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Nancy Van Devanter, DrPH, Virginia Gonzales, EdD, Cheryl Merzel, DrPH, Nina S. Parikh, MPH, David Celantano, PhD and Judith Greenberg, PhD

Nancy Van Devanter, Cheryl Merzel, and Nina S. Parikh are with the Division of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY. Virginia Gonzales is with the Center for Health, Education, and Research, University of Washington, Seattle. David Celantano is with the Infectious Disease Program, Department of Epidemiology, The Johns Hopkins School of Hygiene and Public Health, Baltimore, Md. Judith Greenberg is with the Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, Ga.

Correspondence: Requests for reprints should be sent to Nancy Van Devanter, DrPH, Division of Sociomedical Sciences, Mailman School of Public Health, Columbia University, 600 W 168th St, 7th floor, New York, NY 10032.

	ABSTRACT

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Objectives. This study assessed the effectiveness of a sexually transmitted disease (STD)/HIV behavior change intervention in increasing women's use of the female condom.

Methods. A total of 604 women at high risk for STDs and HIV in New York City, Baltimore, Md, and Seattle, Wash, enrolled in a randomized controlled trial of a small-group, skills-training intervention that included information and skills training in the use of the female condom.

Results. In a logistic regression, the strongest predictors of use were exposure to the intervention (odds ratio [OR] = 5.5; 95% confidence interval [CI] = 2.8, 10.7), intention to use the female condom in the future (OR = 4.5; 95% CI = 2.4, 8.5), having asked a partner to use a condom in the past 30 days (OR = 2.3; 95% CI = 1.3, 3.9), and confidence in asking a partner to use a condom (OR = 1.9; 95% CI = 1.1, 3.5).

Conclusions. Clinicians counseling women in the use of the female condom need to provide information, demonstrate its correct use with their clients, and provide an opportunity for their clients to practice skills themselves.

	INTRODUCTION

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Although sexually transmitted diseases (STDs) have been largely controlled in the vast majority of countries in the developed world, they tragically remain a serious health problem in the developing world and in many regions of the United States.^1,2 Among the 12 million cases of STDs estimated to occur annually in the United States, almost two thirds are in women.¹ The medical consequences of STDs in women contribute greatly to morbidity associated with reproductive health, including pelvic inflammatory disease, infertility, ectopic pregnancy, chronic pelvic pain, compromised birth outcomes, and cervical cancer.^3,4 Studies also show that STDs increase the risk of acquiring HIV.^5,6 Worldwide, approximately 14.8 million women are estimated to be infected with HIV, accounting for almost half of HIV-infected adults.⁷ In the United States, women represent an increasing proportion of new infections and accounted for approximately 25% of AIDS cases reported in 1999.⁸ More than 80% of cases in US women occur in African Americans and Latinas. The most frequently reported mode of infection for women is heterosexual transmission.

The male condom has proven to be highly effective in reducing the transmission of HIV and some STDs.⁹ For many reasons involving economic and social inequalities, as well as gender power dynamics, women may be unable to negotiate with their male partners to use male condoms consistently.^10,11 Thus, there is an urgent need to provide expanded options for women to protect themselves from acquiring STDs and HIV.^12,13 The female condom is 1 option that has been proposed. Approved for use in protection against STDs and unintended pregnancy by the US Food and Drug Administration in 1993, the Reality female condom (The Female Health Co, Chicago, Ill) has been estimated to reduce the rate of STD transmission by 97% when used exactly as recommended by the manufacturer.¹⁴ Clinical trials are under way to empirically test these estimates.¹⁵

A recent review of 42 studies from the developing and developed world examined the acceptability of the female condom among a wide assortment of women who had used the product, including commercial sex workers, women attending family planning clinics, and health care workers.¹¹ Although most of the studies had small sample sizes and were not experimentally designed, some common patterns did emerge. Overall, general acceptability of the product ranged from 52% to 95%, although actual usage was substantially lower.^16,17

