An intervention to promote the female condom to sexually transmitted disease clinic patients.

This article describes a 1-hour behavioral intervention designed to promote female condoms and safer sex to women at a high risk for sexually transmitted diseases (STDs). The intervention includes a promotional videotape; a skills-oriented counseling session with a nurse clinician; assorted take-home items, including a videotape for men; and free supplies of female and male condoms. Designed for women ages 18 to 34 attending public STD clinics, the intervention is developed using a systematic process of formative evaluation influenced by principles of social marketing and drawing on the social cognitive theory. The effect of the intervention on female and male condom use is evaluated using a pretest-posttest design with 1,159 women. Most elements of the intervention could be replicated in settings other than STD clinics and delivered by persons other than nurse clinicians.

Use of psychometric techniques in the analysis of epidemiologic data.

PURPOSE: This article demonstrates techniques for developing reliable multi-item scales for analysis of complex public health data. METHODS: Information from a questionnaire designed to evaluate the acceptability and efficacy of the female condom as a method for STD/HIV prevention was summarized using psychometric analysis. 1159 high-risk women attending STD clinics participated in this study. Questionnaire items were designed to measure nine domains of predictors of condom use. RESULTS: Principal components analysis was employed to reduce the number of potential predictors. Reliability of the multiple-item scales was assessed using Cronbach's alpha. Pearson's correlation coefficients were calculated to evaluate collinearity among multi-item scales. Approximately half (51%) of the questionnaire items that were analyzed were retained in the final scales. Data reduction procedures identified several multi-item scales with acceptable reliability (Cronbach's alpha >0.70). The correlation coefficients between scales was never >.5, suggesting that there was little collinearity among the scales. CONCLUSIONS: When focused on multiple partially interdependent determinants of an outcome, data reduction decreases the number of independent variables to be evaluated, ensures they have adequate reliability, maximizes strength of their association with outcomes, and reduces collinearity among predictors.

Predictors of difficulty inserting the female condom.

This article describes the frequency of initial difficulty inserting the female condom and identifies predictors of insertion difficulty among women at risk of sexually transmitted diseases (STDs). Female STD clinic patients (n = 1144) were taught how to insert the female condom by using an anatomic model, then given an opportunity for self-insertion practice. Correct placement of the condom was verified by a nurse clinician, and the number of attempts required for correct insertion was recorded. Sociodemographic and psychosocial predictors of refusing the insertion practice and of difficulty inserting the female condom were evaluated using logistic regression. Only 5% of study participants refused the self-insertion practice. Women who never had a Papanicolaou smear test, did not use tampons, never used an inserted method of STD prevention/birth control, and disliked the insertion features of intravaginal barrier methods were more likely to refuse the self-insertion practice. Of those who attempted self-insertion, 25% were unable to insert the female condom correctly on the first attempt. Women who never expressed their sexual likes and were indifferent to the positive features of intravaginal contraceptive methods were more likely to experience difficulty their first insertion attempt. Other variables associated with insertion difficulty included longer fingernails. Insertion refusal and difficulty affect use of the female condom for a sizable proportion of women. Women in this study who refused the self-insertion practice had greater aversion to inserting intravaginal barrier methods. Women who had initial difficulty inserting the female condom had a different profile from those who refused and can benefit from intensive skills training that includes supervised self-insertion practice.

Do participant characteristics influence the effectiveness of behavioral interventions? Promoting condom use to women.

