (77%) had been exposed to female condoms, however only 30% reported lifetime use, 16% reported recent use, and only 6% of the sample used female condoms as much or more than they used male condoms. The only factors consistently associated with female condom use were positive attitudes toward female condoms. Women who recently used female condoms were also more likely to have multiple male sex partners and reported fewer unprotected intercourse occasions. Female condoms are therefore used by a small number of HIV-infected women, particularly those with more than one male sex partner. Female condom use may be enhanced by removing barriers to their use, increasing cooperation of male partners, and enhancing proficiency of use.

Adult↗
PubMed1997

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↗
PubMed1999

Increasing use of the female condom through video instruction.

The female condom is effective in preventing sexually transmitted diseases and when used properly reduces risk of HIV infection among women. This field experiment evaluated the effect of a video presentation on reported use of and satisfaction with the female condom. Participants were 100 women tested for HIV infection in a community agency. Ages ranged from 17 to 62 years, and one fifth of the sample were African American or Hispanic. The 23 women who viewed an instructional video were significantly more likely than 13 of the control group of 50 to try the condom and report to the researcher. Video viewing was unrelated to liking the product and future intent to use. Almost three quarters of those who used the condoms reported they liked and would use them.

Adolescent↗
PubMedDate not supplied

Female condom use among women at high risk of sexually transmitted disease.

CONTEXT: Whereas the female condom has been evaluated in many hypothetical acceptability or short-term use studies, there is little information about its suitability for the prevention of sexually transmitted diseases (STDs) or HIV over extended periods of time. METHODOLOGY: As part of a six-month prospective follow-up study of 1,159 STD clinic patients, clients were interviewed during their initial visit, exposed to a behavioral intervention promoting condoms, given a physical examination and provided with instructions on completing a sexual diary. Potential predictors of trying the female condom were evaluated using logistic regression, and three condom-use groups (exclusive users of female condoms, exclusive users of male condoms and users of both types of condoms) were compared using multinomial regression. RESULTS: Among 895 women who reported having engaged in vaginal intercourse during the study period, one-half had sex with only one partner, while one-quarter each had two partners or three or more partners. A total of 731 women reported using the female condom at least once during the follow-up period--85% during the first month of follow-up. Multiple logistic regression analyses indicated that employed women and those with a regular sexual partner at baseline were significantly more likely to try the female condom. By the end of the follow-up period, 8% of participants had used the female condom exclusively, 15% had used the male condom exclusively, 73% had used both types of condom and 3% had used no condoms. Twenty percent of women who tried the female condom used it only once and 13% used it twice, while 20% used 5-9 female condoms and 32% used 10 or more. Consistent condom users (N=309) were predominantly users of both types of condom (75%), and were less often exclusive users of the male condom (18%) or the female condom (7%). According to a multivariate analysis, women who used the female condom exclusively or who mixed condom types were more likely to be black, were more likely to be employed and were more likely to have a regular partner than were users of the male condom. CONCLUSIONS: Women at risk of STDs find the female condom acceptable and will try it, and some use it consistently. Mixing use of female condoms and male condoms may facilitate consistent condom use. The female condom may improve an individual's options for risk reduction and help reduce the spread of STDs.

Adolescent↗
PubMed1998

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↗
PubMed2000

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

BACKGROUND: Alternative female-initiated barrier methods, such as the female condom, are needed among women exchanging street sex to enhance their ability to protect themselves from HIV and STD infection. OBJECTIVE: To describe predictors of female condom use among 96 women exchanging sex for money and drugs on the streets of New York City. STUDY DESIGN: A total of 113 sex workers received a baseline interview, a demonstration on proper female condom use, and 10 female condoms. A total of 101 sex workers received a followed-up evaluation at 2 weeks, of which 96 were included in data analysis. Predictors of condom use were analyzed for (1) any type of use; and (2) use with commercial partners. RESULTS: The strongest predictors of female condom use among this sample of sex workers were (1) living with someone with a drug or alcohol problem; (2) having heard of the female condom; and (3) homelessness. Current physical or sexual abuse by a commercial partner and marriage decreased the probability of female condom use. CONCLUSIONS: Female condom distribution encouraged sex workers who may be most vulnerable or who reported characteristics or behaviors associated with the highest sexually transmitted disease and HIV risk to try female condoms with commercial partners. Implications for intervention development include the need to develop innovative programs provided on the street (e.g., through peers) that can access homeless, drug-using sex workers in the most at-risk environments.

Adult↗
PubMed2000

High-risk adolescents and female condoms: knowledge, attitudes, and use patterns.

PURPOSE: To explore data on high-risk male and female adolescents' attitudes towards female condoms, compared with male condoms. METHODS: Exploratory survey research was utilized with a convenience sample of 65 high-risk adolescents at an emergency homeless shelter. A peer-led intervention was conducted and pre-test and post-test interviews explored barriers to female condom use. The intervention consisted of 15- to 30-minute small group sessions, discussing female condoms' construction; purpose of the rings; efficacy preventing pregnancy and sexually transmitted infection (STIs); and how to lubricate, insert, and use. Content and Chi-square analyses were utilized. RESULTS: Sixty-three percent used male condoms as their primary contraceptive method; almost half (48%) said they always used male condoms, but 44% reported having sex without a male condom at least once in the 2 weeks prior to pre-test. Ninety-five percent had heard of the female condom, half 'good' and 24% 'bad' things, but only 15% had ever used one. At post-test all respondents gave reasons they might use female condoms in the future, and 77% gave reasons why they might not. Most (73%) adolescents said they would still prefer the male to the female condom. The major potential barriers to adolescents' female condom use were not having female condoms available and/or females feeling uncomfortable inserting them. CONCLUSIONS: Female condoms should be offered to adolescents as an additional choice rather than as replacements for male condoms. Further research is needed to assure access, availability, and comfort with female condoms and male participation in their use.

Adolescent↗
PubMed1998

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↗
PubMed1999

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↗
PubMed1998

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↗
PubMedDate not supplied

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↗
PubMed2000

In vitro assessment of the structural integrity of the female condom after multiple wash, dry, and re-lubrication cycles.

Since the introduction of the female condom in the early 90s, there have been numerous reports of reuse of the device. In response to these reports, studies were undertaken to evaluate the safety of female condom reuse. If reuse were shown to be safe, then programmatic costs of introduction of the female condom would be reduced allowing it to be more widely available. This article outlines the results of in vitro structural integrity testing of the female condom after multiple wash, dry, and re-lubrication cycles. Devices were tested up to 10 washes using water leakage, burst, and tensile seam testing. All results were compared to the United States Food and Drug Administration (US FDA) standards for an unused female condom. The results of the structural integrity tests for all 6 washing procedures examined in this study were above the FDA minimum standards for seam strength and burst tests. For the water leakage test, 3 of 6 washing procedures tested passed the required FDA minimum standards (no holes detected). From the results of the study, it seems that washing, drying, and re-lubricating the female condom up to 10 times leads to some deterioration in the structural integrity of the device for specified washing procedures. Further studies are currently being conducted to establish the safety of female condom reuse with respect to microbial retention, structural integrity after in vivo use, and viral permeability.

Single-Use Internal Condom↗
PubMed1996

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↗