Female condom studies in the United States have been limited. Findings in 2 studies of African American women were mixed. One study of 52 women who were given the product after a demonstration reported that 79% had used 1 or more in a 2-week period and that 73% preferred the female to the male condom.¹⁸ This finding contrasts with a study of 178 women who were given a selection of 5 barrier methods to try. Women in this study preferred the male condom to the female condom 2 to 1.¹⁹

Only 1 published US study to date has assessed the acceptability of the female condom in a randomized controlled intervention trial.²⁰ Women (n = 231) in the intervention were introduced to the female condom and encouraged to use the product in the week following the demonstration. At the time of the 1-month follow-up interview, 29% of women had used the product at least once during the period since the intervention, and of those women, 29.9% used it for at least half of the episodes of sexual intercourse. Women who tried the product were significantly more likely to be African American (39%) than Hispanic (30%) or White (18%). They were also more likely to be between the ages of 25 and 34, to live with a partner, to have a history of an STD, or to have been tested for HIV.

The present study assesses the effect of a multisite, randomized controlled STD/HIV behavior change intervention on women's use of the female condom. The intervention sessions included components shown to be effective in STD/HIV risk reduction: education, motivation, and behavioral skills.²¹ Investigators hypothesized that increasing knowledge, coupled with introducing opportunity for skills acquisition in the use of the female condom, would increase the acceptability and use of the product among intervention women.

	METHODS

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The Women in Group Support (WINGS) project is a randomized trial of an education, skills-training, and support-group intervention to increase preventive health behaviors for STDs and HIV in women at high risk for infection. Flyers, newspaper advertisements, community presentations, and on-site recruitment strategies were used to recruit women from 3 cities (Baltimore, Seattle, and New York City) from May 1995 to July 1997. Sources of recruitment included community-based programs, family planning clinics, STD clinics, advertising, and waiting lists for other research studies. HIV-negative women were eligible if they were aged 17 years or older, had had vaginal or anal sex with a male partner during the past 3 months, and had 1 of the following risk factors during the past year: a diagnosed STD, 3 or more sexual partners, use of intravenous drugs, or sex with someone who (1) had other sexual partners, (2) injected illicit drugs, or (3) had sexual intercourse with a prostitute. The New York site differed from the 2 other sites by limiting participation to women aged 17 to 22 years. Names of eligible women who completed the 1.5-hour baseline interview and skills assessments were logged into a record file. After 20 women had been recruited for a cohort, they were invited to attend a meeting. Women who attended the meeting were randomized into the intervention or control group. Women in the control group participated in a 1-hour session featuring a nutrition video on healthy food choices. Women were reimbursed $10 to $20 (depending on the site) to attend the control and each intervention session.

Intervention
The intervention consisted of 6 weekly group sessions. In the first 3 sessions, women received information about STD/HIV and received skills training in communication, goal setting, and use of the male condom. In the fourth session, women received information about the female condom and were shown a video demonstration of how to use it. Following this video, a brief discussion of the advantages of the female condom took place. The group facilitator demonstrated how to properly insert the condom using a pelvic model. Women were then given the opportunity to practice using the condom on the model. At the end of the session, women were encouraged to practice inserting the female condom before using it with a partner. Women who indicated that they were interested in trying the product were given 3 condoms for that week. In subsequent sessions, women who wanted more condoms could ask for them. Details of the intervention have been described elsewhere.²²

Data Collection
Data collection occurred before randomization and 3 months after the end of the 6-week intervention. Interviews were conducted face-to-face in a community or a research setting by trained interviewers. Data were collected in the form of an interviewer questionnaire, a skills demonstration rated by the interviewer, and a brief self-administered questionnaire. All 3 measures were collected at the same time for both the baseline and follow-up assessments.

