Shlay, Judith C. MD, MSPH*†‡; McClung, Melissa W. MSPH*; Patnaik, Jennifer L. MHS‖; Douglas, John M. Jr. MD*§
SEXUALLY TRANSMITTED DISEASES (STDs) are an important and preventable cause of morbidity and mortality. Reliable ways to avoid transmission of STD include abstaining from sexual intercourse or being in a long-term, mutually monogamous relationship with an uninfected partner. For those choosing to be sexually active in partnerships in which sexual exposure is possible, condoms have long been considered to be one of the most effective practical means of reducing the risk of infection.1–3 However, a recent review of the scientific evidence on the effectiveness of condoms in preventing STDs concluded that there was insufficient evidence on the effectiveness of condoms for a variety of STDs.4 An important feature of this report was its emphasis on the significance of methodologic issues in interpreting studies on condom effectiveness, including the importance of infection status of partners as well as consistency and correctness of use.
In a recent 12-year retrospective study of the benefit of condoms in preventing a variety of STDs in men and women, we found that although there was limited evidence of protection among those reporting condom use compared with nonusers, persons choosing to use condoms reported more sexual risk,5 supporting the observation that condom use is a marker for sexual partnerships with greater risks of STD transmission.6 Furthermore, our study found that among condom users, after adjusting for sexual risk, consistent users had lower rates of gonorrhea, chlamydia, trichomonas (women), and genital herpes (men) than inconsistent users. Although the size of this study allowed us to assess the impact of consistently reported use on a variety of specific STDs in both men and women, its retrospective nature did not permit consideration of correctness of use, a limitation of many other studies.4,7,8 Thus, to assess the impact of correct use on the association of consistent condom use with specific STDs, we modified the routine data collection procedures in our STD clinic to determine the prevalence of condom errors among consistent condom users. This analysis describes the results of the first 2 years of this modified data collection approach.
The Denver Metro Health Clinic (DMHC), operated by the Denver Public Health Department, is a free and confidential facility offering comprehensive services for diagnosis, treatment, and prevention of STDs. Services have historically been provided to all interested persons, regardless of income or residency, with approximately 80 patients seen daily. The analysis was based on a computerized medical record review of visits by women, men who have sex with women (MSW), and men who have sex with men (MSM) who were seen for a new problem at the DMHC between January 2001 and January 2003. Only patients who reported vaginal or anal intercourse in the past 4 months were included in the analysis. The Colorado Multiple Institutional Review Board reviewed and approved this study. Abstracted data included patient demographics, information on lifetime number of sexual partners, STD history, number and type of sexual partners in the past 4 months, and use of condoms and other contraceptives (for women) in the past 4 months.
Condom use over the past 4 months was determined during the routine clinical interview before an STD diagnosis and was classified as 0%, 25%, 50%, 75%, or 100%. Inconsistent users were those persons who reported using condoms between 25% to 75% of the time. Those patients reporting 100% condom use (consistent users) were further surveyed using a structured series of questions as to whether any error had occurred with the use of condoms during intercourse. Errors specifically elicited included breakage, leakage, slippage, condom turned inside out, reuse of a condom, initiation of sex before using a condom, or removal of the condom before finishing sex. The type and frequency of each error and the number of acts of anal or vaginal intercourse over the prior 4 months were recorded.
Sexually Transmitted Disease Diagnoses
Prevalence rates were calculated for 3 microbiologically confirmed STDs and 2 syndromic STDs. Microbiologically confirmed STDs included Neisseria gonorrhoeae, which was diagnosed by culture of cervical and urethral swabs; Chlamydia trachomatis, which was diagnosed by nucleic acid amplification tests (polymerase chain reaction or strand displacement assay) of cervical swabs in women and urine in men; and Trichomonas vaginalis, which was diagnosed by detection of motile trichomonads on microscopic examination of vaginal fluid in women; syndromic STDs included nongonococcal urethritis (NGU), which was diagnosed in men by both the presence of urethral discharge and by demonstrating on a urethral Gram stain ≥4 polymorphonuclear leukocytes per high-powered field, and pelvic inflammatory disease (PID), which was diagnosed in women based on a history of abdominal pain or dyspareunia in combination with physical findings of cervical motion, uterine, or adnexal tenderness; enlargement or induration of fallopian tubes; pelvic mass; or direct or rebound abdominal tenderness.
