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Estimated condom failure and frequency of condom use among gay men.

OBJECTIVES: Condoms are designed to bar transmission of the human immunodeficiency virus (HIV), but they sometimes fail. This paper explores the effect of experience with condoms on condom failure among gay men. METHODS: Risk of condom failure (breakage or slippage) on a single occasion is estimated for four sexual acts reported over 12 months by a sample of gay New York City men (n = 741). The estimation procedure assumes that each episode in which a condom is used is an independent event. Evidence is offered to support this assumption. RESULTS: Risk of condom failure in a single episode was fairly high, particularly in anal intercourse, for men who had engaged in each act only a few times in the previous year. It declined rapidly with experience (e.g., to below 1% for receptive anal intercourse after about 10 episodes in the previous year). Condoms failed less often in oral than anal sex, but estimated risk of failure also decreased with experience. CONCLUSIONS: Gay men should be especially cautious the first few times they use a condom; after moderate experience, however, they may expect a low risk of condom failure.

Adolescent↗

Objective markers of condom failure.

BACKGROUND: Studies of condom efficacy rely on self-reported behavior. Objective markers of exposure to semen may provide a more valid assessment of condom failure and failure to use condoms. GOALS OF THIS STUDY: To compare three semen biomarkers: acid phosphatase (AP) activity, prostate specific antigen (PSA), and the human seminal plasma antigen (MHS-5). STUDY DESIGN: Twenty women were intravaginally inoculated with six measured, increasingly larger amounts of their partners' semen. Vaginal fluid was collected by the participant using swabs and tested. RESULTS: Background levels of PSA were low (0.00-1.25 ng/ml), background levels of AP were variable (0-350 U/l), and all preinoculation samples were negative for MHS-5. All postinoculation samples were positive for PSA, 64 of 117 (55%) for AP, and 14 of 120 (12%) for MHS-5. CONCLUSION: The PSA immunoassay was the best semen biomarker under these sampling and testing conditions.

Acid Phosphatase↗

Sex in Australia: experience of condom failure among a representative sample of men.

OBJECTIVE: Condom use is a central part of strategies to prevent the transmission of human immunodeficiency virus and other sexually transmissible infections. The objective of this study was to provide reliable estimates of the prevalence and correlates of condom failure among a representative sample of Australian men. METHODS: Computer-assisted telephone interviews were completed by a representative sample of 10,173 men aged 16-59 years from all States and Territories. The response rate was 69.4%. RESULTS: Among men who used condoms in the year prior to being interviewed, 23.8% experienced at least one condom breakage in the past year and 18.1% experienced at least one condom slippage in the past year. Experience of condom breakage in the past year was significantly related to younger age, having a blue-collar occupation, and using more condoms. Neither condom slippage nor condom failure was significantly related to use of water-based lubricants or oil-based lubricants. CONCLUSION: Condom failure is related to certain characteristics of individuals and is not randomly distributed across all condom users. Lubricant use did not affect condom failure. IMPLICATIONS: There may not be a need to promote lubricant use for vaginal intercourse, as there was no association between lubricant use and condom failure.

Adolescent↗

Correlates of condom failure in a sexually active cohort of men who have sex with men.

Condom failure (slippage or breakage) has been shown to be associated with HIV seroconversion among men who have sex with men (MSM), but predictors of failure have been poorly elucidated. Of 2592 HIV-seronegative MSM participants in the HIV Network for Prevention Trials (HIVNET) multisite Vaccine Preparedness Study who reported condom use for anal sex in the 6 months before enrollment, condom failure was reported by 16.6%, with failure rates of 2.1/100 episodes of condom usage (2.5 failures/100 episodes for receptive anal sex and 1.9/100 episodes for insertive anal sex). In separate multivariate models evaluating predictors of condom failure reported by the insertive and receptive partners, more frequent condom use was associated with a decreased per-condom failure rate and amphetamine and heavy alcohol use with increased rates in both models. Being employed, having private medical insurance, and using lubricants for >80% of anal sex acts were significantly associated with decreased failure rates in the insertive model. Safer sex counseling should particularly target men of lower socioeconomic status, promote proper and consistent use of condoms with appropriate lubricants, and address the impact of drug use, especially amphetamines and alcohol, on condom failure.

