Female Condom Reuse Examined

Structural integrity of the device remains intact after multiple washings, but more research is needed.

Network: 2000, Vol. 20, No. 2

The female condom is intended to serve a dual role, offering protection against pregnancy and sexually transmitted disease (STD). Early research shows some women and men find it to be an acceptable option.

However, research is needed to determine more precisely how effective it can be. Also, it is relatively expensive and is currently approved for only one act of intercourse. If it could be used safely and effectively more than once, it would be less expensive to use. Preliminary research on reuse of the device is promising but more information is needed.

The only widely available method of preventing transmission of HIV and other STDs is the male latex condom. If a woman cannot persuade her partner to use a male condom, the female condom may be a practical alternative.

"The female condom is a very important barrier method, one that provides an additional device for women and men to protect against pregnancy and STDs, including HIV," says Bunmi Makinwa, who directs condom programs for the United Nations Programme on HIV/AIDS (UNAIDS). Although the female condom still requires a partner's acceptance, it is the only barrier method that women can use themselves that offers protection against HIV.

The extent of HIV protection is not fully understood. For example, researchers are assessing whether the availability of the female condom leads to more protected sex acts and hence lower STD rates, and if so, in what situations. HIV rates are increasing rapidly in many parts of the world, especially sub-Saharan Africa and Asia, with some 16,000 new HIV infections worldwide every day. Six of every 10 new infections are among women, who are at greater risk due to biological and cultural reasons.

The female condom is made of polyurethane plastic, which is sturdier than latex. It is a soft, loose-fitting sheath with a flexible polyurethane ring at each end. The woman inserts it into her vagina, with the inner ring anchoring the device. The outer ring remains outside the vagina, providing some protection to the labia and the base of the penis during intercourse. The U.S. Food and Drug Administration approved the female condom in 1993 for one-time use for prevention of pregnancy and, in cases where women's partners will not use a male condom, for prevention of STDs as well.

Is reuse safe?

The female condom is typically more expensive than a male condom. If the device can be used safely more than once, the cost of each use would decline even if the price of the device itself remained unchanged. FHI and the Reproductive Health Research Unit (RHRU), University of the Witwatersrand, Baragwanath Hospital in Soweto, South Africa, are examining several reuse issues. Will the device remain structurally sound after repeated washing and reuse? Can sexually transmitted pathogens be removed effectively from the device after use by a simple washing procedure? Will reuse harm the vagina?

An unpublished FHI study has found that the structural integrity of the female condom remains intact after a single act of intercourse. The device also remains intact in the laboratory after up to 10 washes with or without bleach disinfection. The washing procedure used mild soap in warm water and rinsing, followed by pat-drying of both sides of the condom with a towel. Four laboratory tests compared the test condoms with unused female condoms (seam tensile strength, water leakage, air burst and tear propagation).

"Now that we know the device can remain structurally sound after multiple washes, we feel we can proceed with multiple uses in human subjects," says Carol Joanis of FHI, who is coordinating the studies. FHI is studying how five uses may affect the vagina and penis. Couples who use one device five times are being compared with couples who use new devices for five acts of intercourse.

The RHRU has studied structural integrity and pathogen removal among women who have used the same female condom up to seven times. If a condom remained structurally sound after one use and wash, the woman could volunteer to use and wash another new device two times. If that condom remained structurally sound after two washings, she could receive a new condom that could be used and washed up to three times. This process continued for up to seven uses. The study recommended that women use liquid detergent, but some women used bar soap instead.

"While preliminary data are still under review, the results look promising," says Mags Beksinska, who helped manage the RHRU study. "The critical issue for me is the ability of women to detect damage after reuse."

The study also tested for the presence of Neisseria gonorrhoeae and Gardnerella vaginalis. When the women returned used and washed condoms, they had vaginal and cervical swabs taken by clinic personnel. These swabs were tested to see what bacteria were inside the woman's vagina that could have been transmitted to the female condom.

The study found that many organisms are introduced onto the female condom by environmental contaminants through dirty towels or other sources, but their presence in relatively small numbers should not be problematic in a healthy vagina.

