CHOI, KYUNG-HEE PhD, MPH; GREGORICH, STEVEN E. PhD; ANDERSON, KIM MS; GRINSTEAD, OLGA PhD, MPH; GÓMEZ, CYNTHIA A. PhD
WOMEN IN THE UNITED STATES are increasingly at great risk for HIV infection. In the last decade, the proportion of new AIDS cases reported among adolescent and adult women has more than doubled, from 11% in 1990% to 25% in 2000 (CDC, 1991 and 2001). 1,2 Moreover, heterosexual contact is the major risk factor for HIV infection among women. In 2000, 38% of all new cases in women resulted from heterosexual contact. 2
Women can now use the female condom to protect themselves from HIV infection and other sexually transmitted diseases (STDs). 3 This barrier method is a polyurethane sheath worn inside the vagina and has been available in the United States since 1994. 3 Numerous studies of women have found favorable attitudes toward the device and willingness to try it. 4,5 However, limited data on predictors of female condom use are available to help guide the development of interventions that promote the female condom and safer sex practices among at-risk women. 5 Acceptability studies have identified factors that affect the use of the female condom, including technical difficulties with device insertion and removal, attitudes about the female condom, partner cooperation, relationship status, sexual communication, and access to the device at the time of intercourse. 6–10 The studies, however, are mostly qualitative and need to be replicated in quantitative research. Quantitative studies, on the other hand, have mainly focused on demographic and partner characteristics, STD and HIV testing history, and sexual and substance use behavior related to female condom use. 11–19 Few surveys have investigated the influence of attitudes and beliefs on female condom use in a quantitative fashion, even though these variables have consistently been found to be significant determinants of male condom use. 20–25
Using longitudinal survey data collected from ethnically diverse women, we examined condom self-efficacy, frequency of and comfort with communication about sex, comfort with device insertion, and traditional gender role expectations to determine whether these predictors of male condom use have the same explanatory power for female condom use. We also considered demographic characteristics, sexual behavior, contraceptive use, relationship status, and attitudes about the device to validate the findings of previous research on female condom use.
Several studies have found that promoting more options for HIV prevention leads to higher rates of protected sex. However, these studies have yielded mixed results regarding whether female condom use supplements or replaces male condom use. 16,26–32 Moreover, study populations have been mostly high-risk groups such as commercial sex workers, 26 drug users, 27 and patients with STDs. 16,28–31 Little information is available on women who use family planning clinics, even though these women have been found to be at great risk for HIV. 33 These clinics are an appropriate setting to promote the female condom as both a birth control method and an option for disease prevention. This study investigated whether providing male and female condoms increases the level of overall protection among women attending family planning clinics. We also examined whether male condom use is replaced by female condom use when women have access to both.
Subjects and Procedures
Between July 1998 and April 1999, we recruited a total of 238 women from four family planning clinics in the San Francisco Bay Area (San Francisco, Oakland, and Hayward) that serve ethnically diverse populations. Potential subjects were approached in the waiting rooms of the study sites and screened for eligibility. Trained female interviewers approached potential participants in the waiting areas of the clinics and screened them for eligibility. This face-to-face approach was supplemented by advertisement flyers. The flyers were distributed to women waiting for service at the clinics and posted on the clinic bulletin boards. The inclusion criteria included being African American, Asian American, Latina, or white; being aged 18–39 years; having two or more male partners in the past year; and currently having a male sex partner. The exclusion criteria were having HIV infection or current STD symptoms; being a commercial sex worker; being unable to speak English; being allergic to polyurethane, latex, or lubricants; and planning to move out of the Bay Area within the next 3 months.
After providing consent, study participants completed standard questionnaires administered by a female interviewer face-to-face. The participants then underwent 10 minutes of individual condom use instruction, including a didactic presentation of facts about the male and female condom, a demonstration of their use, and a question-and-answer period. During this session, both types of condoms were promoted equally as birth control and disease prevention methods. Women were encouraged to use either male or female condoms but to use only one type at a time. All women received written instructions and a 1-month supply of male and female condoms, based on the amount of sexual activity reported during the baseline interview (on average, two per week for each type of condom). For the next 2 months, condom supplies were mailed once a month. At 3 months, the participants returned for follow-up questionnaires.