OBJECTIVES: This study assessed whether participant baseline characteristics modified the effects of a skill-based intervention promoting condom use. STUDY: The randomized, controlled trial enrolled 427 women from a sexually transmitted disease clinic in Birmingham, Alabama. The main outcome measures: consistent (100%) and problem-free (correct, no breakage or slippage) condom use were verified by sexual diary self-report and contraceptive product counts. RESULTS: The enhanced intervention group had a 60% higher consistent condom use rate compared to the basic group (risk ratio [RR], 1.6; 95% confidence interval [CI], 1.4-1.8). There was no statistically significant difference between groups in relationship to problem-free, consistent use (RR, 1.0; 95% CI, 0.9-1.1). A binomial regression analysis identified the following factors as significant modifiers of intervention effectiveness on consistent condom use: intention to use condoms next time, early-age sexual debut, marital status combined with place of intercourse, and substance use before sex. CONCLUSIONS: The results suggest that participant baseline characteristics can be modifiers of intervention effectiveness.

Female condom and male condom failure among women at high risk of sexually transmitted diseases.

OBJECTIVE: The objective of this study was to study the frequency and determinants of breakage and slippage during female and male condom use. GOAL: The goal of this study was to determine condom breakage and slippage rate. STUDY: We conducted a 6-month prospective follow-up study of women attending 2 sexually transmitted disease clinics. Breakage and slippage rates were computed. Logistic regression was used to evaluate baseline characteristics and time-dependent behaviors. RESULTS: A total of 869 women used condoms in 20,148 acts of intercourse. Breakage was less common for female condoms (0.1%; 95% confidence interval [CI], 0.05-0.21) than for male condoms (3.1%; 95% CI, 2.80-3.42). Slippage was more common for female condoms (5.6%; 95% CI, 5.10-6.13) than for male condoms (1.1%; 95% CI, 0.90-1.28). Rates significantly decreased with use and increased with number of previous failures. From first use to >15 uses, combined failure rate fell from 20% to 1.2% for female condoms (P < 0.0001) and 9% to 2.3% for male condoms (P < 0.01). CONCLUSIONS: Both condoms may provide good protection against sexually transmitted diseases. Experience determines success with either condom.

A randomized trial of clinician-delivered interventions promoting barrier contraception for sexually transmitted disease prevention.

OBJECTIVE: The objective of this study was to compare 2 interventions promoting condoms and vaginal microbicides to prevent sexually transmitted disease (STD). STUDY: Women (N = 427) attending an STD clinic were randomly assigned to 2 clinician-delivered interventions and followed up monthly to assess condom/microbicide use and incidence of gonorrhea, chlamydia, and syphilis. RESULTS: During follow up, condom use rates were 69% (enhanced) and 49% (basic) and microbicide use rates were 44% and 29%, respectively. STD rates did not significantly differ between intervention groups. Perfect condom use (regardless of intervention arm) was associated with a 3-fold decrease in STD rates (relative risk [RR], 0.3; 95% confidence interval [CI], 0.1-0.8). Using a vaginal microbicide during > or =50% of the acts of intercourse was associated with reduced STD rates (RR, 0.5; 95% CI, 0.3-1.0) across intervention groups and condom use categories. CONCLUSIONS: The enhanced intervention increased use of condoms and vaginal microbicide; however, STD rates did not decrease because a protective effect was seen only among perfect barrier users, and the enhanced intervention only modestly increased perfect use.

Application of the case-crossover design to reduce unmeasured confounding in studies of condom effectiveness.

This analysis examined how unmeasured confounding affects estimates of the effectiveness of condoms in preventing sexually transmitted infections. Data were analyzed from a prospective cohort study of 1,122 female sexually transmitted disease clinic patients in Alabama (1992-1995), wherein participants were evaluated for sexually transmitted infections at six 1-month intervals. Associations between condom use and incident gonorrhea and chlamydia infection were compared between case-crossover and cohort analyses. In a case-crossover analysis of 228 follow-up visits ending in gonorrhea/chlamydia ("case intervals") and 743 self-matched follow-up visits not ending in gonorrhea/chlamydia ("noncase intervals") (183 women), consistent condom use without breakage or slippage was associated with significantly reduced risk of infection relative to nonuse (adjusted risk odds ratio = 0.49, 95% confidence interval: 0.26, 0.92). Conversely, a cohort analysis of 245 case intervals and 3,896 noncase intervals (919 women) revealed no significant reduction in infection risk from consistent use of condoms (adjusted risk odds ratio = 0.79, 95% confidence interval: 0.53, 1.17). Dose-response relations between the number of unprotected sex acts and infection were stronger in the case-crossover analysis (p for trend = 0.009) than in the cohort analysis (p for trend = 0.18). These findings suggest that epidemiologic studies confounded by unmeasured differences between condom users and nonusers underestimate condom effectiveness against these infections. The case-crossover method provides an additional technique for reducing unmeasured confounding in studies of condom effectiveness.