While these studies seem promising, most public health officials remain cautious. UNAIDS and the World Health Organization (WHO) plan to convene a panel of experts to review the issue of reuse. "We know this is an important method that women can use, and we want to be sure to do what is in women's best interests," says Dr. Peter Fajans, a WHO scientist involved with the panel's work. The technical group will include experts in women's health, STDs, microbiology, materials science and programmatic issues.

Some women already reuse the device. In a small FHI study in Zambia among 37 female condom users, 14 of the women acknowledged having used a female condom more than once, even though they were instructed to use it only once. Some had used one device up to four times. Two of these women, who were sex workers, sometimes shared a device after cleaning it with water and beer. One told researchers, "My friend and I would be caught in a situation when we would have many customers and only one condom. This meant exchanging the same female condom between ourselves on condition that the one borrowing brings it back clean." The study concluded that levels of reuse would rise as availability expands, particularly in resource-poor settings. "Providers of the female condom have an opportunity to shape responses to reuse for the better, rather than leaving women to devise their own 'common sense' solutions."¹

Another approach that could reduce the price is the creation of a less expensive device. A less expensive latex device called the Reddy female condom is under study. It uses a sponge insertion mechanism rather than an internal ring. FHI and the U.S.-based Contraceptive Research and Development (CONRAD) Program are conducting acceptability and performance evaluation tests of the prototype device. In a study of an earlier prototype, the sponge was too small and the outer ring sometimes pulled off, leaving the condom inside the woman, explains Joanis of FHI.

Pregnancy and STD prevention

Researchers have found the female condom to be an effective contraceptive if used consistently and correctly. Within the first year of consistent and correct use, only about 5 percent of women relying on the female condom will have an unintended pregnancy, compared to 3 percent for male condoms. Under typical conditions, when use is not always correct or consistent, the unintended pregnancy rate is 21 percent for the female condom, compared to 14 percent for the male condom. These female condom rates are based on a study in the United States and Latin America, which measured pregnancy rates over a six-month period.²

An earlier study in the United Kingdom found a 12-month pregnancy probability of 15 percent.³ Recently, a study in Japan found a six-month pregnancy rate of 1 percent when used consistently and correctly and 3 percent under typical use.⁴ In Japan, the male condom is the predominant method of family planning.

Limited data are available regarding the female condom's ability to prevent STD transmission. In Thailand, sex workers who had access to both male and female condoms had a lower incidence of STDs, with 2.8 infections per 100 women per week, compared to 3.7 infections per 100 women per week for those using only male condoms. The study measured gonorrhea, chlamydial infections, trichomoniasis and genital ulcers over 24 weeks. Availability of the female condom also resulted in fewer unprotected sex acts, 5.9 percent unprotected compared to 7.1 percent for the male-condom-only group.⁵

In another study, women were treated for trichomoniasis and then offered the female condom to prevent reinfection. None of the women who used the female condom consistently for 45 days were reinfected, compared to 15 percent reinfected among those who used it inconsistently and 14 percent reinfected among those who used no protection.⁶

Laboratory studies have found the device impermeable to various STDs, including HIV.⁷ The presence of other STDs contributes to HIV transmission, so a reduction in other STDs can contribute to lower HIV transmission. Extrapolating from results of contraceptive efficacy is another indication of HIV prevention. "Perfect use of the female condom may reduce the annual risk of acquiring human immunodeficiency virus by more than 90 percent among women who have intercourse twice weekly with an infected male," concluded Dr. James Trussell of Princeton University and colleagues from FHI, basing this conclusion on the contraceptive efficacy of the device.⁸

Several small studies have found that making the female condom available appeared to increase the number of protected acts of intercourse. In Zambia, an FHI study found that couples at high risk of HIV who used the female condom more often over a 12-month period and had appropriate counseling about its use appeared to have more protected acts of intercourse, compared to couples relying primarily on the male condom. While the proportion of couples using the female condom decreased over time, the proportion of coital acts protected by the female condom remained stable. "Thus, female condom use became more focused in a smaller proportion of couples," the study's authors wrote. "It is likely that, as couples gained experience, attitudes toward the device became stronger, and couples who disliked it discontinued its use, whereas couples favoring the device increased use." ⁹ A study at a U.S. STD clinic found similar results.¹⁰

FHI is conducting studies in Bangladesh, Kenya and Mexico to measure whether making the female condom available adds to the number of protected sex acts. The studies are examining the impact of peer educators on female condom use among sex workers as well as factors that contribute to the non-use of male condoms.

