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Evaluate the efficacy of skills training designed to increase female condom use among women.
A randomized trial of 409 women, recruited from family planning clinics in northern California, randomly assigned to the experimental 4-session female condom skills training intervention or the comparison 4-session women's general health promotion intervention. Participants received condom use instructions at baseline and male and female condoms during the study. They completed audio computer-assisted self-interviews at baseline, 3, and 6 months.
At 3 and 6 months, women in the experimental group were more likely than those in the comparison group to have used the female condom at least once in the prior 3 months. The increase in the percentage of sex acts protected by female condoms from baseline to the 6-month follow-up was greater for the experimental group. The percentage of sex acts protected by any condom was higher in the experimental group at 6 months. There were no group differences in male condom use.
Outcomes suggest that skills training can increase female condom use and protected sex acts without reducing male condom use among women.
Women account for almost half of the 40 million estimated human immunodeficiency virus (HIV) infections worldwide.1 Effective female condom promotion programs that could help facilitate more widespread use of the device could have a significant impact on reducing the incidence of HIV among women and their sex partners. The female condom, a polyurethane sheath worn inside the vagina, is the only female-initiated barrier method currently available to protect against HIV and other sexually transmitted infections (STIs).2 Early acceptability studies have shown that the female condom is a promising disease prevention option for diverse subpopulations of women in developing and developed countries.3-7 Among U.S. women attending family planning clinics, 82% of respondents who were introduced to the female condom at their baseline visit reported having used the device at least once during the 3-month study period.7 However, women's initial interest in the product has not moved beyond the “novelty” phase,2, 5, 8 and its uptake has been limited because it has not been promoted actively by the private or public sectors in this country.2, 5 U.S. studies have found low levels of lifetime use ranging between 3% and 6%.9-11
Few clinical trials have demonstrated efficacy in any intervention designed to increase female condom use. Five published U.S. studies evaluated female condom interventions using a randomized controlled design, 9-13 and only two of these 9, 12 demonstrated effects on ever-use or first-time use over a short term (i.e., 6 weeks and 1 month). Three studies found an increase in use of female condoms during sex acts, but included a follow-up of only 3 months. 10, 11, 13 Moreover, one of these studies had a small sample size (81),13 whereas the other two did not match treatment dosage and compared a multi-session experimental intervention to a single-session control intervention.10, 11
We conducted a randomized trial with a sample of 409 U.S. women to test the hypothesis that female condom skills training would be efficacious in increasing sustained use of female condoms and protected sex. We matched the length and delivery mode of the intervention for experimental and comparison groups and assessed both short- and longer-term effects (i.e., 3 and 6 months).
The study population was family planning clinic attendees in four San Francisco Bay Area cities (Concord, Mountain View, Santa Cruz, and San Francisco). From June 2003 to November 2004, recruitment flyers were posted at the clinics and 3 trained female recruiters approached women at the study sites in the waiting areas and screened them in private areas of the clinics. Eligible women self-identified as African American, Asian, Latina, or white; were 18 to 39 years old; had two or more male sex partners in the prior year; had no known allergies to polyurethane, latex, or lubricants; were HIV negative; had no plan to get pregnant within the subsequent 6 months; and were English speakers. Eligible participants were enrolled in the trial and randomized when they arrived for their scheduled first intervention session. Eligible women who failed to attend their first scheduled intervention session were not enrolled in the trial and were deemed ineligible for further participation.
At screening, we briefly described the purpose of the study to potential participants and obtained written informed consent from those who were eligible and willing to participate in the study. The consented participants then completed a standardized baseline questionnaire using an audio computer-assisted self-administered interview (ACASI) system. At the end of each baseline visit, the participants received $10 in cash immediately following the survey and were informed that a study-affiliated health educator would contact them to schedule their first intervention session.
Randomization was stratified by site and race/ethnicity. Prior to initiation of the study, stratum-specific sequential identification numbers were generated and randomly pre-assigned to intervention groups in blocks of four (i.e., 2 intervention and 2 control participants per block). Participants were blind to assignment until their first intervention session.
