AIDS and Behavior, Vol. 2, No.

3, 1998

The Female Condom: What We Have Learned Thus Far

Heather Cecil,1,2 Melissa J. Perry,1 David W Seal,1 and Steven D. Pinkerton1
Received June 13, 1997; revised Dec. 29, 1997; accepted Feb. 5, 1998

High rates of sexually transmitted diseases (STDs), including Hiy and unplanned pregnancies persist in the United States. Women are more likely than men to be infected with an STD and to bear the burdens associated with unplanned pregnancies and with STD-associated complications. Condom use is advocated for sexually active individuals. However, for some persons condom use remains infrequent and inconsistent; this is particularly true for women, who may face substantial barriers (e.g., partner aggression) to enacting consistent condom use. The female condom is the only female-controlled barrier method currently available to protect women from STDs and unplanned pregnancies. In this paper, we review and summarize the literature on the female condom with regard to efficacy, use-effectiveness, and acceptability among potential and current users. In addition, we identify gaps in the literature and suggest paths for future research.
KEY WORDS: Female condom; review; barrier method; user acceptability.

INTRODUCTION Reducing the prevalence and incidence of sexually transmitted diseases (STDs) and unplanned pregnancies is a pressing societal concern. In the United States each year there are over 4 million new cases of chlamydia, 3 million new cases of trichomoniasis, 800,000 new cases of gonorrhea, and 110,000 new cases of syphilis (Biro, 1992; Institute of Medicine, 1997). It is estimated that STDs affect 12 million Americans annually (Institute of Medicine, 1997; Tanfer et al., 1995). Overall, STD rates are substantially higher among women than men (Biro, 1992; Gates, 1991; Leukefeld and Haverkos, 1993). For example, Chlamydia trachomatis, which is the most common sexually transmitted infection, is six times more prevalent among women than men (Centers for Disease Control [CDC], 1997a). Women's biological vulnerability to STDs is greater than that of men, and women disproportionately bear the burden of STDassociated complications. For instance, untreated cer^enter for AIDS Intervention Research, Medical College of Wisconsin, Milwaukee, Wisconsin. Correspondence should be directed to Heather Cecil, Ph.D., Center for AIDS Intervention Research, 1201 N. Prospect Avenue, Milwaukee, Wisconsin 53202 (e-mail: Hcecil@mcw.edu).

vical gonorrhea and chlamydia can lead to pelvic inflammatory disease, which increases women's risk for infertility and ectopic pregnancy as well as their risk for acquiring asymptomatic STDs later in life (Gates, 1991; Tanfer et al., 1995). In addition to the negative personal consequences associated with STDs, there are also enormous societal costs. The annual cost of pelvic inflammatory disease in the United States, for example, has been estimated at 4.2 billion dollars (Biro, 1992), while other STDs cost 3.5 billion annually (Tanfer et al, 1995). The growing prevalence of presently incurable viral STDs such as herpes and HIV disease is especially alarming. The HIV/AIDS epidemic has exacted a daunting toll on the United States. Thus far, over a million people have been infected with HIV, and over half a million people have been diagnosed with AIDS62% of whom have died (CDC, 1996, 1997b). By January 1995, AIDS had surpassed unintentional injury to become the leading cause of death among American males between the ages of 25 and 44 years, and the third leading cause of death among women in this age group (Altman, 1995; CDC, 1997b). Moreover, the rate of HIV infection is rising more rapidly among women than among men, and especially among women of color (CDC, 1996).

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1090-7165y98/0900-0241$15.00/0 1998 Plenum Publishing Corporation

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Rates of unplanned/nonmarital pregnancies are high in the United States and have risen substantially over the past 50 years, from 7.1 per 1,000 in 1940 to 45.3 per 1,000 in 1993 (U.S. Department of Health and Human Services [USDHHS], 1995). In 1993, over 1.2 million nonmarital pregnancies were reported, compared to only 89,500 in 1940 (USDHHS, 1995). The majority of unplanned pregnancies occur among female adolescents and women between the ages of 20 and 29 years (Alan Guttmacher Institute, 1994; Child Trends, 1995). The U.S. adolescent pregnancy rate is substantially higher than that of other Western countries (Hovell et al, 1994). Abstaining from sexual intercourse remains the most effective strategy for preventing the transmission of HIV and other STDs. However, for sexually active individuals the U.S. Public Health Service recommends that (male) condoms be used consistently and correctly (CDC, 1993). Correct and consistent condom use can substantially reduce the risk of STD transmission and unintended pregnancy (Bounds, 1989; Gates and Stone, 1992a, b; CDC, 1993; Conant et al., 1987; Hatcher et al, 1994; Pinkerton and Abramson, 1997; Irussell and Kost, 1987; Van de Perre et al, 1987; World Health Organization, 1993). A recent meta-analysis of HIV-seroconversion studies of serodiscordant heterosexual couples suggests that, in practice, consistent condom use can reduce the per-act probability of HIV transmission by 9095% (Pinkerton and Abramson, 1997). In one such study, among the 124 couples who reported consistent condom use for vaginal and anal intercourse, none of the seronegative partners seroconverted during the course of the study despite nearly 15,000 episodes of intercourse (DeVincenzi et al, 1994). In marked contrast, the seroconversion rate was 4.8 per 100 person-years among couples reporting inconsistent condom use. Although condom use is increasing in the United States overall (Choi and Catania, 1996; Cochran et al, 1990; DeBuono et al, 1990; Joseph et al, 1990; Peterson, 1995), it remains particularly low among certain subgroups of the population, including (1) high-risk heterosexual couples (Catania et al, 1992; Roper et al, 1993), (2) women (Choi and Catania, 1996), and (3) injecting drug users and their sexual partners (Tross et al, 1992). Rates of consistent condom use among unmarried women contacted in the National Survey of Family Growth ranged from 15% to 21.9% (Anderson et al, 1996). Of particular concern is that approximately 59.4% of these women reported never using condoms. These rates

