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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↗

Consumer preference study of the female condom in a sexually active population at risk of contracting AIDS.

To determine the acceptability of the female condom among commercial sex workers in Khon Kaen, Thailand. Twenty sex workers from a massage parlor and 21 from a brothel were trained in the use of the female condom. The voluntary participants were instructed about the risk of HIV and advised that they could use the female condom as an alternative method to the male condom for protection. The female condom was used in 28.4 per cent and 17.8 per cent episodes of sex in each site during the two weeks. Continuation of use of the female condom increased from 0 per cent in the first group to 43 per cent in the second group. The reasons for discontinuing its use were that it was inconvenient and because of their partners' objection. More users said they liked the female condom even though more thought it was difficult to insert and it did cause pain. However, they would recommend it to others and most felt that other women would want to try it. The participants also saw the advantage of the female condom as a back-up method in case of clients' refusal to use the male condom but all prefered the male condom if there was a choice.

Acquired Immunodeficiency Syndrome↗

Intention to use the female condom following a mass-marketing campaign in Lusaka, Zambia.

OBJECTIVES: This report examines intention to use the female condom among men and women in Lusaka, Zambia, who were exposed to mass-marketing of the female condom. METHODS: The study used data from a representative sample of consumers at outlets that sell or distribute the female condom and the male condom. RESULTS: In spite of a high level of awareness of the female condom, use of this method in the last year was considerably lower than use of the male condom. Intention to use the female condom in the future was highest among respondents who had used only the female condom in the last year. CONCLUSIONS: The female condom is likely to be most important for persons who are unable or unwilling to use the male condom.

Adolescent↗

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↗

Sex, life and the female condom: some views of HIV positive women.

This article offers some insights into the experiences of HIV positive women with the female condom, drawing on my own personal experience and responses of 18 members of the International Community of Women Living with HIV/AIDS to an e-mail survey conducted in 2005. Major barriers reported to female condom use were cost and sporadic or very limited access. All respondents talked about needing to negotiate the use of female condoms with their male sex partners. Most felt more in control and more confident during sex when using the female condom than with the male condom or unprotected sex. Concerns about female condoms appear to be common, especially among women who have never used one; those who had used the female condom for long periods of time said good things about it. Women reclaiming our bodies is a central part of the joy and the challenge of promoting the female condom. For HIV positive women and girls, using a condom is more than protection against pregnancy, but a matter of life and death greater than the risks pregnancy can bring. Female condoms could make a critically important contribution to protecting HIV positive women's sexuality and continued sexual activity, as a fundamental part of our sexual and reproductive rights, if only they were more widely available and affordable.

Attitude to Health↗

A prospective study assessing the effects of introducing the female condom in a sex worker population in Mombasa, Kenya.

OBJECTIVE: To assess the impact and costs of adding female condoms to a male condom promotion and distribution peer education programme for sex workers in Mombasa, Kenya. DESIGN: A 12 month, prospective study of 210 female sex workers. METHODS: We interviewed participants about their sexual behaviour every 2 months for a total of seven times and introduced female condoms after the third interview. We also collected cost data and calculated the cost and cost effectiveness of adding the female condom component to the existing programme. RESULTS: Introduction of the female condom in an HIV/AIDS prevention project targeting sex workers led to small, but significant, increases in consistent condom use with all sexual partners. However, there was a high degree of substitution of the female condom for male condoms. The cost per additional consistent condom user at a programme level is estimated to be 2160 dollars (1169 pounds sterling, 1711 euros) (95% CI: 1338 to 11 179). CONCLUSIONS: The female condom has some potential for reducing unprotected sex among sex workers. However, given its high cost, and the marginal improvements seen here, governments should limit promotion of the female condom in populations that are already successfully using the male condom. More research is needed to identify effective methods of encouraging sex workers to practise safer sex with their boyfriends.

Single-Use Internal Condom↗

Female condom reuse in Lusaka, Zambia: evidence from 12 cases.

Female condom reuse could address one of the principal barriers to use, namely, cost; however, the safety of reuse has not been established. Recent reports have provided information related to reuse safety under carefully specified research study conditions. Still, little is known about reuse outside a research study context, and there are outstanding questions related to feasibility of reuse among general populations. This study reports on naturally occurring reuse from a small, purposive sample of self-identified women who, prior to the study, had reused the female condom of their own volition without reuse instruction. Three types of reuse were identified. Most women attempted to clean devices between removal and reinsertion. A number of agents, including water (only), bath soap, laundry detergent, Dettol, and beer were used for cleaning. A number of agents were used for relubrication, including Reality((R)) lubricant, various kinds of cooking oil, and Vaseline((TM)). Perception of the strength and integrity of female condoms making them suitable for reuse were influenced by both provider advice and product packaging. Most participants reported no problems with reuse. Some women, faced with barriers to single use of a female condom or use of an acceptable alternative, will resort to reuse and rely on their own "common sense" notions to implement reuse. Providers and purveyors have opportunities to shape responses to reuse for the better, and the research community is obligated to provide a solid scientific base regarding reuse safety.