Study participants returned to the clinic to attend intervention sessions (Table 1) offered by health educators. The experimental female condom skills training intervention applied social learning theory14 to increase knowledge about safer sex practices, condom use skills, and ability to negotiate condom use. The efficacy of this intervention was assessed by contrasting it to a comparison intervention that focused on women's general health issues, such as cancer and heart disease. The comparison intervention was designed to increase knowledge about behaviors associated with major health problems for women and to improve motivation to change health risk behaviors. The format and length of the experimental and comparison interventions were identical. Sessions 1, 2, and 4 of these two interventions were delivered individually by a health educator. The first two sessions lasted 2 hours each, while the fourth session lasted 30 minutes. Session 3 of both interventions was conducted in small groups of 6 to 10 participants and was facilitated by two health educators. This session lasted for 2.5 hours. In addition, similar techniques were used to achieve the objectives of the two treatment arms, including didactic lectures, individual and group discussions, role plays, skills exercises, video viewing, and interactive activities. Education on female condom use during the first session, however, differed by intervention type. The experimental intervention demonstrated how to use the female condom on a female pelvic model, followed by self-insertion and removal practice with three samples in a private area and discussion of difficulties that arose during the practice. The comparison intervention demonstrated female condom use only with a female pelvic model. The first intervention session occurred 1 week after the baseline visit, sessions 2 and 3 in the following 2 weeks, and session 4 in the 2 weeks after session 3. All participants received monetary incentives after completing each session (i.e., $20 each at sessions 1 and 2, $30 at session 3, and a $10 Safeway gift card at session 4).
Three and 6 months after completing the last intervention session, participants returned to the clinic for follow-up assessments. They completed the identical ACASI survey instrument used at baseline for both follow-ups and afterwards received $30.
During the entire study period, participants received male and female condoms regardless of their intervention assignment. At the conclusion of their first intervention session, the women received condom supplies based on their reported amount of sexual activity (on average, two male and two female condoms per week). One month after completing their last intervention session, they received condom supplies by mail. For the next 4 months, condom supplies were mailed once a month.
At baseline, 3 months, and 6 months, a 30-minute standardized questionnaire assessed participants' demographic characteristics, lifetime history of STIs, sexual behavior, condom use, and female condom knowledge, attitudes, and self-efficacy.
Behavioral outcomes included using female or male condoms at least once during vaginal or anal intercourse in the past 3 months and percentage of vaginal and anal sex acts protected by female condoms, by male condoms, or by any (female or male) condom in the past 3 months. These outcome measures were derived from responses to partner-specific assessments of condom use. Respondents were first asked about the number of sexual partners they had during the 3 months prior to the interview. Starting with their most recent partner (“partner 1”), they were asked about the number of times they had vaginal and anal intercourse with this partner 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.
The impact of our intervention on female condom knowledge, attitudes, and self-efficacy was assessed using psychosocial scales. A knowledge score was created by averaging correct responses to nine items (e.g., “Is the female condom made of latex?”). Each item had a value of 1 for a correct answer or 0 for an incorrect answer.
Items related to female condom attitudes and self-efficacy were assessed using a 4-point response set (1=strongly disagree to 4=strongly agree). Maximum likelihood factor analysis with oblique rotation resulted in 10 scales (results not reported). For each of seven female condom attitude scales, we present the number of items, i, a sample item, and the baseline Cronbach's alpha estimate: more prevention options (i=2; “The female condom provides women another option to protect themselves against HIV and other sexually transmitted diseases;” α=0.65); prophylactic efficacy (i=3; “Female condoms offer better protection against sexually transmitted diseases than regular male condoms do;” α=0.64); empowerment (i=2; “Female condoms put the woman in charge;” α=0.47); concern about device appearance (i=4; “Having part of the female condom hang out is gross;” α=0.66); concern about device insertion (i=2; “You don't like having to touch yourself to put the female condom in;” α=0.80); sexual enjoyment (i=2; “Female condoms make sex better for women;” α=0.60); and decreased sexual pleasure (i=3; “Female condoms make it hard for a woman to have an orgasm (cum);” α=0.76). The three female condom self-efficacy scales included condom discussion (i=2; “You can discuss female condom use with any sexual partner you might have;” α=0.88); partner resistance (i=4; “You can insist on female condom use if a partner does not want to use one;” α=0.89); and regular partner (i=4; “You can start to insist on female condom use with a long time partner with whom you haven't used condoms in the past;” α= 0.88). Each individual's scale scores were defined as the average of their responses to the corresponding items.
Repeated measures regression models estimated the effects of intervention on study outcomes and psychosocial variables across the baseline, 3-month, and 6-month assessments. Logistic models were fit to the binary condom use outcomes and linear models were fit to the proportionate condom use outcomes. Model estimates were based upon generalized estimating equations (GEE),15 and accounted for the correlation of repeated measurements within respondents. Explanatory variables included an intervention group indicator, categorical time indicator, and group-by-time interaction. Custom contrasts estimated differences between intervention groups at each assessment as well as the groups-by-linear-time interaction.