are generally consistent with the findings of other national samples and selected convenience sample studies (Catania et al, 1992; Peterson, 1995; Seidman and Rieder, 1994; Sheahan et al, 1994). Because the condom is ultimately male-controlled, women may face substantial barriers to enacting consistent condom use. Some of these barriers include refusal by male partners to wear a condom, compliance with traditional gender roles of female passivity in sexual situations, negative stigma associated with female-initiated male condom use, fear of physical and psychological abuse, and economic and relationship-associated power imbalances (Amaro, 1995; Amaro and Gornemann, 1991; Ehrhardt et al, 1992; Weeks et al, 1995; Wight, 1992). There is thus a pressing need for the development of female-controlled alternatives to the condom, especially since women are more vulnerable to and negatively impacted by STDs and unplanned pregnancies (Bounds, 1989; Short, 1994; Stein, 1990, 1993,1995). One especially important recent technological advancement is the development of a female condom. In December 1992, the Obstetrics-Gynecology Devices Advisory Panel of the U.S. Food and Drug Administration (FDA) approved the Reality female condom (developed by the Wisconsin Pharmacal Company) for use as both a contraceptive and as a barrier device for the prevention of STD transmission (Gollub and Stein, 1993). The female condom is the only female-controlled barrier method currently available to protect women from STDs and unplanned pregnancies. The Reality female condom consists of two flexible polyurethane rings and a thin, soft, loose-fitting, 6-inch-long polyurethane sheath that lines the vagina. One ring lies inside the closed end of the sheath and is used for inserting the device and anchoring it internally. The outer ring is designed to cover the labia and protect the base of the man's penis during intercourse. The female condom is available in one size only and thus does not require fitting by a health care professional. Like the male condom, it is intended for one-time use only. Although it is prelubricated with a silicone-based lubricant, additional lubrication can be applied either inside or outside the sheath (because it is made of polyurethane, oil-based lubricants can be used with the female condom, unlike male condoms made from latex). The polyurethane material from which the female condom is made is also stronger and less likely to rupture than latex (although most male condoms are latex, a polyurethane male condom has recently

The Female Condom: A Literature Review been developed as well; Farr et al, 1994). Other advantages to the female condom include (1) the greater anatomical coverage it provides (the female condom covers the entrance to the vagina, where lesions may occur, and also the female's urethra and the base of the male's penis, which may help protect against herpes), (2) the fact that it can be inserted in advance, and does not require the penis to be erect, (3) the fact that it does not need to be removed immediately after intercourse, and (4) the fact that in comparison to the male condom, slippage of the female condom is less likely to result in semen spillage (Bounds, 1989; Gold, 1995; Leeper, 1990; Leeper and Conrardy, 1989; Soper et al., 1991). Although the female condom has only been available for a few years, the body of literature concerning it has grown rapidly. In the present paper we review the literature with regard to the efficacy, effectiveness, and acceptability of the female condom to potential and current users. In addition, we identify gaps in the literature and suggest paths for future research. Methods Used to Identify Studies To identify relevant studies, literature searches were conducted of the following scientific databases: AIDSline (1966-April 1997), PsychlNFO (1984March 1997), and MedLine (1966-April 1997). The search strategy was similar for all three databases, with the use of female condom as the key word and the use of contraception as a mesh heading. The search was limited to English-language abstracts, publications in peer-reviewed professional journals, monographs, and books (when both a published article and abstract describe the same study, only the article was considered for inclusion in this review). References in recent articles then were carefully examined to identify additional sources. This search produced 31 articles and abstracts concerning the acceptability of the female condom that were deemed appropriate for inclusion. Table I lists these articles, classified according to author/year, sample description, country, and recruitment site, (Note: articles pertaining to the efficacy and effectiveness of the female condom are not included in this summary table.) As Table I indicates, many of these studies employed small sample sizes and/or convenience samples. More sophisticated, methodologically rigorous investigations have not yet been conducted. The

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present lack of rigor stems from the newness of the field; research has only recently been initiated on the female condom.

EFFICACY AND EFFECTIVENESS The efficacy of the female condom in preventing the transmission of HIV and other STDs has been explored in the laboratory, and its effectiveness against chlamydial transmission examined in the field. The contraceptive effectiveness of the female condom also has been assessed in several studies. Finally, the durability of the female condom, which potentially affects its usefulness for either disease or pregnancy prevention, has been evaluated. These studies are reviewed and summarized below. Prevention of HIV and STDs Several laboratory tests confirm that the polyurethane material from which female condoms are made is highly impermeable to virus-sized particles, and by implication, to sexually transmitted viruses. For instance, Voeller et al. (1991) investigated the permeability of intact and sectioned female condoms to gas, liquids, and the 0X174 virus under static and simulated coital conditions. Their laboratory investigation indicated that polyurethane is highly impermeable; hence, these authors concluded that the female condom can provide a highly efficacious protective barrier for contraception and STD transmission. A more recent, highly sensitive in vitro evaluation of the permeability of latex and polyurethane male condoms to the 0X174 virus found that both types of condoms were generally impervious to viral passage, from which the authors concluded that polyurethane condoms provide a substantial barrier to viral transmission (Lytle et al, 1997). (The 0X174 virus is smaller than such common sexually transmitted viruses as HIV, hepatitis B, and herpes virus. Permeability to 0X174 is therefore a conservative test for permeability to these other viruses.) Similar conclusions were reached in laboratory tests conducted by Drew and colleagues, whose studies indicated that the polyurethane female condom is impermeable to HIV and cytomegalovirus (Drew et al., 1989, 1990). Trussell and colleagues have estimated that correct use of the female condom could reduce the per-act probability of HIV transmission

