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. Author manuscript; available in PMC: 2011 Sep 1.
Published in final edited form as: AIDS Educ Prev. 2011 Aug;23(4):329–340. doi: 10.1521/aeap.2011.23.4.329

Female Condom Skill and Attitude: Results from a NIDA Clinical Trials Network Gender-specific HIV Risk Reduction Study

Aimee N C Campbell 1, Susan Tross 2, Mei-Chen Hu 3, Martina Pavlicova 4, Jennifer Kenney 5, Edward V Nunes 1
PMCID: PMC3162343  NIHMSID: NIHMS302981  PMID: 21861607

Abstract

The female condom is effective in reducing unprotected sexual acts; however it remains underutilized in the U.S. This study examined whether a 5-session HIV prevention intervention (Safer Sex Skills Building (SSB)), including presentation, discussion, and practice with female condoms, improved female condom skills and attitude among women in outpatient substance abuse treatment. Mixed-effects modeling was used to test the effect of SSB on skills and attitude over 3- and 6-month post treatment among 515 randomized women. SSB was significantly associated with increases in skills and attitude, and the female condom demonstration session was primarily responsible for skills improvement. Attitude was a partial mediator of the intervention effect in reducing unprotected sex. Findings emphasize the utility of integrating female condom messages targeting proximal behavioral outcomes into HIV prevention. The study supports the use of female condom skill instruction via brief, hands-on exercises, as well as further research to enhance attitudinal change to reduce sexual risk.

Keywords: Female Condom, Substance Abuse, HIV Prevention, Behavioral Intervention

Introduction

The female condom (FC1) is the only female-initiated barrier contraceptive with protection against HIV, other sexually transmitted infections (STIs), and pregnancy. Given the current lack of a HIV vaccine, a female controlled method of protection is one of the most promising ways to address heterosexual transmission of HIV – the leading cause of HIV transmission among women (Center for Disease Control and Prevention [CDC], 2008).

Over the past decade, studies have demonstrated a number of predictors of increased female condom use among women: 1) use of the male condom (Cabral et al., 2003; Surrat et al., 1998; El-Bassel, Krishnan, Schilling, Witte, & Gilbert, 1998); 2) women reporting greater control over whether male condoms are used (Cabral et al., 2003); 3) previous experience using an internal contraceptive method (e.g., diaphragm) (Surrat et al., 1998; El-Bassel et al., 1998; Hoffman, Exner, Leu, Ehrhardt, & Stein, 2003); 4) a positive initial experience with the female condom (Surrat et al., 1998; El-Bassel et al., 1998); and 5) use with a main or steady partner (Hirky et al., 2003; El-Bassel et al., 1998). A recent systematic review found that the female condom is effective in increasing protected sexual acts, most commonly by increasing both male and female condom use, and primarily through interventions promoting the male and female condom as dual methods of protection (Vijayakumar, Mabude, Smit, Beksinska, & Lurie, 2006).

Despite the promise of the female condom, it has limited use in the United States. Several reasons have been posited for low use rates including prohibitive cost and limited accessibility (Surrat et al., 1998; El-Bassel et al., 1998), gendered power differentials in heterosexual relationships that may impede female-initiated methods for contraception and disease prevention (Cabral et al., 2003; Mantell et al., 2006), acceptability of the design and an initial learning curve for proper use (Hirky et al., 2003), and resistance to overt criticism about the dangers of heterosexual sex (Kaler, 2004). The FC1 was initially approved by the U.S. Food and Drug Administration (FDA) in 1993, with the second generation (FC2) approved by the FDA in March 2009 (U.S. FDA, 2009). The new FC2 is cheaper (approximately 30% less than the FC1) due to changes in materials and manufacturing processes and may be more appealing (e.g., quieter during sexual intercourse) (Female Health Company, 2009). Thus, it is an opportune time to promote interest in, research on and use of the female condom in the U.S. and to explore ways to enhance female condom use.