Measures
Interview data. At the baseline and 3-month follow-up interviews, we assessed women's attitudes toward the female condom by asking respondents to rate the female condom as poor, fair, good, very good, or "don’t know" on the following factors: comfort, ease of insertion, ease of removal, sensation, effects on movement of penis, and tendency to stay in place. Women were asked whether they strongly agreed, agreed, disagreed, or strongly disagreed that the female condom protects against disease and would be acceptable to a male partner. For the question "How likely are you to use the female condom in the future?" a 4-point scale from "very likely" to "very unlikely" was used. We assessed use of the female condom by asking whether respondents had used the female condom in the last 3 months for STD/HIV protection or for pregnancy prevention. We assessed partner communication skills by asking whether the subject had asked a main or other male partner to use a male condom in the past month. We assessed self-efficacy for condom use by asking women how confident they were that they could use a condom every time with their main and other male partners. We assessed partner communication efficacy by asking women how confident they were in their ability to refuse unsafe sex with a main or other partner. We also examined variables that have been predictive of female condom use in other published studies, including risk perception for STDs and HIV, having a steady male partner, comfort with putting something into the vagina, and previous use of barrier protection methods.

Skills demonstration. At the end of the interview, women were given a female condom and asked to demonstrate use on a pelvic model. Interviewers rated the respondent's performance on the following aspects: (1) held the pouch with open end hanging down; (2) while holding outside pouch, squeezed inner ring while inserting; (3) inserted squeezed condom into vaginal opening, making sure pouch was straight, not twisted; (4) with finger inside, pushed inner ring and pouch the rest of the way up into the vagina. For each of these aspects, respondents were rated "0" (no), "1" (yes), or "9" (refused). All interviewers were trained and observed for skills demonstration scoring to ensure interrater reliability.

At the end of the baseline skills assessment, women in the control group were given printed instructions on correct use of male and female condoms, but they received no verbal instruction or demonstration.

Self-administered questionnaire. Subjects were also asked to complete a self-administered questionnaire that contained scales measuring general mastery²³ ( = .75) and general self-esteem²⁴ ( = .84). (Alpha values presented are based on this sample.)

Data Analysis
For the purposes of this report, analyses were limited to women who reported sexual activity within 3 months of the follow-up interview. Among the 442 sexually active women, there were no differences between the experimental and control groups in age, ethnicity, marital status, number of children, employment status, and education. Eighty-four percent of women completed the 3-month follow-up interview.

Intervention and control groups were compared at baseline and at 3-month follow-up for use of the female condom with a partner or for practice, attitudes about the female condom, skills in its use as demonstrated on a pelvic model, and future intention to use the female condom.

Female condom use at baseline was determined by an affirmative response to any of several questions regarding whether or not the respondent had ever tried the female condom or had used it within the past 3 months, for contraception, disease prevention, or practice. Female condom use at follow-up was defined as use within the past 3 months for pregnancy or STD prevention. Attitudes toward female condoms were measured by a 6-item scale (comfort, ease of insertion, ease of removal, sensation, effects on movement of penis, and tendency to stay in place) ( = .95). In the analysis, female condom attitudes were summarized in an index derived from the total number of "good" and "very good" responses across the 6 items. This method was selected instead of scaling the responses because there were sizable numbers of cases in which the participant responded "don’t know" to many of the items. Thus, we were able to retain almost all cases in the analysis. The 1 or 2 cases with missing responses to any of the items were excluded from these summary variables. Demonstration of skills in inserting the female condom was measured with a summary index counting the number of skills correctly performed out of a total of 6 ( = .97). Tests of group differences were based on the ² statistic for categorical variables and the t test and analysis of variance for continuous variables. In several instances, when the expected cell size was too small to permit reliable ² estimation, the Fisher exact test was used. Logistic regression was employed to examine predictors of female condom use at follow-up.