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Table I. Published Female Condom Studies Author/year Ashery et al. (1995) Sample Descripion 37 predominantly AfricanAmerican (67%) and White (30%) female drug users (18 injection drug users, 19 crack users); aged 20+ 247 women and 115 men 106 women 24 couples; aged 21-56 29 female sex workers 25 female psychiatric in-patients 27 street prostitutes 100 female commercial sex workers; 90 urban women; 30 rural women Country United States

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Recruitment Site Street outreach program

Earth et al. (1992) Bounds et al. (1992) Bounds et al. (1988) Chan and Soon (1994) Collins et al. (1997) DeVincenzi et al. (1992) Dithan et al. (1996)

Cameroon United Kingdom United Kingdom Singapore United States Not specified (Europe) Uganda

Not specified Family planning clinics; media advertisements Family planning clinic STD clinic Psychiatric center Street outreach Family planing clinic (urban women); recruitment sites for other subsamples not specified Family planning clinic

Ehrhardt et al. (1996)

180 predominantly AfricanAmerican (68%) and Latina (20%) women; aged 18-30 178 African-American women; aged 17-55 377 women; aged 18-40

United States

Eldridge et al. (1995) Farr et al. (1994)

United States United States (n = 262); Latin America (Mexico, Dominican Republic, n = 115) United Kingdom

Health clinics Family planning clinics and service agencies; media advertisements Family planning clinics; general medical practices

Ford and Mathie (1993)

214 women; aged 18+; 59 male partners also completed one or more questionnaires 202 at-risk women; aged 14-60 52 predominantly AfricanAmerican (87%) and Latina (12%) women; aged 18-57 1,600+ female, STD clinic attendees 30 female sex workers and 30 female non-sex workers 18 married women and 13 of their husbands 151 female methadone patients (50% Latina, 39% AfricanAmerican, 10% White)

Gil (1995)

Puerto Rico

Low-income, high-HIVseroprevalence, public housing neighborhoods Community hospital

Gollub et al. (1995)

United States

Gollub et al. (1996) Hernandez et al. (1995) Jivasak-Apimas (1991) Krishnan et al. (1996)

United States Mexico Thailand United States

STD clinic Not specified Family planning clinic Inner-city methadone clinic

The Female Condom: A Literature Review

Table I. Continued Author/year Leeper (1990); Leeper and Conrardy (1989) Musaba et al. (1996) Niang et al. (1996) Perry et al. (1996) Sample Descripion Country Recruitment Site Independent clinical research testing laboratory STD clinic Not specified Low-income inner-city housing projects Peer education program (sex workers); family planning clinic (urban women); HIV/AIDS needs assessment research project participants (rural women) Family planning clinics; private obstetrics/ gynecology clinics Not specified

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108 couples (study 1); 50 couples United States (study 2); 50 couples (study 3); 15 women (study 4) 99 married couples with one symptomatic STD partner 45 women and 5 men 344 predominantly AfricanAmerican (57%) and White (16%) women 89 female sex workers; 84 urban women; 23 rural women; aged 15-59 Zambia Senegal United States

Ray et al. (1995)

Zimbabwe

Ruminjo et al. (1996)

48 women; indirect reports of male partner preferences 20 high-risk female sex workers 20 African-American and 37 Latin American women on methadone

Kenya

Sakondhavat (1990); Sakondhavat and Potter (1990) Schilling et al. (1991)

Thailand

United States

Methadone clinic

Seal and Ehrhardt (in press) Shervington (1993)

71 men (51% African-American; United States 25% Latino; 17% White; 7% other); aged 18-38 45 African-American women; aged 14-65 United States

STD or health clinic; high-HIV-seroprevalence inner-city neihborhoods University medical center students; self-help, community-based, health improvement group; housing project health clinic Medical center Unspecified clinic patients

Shervington (1994) Soper et al. (1991)

18 African-American women; aged 27-45 30 predominantly White (60%) and African-American (37%) women; aged 26-39 126 predominantly minority women with vaginal trichomoniasis; aged 21-41 377 women in female condom arm of study

United States United States

Soper et al. (1993)

United States

Low-income, gynecology outpatient clinics Planning clinics or service agencies; media advertisements Hospital STD clinic Inner-city STD clinic

Trussell et al. (1994)

United States (n = 262); Latin America (Mexico, Dominican Republic, n = 115) Uganda United States

Walker et al. (1993) Witte et al. (1996)

200 STD patients (women and men) 45 female and 55 male STD patients (African-American, Latina)

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by 97% (Trussell et al, 1994), which is similar to the protection afforded by male condoms (Pinkerton and Abramson, 1997). Field studies also demonstrate the female condom to be an efficacious barrier against STDs if used properly (Soper et al., 1991, 1993; Trussell et al., 1994). Soper et al. (1993) examined the rate of recurrent vaginal trichomoniasis among 104 sexually active women already diagnosed with this STD. Of the study participants, 20 reported correct and consistent use of the female condom (compliant-users), 34 were inconsistent users (noncompliant-users), and 50 women were in the control group. None of the women in the compliant users group were reinfected, whereas about 14% in both the noncompliant-users group and the control group became reinfected. Thus, the consistent and correct use of the female condom is efficacious in the prevention of recurrent vaginal trichomoniasis. Direct evidence of the effectiveness of the female condom against other STDs has not been established. Due to the difficulty of designing an ethically acceptable and feasible direct clinical trial of STD effectiveness, the FDA has concluded that pregnancy can be used as a surrogate marker for STD transmission in establishing the protective effectiveness of the female condom (Trussell et al., 1994), despite the fact that sperm is larger in size than many sexually transmitted viruses (hence, contraceptive effectiveness does not necessarily imply effectiveness in STD prevention).
Contraceptive Effectiveness