A 30-minute standard instrument asked study participants about their demographic characteristics, sexual behavior, condom use, and attitudes and beliefs related to condom use and their sex partner's attitudes toward condom use. We used three levels of measurement for this article: participant-specific, partner-specific, and episode-specific. Both participant-specific and partner-specific questions were asked of all respondents. Episode-specific measures assessed condom use behaviors during individual sexual episodes and were created from the partner-specific data.
We measured at baseline respondents’ age, ethnicity, marital status, and education.
Respondents were asked at baseline what type of contraceptive they used most often to prevent unwanted pregnancy (pills, IUD/coil/loop, male condom, female condom, foam/jelly/cream, rhythm, withdrawal, sterilization, and other).
An 18-item measure 21 assessed respondents’ beliefs about their ability to negotiate condom use (condom type not specified) under varying circumstances (alpha = 0.88). Respondents were asked at baseline whether they believed that they could discuss condom use with various types of partners (e.g., any partner, a steady partner), insist on condom use under the influence of alcohol or drugs, handle partner resistance to condom use, and control sexual impulses and use condoms. A 4-point Likert scale was used (1 = “definitely no,” 2 = “probably no,” 3 = “probably yes,” 4 = “definitely yes”). The condom self-efficacy scale was based on the mean of the 18 items.
Gender role expectations.
A 10-item scale 21 assessed baseline beliefs about appropriate sexual behaviors for men and women (e.g., “It's important that a woman be a virgin before marriage”; alpha = 0.77). Response to each item was scored on the same 4-point scale used for the condom self-efficacy scale. Response scores were averaged to create the gender role expectations scale.
Comfort with device insertion and sexual communication.
We assessed comfort with device insertion and comfort with sexual communication at baseline. 21 The first three-item scale measured how comfortable respondents felt about inserting a birth control device inside their vagina when they are alone, in front of their partner, and having their partner insert the device (alpha = 0.77). The second four-item scale asked how comfortable they felt about talking to their partner about sex, condoms, and sexual fantasies and about teaching the partner what feels pleasurable to them during sex (alpha = 0.70). For each item asked, respondents had four possible answers: 1 = “very uncomfortable,” 2 = “somewhat uncomfortable,” 3 = “somewhat comfortable,” and 4 = “very comfortable.” The averaged scores across the items formed the comfort scales.
Attitudes about the female condom.
We measured attitudes about the female condom at follow-up using 30 candidate items adapted from a scale measuring attitudes about the male condom 23 and a scale measuring attitudes about the female condom (Maurizio Macaluso, personal communication, March 25, 1998). Responses to these items were scored with a 4-point Likert response format (1 = “disagree a lot,” 2 = “kind of disagree,” 3 = “kind of agree,” and 4 = “agree a lot”). We conducted exploratory factor analyses to examine the interrelations among these 30 items and identified four subscales: prophylactic efficacy over the male condom (e.g., “Female condoms offer better protection against STDs than regular male condoms do”; alpha = 0.78), device appearance (e.g., “Female condoms are weird”; “Having part of the female condoms hanging out is gross”; alpha = 0.67), device insertion (“You don't like putting the female condom inside yourself”; alpha = 0.84), and sexual pleasure (“Sex doesn't feel as good when you use a female condom”; alpha = 0.85). In addition, we created two single-item measures:women in charge (“Female condoms put women in charge.”) and suspected of having other partners (“If a woman wants to use a female condom, her partner might think she was having sex with someone else.”).
Respondents were first asked about the number of sex partners they had during the 3 months before interview. Starting with the most recent partner (partner 1), they were asked who this partner was (i.e., spouse, boyfriend, lover, friend, coworker, acquaintance, stranger, or other), whether he was a new partner, the number of episodes of vaginal intercourse with him during a 3-month period, and the number of times they used male and female condoms. These questions were repeated up to 10 times, depending on the number of partners reported by respondents.
At follow-up, we asked about the frequency of sexual communication with each sex partner. 34 Respondents were asked how frequently they had discussed each of the following five topics with their partner: respondent's previous sex partners, partner's previous sex partners, partner's history of STD, partner's history of drug injection, and the couple's need to get tested for HIV. Each question had four response options: 1 = “never,” 2 = “rarely,” 3 = “sometimes,” and 4 = “often.” The mean of the first two items formed a scale labeled Communicating about Previous Sex Partners (alpha = 0.87), and the average of the last three items defined a measure labeled Communicating About HIV-Related Risk (alpha = 0.76).