Each model was fit to 20 multiply imputed data sets created using SAS PROC MI software (Version 9.1.3; SAS Inc., Cary, NC). The imputation model included all outcome and explanatory variables described above. Because the PROC MI Markov Chain Monte Carlo algorithm assumes a multivariate normal distribution, imputed values for binary variables were subsequently rounded to the nearest applicable integer.16, 17 All parameter estimates and significance tests were calculated by combining results across the imputed data sets.18, 19
A total of 756 women were eligible for the study. Of these 756 women, 409 (54%) enrolled in our trial and were randomized. The sample of 409 randomized participants was ethnically diverse (11% African American, 8% Asian, 17% Latina, and 64% white). At baseline, a majority of these participants was between the ages of 18 and 24 years old (77%; mean, 22 years), never married (98%), and college educated (58%). Approximately one third had a lifetime history of STIs. The median number of male sex partners that participants had in the past 3 months was 1 (range, 0-8). The median number of vaginal or anal sex acts reported during the prior 3 months was 14. Sixty-seven percent reported using a male condom during vaginal sex at least once during the prior 3 months. Only 4% reported having ever used the female condom in their lifetime. We found no differences in demographic characteristics, sexual behaviors, and condom use between the intervention and comparison groups at baseline (Table 2).
Intervention session attendance rates were 100%, 81%, 57%, and 78% for sessions 1 through 4, respectively. A longitudinal model of attendance across sessions 2 through 4 found no evidence of differences in attendance rates (p = 0.5502) between intervention groups or a group-by-session interaction (p = 0.9814). The attendance level of session 3 (group session) was lower than that for sessions 2 and 4 (p < 0.0001). Overall, retention rates equaled 85% for both the 3- and 6-month assessments. There was no significant intervention group difference in retention rates at 3 (p = 0.1950) or 6 months (p = 0.1478), and the groups-by-assessment-time interaction was also non-significant (p = 0.8522).
We found no group-by-time effect on using a female condom at least once, but the treatment main effect was statistically significant at both follow-up assessments (Table 3). Women in the experimental group were more likely than those in the comparison group to have used the female condom at least once in the prior 3 months at both 3 month (45.31% vs. 19.11%; p < 0.0001) and 6 month (30.80% vs. 7.65%; p < 0.0001) follow-ups. There was a statistically significant group-by-time interaction for the percentage of sex acts protected by female condoms (p = 0.0399). The increase in the percentage of sex acts protected by the female condom from baseline to the 6-month follow-up was greater for the experimental group (15.05 percentage points) than for the comparison group (6.78 percentage points).
We found no significant differences in male condom use between the two groups at 3-and 6-month follow-ups (Table 3). Women in the experimental group were as likely as those in the comparison group to have used the male condom at least once in the past 3 months at both follow-ups. The percentage of sex acts protected by male condoms was also similar across the treatment groups at 3 and 6 months.
We found statistically significant group-by-time interaction (p = 0.0321) and group main effects at 6 months for the percentage of sex acts protected by any condom (p = 0.0281). The increase in the percentage of sex acts protected by any condom from baseline to the 6-month follow-up was greater for the experimental group (12.32 percentage points) than for the comparison group (1.31 percentage points). Also, the percentage of sex acts protected by any condom was greater in the experimental group (50.42%) than in the comparison group (40.97%) at 6 months.
Table 4 shows the effects of female condom skills training on female condom knowledge, attitudes, and self-efficacy. Knowledge and attitude scores at follow-ups differed by treatment status. Women in the experimental intervention became more knowledgeable about the female condom than did those in the comparison intervention and also had more favorable attitudes toward the female condom. More specifically, they were more likely to report a belief that the device gave women more options for disease prevention, provided better prophylaxis than the male condom, empowered women, increased enjoyment of sex, and did not decrease sexual pleasure. The intervention had no impact on female condom self-efficacy.