Cecil, Perry, Seal, and Pinkerton

for U.S. and Latin American participants, respectively. Accidental pregnancy rates were substantially lower among participants reporting consistent and correct use of the female condom: 2.6% for U.S. sites and 9.5% for Latin American sites. Bounds et al. (1992) examined rates of accidental pregnancies among a small sample of women who used the female condom as their sole method of contraception. They observed seven accidental pregnancies in 441 months of observation; however, four of the pregnancies occurred among women who reported inconsistent use of the female condom. The overall use-effectiveness failure rate was about 15%. In summary, the rates obtained for accidental pregnancy are similar to, and in some case even better than, those obtained for other contraceptive devices, indicating that the female condom is an effective method of pregnancy prevention (Farr et al, 1994; Trussell et al, 1994).
Durability

The female condom compares favorably with other methods in regard to contraceptive effectiveness (Farr et al., 1994; Leeper, 1990; Leeper and Conrardy, 1989; Trussell et al., 1994). For instance, Trussell et al. (1994) compared the contraceptive utility of the female condom with published effectiveness data on other barrier methods. This analysis indicated that the contraceptive effectiveness of the female condom does not differ significantly from that of the diaphragm, the sponge, or the cervical cap. Similar conclusions were reached by Farr et al. (1994), who assessed the contraceptive effectiveness of the female condom for the FDA. The investigation took place at six U.S. sites and three sites in Latin America, with a final sample of 328 women. Overall, accidental pregnancy rates were 12.4% and 22.2%

The female condom is constructed of polyurethane, a durable material that is less prone than latex to breaks and tears. In a clinical trial of the female condom involving 44 women, instances of method failure (i.e., rips or tears occurring during use or withdrawal) were reported in less than 1% of all sexual intercourse occasions (Leeper and Conrardy, 1989). In contrast, the rate was 3.4% for male condoms. Rates of user failures (i.e., rips or tears occurring before intercourse due to incorrect or abnormal use) were similar for each device (about 3%). This study also examined the probability of semen exposure as a consequence of tears or dislodgment of the female or male condom. This analysis revealed exposures to be significantly less likely for the female condom (2.7%) than for the male condom (8.1%). Low rates of breakage also were reported in a study of Kenyan couples who used the female condom on a trial basis. Three of 113 (2.7%) female condoms were reported to have broken during sexual intercourse. However, on 11 occasions (9.7%) the female condom was displaced during intercourse, and in 8 of these instances the outer ring of the device was partially pushed into the vagina. In addition, on 4 occasions (3.5%) the penis was reportedly misrouted, so that penetration occurred outside the female condom.

The Female Condom: A Literature Review ACCEPTABILITY

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In studying the acceptability of the female condom, four areas of research have been explored: (1) respondents' attitudes and initial reactions to the female condom, (2) reactions to using the female condom, (3) the impact of a brief intervention on participants' willingness to use, subsequent use, and attitudes toward using the female condom, and (4) adverse physiological reactions to the female condom. Each of these domains is reviewed and key findings summarized below and in Table I. Examination of Table I indicates that methodological limitations are present in many of the studies. In particular, numerous investigations employed small samples, often convenience samples. More-rigorous studies have not yet been conducted.
Attitude/Receptivity Investigations

Several studies have assessed women's attitudes and initial reactions toward the female condom. These investigations, which have been conducted both in the United States and abroad, report that the majority of women studied hold favorable attitudes toward the female condom when first introduced to it (Chan and Soon, 1994; Dithan et al, 1996; Farr et al., 1994; Gollub et al, 1995; Krishnan et al., 1996; Niang et al., 1996; Schilling et al, 1991; Shervington, 1993, 1994). Three investigations are particularly noteworthy in that they included relatively large sample sizes (Eldridge et al, 1995; Gil, 1995; Walker et al, 1993). Eldridge et al. (1995) investigated the attitudes of 178 African-American women toward five barrier contraceptive methods (male condom, female condom, Today sponge, Protectaid Sponge, and vaginal contraceptive film). All participants received a demonstration of how to use each method. Afterward, participants indicated their preference by rank ordering the devices. This analysis revealed that the majority preferred the male condom (45%), followed by the female condom (23%). Reasons for not selecting the female condom over the male condom as a preferred method focused on its cost and its "unusual" appearance. In another investigation, 144 low-income Puerto Rican women received a visual demonstration of the female condom and then completed an attitudinal survey (Gil, 1995). Many of the women reported a willingness to try the female condom (64.6%) and be-