Community interventions

Small studies suggest that offering the female condom to certain groups of people will decrease STD/HIV transmission. But will this always be the case in real life? To answer that question, FHI conducted a community intervention study in rural Kenya involving women who lived and worked on plantations with health clinics.

Providers and outreach workers received training in male condom provision, STD prevention and STD treatment. At some plantations, female condoms were also offered, along with provider training, counseling and community education events on this method. For 12 months, the study followed 1,600 women for three infections -- gonorrhea, chlamydia and trichomoniasis.

"We had hoped to be able to demonstrate that the availability of the female condom would result in lower STD rates," says Dr. Paul Feldblum of FHI, who coordinated the study. "But the preliminary data at 12 months indicate that this is not the case."

At the beginning of the study, overall STD rates were similar at both plantations where female condoms were available and plantations where the devices were not available, with about 24 percent of all the women having one or more of the three STDs. After 12 months, rates were about 18 percent in both groups. "There was considerable increase in male condom use in both the control and intervention sites, which is good," says Dr. Feldblum. "But in the intervention sites (where female condoms were available), there may have been a substitution process, with the female condom eroding what could have been still higher male condom use rather than adding to the total amount of protection."

Acceptability

More than 40 studies, most with small numbers of women or couples, have found the female condom to be acceptable to a wide range of users. While some users have problems with appearance, noise, insertion and other issues, with proper counseling and support, most people like it, and many men and women prefer it to the male condom.¹¹

FHI studies in Kenya and Brazil found that introducing the female condom through peer support groups to women vulnerable to STDs helped them to negotiate its use with reluctant partners. "The women found it easier to introduce the female condom to men as a contraceptive device rather than as protection against STDs first," explains Dr. Wangoi Njau of the Centre for the Study of Adolescence in Nairobi, Kenya. Women got this idea from their peers to help them start, and they gradually raised the issue of STDs with their husbands as the study progressed.¹²

Many questions about long-term acceptability remain. In recent years, marketing campaigns by Population Services International, a Washington-based organization, have introduced the female condom to urban areas of Zambia and Zimbabwe, which have high rates of HIV infection. Studies in both countries indicate women need counseling and other support in order to sustain consistent use of this method. A 1,500-person survey at Zambian outlets selling or distributing the female condom concluded that "intensive counseling/education about the female condom, especially about insertion, is likely to be extremely important in sustaining women's intentions to use the method and in motivating them to use it." The main reasons women cited for not intending to continue use were difficulty with insertion (27 percent), not liking the method (27 percent) and partner not liking the method (9 percent).¹³

"We need to know what kind of introduction system works," says Barbara de Zalduondo, who coordinates a U.S. Agency for International Development team on female condom issues. "The pattern in qualitative work suggests that if you can get a couple to use it three times, then they are much more likely to continue use."