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↗

The female condom: attitudes and experiences among HIV-positive heterosexual women and men.

The female condom is a potentially effective method for the prevention of HIV, other sexually transmitted disease, and pregnancy. This study describes attitudes toward and experiences with the female condom of 89 HIV-positive individuals (n = 56 women; n = 33 men) reporting heterosexual behavior. Qualitative interviews were conducted to inform the design and implementation of a cognitive-behavioral risk-reduction and health-promotion intervention. Most respondents (n = 78) had seen or heard of the female condom. However, relatively few (n = 14 women; n = 5 men) had used it at least once. Reactions from both women and men across user groups, regardless of favorable or unfavorable attitude or experience with the female condom, centered around a similar set of factors: aesthetics, difficulties with the male condom, male partner reaction, beliefs about efficacy, and lack of training. These findings underscore the need for additional research and comprehensive education efforts aimed at both technical use and communication skills-building in order to realize the potential of the female condom as an alternative barrier method.

Adult↗

The female condom: acceptability and perception among rural women in Zimbabwe.

This study was conducted to generate data for developing an action plan for accessing the female condom through primary health care centres in Zimbabwe. It used both quantitative and qualitative methods to gather information from sexually active women and men on the perception and acceptability of the female condom among users in rural areas of Zimbabwe. The findings show that very few women had used the female condom prior to the survey. Several women (93%) liked the condom especially young women aged 20-39 years (83%), compared to older women aged 40 years and above (11%). Both women and men liked the dual role of contraception and protection against STIs including HIV/AIDS played by the female condom. Most women (98%) felt that it is important for women to have their own condom. However, both men and women pointed out that it will be difficult to introduce the female condom in married situations due to the stigma associated with condoms in general. Over 80% of women said they will have to seek permission from their partners to use the female condom. Women had problems with inserting the condom and were concerned with lubrication, size and appearance, and how to dispose of used condom. Regarding cost, 77% felt that the female condom is too expensive given that the male condom can be obtained free from health centres. The cost of the female condom could hinder its continued use and would encourage women, especially commercial sex workers, to re-use it. Respondents still require more information relating to side effects (45%), effectiveness in STIs prevention including HIV/AIDS (44%), proper use (43%) and cost (32%).

Adolescent↗

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↗

Female condom launched in UK.

The lone-awaited female condom, Femidom, is to be launched at the end of September by manufacturers Chartex. It is being welcomed by the FPA [Family Planning Association] and other family planning experts as a valuable addition to the existing range of contraceptive methods and as an alternative to the male condom in offering effective protection against sexually transmitted diseases including HIV. A lubricated, loose-fitting polyurethane sheath, Femidom is inserted into the vagina at any time before sex. An inner ring holds the condom in place beyond the pubic bone and an outer ring lies flat against the vulva. In addition to extending choice, it is under direct control of the woman. As FPA Director Doreen Massey puts it: "We have to face the fact that some women who want safer sex can't get their partners to use condoms. for the 1st time with Femidom, you can insist that if he won't use a condom, you'll use yours." In trails of self-selected couples, up to 2/3 of women and their partners found the product acceptable. a study at the Institute of Population Studies in Exeter showed that while some couples had initial misgivings about the condom's size and appearance, especially its visibility when in position, these often declined with repeated use. Researcher Dr. Nicholas Ford pointed out that if the female condom makes a woman feel unattractive, her partner's comments may well influence these feelings. Users' experience of insertion and the condom's comfort also improved with repeated use. While there are no large studies showing ranges of effectiveness, it is likely to be as effective as the male condom (about 85%-98%). In a study of 106 women at the margaret Pyke Center in London, there were 7 unplanned pregnancies: 4 were due to inconsistent use of the method and 3 were method failures. Breakages were rare. 1/3 of participants dropped out in the 1st month. Users should continue with their existing contraceptive method until they are sure that they are using Femidom efficiently, recommended the authors. In October the FPA is launching a new free consumer leaflet on male and female condoms. 1/2 million leaflets will be distributed to UK pharmacies in October and November via the Pharmacy Healthcare Scheme as part of a safer sex campaign. a launch event will include the results of a survey asking pharmacists and consumers what they think of condoms.

Behavior↗

The female condom: tool for women's empowerment.