Health behavior theories (e.g., Social Cognitive Theory, Bandura, 1986, 1994; Theory of Reasoned Action, Ajzen & Fishbein, 1977; Information-Motivation-Behavioral Skills, Fisher & Fisher, 1992) assert that proximal outcomes, such as changes in attitudes and enhanced skill, precede improvements in distal behavioral outcomes, such as female condom use (Longabaugh et al., 2005). Often proximal outcomes are the ingredients that comprise HIV risk reduction behavioral interventions. Female condom skills and attitude have received little primary attention (e.g., Vijayakumar et al., 2006), yet they likely have an important impact on distal behavioral outcomes, such as condom use. Several studies have demonstrated that relatively brief interventions (4–6 sessions) can increase female condom skills (Van Devanter et al., 2002) and positive attitude toward the female condom (Choi et al., 2008; Van Devanter et al., 2002) among high risk women and women attending family planning clinics. Van Devanter et al. also reported that women who used the female condom had significantly higher female condom skills and attitude compared to non-users, although neither skills nor attitude were significant predictors of use after controlling for intervention. Further understanding of the components of behavioral interventions that directly target skills and attitude and which in turn may impact prevention behavior is required.

Some have argued that the female condom may be more acceptable and better utilized among drug-involved women. Gollub (2008) discusses specific challenges faced by this population of women related to HIV/STI prevention, including partner violence, social and economic dependence on partners, and an increased potential for non-consensual or coercive sex. Woman-initiated barrier methods may be most useful in situations marked by a lack of power and social standing, and stigma. Prior research has demonstrated that interventions which include female condom use promotion can significantly increase the use of condoms among women who receive the intervention, both in populations of incarcerated women (Harrison, Bachman, Freeman, & Inciardi, 2001), low-income disadvantaged women (Harrison et al., 2001), women at high risk for HIV transmission (Harrison et al., 2001; Van Devanter et al., 2002), and drug-involved couples (Witte et al., 2006).

The purpose of this paper is to examine the results of a 5-session HIV prevention intervention, including presentation, discussion, and practice with female condoms, for increasing female condom skill and positive attitude. As one of the largest studies of HIV risk reduction with women in substance abuse treatment, this study offers a unique opportunity to study female condom behaviors. Further, the analysis looks at whether the acquisition of female condom skill and positive attitudes is associated with decreases in risky sexual acts over time, a practical question directly linked to reduction in heterosexual HIV transmission among this traditionally high-risk sample of women.

Methods

Study Procedures

Data for this study were drawn from a national, multi-site, randomized clinical trial conducted in the National Institute on Drug Abuse Clinical Trials Network to test the effectiveness of Safer Sex Skills Building (SSB) (El-Bassel & Schilling, 1992), a 5-session group intervention, compared to a 1-session standard HIV education intervention (HE) comparison condition. Data were collected from May 2004 through June 2006. Participants were 515 women recruited from 7 methadone maintenance and 5 outpatient psychosocial drug treatment programs who met eligibility criteria for being at heightened risk for HIV/STI heterosexual transmission defined as at least one unprotected vaginal or anal sex occasion with a male partner in the prior 6 months. Evidence strongly suggests that women with substance use disorders are at heightened risk for HIV and other STIs (Logan, Cole & Leukefeld, 2002), therefore eligibility criteria were kept purposefully broad in an effort to maximize representativeness of the sample. Participants were randomized to either the SSB or HE intervention within individual sites in cohorts of 3–8 women. Both interventions were co-facilitated by two female counselors.

The SSB intervention is characterized by 3 defining features of effective HIV sexual prevention programs for women, as identified in a comprehensive literature review (Exner, Seal and Ehrhardt, 1997). These are: (1) gender specificity; (2) use of (cognitive, behavioral and affective) skills building; and (3) sufficient intensity (i.e., ≥ 4 sessions). SSB groups consist of skills building on HIV risk assessment, safer sex obstacle problem solving, condom use skill building, negotiation skill building, and assertiveness training. Session 3 of the SSB intervention includes an activity where participants are provided female condoms and instructions for use (including a video) and then practice using the condoms with a female pelvic model. Women are encouraged to practice using the female condom and provided 2 female condoms, lubricant, and an instruction booklet to take with them. The HE condition consists of a single 60-minute, group informational session of HIV/STI education designed to simulate standard HIV prevention offered within substance abuse treatment programs. Female condoms are shown to participants in the single session intervention, but participants do not practice with the condoms, there is no overt encouragement to use them, and condoms are not provided to participants to take away from the session.