The study outcome of condom error was based on the occurrence of any reported condom use error during the past 4 months. The condom error rate was determined separately for females, MSW, and MSM by calculating the total number of errors and then dividing this number by the total number of acts of anal or vaginal intercourse. The condom use error rate was calculated as previously described by Warner et al.9 Because more than 1 error could have occurred per sex act, we conservatively assumed that the total number of sex acts with errors was equal to the number with the most frequently described error type (eg, a survey mentioning 3 breakage events and 2 slippage events was considered to have had 3 errors).
Associations between demographic and clinical variables and STD rates by level of condom use (none, inconsistent, and consistent) and any condom use error were assessed separately by chi-squared analysis for females, MSW, and MSM. Logistic regression modeling was used to determine variables associated with any condom use error as well as to adjust for the associations of condom use errors with each of the STDs. Variables included in the modeling were those found to be significant by bivariate analysis at P values ≤0.20 or ones that were considered clinically relevant. Backward elimination was used for logistic regression modeling. SAS version 8.1 was used for all data analysis (SAS Institute Inc., Cary, NC).
From January 2001 through January 2003, a total of 26,291 patients were seen at the DMHC, 36.0% women, 54.7% MSW, and 9.3% MSM. Of these, 9941 (37.8%) reported no condom use, 12,962 (49.3%) reported inconsistent use, and 3388 (12.9%) reported 100% use. Of the 3388 persons with consistent use, clinicians completed the additional condom error survey for 1973 (58.2%). MSM were more likely than either MSW or women to report consistent condom use (25.6% vs. 11.8% vs. 11.2%, P <0.01). No significant demographic or behavioral differences were seen between all consistent condom users and those persons who completed the condom error survey (data not shown).
The demographic and clinical characteristics of the 1973 patients who completed the condom error questionnaire stratified by gender and sexual orientation are outlined in Table 1. Median age was 22.6 years for women, 26.6 years for MSW, and 33.5 years for MSM. The majority of the women and MSW were nonwhite, whereas the majority of MSM were white. The median number of lifetime sex partners was 7 for women, 13 for MSW, and 30 for MSM, and approximately half of all patients had a prior history of an STD. Most patients had recently had a new sex partner, and 42.0% of women, 48.5% of MSW, and 78.9% of MSM reported having multiple sex partners within the past 4 months. The median number of sex acts (ie, vaginal or anal) within the past 4 months was 8 for women, 7 for MSW, and 5 for MSM. Anal sex was reported by 6.1% of women and 4.9% of MSW. The proportion of MSM who reported receiving oral sex was higher than MSW (92.1% vs. 44.7%, P <0.0001).
The occurrence of any condom use error was reported by significantly more women (57%) than MSW (48%) or MSM (33%) (P <0.0001, women vs. MSW, women vs. MSM) (Table 2). In addition, multiple types of errors were reported more frequently by women (16.8%) than by MSW (13.1%) or MSM (10.3%) (P <0.05 for each comparison). The most frequently reported error for all groups was condom breakage, followed by condom slippage or initiation of sex before use of a condom. The overall error rate per reported sex act was 6.4% and was lower for women (5.5%) than MSW (6.9%) or MSM (7.5%) (P <0.0001 for each comparison) (Table 2). MSW <20 years old had a higher condom error rate than older MSW, whereas women and MSM had no significant differences in error rate by age. Error rates varied by ethnicity, with whites having a significantly lower error rate than blacks or Hispanics among women and MSW, whereas blacks had the highest error rate among MSM. For all groups, the error rate decreased significantly with increasing sexual frequency, with the lowest error rates occurring among those with ≥15 sex acts within a 4-month timeframe.