We demonstrated the efficacy of skills training in improving female condom knowledge, attitudes, and use among U.S. women attending family planning clinics. When compared to women who received brief instructions on female condom use as part of a behavioral intervention aimed at promoting women's general health, women who participated in intense skills training sessions that exclusively focused on the female condom became more knowledgeable about the female condom, had more favorable attitudes toward the device, and were more likely to use it. The same treatment dosage for both experimental and comparison groups allowed to control for Hawthorne effects and, in turn, reduced the likelihood that the efficacy of female condom skills training can be attributed to nonspecific factors, including group interaction and individual attention. The study design also ruled out the possibility that the differences in use were due to access to the female condom, as both groups were given identical access.
We found that the absolute difference in percentage points in using the female condom at least once between the experimental and the comparison group was 26.2% at the 3-month and 23.15% at the 6-month follow-ups. These results were comparable or greater than those reported in other female condom intervention trials (i.e., 13.89% and 24.1% at 3-month).10, 11 Moreover, whereas previous studies showed only a short-term intervention effect on female condom use (i.e., 3 months or less),9-13 our study found a significant longer-term (i.e., 6 months) effect. Also, the treatment effect achieved for female-condom-protected sex acts at 3 months did not diminish at 6 months. In fact, the mean percentage of sex acts protected by female condoms rose from 11.57% at 3 months to 18.87% at 6 months.
The greater magnitude of treatment effects, as well as the longer-term effects found in our study, may be due to the unique characteristics of our intervention that focused exclusively on the female condom, included self-insertion practice and feedback, and provided monthly condom supplies; other interventions did not include these features.9-13 A six-session group HIV/STI prevention intervention developed by van Devanter and colleagues,10 for example, devoted only one session to the female condom, used a pelvic model for condom demonstration and practice, and supplied female condoms upon request. Hoffman and colleagues9 covered the female condom in more than one session in their four- or eight-session HIV risk reduction intervention, but limited condom use practice to a pelvic model and provided female condoms only upon request after giving two samples to try at home. Our intervention is also distinguished from prior interventions in that we used both individual and group counseling to promote the female condom. This approach might have made our intervention more powerful by addressing issues unique to each woman during individual counseling sessions and thereby causing additional behavioral changes in an “individual” effect that group counseling alone might not have produced.
In addition to increasing female condom use, our female condom skills training increased the proportion of protected sex acts. We also found no reduction in male condom use among women in both experimental and comparison groups during the study. These findings were consistent with several studies that made both male and female condoms available to women7, 20-24 and indicated that female condom use supplemented male condom use to contribute to an increase in overall protection against HIV among women.
Our female condom skills training included activities aimed at improving women's self-efficacy related to female condom use. Women were taught, for example, how to introduce the female condom to their sexual partners and how to negotiate its use. However, we found no group differences in female condom self-efficacy at 3 and 6 months. One possible explanation for these findings is that we might have sampled women who were already highly confident in their ability to assert female condom use, and thus our intervention activities failed to produce a treatment effect. Our baseline data showed that mean scores on three measures of female condom self-efficacy ranged from 3.50 to 3.61 of a possible maximum of 4, indicating high levels of self-efficacy at baseline. Another finding of note is a reduction in women's perceived ability to discuss female condom use with sexual partners and resist partner objections to its use in the experimental group. It is possible that at baseline these women tended to overestimate their negotiation skills and later made more accurate assessments of their ability after participating in a role-play exercise or after actual experience trying to negotiate use with their partners.
Three study limitations should be noted. First, the findings of this study may be generalizable only to women attending family planning clinics. Second, because we advertised our clinical trial as a study to promote women's general health including sexual health and the female condom, we might have oversampled women who are interested in female-initiated barrier methods. Third, the accuracy of our data might have been compromised due to reliance on self-reports. However, any self-report bias is less likely to influence the differences observed between the intervention groups as it is expected to operate in both groups.
Our female condom skills training was successful not only in increasing female condom use, but also in increasing protected sex among U.S. women attending family planning clinics. We also found that the female condom contributed to increasing safer sex practices among these women without affecting their use of the male condom. These results suggest that our intervention has the potential to reduce HIV risk among women and can be an effective supplement to other HIV prevention strategies currently available for women and their sex partners.
This research was supported by the National Institute of Child Health and Human Development grant R01 HD39118.
The authors acknowledge the following individuals for research assistance: Katie Bowman, Michele Dubuisson, Jessica Jarboe, Bettina O'Brien, Jan Raissle, LeAnn Ravinale, Jill Schettler-Susskind, Christine Soriano, Amber Steele, Cielle Taaffe-Johnson, Lorrie Tanioka, and Kim Toevs.
Human Participant Protection The Committee for Human Research of the University of California, San Francisco approved all procedures for this study.