Trained research assistants collected data at community treatment programs. They administered all measures in interview format, except for the sexual risk behavior items, which were collected privately via computer-assisted self-interview (ACASI) without contact with the research assistant.

Measures

Demographics

Age and education were collected at the baseline assessment. Education, collected as a continuous variable based on years of formal education, was recoded into three categories based on distribution: less than high school, high school or GED equivalent, and greater than a high school education. Age was dichotomized based on distribution (< 40 and greater than or equal to 40). The binary variable reflects the data and provides a clear interpretation of older versus younger age in the models.

Female Condom Skills

Skill level was determined through direct observation by centrally trained research assistants as the participant verbally and behaviorally demonstrated the steps of placing a female condom in the female pelvic model. A point was earned for each step successfully executed. Female condom skill consisted of 11 distinct steps of condom placement (e.g., checking expiration date, checking for condom damage, placing inner ring of condom against cervix). Scores ranged from 0–11. The internal consistency reliability for the female condom skill measure was adequate (Cronbach’s alpha = 0.72).

Female Condom Use

Female condom use is captured on the ACASI administered sexual risk behavior survey. Participants were asked about vaginal and anal sex occasions and whether a female condom was used during these occasions. The variable was dichotomously coded yes or no for female condom use during vaginal or anal sex in the past 3-month period.

Female Condom Attitude

This variable was derived from the Attitudes Towards Female Condom Use scale (Witte, El-Bassel, Wada, Gray, & Wallace, 1999; Witte et al., 2006), an 18-item measure using a 1–5 point Likert-type scale (strongly disagree to strongly agree) for each statement (7 items require reverse coding). Examples of statements include “The female condom gives me more options for protection” and “I am comfortable using a female condom with my partner”. The mean response is reported with higher scores indicating more positive attitudes. Internal consistency reliability of the measure was adequate (Cronbach’s alpha = 0.69).

Intervention Completion

SSB intervention completion was defined a priori as attending 3 or more of the 5 sessions. HE completion was defined as attending the single session offered.

Unprotected Sexual Occasions

This variable was captured using the ACASI administered sexual risk behavior survey. Participants were asked about the number of vaginal and anal sex occasions and on how many of those occasions male or female condoms were used in the prior 3 months. The number of protected occasions was subtracted from the total number of vaginal and anal sex occasions.

Data Analysis

The current analysis uses data from baseline, 3-, and 6-month follow-up assessments. Means and standard deviations were calculated and reported for continuous variables and percentages for the categorical variables. T-tests and chi-square statistics were performed to determine whether there were differences between the two intervention groups on any variable.

Mixed-effects modeling (MEM) was used to examine the effects of the two intervention conditions (SSB versus HE) on female condom skills and attitudes towards female condom use during follow-up for all randomized participants for whom outcome data were available. MEM was used to analyze the effects of intervention conditions on repeated outcome measures (missing outcomes were assumed to be missing at random) while estimating random effects due to site, cohort, and individual subjects (Brown & Prescott, 2006; Little & Rubin, 2002). The model included baseline covariates (age, education, female condom use, and female condom skills or attitude), as well as assessment time point, intervention condition, and intervention completion status. The possible interactions between assessment time point, intervention condition, and completion were tested and included in the final model if significant (p-value < 5%). Further analyses examined the effect on female condom skills and attitude of attending session 3 of the SSB intervention which focused on condom use skill practice among participants in this group.