lieved that it would protect them against acquiring STDs (63%). Approximately half of the respondents (56.2%) thought that it would be easier to use than the male condom. However, a large minority (29.9%) indicated that they would be unwilling to try the female condom. Unfamiliarity with the device was associated with not wanting to try it, as was a lack of need (i.e., the respondent was in a monogamous relationship) and perceived difficulty of use. An additional concern focused on partner receptivity. Almost 27% reported that they believed their male partners would not be willing to try it. Those women who reported an ability to negotiate use of the male condom with their partners were more likely to express a willingness to try the female condom with their male partners. Finally, Walker et al (1993) examined the attitudes and beliefs with regard to both the male and female condom of 200 patients attending an STD clinic. The majority (76%) indicated an interest in learning more about the female condom and 57% reported an interest in trying the device. Those who used or had used the male condom were more likely to consider using the female condom. The authors concluded that receptivity to the female condom among this population is high. Respondents recruited from drug clinics also hold favorable attitudes toward the female condom. For instance, Schilling et al. (1991) surveyed 20 African-American women and 37 Latin American women attending a methadone clinic. Almost 60% were strongly in favor of the female condom and 17.5% were somewhat favorable. Similar proportions reported being very willing or somewhat willing to try the female condom. Comparable findings are reported in a more recent study conducted by Krishnan et al. (1996). Seal and Ehrhardt (in press) conducted a qualitative study of 71 men that explored their attitudes toward the female condom. The majority of men were unfamiliar with the device and only one individual reported experience with it. However, many of the men expressed a willingness to try the female condom if their partner requested it. Concerns about the female condom were similar to those expressed by women and focused on the appearance of the female condom and its potential interference with sexual pleasure. Although several studies report somewhat mixed or even negative attitudes toward the female condom among the women in their samples (Chan and Soon, 1994; DeVincenzi et al, 1992; Ehrhardt et al, 1992,

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1996; Eldridge et ai, 1995; Gil, 1995; Hernandez et al, 1995; Jivasak-Apimas, 1991), taken in toto the attitudinal investigations reviewed above suggest that many women respond favorably when first shown the female condom. Concerns center on the unusual appearance of the female condom, anticipated difficulties with insertion, and negotiating its use with a male partner. Nonetheless, these findings suggest that the female condom may be perceived as a viable barrier method by some women. (Caution is warranted in interpretation of these studies, however, in light of their methodological limitations, including small sample sizes, nonrepresentative samples, and failure to measure actual use.)
Acceptability Among Users

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A second group of studies examined the attitudes and reactions of people who have tried the female condom. The results of these investigations are mixed: some women and men report negative reactions to using the female condom, while others indicate positive reactions to its use. Mixed or primarily negative reactions toward the female condom tended to be reported among persons surveyed in Uganda, Thailand, and Zambia. In contrast, more positive responses were observed among couples, female sex workers, and clinic patients recruited in Kenya, Senegal, Zimbabwe, the United Kingdom, and the United States. It is possible that these disparities reflect cultural differences in sexual behavior and attitudes. Alternatively, these dissimilar findings may reflect differences in sample size, participant characteristics, or measurement instruments. (Many of these findings were presented only as abstracts. As a result, only limited information is available concerning study design, measures employed, and results, making it difficult to form any definitive conclusions.) Findings from published studies conducted in Thailand suggest that the female condom may be a viable option for sex workers, but not couples. In addition, these studies highlight the importance of partner receptivity with respect to female condom use. For example, Sakondhavat (1990; see also Sakondhavat and Potter, 1990) reports that the majority of female sex workers in Thailand evaluated the female condom as acceptable, while one third disliked it. Female condoms were used for 32% of sexual acts and male condoms for 35% (the remaining acts were unprotected). None of the sex workers reported any

rips or tears. Complaints concerned the size of the device and the need to use lubricant. Fifteen percent of the sex workers reported difficulties inserting the female condom; however, only 19% indicated that the female condom was less convenient to use than the male condom. Most of the sex workers did not continue use of the female condom, due to partners' objections. Jivasak-Apimas (1991) studied the acceptability of the female condom among 56 Thai couples. Thirty-six of the women declined participation because they believed the device was too large and feared inserting it, and 2 others worried that their husbands would not be cooperative. Most of the 18 women who did participate found insertion to be "acceptable," but many felt that the rings caused discomfort during sexual intercourse. In addition, although the women's responses were more positive than those of their spouses, both partners reported diminished sexual satisfaction. (Several of the women reported inserting the device ahead of time and indicated that this was uncomfortable and undesirable.) These somewhat negative findings are especially noteworthy in that they were obtained after self-selection had already eliminated a substantial proportion of women who were unwilling to participate in the study. In contrast, in a study of 38 Kenyan couples who had used both devices, the female condom was preferred to the male condom by about two thirds of the women and half of their male partners (Ruminjo et al., 1996) (in this study, the perceptions of the male partners were assessed indirectly through the women's responses). The majority of women reported that they liked the female condom, would recommend it to their friends, and would use it if it were available. The features of the female condom that women liked best were that it made sex more enjoyable, provided protection against pregnancies and STDs, and was under their control. The least liked aspects were that it was messy, reduced sexual pleasure, and was difficult to insert. Similar findings were obtained by Ray et al. (1995), who conducted a study in Zimbabwe with three different groups of women: sex workers, urban women, and rural women. All participants received educational and instructional information on the female condom and then were asked to use it with their partners. Many of the women liked the female condom very much (56-100%), and the majority preferred it to the male condom (66-100%). Most of the women reported that they experienced few diffi-