Suggesting female condom use to one's partner.
This variable was measured by a single question asked at follow-up: “Since enrolled in the study, have you asked [the name or initials of the currently indexed partner] to use a female condom?”
Partner attitudes about the female condom.
Women's perception about their partner's attitudes about the female condom were assessed at follow-up with a five-item scale (alpha = 0.83). Respondents were asked whether their partner thinks that female condoms are better than male condoms, are weird, take all the fun out of sex, make sex better for men, and feel more natural than male condoms. Because of a potential recall bias, we asked about only the most recent sex partner (partner 1) in the 3 months before the follow-up interview. The four-point disagree/agree Likert scale was used to record responses.
Partner-specific information about vaginal intercourse and condom use was used to create an episode-specific data set, including one record for each reported sexual episode. Two binary outcomes were created for each reported episode: use/nonuse of a female condom and use/nonuse of a male condom. Finally, the episode-specific data did not specify the temporal ordering of episodes and condom use patterns reported during any single interview.
Four binary condom use outcomes were modeled. The first, a participant-specific measure, indexed whether each woman used a female condom at least once since baseline. A parallel partner-specific measure indexed whether each participant–partner pair used a female condom at least once since baseline. Finally, two episode-specific outcomes indexed whether a male or a female condom was used for each reported sexual episode. The participant-specific outcome was modeled with use of standard logistic regression. Logistic regression models were fit to the partner- and episode-specific outcomes via generalized estimating equations (GEEs). 35 Partner- and episode-specific outcomes were considered nested within participants, and compound symmetric working correlation structures were specified. Note that all tests based upon partner- and episode-specific data, including chi-square tests, result from GEE logistic regression models. Only those explanatory variables with P values <0.25 were included in multivariate analyses. Multivariate models were also modified through backward elimination by dropping explanatory variables with P values >0.25.
Of the sample of 238 women enrolled at baseline, 218 returned for follow-up interviews at 3 months (a 92% retention rate; median duration of follow-up = 111 days, range = 63–343). Of these 218 women, 206 reported having sex partners during the 3-month study period. These three groups did not differ in terms of demographic characteristics and sexual behavior. Table 1 presents the sample characteristics of the 206 sexually active women who completed both baseline and follow-up interviews. Responses from these 206 women form the basis of all subsequent analyses.
Changes in Condom Use During the Study
The total number of vaginal sexual acts reported by the 206 sexually active study participants was 6130 at baseline and 7366 at follow-up. As shown in Figure 1, the proportion of vaginal sexual acts protected by the female condom increased significantly during the study (<1% [5/6130] versus 17% [1274/7366]; chi-square = 51.05;P < 0.0001), whereas male condom use during the same time period remained unchanged (44% [2681/6130] versus 42% [3100/7366]; chi-square = 0.76;P = 0.3842). There was a significant increase in the proportion of sexual acts protected by the male or female condom, from 44% [2681/6130] at baseline to 59% [4320/7366] at 3 months (chi-square 1 = 9.28;P < 0.01). When we compared three types of male condom users at baseline (nonusers, inconsistent users, and consistent users), we found no difference in female condom use at follow-up among these three groups (16% [242/1543] versus 16% [690/4358] versus 23% [342/1463], respectively; chi-square = 0.86;P = 0.65).
Patterns of Female Condom Use
Among 206 sexually-active women at follow-up, 82% reported having used the female condom at least once over the study period. We found no difference in any use in relation to ethnicity, age, marital status, education, number of sex partners, contraceptive use, or past condom use (Table 2).
We examined whether any female condom use varied by partner type, using partner-specific data (Table 3). At follow-up, women reported 1 to 4 sex partners in the previous 3 months, resulting in a total of 279 male partners identified. The majority of these partners were a spouse or boyfriend (63%), followed by a friend (20%), a lover (11%), or others (6%). Women were more likely to use the female condom at least once with their spouse or boyfriend (77%) and a lover (75%) than with their friends (42%) or other types of partners (28%; chi-square = 35.39;P < 0.0001). They were less likely to use the device with new partners than with partners not identified as new (48% versus 72%; chi-square = 13.69;P = 0.0002).