The association of demographic and behavioral characteristics with any condom use error was assessed by logistic regression (Table 3). Among women, condom use error was associated with black race/ethnicity (adjusted odds ratio [AOR], 1.85; 95% confidence interval [CI], 1.22–2.79) and with having ≥15 sexual acts over the prior 4 months (AOR, 1.61; 95% CI, 1.08–2.42). Among MSW, condom use error was associated with age <20 years (AOR, 1.96; 95% CI, 1.26–3.04), black race/ethnicity (2.36; 95% CI, 1.69–3.30), recently having had either a new (AOR, 1.49; 95% CI, 1.07–2.07) or multiple sexual partners (AOR, 1.69; 95% CI, 1.25–2.30), >10 lifetime sexual partners (AOR, 1.61; 95% CI, 1.19–2.17), and reporting ≥15 sexual acts over the prior 4 months (AOR, 2.01; 95% CI, 1.43–2.83). Finally, among MSM, condom use error was only associated with Hispanic race/ethnicity (AOR, 1.85; 95% CI, 1.07–3.20) and with having ≥15 sexual acts over the prior 4 months (AOR, 2.68; 95% CI, 1.49–4.81).
Table 4 compares STD prevalence rates by various levels of condom use, including both the total population (n = 26,291) stratified by no condom use, inconsistent use, and consistent use, as well as the consistent users who completed the condom error questions (n = 1973). Among the total population, rates of STD were higher among inconsistent users than nonusers for gonorrhea and chlamydia among women; gonorrhea, chlamydia, and NGU among MSW; and gonorrhea and NGU among MSM (P <0.05 for all comparisons). However, STD rates were significantly lower among consistent than inconsistent users for gonorrhea, chlamydia, and PID among women; for gonorrhea, chlamydia, and NGU among MSW; and for gonorrhea among MSM (P <0.05 for all comparisons). Among consistent users who completed the condom error questions, rates of gonorrhea, chlamydia, and NGU were significantly higher among those with errors than those without for MSW. Similar trends toward higher rates in those with errors than those without were noted for each STD for women, although differences were not statistically significant. In contrast, among MSM, there was no difference between consistent users with or without errors for any STD.
To control for the effect of potentially confounding demographic and sexual behavior variables, the association of condom error with the odds of different STD was assessed by logistic regression (Table 5). For MSW, after controlling for demographic and behavioral variables, condom use error continued to be associated with gonorrhea (AOR, 5.53; 95% CI, 2.48–12.35), chlamydia (AOR, 3.19; 95% CI, 1.80–5.65), and nongonococcal urethritis (AOR, 2.09; 95% CI, 1.45–3.01). Alternatively, for women and MSM, condom error was not significantly associated with any STD outcome.
Figure 1compares the proportion with any STD among the 3 categories of condom users: inconsistent use (as measured in the total population) and consistent users with or without errors (as measured in those who completed the condom error survey). Although STD rates tended to decline with increasing consistency and correctness of use in all groups, the nature of the declining trend varied for women, MSW, and MSM. Among women, rates of STD were significantly lower among consistent users with errors (16.6%) than inconsistent users (23.9%; P <0.01), but the further decrease among consistent users without errors (14.0%) was not significant. In contrast, among MSW, rates of STDs were essentially the same in inconsistent users (39.9%) and consistent users with errors (39.6%), and declined substantially only among consistent users without errors (15.0%; P <0.0001). Finally, among MSM, compared with STD rates among inconsistent users (34.8%), rates were only slightly lower among consistent users with errors (30.6%) and consistent users without errors (29.4%).
By expanding routinely collected STD clinic data to include condom use errors as well as frequency of use, our study provided an opportunity to determine the impact of incorrect use among patients reporting complete consistency of use. The findings of the current study replicate those of our recent retrospective study on women and MSW, with lower rates of gonorrhea, chlamydia, and trichomoniasis (in women) in consistent than inconsistent condoms users, and also document similar trends for NGU in MSW, PID in women, and gonorrhea in MSM. Our study extends these findings by demonstrating trends toward lower rates of STD with increasing consistency and correctness of condom use, with significantly lower rates of gonorrhea, chlamydia, and NGU in MSW who consistently use condoms without errors.