International and US experience with the female condom has shown that the device empowers diverse populations of women, helping them negotiate protection with their partners, promoting healthy behaviors, and increasing self-efficacy and sexual confidence and autonomy. This commentary reflects on some approaches that have been taken to study empowerment and makes several observations on the political and scientific initiatives needed to capitalize on this empowerment potential. Women's interest in the female condom indicates a need for more women's barrier methods to be made available. For some women, cultural proscriptions against touching the genitals may create initial hesitancy in trying these methods. But the disposition of regulatory agencies and the attitudes of health care providers has unfortunately exaggerated this reticence, thereby effectively reducing access to these methods. Also, lack of important detail in clinical studies restricts our capacity to introduce the female condom, or similar methods, under optimal conditions. Future trials should prioritize community-based designs and address a range of other critical health and social issues for women. Women's need for HIV/AIDS prevention technologies remains an urgent priority. Both political and scientific efforts are needed to realize the public health potential embodied in the female condom.

Attitude of Health Personnel↗

Long-term female condom use among vulnerable populations in Brazil.

We carried out an evaluative study on factors associated with long-term use of female condoms for STI/HIV prevention. A total of 255 women and 29 men who were using female condoms for at least 4 months participated in qualitative/quantitative interviews. The study was conducted in six Brazilian cities. Four primary themes were identified as influencing acceptability and adoption of the female condom: (1) personal "assistance" (counseling) during the early adoption phase; (2) safety; (3) pleasure; and (4) increased sense of power for safer sex negotiation. Alternate use of male and female condoms was the norm among participants, but for approximately one third of the sample, the female condom was the preferred option for safer sex. The study findings suggest that providing clients with explicit and sustained intervention strategies may have a decisive influence on long-term adoption of female condoms.

Adult↗

"Female condom" approved.

The Food and Drug Administration approved the first so-called female condom on May 7. Despite limited data on the effectiveness of the Reality Vaginal Pouch in sexually transmitted diseases (STDs) and a relatively high pregnancy rate among users, the device was approved because it is the first barrier contraceptive for women that provides some protection against STDs. The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, latex condoms for men are the best choice. The panel must also compare the pregnancy rate for the female condom--approximately 26%/year--to rates for other barrier contraceptives, which are lower. For example, the pregnancy rate for male latex condoms is approximately 15%/year. The females condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm; the other remains outside, partially covering the labia. In addition to the labeling restrictions, FDA is also requiring the manufacturer of the product, Wisconsin Pharmacal of Jackson, Wis., to take part in additional effectiveness studies for the product. FDA's decision to approve the female condom was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of the agency's Obstetrics and Gynecology Devices Advisory Panel at its meeting on December 10, 1992. Wisconsin Pharmacal studies 200 women who used the device for 6 months. The estimated pregnancy rate of 26%/year in the study is believed to have been due in part to improper use of the device by some of the subjects. (The expected rate of pregnancy among women not using any contraceptive method is 85%). Women who use the device correctly each time they have intercourse can expect a lower pregnancy rate.

Americas↗

Hispanic adults' beliefs, attitudes, and intentions regarding the female condom.

The present study used the theory of planned behavior (TPB) (Ajzen, 1985) augmented by AIDS knowledge to investigate factors influencing intentions of Hispanic adults to use the female condom. A total of 146 persons (75 women and 71 men; mean age, 27 years) recruited from community-based organizations completed an anonymous survey regarding intentions to use the female condom with their main sex partner. The TPB model had greater predictive utility for women's, than for men's, female condom use intentions. For men, attitudes and norms did not predict female condom use intentions, but greater AIDS knowledge was related to lower intentions to use the female condom, above and beyond the TPB constructs. Perceived behavioral control, operationalized as self-efficacy, significantly increased the predictive utility of the TPB model for women's female condom use intentions but not for men's. Behavior change strategies to increase female condom use are discussed in light of these findings.

Acquired Immunodeficiency Syndrome↗

Promoting female condoms in HIV voluntary counselling and testing centres in Kenya.

Promotion of male condoms and voluntary counselling and testing for HIV (VCT) have been cornerstones of Kenya's fight against the HIV epidemic. This paper argues that there is an urgent need to promote the female condom in Kenya through VCT centres, which are rapidly being scaled-up across the country and are reaching increasingly large numbers of people. Training of counsellors using a vaginal demonstration model is needed, as well an adequate supply of free female condoms. In a study in five VCT centres, however, counsellors reported that most people they counselled believed female condoms were "not as good" as male condoms. In fact, many clients had little or no knowledge or experience of female condoms. Counsellors' knowledge too was largely based on hearsay; most felt constrained by lack of experience and had many doubts about female condoms, which need addressing. Additional areas that require attention in training include how to re-use female condoms and the value of female condoms for contraception. VCT counsellors in Kenya already promote male condoms as a routine part of risk reduction counselling alongside HIV testing. This cadre, trained in client-centred approaches, has the potential to champion female condoms as well, to better support the right to a healthy and safe sex life.

Single-Use Internal Condom↗