Partner characteristics, intensity of the intercourse, and semen exposure during use of the female condom.

The objective of this study was to assess how characteristics of the intercourse and the couple relate to semen exposure during use of the female condom. From 1996 to 1998, 210 women in Birmingham, Alabama, were trained to use the female condom and follow study procedures during a group session and individually practiced inserting the device. The outcome was semen exposure as defined by comparing pre- and postcoital prostate-specific antigen levels in vaginal fluid. Women who had high income levels had lower rates of semen exposure (odds ratio (OR) = 0.3, 95% confidence interval (CI): 0.2, 0.7), while those in a relationship of less than 2 years were at greater risk (OR = 2.4, 95% CI: 1.3, 4.1). Couples with a large disparity in vaginal fundus size and penis size were at increased risk of semen exposure (OR = 2.7, 95% CI: 1.2, 6.0). Engaging in very active intercourse also increased the risk (OR = 1.7, 95% CI: 1.1, 2.6). Thus, the protective effect of the female condom appears to be a function of user- and intercourse-specific characteristics. Future studies of male condom efficacy should focus on collecting detailed data about the users and characteristics of intercourse to predict failure accurately.

Do main partner conflict, power dynamics, and control over use of male condoms predict subsequent use of the female condom?

This study assessed hypotheses that measures of power and control over male condom (MC) use would predict use of the female condom (FC) among women with main partners from two public STD clinics (n = 616). The women (mean age 24 years, 87% African American) were enrolled in an intervention study to promote barrier contraceptive use and were interviewed at baseline and at 6 monthly follow-up visits. Seven baseline predictor variables were assessed: her having requested MC use, his having objected, her having wanted a MC used but not asking, percentage of MC use, perceived control over MC use, anticipated consequences of refusing unprotected sex, and physical violence. In the first Poisson regression analysis, none of the hypothesized predictors was significantly associated with FC use during follow up. In the second regression analysis, which assessed the influence of the hypothesized set of predictors on follow-up FC use in situations when MCs were not used, we found two effects. Either no or inconsistent MC use before study entry was associated with less subsequent FC use; women who reported, at study entry, having more control over MC use were more likely to use FCs during follow up. We found no evidence of adoption of the FC by women in relationships marked by history of conflict over the MC, circumstances in which alternatives are most needed. On the contrary, we found that women with a history of control and consistent use of MCs were the most likely users of FCs when MCs were not used.

Presenting the female condom to men: a dyadic analysis of effect of the woman's approach.

Although male partner resistance to female condom use has been reported, little is understood about circumstances under which partners will agree to female condom use. This study documents the experiences of couples who have worked together to achieve female condom use. As part of a prospective female condom efficacy study, female participants (age 18-34) received a behavioral intervention and an assortment of take-home items. Selected women and their partners were recruited for a qualitative interview focusing on their experience with the female condom. Interviews were transcribed, double-coded, and verified using a standard retrieval coding system. Twenty-six pairs of linked interviews were analyzed dyadically: 9 couples who used the female condom "consistently," 12 "experimenters," and 5 "non-users." Women who successfully promoted the female condom to their partners used multiple presentation strategies. Initial male partner reaction did not predict continued use beyond the first trial. In conclusion, employment of multiple strategies facilitates successful introduction of the female condom into a sexual partnership.