Tables 2 and 3 report proportions of vaginal sexual acts protected by the female condom at follow-up by demographics, contraceptive and condom use at baseline, and partner characteristics. Only number of partners (chi-square = 8.86;P < 0.05) and partner type (chi-square = 24.83;P < 0.0001) affected proportionate use of the female condom. We further analyzed data to compare women with and without college education but found no statistically significant difference between these two groups (14% versus 26%, respectively; chi-square = 2.28;P = 0.13 ).
Factors Associated With Female Condom Use
Table 4 shows the results of bivariate and multivariate analyses conducted to identify factors associated with female condom use during the 3 months between baseline and follow-up. Bivariate results showed that female condom use was associated with having a steady partner, communicating about HIV-related risk, suggesting female condom use to one's partner, four attitudes about the female condom (better prophylactic efficacy over the male condom, less concern about device appearance, less concern about device insertion, and enhanced sexual pleasure), and having a partner who has favorable attitudes about the female condom. Multivariate analyses identified three independent factors associated with female condom use: suggesting female condom use, less concern about device appearance, and partner's favorable attitudes about the female condom. All the other variables were not statistically significant.
Our survey of women attending family planning clinics showed that any use of the female condom was high: 82% of participants used the device at least once in a 3-month period. However, the proportion of sexual acts protected by the female condom was only 17%. These findings are similar to previous research data. Rates of any use found in other studies range from 70% among commercial sex workers 12 to 79% and 85% among STD patients. 9,31 In terms of proportionate use, a survey of US women with STDs revealed that the female condom protected approximately 25% of all sexual acts reported at 3- to 6-month follow-ups. 16 A study of Zambian couples with STDs found comparable rates of 24% at 3 months, 27% at 6 months, and 23% at 12 months. 30
Previous research has found that male condom use is lower among ethnic minority women than among white women. 23 In our study, both any use and proportionate use of the female condom were similar across the four ethnic groups. African Americans, Asian Americans, and Latinas were as likely to have tried the device at least once and used it at a proportion almost equal to that among whites. This study provides some evidence that ethnic minority women are as willing to use a barrier method that requires vaginal insertion as are white women. The female condom may offer another option for those who are unable to negotiate male condom use with their sex partners.
Our study participants reported a significantly higher level of sex acts protected by the female condom at 3-month follow-up, in comparison with baseline, and little change in male condom use during the study. These results suggest that female condom use supplements male condom use, which in turn leads to an increase in overall protection. The findings add more evidence supporting the view that the more options women have for disease prevention, the more likely they will engage in safer sex. 5,16,26–29 The finding that male condom use was not reduced corroborates two 27,28 studies that promoted both male and female condoms and allowed women to select any method, depending on their preference.
Female condom use at follow-up did not depend on women's experience with the male condom at baseline. The use was similar for nonusers, inconsistent users, and consistent users of the male condom. The lack of difference in female condom use in relation to type of male condom users may be associated with the novelty of the female condom.
Female condoms cost approximately $2.75 each in U.S. retail stores and $0.63 for the public sector. 36 By comparison, the wholesale price per male condom is $0.04. Several studies, including ours, have shown that use of the female condom was low despite promotion of the product through health education, skills training, mass media campaigns, and/or distribution of free female condoms. 31,32,37 For example, a recent randomized clinical trial of a community-level intervention conducted in Kenya found that only 11% and 7% of study participants were consistent users of the female condom at 6-month and 12-month follow-ups, respectively. 37 This trial also detected no difference in STD prevalence between intervention and comparison communities. Because of the high cost and limited use of the female condom, a question has been raised about its public health benefit in reducing HIV transmission. 37–40 Our data suggest that the female condom can play an important role in reducing HIV transmission by filling the protection gap left by the male condom. The proportion of protected sexual acts increased from 44% at baseline to 59% at 3 months. This 15% increase resulted mostly from use of the female condom, with few reductions in male condom use. In addition, a cost-effectiveness study demonstrated that female condom promotion programs would save public health expenditures for treatment in both low- and high-risk groups such as women with one casual partner (US$199) and commercial sex workers (US$5,421). 40
Consistent with both previous quantitative surveys of male condom use 21–24 and qualitative female condom acceptability studies, 6,8–10 women's attitudes toward the female condom were a strong predictor of its use. Women in our study used the device more frequently if they believed that the female condom provided better prophylactic efficacy over the male condom, that device appearance and insertion presented less concern to them, and that the device increased sexual pleasure. Device appearance, in particular, remained a statistically significant variable after controlling for demographics, multiple sexual partnerships, partner type, and other attitudinal factors in the multivariate model. Partners’ favorable attitudes also affected more frequent use of the device. These findings underscore the need to help both women and their partners overcome attitudinal barriers to use through health education and skills training programs. That might include sharing factual information about the female condom, counseling about ways to overcome negative feelings related to vaginal insertion, and teaching how to properly use the female condom through demonstration and practice.