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Brief Intervention Studies

culties with insertion (61%-100%). The main complaint about the female condom was that it was uncomfortable during sexual intercourse; also, some respondents disliked the lubrication. Positive results also were obtained by Bounds et al. (1988), who studied the acceptability of the British female condom among 24 couples. Approximately half of the women (50%) and half of the men (54%) reported that the female condom was acceptable and 87% believed it to be an effective contraceptive method. In addition, the majority of women (63% and men (79%) did not report any difference between the male and female condom in the level of sexual pleasure they experienced. Half of the women, compared to only 9% of the men, preferred the fe male condom to the male condom. In a study of receptivity to the British female condom in the United Kingdom, 214 female participants received educational and instructional information on the female condom along with free samples (Ford and Mathie, 1993). Respondents were instructed to complete an attitudinal survey after the first, fifth, and tenth use of the female condom. Before using the female condom, 53% felt neutral and 39% felt positive toward it. At follow-up, more than half of the women reported using the female condom at least once, of whom 72% used it five or more times, and 56% used it ten or more times. Reasons for not continuing use of the female condom were discomfort during sexual intercourse and partner resistance. Similar to other investigations, 32% reported insertion difficulties. Additional complaints were that it interfered with foreplay and that sexual intercourse seemed less spontaneous. Gollub et al. (1995) examined the short-term acceptability of the female condom among personnel and patients attending New York's Harlem Hospital. The 52 women participants received education concerning the female condom and were given six female condoms and three male condoms. A follow-up interview revealed that 79% had used the female condom at least once. Of those who reported using it, two thirds indicated that they liked the female condom either very much or somewhat, 20% were neutral, and 15% reported not liking it. Half of the respondents who had used the female condom replied that their partner had liked it, 17% replied that their partner was neutral about its use, and approximately 25% indicated that their partner did not like it. Overall, 73% preferred the female condom to the male condom and 44% said that their partners preferred the female condom to the male condom.

Several studies have demonstrated women's willingness to use the female condom following a brief, single-session demonstration (e.g., Ashery et al, 1995; Bounds et al, 1988,1992; Chan and Soon, 1994; Hernandez etal, 1995; Ortiz etal, 1992; Perry etal., 1996 Shervington, 1994). Of these studies, three employed controlled comparison designs. Perry et al. (1996) investigated the receptivity and actual use of the female condom among 344 women living in inner-city housing developments in five locations nationally. Data on female condom use were collected as part of a fivesite HIV prevention trial of a cognitive-behavioral skills training intervention. Women participated in four small-group educational sessions concerned with sexual health and HIV/AIDS prevention. During the second session, group facilitators demonstrated the use of the female condom to participants using a model of the female pelvis. Participants were given individual practice opportunities with the pelvic model and then were supplied with a package of three female condoms and an accompanying bottle of lubricant. One week later, during the fourth session, participants completed a survey assessing their receptivity to the female condom. Prior to the demonstration, most of the respondents held positive attitudes toward the female condom. Seventy-four percent reported that they would encourage their friends to use it and 86% agreed that the female condom is a good option for preventing STDs. Positive attitudes toward the female condom were associated with higher SES, but were unrelated to HIV knowledge scale scores and to perceived male condom use social norms. Before the demonstration, 1.4% of women in the intervention group and 1.2% of women in the control group had used the female condom. At follow-up, 2.7% reported use of the female condom in the intervention group, compared to 0.6% in the control group. This suggests that the brief intervention influenced behavior, but only modestly. However, the female condom did not receive primary emphasis during the intervention training session, which may explain why there was not widespread adoption in this particular sample. The authors suggest that interventions exclusively devoted to female condom use instruction and practice may achieve broader adoption. Gollub et al. (1996) examined the risk of STD reinfection and unplanned pregnancy among 233 women attending an inner-city STD clinic. The objective of this study was to assess the effects of three

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different counseling programs: full choice of women's barrier methods (female condom, diaphragm, spermicides, etc), enhanced male condom counseling only, and female condom counseling only. Among women who received counseling about all the different methods available to them (i.e., full-choice group), 86% chose the female condom and 63% chose the male condom at intake. A larger reduction in the number of unprotected acts of sexual intercourse was observed in the full-choice condition than in the male-condom-only or female-condom-only conditions. In addition, current users of the male condom tended to supplement it rather than switch to another method. Collins et al (1997) examined the impact of a hierarchical intervention on the sexual behavior of inpatients from a large state psychiatric center. Of the 25 female participants, 13 were randomly assigned to the experimental group and 12 to the control group. Participants in the experimental group received a ten-session intervention designed to reduce sexual risk behavior through the introduction of female-controlled methods of protection. The intervention was conducted in the format of a television talk show. Participants assumed the roles of celebrities (e.g., Madonna) or participated as audience members. This format allowed for lively discussions of sexual issues, role playing, and instruction. Detailed instructions for proper use of the female condom, along with opportunities for practice and mastery of skills, were provided to participants. In contrast, the control group received a 1.5-h educational session on HIV prevention. Results indicated that the intervention was well received by the women. The researchers observed significant changes in intentions to use microbicides, but not female condoms. The latter finding may stem from women's difficulty, due to mental illness, in learning proper usage of the female condom. Three investigations examined subsequent use of the female condom following participation in either an intervention or a focus group (Chan and Soon, 1994; Hernandez et al, 1995; Ortiz et al, 1992). Hernandez et al. (1995) conducted a qualitative/ethnographic study of sexual negotiation that was followed by a three-session intervention. The intervention phase consisted in presenting participants (sex workers and non-sex workers) with information pertaining to gender relations, STDs, and a demonstration of the female condom. Participants were interviewed 2 and 6 months after participating in the intervention. Analyses of focus group discussions indicated that

nonuse of the female condom was related to sexual negotiation difficulties. In addition, women who reported using the male condom to avoid pregnancy were very reluctant to switch their contraception method. In a noncontrolled investigation, Chan and Soon (1994) examined user acceptability of the female condom among female sex workers in Singapore. Participants attended a workshop in which the female condom was discussed and demonstrated. Of the 29 participants, 21 reported using the female condom over a 1-week period. Fifty-two percent liked it and 43% found it to be easy to use. Ease of use increased with subsequent use. Major barriers to use included partner objections to the female condom's appearance and decreased pleasure during sexual intercourse. Even though most sex workers were favorably inclined toward using the female condom, they often were unable to use it due to partner reluctance. Ortiz et al. (1992) conducted a small study designed to examine attitudes toward the female condom among female sex workers in Mexico City, Women participated in focus groups in which they received educational information pertaining to the female condom, along with free samples of the device. Initial reactions toward the female condom were negative and focused on its appearance. Eighteen of the sex workers were subsequently reinterviewed. These women indicated that when they used the female condom, their clients either did not notice the device or reported increased sexual pleasure. None of these participants reported any use difficulties. Even though clients' reactions were positive, very few of the sex workers requested additional supplies of the female condom.
Adverse Reactions