MEM was also used to test whether female condom skills or female condom attitude were mediators of the intervention effect on reducing unprotected sexual occasions during follow-up. Unprotected sexual occasions was selected as the outcome variable as it is a commonly used epidemiological marker of HIV transmission. The first model tested the main effect of the intervention on unprotected sex, with two additional models testing each of the proposed mediators. Baseline covariates, as noted above, were included in all three models; a negative binomial model was utilized to account for the distribution of the outcome variable. PROC Glimmix in SAS 9.2 (SAS) was used to conduct all analyses.

Results

Sample Characteristics

Table 1 presents sample characteristics for the randomized sample (N = 515) and for each treatment condition subsample for variables included in the analytic models. Approximately half the sample was 40 years of age or older (45.8%). Most had completed high school (37.6%) or had some higher education (34.2%). The mean score for female condom skill at baseline was 5.3 out of a possible 11 points. The mean response (on a 5-point scale) for Attitudes Towards Female Condom Use was 3.1 (SD = 0.4). About three percent (2.9%) reported use of the female condom in the 3 months prior to baseline (this increased to 5.6% and 5.4% at 3- and 6-month follow up respectively). The mean number of unprotected sexual occasions at baseline was 19.3 (SD = 30.8). No significant differences were found between SSB and HE participants on these variables. SSB and HE samples differed in rates of intervention completion. Among the SSB sample, 43.5% were completers (i.e., attended 3 of 5 sessions) versus 62.3% of the HE sample (i.e., attended its single session). On average, SSB participants attended 2.1 of the possible 5 sessions; 49 (19.6%) attended all 5 sessions and 96 (38.4%) did not attend any sessions.

Table 1.

Demographic and Descriptive Characteristics (for Variables Included in Analytic Models) for the Total Sample and by Safer Sex Skills Building (SSB) or HIV Education (HE) Intervention Condition

Total Sample
N = 515		 SSB (5 sessions)
n = 250		 HE (1 session)
n = 265
% or Mean (SD) P
Age (≥ 40) 45.83 47.60 44.15 .43
Education .29
 < High School 28.21 26.40 29.92
 High School 37.55 36.00 39.02
 >High School 34.24 37.60 31.06
Female Condom Use (baseline) (yes) 2.91 2.40 3.40 .50
Female Condom Skills (baseline)a 5.25(2.30) 5.30(2.30) 5.21(2.43) .66
Attitude Towards Female Condom (baseline)b 3.07(0.40) 3.07(0.41) 3.07(0.39) .99
# of Unprotected Sexual Occasions (baseline) 19.30(30.77) 18.60(27.78) 19.96(33.39) .62
# of Intervention Sessions Attended 2.08(2.02) 0.62(0.49)
Intervention Completionc 53.11 43.47 62.26 <.001
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a

Female Condom Use Skill measure: range=0–11.

b

Attitudes Towards Female Condom Use scale: range=1–5.

c

Intervention completion was defined a priori as attending 3 or more SSB sessions or attending the single HE session.

The racial/ethnic composition of the sample was 57.9% White, 24.3% Black/African American, 8.9% Hispanic/Latina, 7.4% mixed race/ethnicity, and 1.6% other. About a third of the sample reported never being married (37.9%), 21.4% identified as married, and 40.7% were widowed, separated or divorced. Almost three quarters of the sample reported using at least one method to prevent pregnancy in the prior 3 months (72.0%). The most frequently cited methods of contraception were: tubal ligation (28.5%); the male condom (22.6%); withdrawal method (11.3%), and hysterectomy (10.1%). No significant differences were found between the two intervention arms on race/ethnicity, marital status, or use of at least one method to prevent pregnancy.

Intervention Effect on Female Condom Skills and Attitude

Table 2 shows the results of the separate models testing the intervention effect and intervention completion effect on female condom skills and attitude over time. The SSB group had a trend towards higher number of female condom skills compared to the HE group over time (F = 2.85, p = .09), and those that completed either intervention had higher scores (F = 13.10, p < .001). There were no significant interactions between time, intervention, and completion status. The association between the intervention and female condom attitude was tested showing a significant interaction effect of treatment condition by time. That is, for participants in the SSB condition, female condom attitude was significantly higher at 6-month post-treatment follow-up compared to the single session HE condition (t = 2.05, p = .04). There was no difference at 3-month follow up and no association between intervention completion and attitude.

