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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."
References
- 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.
- 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.
- 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.
- Trussell J. Contraceptive efficacy of the Reality
female condom. Contraception 1998;58(3):147-48.
- 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.
- 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.
- 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.
- Trussell, Sturgen, Strickler.
- 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.
- 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.
- The Female Condom: A Review. Geneva: World
Health Organization, 1997.
- 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.
- 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.
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sZimbabwe
Project Promotes Female Condom Use
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| 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
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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