The greater difference in STD rates between consistent condom users with and without errors for MSW than women or MSM is of interest. It could be more difficult for women than MSW to appreciate that an error such as breakage, slippage, or leakage has occurred. Consistent with this premise, a recent study of college students reported that over 30% of men had failed to disclose condom breakage to their female partners, comprising 13% of condom breakage episodes in which they were involved.10 Such an issue could lead to differential classification bias among women and MSW and thus obscure common trends. This possibility is supported by the lower rate reported by women than MSW in our study. Alternatively, symptomatic persons presenting to our STD clinic suspecting they have been exposed to an STD could prefer to offer a history of condom errors “as an excuse” rather than acknowledge inconsistent or nonuse. If such a phenomenon were common among MSW, it could accentuate the difference in STD rates between those who report consistent use with and without errors. Finally, among MSM, both of the above explanations could obscure the potential differences in STD rates among different levels of consistency and correctness of condom use. In addition, high rates of unprotected oral sex, which has been associated with both urethral gonorrhea and NGU11,12 and which was not considered in our study, could contribute to high prevalence of urethral infection and thus obscure differences in STD rates by condom use. The substantially higher proportion of MSM than MSW engaging in this practice in our study support the likelihood of this explanation.
Our overall error rate of 6.4% was comparable to other studies,9,13–18 with errors commonly reported by over half of the women and MSW and almost one third of MSM. As seen in other studies, breakage and slippage were the most common errors reported,9,18–21 with the initiation of sex before the condom was put on also being relatively common. Although our study did not assess a number of factors that have been associated with condom error (eg, education level, marital status, prior experience with condoms, use of vaginal spermicides, past errors, alcohol/drug use, allergic reactions),9,13,16,18,22 we did identify other characteristics that were predictive of a condom use error. We found that for both women and MSW, blacks were more likely to experience a condom use error, whereas among MSM, condom use errors were more common among Hispanics, an association that has been reported previously.16,17,20 In addition, for MSW, those clients that were younger and who reported high-risk sexual activity (ie, new partner, multiple partners, >10 lifetime sex partners) were also more likely to report a condom use error. Finally, we found an association of any condom use error with an increased frequency of sexual activity in all groups. That this association is simply the result of the greater number of chances with an increased frequency of any error with intercourse is supported by the decline in the rate of errors in those with greater sexual frequency. Although our assessment of factors associated with condom use errors was limited, identifying characteristics that are readily available during a clinical encounter and which can identify subgroups at increased risk for errors could support a counseling approach that can focus on prevention of errors.13,23
Our investigation had several potential limitations. First, although patients’ responses have been reported to be more accurate when the recall is of a moderate duration (ie, 3–6 months),24 because information was obtained through self-report, there was the potential for recall bias or respondents providing socially desirable responses (eg, consistent condom use, no condom use errors), as noted here. Second, because clinicians failed to survey all consistent condom users about condom use errors, there is the potential that these results might not be representative of all consistent condom users. However, no significant demographic or behavioral differences were seen between all consistent users and those who completed the error questions. Finally, because this study was conducted as part of a routine clinical assessment in an STD clinic, limited information was available on risk behaviors that have been found to be associated with condom use errors such as partner types and length of relationship(s).
In summary, among those persons reporting consistent condom use that were surveyed in this STD clinic population, condom use errors were common. Although consistent condom use significantly reduces STD in both men and women,5 incorrect condom use undermines this benefit, significantly so among MSW. These data support the premise that correctness of condom use is an important methodologic issue in studies assessing condom effectiveness. Furthermore, they highlight the importance of promoting careful attention to correct as well as consistent use of condoms among sexually active persons who want to reduce their risk of STDs.
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