Table 2.

Intervention effect (Safer Sex Skills Building vs. HIV Education) on Female Condom Skills and Female Condom Attitude Over Time

Skills
n = 355		 Attitude
n = 383
F p F p
Age (≥ 40) 2.74 .10 0.14 .71
Education 3.55 .03 1.84 .16
Female Condom Use (baseline) 0.16 .69 1.73 .19
Female Condom Skills (baseline) 60.55 < .001
Female Condom Attitude (baseline) 79.16 < .001
Time 0.72 .40 0.26 .61
Intervention 2.85 .09 0.85 .36
Intervention Completion 13.10 < .001 0.75 .39
Time (6 month follow-up) × Intervention (SSB) 5.78 .02
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Effect of Session 3 Attendance on Female Condom Skills and Attitude

Table 3 displays the effect of attending session 3 of the SSB intervention on female condom skills and attitude over time for participants in the SSB group. Model results indicate that attending session 3 significantly increased female condom skills over time (F = 8.36, p = .005). At 6-month follow-up, women who completed session 3 had observed female condom skill means of 7.44 compared to an observed mean of 6.18 for those who did not attend session 3. Completion status was not a predictor of female condom skills. Thus it can be inferred that attendance at session 3, rather than attending 3 or more of the 5 session intervention (definition of completion), was responsible for increased skill. In the second model, neither session 3 attendance nor SSB completion was associated with female condom attitude.

Table 3.

Effect of Session 3 Attendance among Participants in Safer Sex Skills Building on Female Condom Skills and Female Condom Attitude Over Time

Skills
n = 167		 Attitude
n = 176
F p F p
Age (≥ 40) 5.19 .02 1.30 .26
Education 1.67 .19 2.91 .06
Female Condom Use (baseline) 0 .97 0.60 .44
Female Condom Skills (baseline) 19.12 < .001
Female Condom Attitude (baseline) 32.41 < .001
Time 0.58 .45 1.30 .26
Session 3 8.36 .005 0 .98
Intervention Completion 0.03 .87 0.80 .37
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Skills and Attitude as Potential Mediators

Two additional models were tested to determine if either female condom skills or attitude mediated the effect of the intervention on unprotected sexual occasions at follow-up. First, in the model testing the effect of the intervention on unprotected sex, there was an interaction between intervention and time whereby at 6-month follow-up unprotected sex was significantly higher among the HE group than the SSB group (t = 2.53, p = .01). Unprotected sex did not differ by intervention group at 3-month follow-up. A second model, including female condom skills at follow-up, displayed similar results with the SSB group demonstrating fewer unprotected sexual occasions compared to the HE group (t = 2.93, p = .004). Female condom skills were not a significant predictor of number of unprotected sexual occasions. A final model, shown in Table 4, including female condom attitude also showed similar results of the intervention effect with an interaction between intervention and time (unprotected sex was significantly higher among HE group than SSB group at 6-month follow-up, t = 1.94, p = .05). However, more positive female condom attitude was also associated with fewer unprotected sexual occasions (t = −2.97, p = .003). Thus, attitude towards the female condom appears to partially mediate the association between the intervention and unprotected sex occasions (for the model without attitude included, b = 0.53, SE = 0.21, t = 2.53 for the intervention; for the model with attitude included, b = 0.40, SE = 0.21, t = 1.94 for the intervention).

Discussion

Female condoms are promoted as an additional tool in the HIV prevention toolbox for women (Mantell et al., 2006). Although female condoms are underutilized, they are the only female controlled barrier method available combining HIV/STI and pregnancy protection. Numerous barriers challenge the general uptake of the female condom, including limited accessibility, higher cost compared to the male condom, and lack of knowledge among service providers. Female condoms also may be less utilized due to traditional social norms regarding women’s sexual agency. Thus, the current study sought to examine whether a gender-specific HIV prevention intervention, which included hands-on practice with and distribution of the female condom, might be associated with increased proximal behavioral outcomes which could, in turn, influence risk reduction behaviors.