In most studies, few (if any) negative physiological/biological reactions were observed in study participants (Parietal., 1994; Gregersen and Gregersen, 1990; Leeper, 1990; Leeper and Conrardy, 1989; Leeper et al., 1989; Soper et al., 1991). A small percentage of participants report vaginal or penile irritation, or urinary tract or other infections (Cleary and Winters, 1994; Leeper, 1990; Leeper and Conrardy, 1989). The female condom is not recommended for persons who have a sensitivity or allergy to polyurethane or silicone (similarly, latex-sensitive persons should avoid contact with male condoms).

The Female Condom: A Literature Review Soper et al. (1991) investigated whether the female condom was traumatic to the vaginal mucosa and/or vulvar skin and whether it has an effect on resident vaginal bacterial flora. Thirty female participants were randomly assigned to use either the female condom or a diaphragm. Neither contraceptive device was associated with significant trauma to the lower genital tract. Moreover, use of the female condom did not appreciably affect the microbial flora of the vagina.

251
male condom) and is available to family planning clinics for about half this amount (Anonymous, 1993). As more women become aware of the female condom as a viable option, increased demand can be expected to drive down the cost somewhat, ameliorating this concern. Although the female condom is female-controlled, the data suggest that some of the same problems exist with using the female condom that exist with using the male condom. Although use may be initiated by the woman, some cooperation is still required by the male partner to actually use the device. Hence, it is not surprising that male partner objections to the female condom are related to nonuse or discontinuation of female condom use (Ford and Mathie, 1993; Gil, 1995; Ruminjo et al, 1996; Sakondhavat, 1990; Sakondhavat and Potter, 1990). This suggests that when marketing the female condom, appeals will need to be made to both sexes, not just to women. Many women report a willingness to discuss using the female condom with their male partner (Gil, 1995; Schilling et al, 1991). In addition, many women perceive the female condom as providing them with greater control over safer-sex negotiations (Ashery et al, 1995; Ehrhardt et al, 1992; Gollub et al, 1995; Niang et al, 1996; Ray et al, 1995; Ruminjo et al, 1996; Schilling et al, 1991; Shervington, 1993). However, it is not known whether women can successfully introduce this topic to their partner and whether or not their partners would respond negatively or aggressively. Research is needed to determine whether the female condom can help empower women in gender-imbalanced sexual relationships (Ashery et al, 1995). Indeed, the maximum benefit of female condom use is obtained by women who would otherwise have no protection against pregnancy and STDs (due perhaps to partner reluctance to wear a condom). From a public health standpoint, little would be gained if women simply switched from relying on the male condom to using the female condom, since these methods appear to be about equally effective. However, the female condom perceptions of women who are not currently using any barrier method have not specifically been investigated. More generally, it is not known what factors predict preference for one method (female or male condom use) over the other, although one study suggests that men tend to prefer the male condom and women tend to prefer the female condom (Musaba et al, 1996).

SUMMARY AND LIMITATIONS OF CURRENT RESEARCH In summary, when used properly the female condom can be a useful and efficacious barrier method for preventing pregnancy and the transmission of HIV and other STDs. It appears that the preventive effectiveness of the female condom is comparable to that of the male condom. However, as a female-controlled method, the female condom enables women to protect themselves from HIV and other STDs, and to reduce their risk of unintended pregnancy, without requiring their male partners to agree to wear a condom. Although the acceptability of the female condom varies among different groups of women (largely selected from convenience samples), many women hold favorable attitudes toward the female condom and express a willingness to use it as their primary method of contraception and disease prevention. There are numerous advantages to the female condom, in addition to those listed previously. Positive characteristics of the female condom reported by women in the studies reviewed above include (1) greater control over safer sex negotiation and behavior, (2) effectiveness for STD and pregnancy prevention, (3) ease of use, (4) increased sexual pleasure, and (5) provision of a viable alternative for men who dislike the male condom. Reasons for less favorable or unfavorable attitudes toward the female condom include (1) discomfort during sexual intercourse, (2) necessity of partner's consent to use, (3) difficulties of use, (4) aesthetic concerns, (5) noise during intercourse, (6) interference with foreplay and sexual pleasure during intercourse, (7) sensitivity to silicone or polyurethane, and (8) cost. Cost, in particular, may be a substantial impediment to use by lower income women (Faundes et al., 1994; Gold, 1995; Ray et al, 1995). The Reality female condom retails for about $2.50 (which is more than twice the cost of a