-- William R. Finger

References

1. Smith JB, Nkhama G, Sebastian P, et al. Qualitative Research on Female Condom Reuse among Women in Two Developing Countries. Research Triangle Park, NC: Family Health International, 1999.
2. Farr G, Gabelnick H, Sturgen K, et al. Contraceptive efficacy and acceptability of the female condom. Am J Public Health 1994;84(12):1960-64; Hatcher RA, Trussell J, Stewart F, et al., eds. Contraceptive Technology, Seventeenth Revised Edition. (New York, Ardent Media, Inc., 1998)216-17; Trussell J, Sturgen K, Strickler J, et al. Comparative contraceptive efficacy of the female condom and other barrier methods. Fam Plann Perspect 1994;26(2):66-72.
3. Bounds W, Guillebaud J, Newman GB. Female condom (Femidom). A clinical study of its use-effectiveness and patient acceptability. Br J Fam Plann 1992;18(2):36-41.
4. Trussell J. Contraceptive efficacy of the Reality female condom. Contraception 1998;58(3):147-48.
5. Fontanet AL, Saba J, Chandelying V, et al. 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. AIDS 1998;12(14):1851-59.
6. Soper DC, Shoupe D, Shangold GA, et al. Prevention of vaginal trichomoniasis by compliant use of the female condom. Sex Transm Dis 1993;20(3):137-39.
7. Drew WL, Blair M, Miner RC, et al. Evaluation of the virus permeability of a new condom for women. Sex Transm Dis 1990;17(2):110-12.
8. Trussell, Sturgen, Strickler.
9. Musaba E, Morrison CS, Sunkutu MR, et al. Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia. Sex Transm Dis 1998;25(5):260-64.
10. Latka M, Gollub EL, Fench PP, et al. Do women abandon condoms after exposure to a safer sex hierarchy? Poster session. The 12th World AIDS Conference. Geneva, July 1998.
11. The Female Condom: A Review. Geneva: World Health Organization, 1997.
12. Ankrah EM, Attika SA. Adopting the Female Condom in Kenya and Brazil: Perspectives of Women and Men. A Synthesis. Arlington, VA: Family Health International, 1997.
13. Agha S. Consumer Intentions to Use the Female Condom after One Year of Mass-Marketing (Lusaka, Zambia), Working Paper No. 26. Washington: Population Services International, 1999.

Zimbabwe Project Promotes Female Condom Use

A recent introduction of the female condom in Zimbabwe illustrates the limitations of generating wide-spread public interest in the device. The important public health advantages from having this option available, however, suggest targeted marketing may be worthwhile. In Zimbabwe, a marketing assessment led to the adoption of the name "care contraceptive sheath" for the female condom, to distinguish it from the male latex condom, generally considered to be used only with casual partners. The female condom was marketed to reach couples in need of family planning, rather than focusing exclusively on commercial sex workers. However, a study found that continued use may have been discouraged due to "difficulties of insertion, and reported discomfort experienced during sexual intercourse (mainly by the women)." It also found that people using it for disease prevention were more likely to continue use (66 percent), compared to those who adopted it mainly as a contraceptive (55 percent).1 "We are trying to determine why it's used and with whom, and under what circumstances," says Steven Mobley, research associate at Horizons Project, an AIDS research and prevention project led by the New York-based Population Council. "It is a product that may be useful in certain cases where women find themselves at risk and where the male condom is not an option." The Horizons Project and Population Services International, a Washington-based organization that coordinates the Zimbabwe marketing campaign, conducted the study, working with Target Research, a Zimbabwe company. Using the device is not entirely the woman's decision. Consequently, some experts have suggested that marketing should focus on women who can successfully negotiate female condom use with their partners, as well as encourage men to accept the device. The Zimbabwe campaign is highly subsidized, which raises questions about how popular the device would be if higher prices were charged to cover the actual costs. Currently, each female condom in the Zimbabwe program only costs U.S. 12 cents (or about eight female condoms for U.S. $1). This price is well below the typical retail price in the United States of about $3 for one device, and is even a fraction of the relatively low public-sector price of U.S. 65 cents that the manufacturer charges HIV prevention projects. However, male condoms are also highly subsidized in countries with high STD rates, such as Zimbabwe. One study suggests that the public health benefits of offering female condoms at subsidized prices in sub-Saharan urban settings should be cost effective, compared with other HIV/STD prevention and family planning programs. "Such an intervention may generate net savings in the form of averted HIV, STD and pregnancy-related medical costs," concluded Dr. Elliot Marseille of the University of California at San Francisco and colleagues. "These findings suggest that female condoms are a good candidate for public sector subsidies. They are likely to reduce disease transmission, and save public funds in the process." The study found that targeting high-risk groups such as sex workers and other women who are likely to have multiple partners would be most cost effective. The study estimated the number of HIV, syphilis and gonorrhea cases, and pregnancies that would be averted by the introduction, as well as net cost or savings to the public health system, cost per HIV infection averted, and other costs.2 -- William R. Finger References Horizons/Population Council, Population Services International, Target Research. Female Condom User Study in Zimbabwe. New York: Population Council, 2000. Marseille E, Kahn JG, Saba J. Cost-effectiveness of the female condom in preventing HIV, STDs and pregnancy in urban Sub-Saharan Africa. Unpublished paper. University of California at San Francisco, n.d.

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