Attendance at session 3 of the 5-session SSB intervention, which included female condom demonstrations, skills practice, and encouragement to try the female condom, was a significant predictor of increased female condom skills. The SSB group intervention overall was superior to the single session HE group for increasing female condom skills, but only at a trend level. Thus, it appears that a brief, hands-on exercise in a group setting can increase women’s skill level with female condoms. Analyses did not detect a mediation effect of female condom skill on protected sexual occasions. Although the intervention increased the number of demonstrable individual skills, this was not a direct route to condom use.

Other, more intensive interventions to increase skill may produce stronger results. For example, a study, by Artz et al. (2005), used a nurse clinician to aid women through the first few insertions of the female condom. After the first insertion, 25% of the women did not use the female condom correctly and 3% of women were never able to accurately insert the female condom after three attempts. A highly intensive skills session, however, may be unrealistic in most settings, especially within community-based substance abuse treatment where HIV prevention is typically offered in a single 60–90 minute session (Shoptaw, Tross, Stephens, Tai, & the NIDA AIDS Workgroup, 2002). Thus, research targeting improvements and tailoring of interventions that can be implemented in “real-world” settings and can improve skills are warranted.

The SSB intervention was associated with increases in positive female condom attitude, but there was no indication that this was associated with attending more sessions (completion status) or attendance at the condom skills session (session 3). In our intervention, and even more true for other interventions, relatively limited time was spent on the topic of female condoms and this time was most explicitly devoted to female condom skills. Rich coverage was allotted for enhancing attitudes towards safer sex, with less coverage on attitudes towards female condom use specifically. These results argue for more time being spent on attitude change and preparation, in addition to promoting skills. Shifts in attitude may also be more likely with social or structural level change in female condom use and perception. For example, increasing visibility and accessibility of female condoms in locations where male condoms are typically distributed may help to improve overall attitude. Further, attitude may be shaped more readily by observing broader positive peer reaction and norms around acceptability and use of the female condom.

Findings also support the role of female condom attitude as a mediator of the intervention effect on unprotected sexual occasions; participant attitude about the female condom method translated into actual behavioral outcomes. Traditional theoretical models used in HIV prevention, often social cognitive in orientation, support this finding (e.g., Information-Motivation-Behavioral Skills; Theory of Reasoned Action). Although skills are essential ingredients, behavior change might be more directly associated with attitudinal shifts that allow skills to be enacted. Further, it may be helpful to provide more tailored interventions; that is, assessing women’s safer sex needs prior to treatment may provide information about which intervention components would be most useful. Using brief, but targeted HIV prevention interventions, especially in the context of addiction treatment settings that typically struggle with limited time and resources, is worthy of additional research. Computerized or self-paced instruction that can be accomplished without additional staff time should also be explored.

Study Limitations

Several limitations of the current study should be noted. First, the female condom skill scale was developed and used for the first time in this study. Although the internal consistency coefficient was adequate for the female condom it was not robust. Other psychometric properties are unknown. Second, the 11 steps for proper use of the female condom do not have equal risk attributes but are weighted equally in scoring. For example, disposing of the female condom after use is less related to transmission risk than ensuring the penis is inserted into the condom properly, yet both are valued the same. Further research should differentiate between skills most closely related to transmission routes, as well as re-test the scale used in the current study to determine reliability and validity for other samples.

The current analysis did not control for male condom use or male condom use skill. Though male and female condom use is highly correlated, the purpose of this paper was to the isolate the impact of female condom skills, attitudes, and use. Further, the correlation between the male and female condom skills and use make it statistically challenging to differentiate results. Prior studies have reported associations between male condom skill and female condom skill, typically in the direction of male condom use predicting female condom use (Cabral et al., 2003; Surrat et al., 1998; El-Bassel et al., 1998). This suggests that practice and familiarity with both types of condoms may enhance skill generally. Although the female condom may be a promising method for women who might be unable to effectively introduce and use the male condom, women who are using the male condom may be more likely to try and become skillful with the female condom. This is a rich area for future examination to determine whether the female condom is being used by the most vulnerable and at-risk group of women or whether it is primarily an additional tool for women who may already practice other barrier methods.