	RESULTS

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A total of 604 women completed baseline interviews and were randomly assigned to either the intervention or the control arm of the study between May 1995 and August 1997; 526 of them (87%) completed a 3-month follow-up questionnaire. On the basis of demographic characteristics or variables of interest for this analysis, there were no significant differences between women who completed 3-month follow-up questionnaires and those who did not, except that completers perceived a greater risk of getting an STD at baseline (P = .01). Table 1 describes the demographic characteristics of the 442 sexually active women who completed a 3-month follow-up visit. The mean age for the sample was 28.5 years; however, this differed by site owing to the younger age criteria in New York. Overall, African Americans comprised 58.2% of the sample, Latinas 18.0%, and Whites 16.4%. Racial distribution also differed widely by site. Almost all the Baltimore participants were African American, whereas almost half the participants in Seattle were White. Only 2.7% of women across the sites were currently married, most (73.3%) had never been married, and fewer than half had dependent children. Overall, 77.8% of women were currently unemployed; however, in Seattle, the rate was lower (60.7%). Fewer women in New York had completed high school (37%) than in Baltimore (56.1%) and Seattle (80.5%). There were no significant demographic differences at baseline between women in the intervention and control groups.

We conducted a logistic regression analysis to examine predictors of female condom use at follow-up, controlling for baseline differences (Table 4). Variables indicating a significant (P .10) difference between users and nonusers at follow-up were selected for inclusion in a logistic regression model. Corresponding variables that were significant at baseline also were added to the model to control for preintervention differences. As there were no demographic differences between users and nonusers, these variables were not included in the analysis. Results indicate that, when other factors were controlled for, women in the intervention group were much more likely to use the female condom at follow-up than were women in the control group (adjusted odds ratio = 5.51). When intervention cohort was controlled for, female condom use was strongly related to intent to use at follow-up. The odds of use were more than 4 times higher among those who said that they were likely to use the female condom in the future than among those who said that they were not likely to do so or were not sure. The odds of use among women who had asked a sexual partner (main or other) to use a male condom in the 30 days before the follow-up interview were more than 2 times higher than among those who had not. Women reporting greater confidence at follow-up in asking their main or other partner to use a male condom were also more likely to use a female condom. Sexually active women without a main sexual partner were less likely to use the female condom than those with a main sexual partner or those with both main and other partners. Female condom attitudes and skills were no longer associated with use after intervention cohort was controlled for. The only baseline characteristic predicting subsequent female condom use was positive female condom attitudes.

	DISCUSSION

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Female condom users were significantly more likely at baseline to have asked a partner (main and other) to use a male condom in the past 30 days. This finding is consistent with other studies that have shown that use of the female condom with a male partner requires negotiation.¹¹ Thus, the female condom is not strictly "female controlled," although it may give women more control than the male condom. The female condom may not be an option for women who lack the ability to negotiate with their male partners. Several studies have shown that women more frequently use male condoms with nonmain sexual partners than with main sexual partners.²⁵ In contrast, the present study shows that women with nonmain sexual partners only were less likely to have used the female condom. It may be that, unlike the male condom, the female condom is not well known to the general public and thus requires some discussion with a partner. Women may feel more comfortable in doing so with a main sexual partner.

Rates of acceptability in this and other US studies are lower than in most studies in the developing world. This fact may be related to greater motivation for women in developing countries to try barrier methods due to the higher rates of HIV in those countries, lack of other available options, cultural differences, or differences in educational approaches.

This study has implications for the design of educational interventions to introduce women to the female condom. Clinicians counseling women in its use need to provide information in culturally appropriate ways, demonstrate its correct use with their clients, and provide an opportunity for their clients to practice skills themselves, either with a pelvic model or through self-demonstration. Provider attitudes toward the product may also be an important factor in women's decisions to use the product.

	Footnotes

 
N. Van Devanter planned the study, analyzed the data, and wrote the report. V. Gonzales and J. Greenberg planned the study and contributed to the writing. C. Merzel analyzed the data and contributed to the writing. N. S. Parikh analyzed the data and contributed to the writing of the paper. D. Celantano contributed to the writing.

Peer Reviewed

Accepted for publication December 6, 2000.

	References

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