The female condom has been promoted as an empowering tool that women can use for disease prevention, but there has been skepticism about its ability to confer control to women because of the visibility of the device's outer ring as it hangs out of the vagina. 3 Several in-depth qualitative studies documented that the female condom enhances women's sense of empowerment, and this, in turn, facilitates its use. 3,5,11 Contrary to these findings, our survey data showed that the belief that the female condom puts women in charge did not predict its usage. It is possible that this single-item measure did not fully assess the empowerment dimension of the female condom. 40 Another explanation may be that our sample of American women who willingly volunteered to try the female condom already enjoyed a degree of power in their sexual relationship and empowerment was of less concern to them. Alternatively, these women might not be interested in the female-control attribute of the device. One survey of women showed that female control was not an important feature in selecting disease prevention methods and that other characteristics such as safety, effectiveness, availability, and ease of use were considered more important. 41 Future research should investigate this empowerment issue with various risk groups, as women's control is often part of female condom promotion efforts. 42
Of the three communication variables we considered to be potential determinants of female condom use, suggesting female condom use to one's partner was the only one that predicted female condom use. The other two variables that measured general communication about HIV-related risk and multiple sexual partnerships had no relationship to use. These results are consistent with those of one study that found an association between women's willingness to ask their sex partners to use a condom and male condom use. 34 However, the perceived quality of communication about sexual matters between couples and women's ability to ask prospective sex partners about sexual history and condom use was not associated with male condom use. Data from our study indicate that women need skills-training to negotiate female condom use with their partners. In order to be more effective, the negotiation-skills training may need to focus specifically on how to ask a sex partner to allow use of the female condom.
Three previous studies have shown an association between the demographic characteristics and any use of the female condom. 12–14 We found no such association. The only factor that predicted any use was partner characteristics, and this finding was consistent with prior research data. 14–16,39,43 Women were more likely to try the female condom at least once with their spouse, boyfriend, or lover than with friends or other types of partners, but they were less likely to try the device with a new partner.
Macaluso et al 17 examined the relationship between partner type and sexual acts protected by the female condom. This study found that women used the device more frequently with a steady partner than with a nonsteady partner. We found the same result, but the finding held only in our bivariate analysis. The association disappeared in the multivariate analyses. The inconsistency in the two studies may be explained in part by use of different independent variables in the multivariate models. Whereas Macaluso et al 17 considered only demographic and baseline risk characteristics, we examined psychosocial factors in addition to demographics and risk behaviors. Partner type may play no role in determining how frequently women use the female condom when their attitudes and beliefs related to the device and/or their partners’ are taken into account.
The findings of this study may have limited generalizability because we sampled a relatively small number of women from one geographic area. Self-selection bias may also have influenced the study results. Our convenience sample might have overrepresented women who are interested in female-controlled barrier methods since we advertised our study to promote women's health and the female condom. Presumably this could have led to a greater proportion of women who tried the female condom, compared with women in general. In addition, reliance on self-reports and test–retest bias might have compromised accuracy in our data. Despite these limitations, our study is useful in increasing our understanding of predictors of female condom use. This study is among the few that have examined a variety of psychosocial factors modifiable through interventions and can aid in the development of evidence-based educational programs to promote the female condom. It also offers information about women attending family planning clinics, who are an important population to reach for female condom promotion.
At present the United States remains far behind the international community in increasing widespread use of the female condom through health education and subsidization. 44 Our study suggests that more women will use protection when they have access to both male and female condoms. This study also has provided evidence supporting the need to address attitudinal and communication barriers to help foster female condom use. The female condom can make a significant contribution to preventing HIV infection among women. Without rigorous promotional campaigns, however, this potential may not materialize.
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