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Despite the growing number of studies examining the female condom, several weaknesses of current research are noteworthy. Of the 31 articles reviewed pertaining to acceptability of the female condom, only 18 (58%) were published in peer-reviewed journals. The remaining 13 studies are published abstracts of presentations given at national or international meetings. Moreover, the methodology employed in most of the investigations limits the generalizability of the findings. Specifically, many of the studies have been conducted with very small samples (TV < 50); have not included control/comparison groups; have employed convenience samples (i.e., self-selected participants/volunteers); have explored female condom use as a secondary behavioral outcome to male condom use; have had high rates of participant attrition; and/or have relied primarily upon anecdotal evidence. As a result of these problems, the data obtained are very limited, which may explain why some researchers find positive attitudes/receptivity toward the female condom, while others report less positive attitudes. Studies using sufficiently large, randomly selected samples are needed to assess acceptability of the device in the general population. Moreover, with few exceptions, studies have employed a cross-sectional design. Longitudinal investigations are needed to determine who tries the female condom, who continues to use it over time, and how patterns of use change over time. Furthermore, prospective studies would enable researchers to identify which factors influence continued use. Another limitation is that studies have focused primarily upon women's attitudes toward using the female condom, delineating only some of the potential barriers and facilitators of use. More research is needed that identifies specific factors associated with use and nonuse of the female condom. It is especially important to determine whether the female condom is acceptable to the population of women most at need of the STD protection it can providenamely, women who do not consistently use male condoms. This information is critical to facilitate the development of interventions aimed at increasing the use and utility of the female condom. In addition, too little is known regarding how men evaluate the female condom and whether they would be willing to use it with female partners. Most investigations have asked their female participants to report on their male partners' responses (e.g., Gollub et al, 1995). Given that many women report the need for male cooperation with this device, it is imperative that re-

search be conducted in which men indicate directly their attitudes toward the female condom. Also, few studies have been guided by theoretical models and constructs related to behavior modification. The identification of decision-making influences predictive of female condom adoption is best achieved using a theoretical approach. Among the most prominent models of behavioral change that previously have been applied to male condom use are the Health Belief Model (Rosenstock, 1974; Rosenstock et al., 1988), the Theory of Reasoned Action (Ajzen and Fishbein, 1980), Self-Efficacy Theory (Bandura, 1977, 1989, 1992), the Iranstheoretical Model of Change (Prochaska and DiClemente, 1983; Prochaska et al, 1994), and the AIDS Risk Reduction Model (Catania et al., 1990, 1994). These theories provide useful conceptual frameworks for understanding the myriad interacting factors that govern the performance of risky and self-protective sexual behaviors. Components of these models have been used successfully to guide the development of HIV prevention interventions and teen pregnancy prevention programs. Future research on female condom acceptability and use would benefit from a similar theoretical focus. An emphasis on theory can guide the selection of factors to be studied and can provide a conceptual framework in which to examine the interrelationships among constructs. The modelbased approach enables researchers to determine the relative influences of different components of a prevention program which may allow for customizable intervention approaches (Brown et al, 1991). It also may help researchers to conceptualize more precisely the reasons why some individuals change their behaviors, while others do not (Zimmerman and Olson, 1994). More generally, the factors that encourage or discourage the initiation and maintenance of female condom use have not been clearly identified. Regarding correlates of male condom use, demographic factors, psychosocial factors, past sexual behaviors, and drug and alcohol use have been identified as having an impact on initial and continued use. In particular, demographic factors such as age, ethnicity, and relationship status may mediate male condom use (e.g., Anderson et al, 1996; Basen-Enquist, 1992; Catania et al, 1992, 1994). Relevant psychosocial factors include behavioral intentions (Basen-Enquist, 1992; Catania et al, 1992, 1994), perceived risk (Basen-Enquist, 1992; Goodman and Cohall, 1989), belief that one can use condoms (Basen-Enquist, 1992; Goldman and Harlow, 1993; Wulfert and Wan, 1993), and

The Female Condom: A Literature Review perceived social norms (Adler et al., 1990; Fisher, 1988; Fisher et al., 1995). Finally, condom use is influenced by previous and current sexual behaviors, including having multiple sex partners (Catania et al., 1994), and by the use of alcohol and drugs (Lowry et al., 1994; Siegal et al., 1996; Weinstock et al, 1993). However, the relationship of these variables to female condom use is unknown, as is the relationship between male condom use and acceptance of the female condom. Further studies are needed to delineate the specific variables associated with acceptance of the female condom and subsequent use. In addition, it is important to understand the cultural and contextual factors that may facilitate or impede female condom use (Amaro, 1988; Ehrhardt et al., 1992; Fullilove et al., 1990; Gomez and Marin, 1996; Marin, 1989; Weeks et al., 1995). In conclusion, the female condom currently is the only woman-controlled device on the market that reduces the risk of unplanned pregnancies and STD transmission. As such, the female condom expands the range of choices available to sexually active individuals. Given the high rates of STDs, including HIV infection, and unplanned pregnancies among certain groups of women, further research is urgently needed into the attitudinal, cultural, and situational determinants of female condom use, including the initiation and maintenance of use behaviors. Although the literature suggests that the female condom could constitute an effective and useful defense against STDs and unplanned pregnancies, additional data are needed before intervention programs to promote its use can be designed and effectively implemented. It is especially important to determine whether those women who are most vulnerable to STDs and unplanned pregnancies (e.g., low-income women, partners of injection drug users) would be willing and able to use the female condom if it were more readily available. At present, we cannot conclude definitively that the female condom should be an integral component of health care messages, given the complex range of factors, including users' perceived attributes of different methods, market availability, service provider attitudes and information giving, and the perceived sociosexual climate in which personal and public contraceptive health care decisions are made. The future of the female condom will depend on obtaining a better understanding of these personal and societal factors, along with developing appropriate marketing strategies.
ACKNOWLEDGMENTS

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Preparation of this manuscript was supported by Center Grant #P30-MH52776 from the National Institute of Mental Health. We gratefully acknowledge the assistance of David Holtgrave, Ph.D., for his helpful comments on an earlier draft of this article, Allan Hauth for assistance in bibliographic research, and Ralph Resenhoeft for his editorial help.

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