Finally, the study did not examine the role of gendered relationship power or male partner characteristics. Although this analysis was beyond the scope of the paper, evidence suggests that relationship characteristics and heterosexual power differentials impede the introduction and use of barrier methods of contraception and disease prevention (Amaro, 1995; Cabral et al., 2003; Pulerwitz, Amaro, DeJong, Gortmaker, & Rudd, 2002). Further, feminine passivity within heterosexual relationships or adherence to institutionally sanctioned gender roles and sexual scripts makes introduction of the use of contraception appear outside the norm of ideal romantic relationships (Gavey & McPhillips, 1999; Mantell et al., 2006). This may be especially true in longer term, intimate relationships that are perceived as grounded in trust and love. Steady relationships, where monogamy is assumed, can also lower risk perception, reducing the likelihood of using a barrier method for disease prevention. As the HIV pandemic becomes increasingly feminized, traditional social and gendered norms have widespread consequences.

Future Directions

The 5-session Safer Sex Skills Building intervention was successful in increasing skills and attitude towards the female condom, in line with prior research (Choi et al., 2008; Van Devanter et al., 2002). More information is required on the impact of varying female condom skill levels on condom use behavior. In addition, alternative methods to enhance female condom skill, including directed problem-solving after initial use and male partner involvement (Hoffman et al., 2003), are warranted. Adhering to theories of rational behavioral change, attitude was found to be associated with increases in protected sexual occasions. Attitude may be a more direct route to condom use and future studies should examine attitudinal shifts more closely, including the potential of targeted intervention sessions and structural level interventions.

Changes in skill and attitude are not likely to be effective in increasing female condom use without shifts in external or structural factors, as demonstrated by the markedly low baseline and follow-up rates of use. This may be especially true in suburban or rural locations (which comprised half the sites in this study) with less access to female condoms and fewer marketing campaigns. In order to promote female condoms and increase female condom use, there needs to be normative change among peers (e.g., at the treatment program), male partners, and service providers. An immediate next step should be to provide clinicians and other treatment staff with training to increase familiarity with and comfort in talking about the female condom. Female condoms need to be visible and available in treatment programs (and in other places women frequent) and discussion about female condoms should be integrated into group and individual counseling. Although individual skills and attitude are extremely important, it will not circumvent the external barriers that need to change as well.

Table 4.

Effects on Unprotected Sexual Occasions of Intervention Condition (Safer Sex Skills Building vs. HIV Education) and Female Condom Attitude over 3- and 6-month Post-treatment Follow-up (n = 375)

F p
Age (≥ 40) 7.56 .006
Education 0.05 .96
Female Condom Use (baseline) 0.05 .82
Female Condom Attitude (baseline) 0.11 .74
(log)Unprotected Sexual Occasions (baseline) 76.11 < .001
Female Condom Attitude (3- & 6-month follow-up) 8.81 .003
Time 0.01 .94
Intervention 1.12 .29
Intervention Completion 2.40 .12
Time (6-month follow-up) × Intervention (SSB) 6.04 .01
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Acknowledgments

The following grant supports are acknowledged: National Institute on Drug Abuse Clinical Trials Network U10 DA13035 (Edward Nunes) and National Institute on Drug Abuse K24 DA022412 (Edward Nunes). The trial is registered with ClinicalTrials.gov, a Service of the US National Institutes of Health, Number NCT00084188 (http://www.clinicaltrials.gov/).

We thank the clinical staff, research staff and participants at each of the 12 participating community treatment programs. The Safer Sex Skills Building (SSB) intervention manual is available on the National Drug Abuse Treatment Clinical Trials Network Dissemination Library (http://ctndisseminationlibrary.org/display/398.htm).

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