Adult↗

Does additional lubrication reduce condom failure?

It has been suggested that using additional spermicide with condoms provides added contraceptive effect and protection from infection, and that water-based lubricants may lower condom breakage rates. This questionnaire-based study investigated the use of additional lubrication with condoms amongst 525 female students presenting for post-coital contraception, and the current and past experience of condom and additional lubrication use amongst 481 controls attending the same health centre. Of those requesting post-coital contraception, 83% claimed condom failure as the cause, with 66% of the control group having also experienced condom failure at some time. Use of additional water-based lubrication was significantly associated with lower condom failure rates (odds ratio 8.88, 95% C.I.: 3.79, 20.8). Gender, regularity of use of condoms and using oil-based lubricants were not associated with higher failure rates. Additional lubricant use was not significantly associated with increased condom slippage.

Condoms↗

Correlates of condom failure among adolescent males: an exploratory study.

OBJECTIVE: To identify the prevalence and correlates of condom failure (defined as breakage or slipping off in the past 90 days) among a sample of adolescent males (15 to 21 years of age). DESIGN: A cross-sectional study of 481 condom-using males residing in three US cities (Atlanta, GA, Providence RI, Miami FL). Data were collected, in the years 2000 and 2001, using audio computer-assisted self-interviewing technology. Prevalence ratios were used to determine the strength and significance of bivariate associations between ten assessed correlates and condom failure. Correlates achieving a screening level of significance were entered into a multivariate model that was used to calculate adjusted odds ratios (AOR). RESULTS: Recent condom failure was reported by 34.1%. Younger adolescents were about one-third less likely to report condom failure (AOR = 0.66; P = 0.4). Adolescents reporting multiple sex partners were about 80% more likely to report failure (AOR = 1.84; P = 0.09). Adolescents indicating they had sex with someone on the same day they met the person were about 80% more likely to report failure (AOR = 1.77; P = 0.02). Finally, adolescents indicating recent problems obtaining condoms were about 70% more likely to report failure (AOR = 1.69; P = 0.1). Failure was not less common among those reporting a history of STD infection or those ever impregnating a partner. CONCLUSION: Because adolescent males may commonly experience condom failure, targeted clinic- and community-based programs designed to reduce user error could be an important aspect of preventing pregnancy and the spread of STDs.

Adolescent↗

Condom failures in women presenting for abortion.

AIMS: To document the main reasons for condom failure in women presenting for first trimester termination of pregnancy. METHODS: From 1990-97 an audit was carried out, on the 3283 cases personally operated on by the author, using the information routinely obtained during pre-operative counselling. RESULTS: Two sets of figures were obtained. The first (minimum figures) were restricted to those who used condoms on every occasion of coitus (746 or 22.7% of all women seen). The second (maximum figures) included all of these plus those who did not use condoms on every occasion or who used condoms in conjunction with another method (1494 or 45.5% of all women seen). In this expanded group, there was no obvious cause for the failure in 446 (29.9% of condom users). The main reason for failure was not using condoms every time (736 or 49.3% of condom failures). Leakage of semen occurred in 321 cases (21.5% of condom failures) and 104 of these had used emergency contraception which had also failed (7.0% of condom failures). Condoms failed more often in women under 25 years of age. CONCLUSIONS: There is a need for better education on correct condom use and improved availability of emergency contraception. There is also a need for greater standardisation in reporting contraceptive failure.

Abortion, Legal↗

Condom failure among adolescents: implications for STD prevention.

This study of 921 adolescents found condom failure (past 90 days) was experienced by at least one-third of the sample, regardless of gender. Frequency of condom failure was positively associated with STD diagnosis (AOR = 1.22, 95% CI = 1.01-1.48), with the odds of testing positive increasing 22% for each added event of failure.

Adolescent↗

Evaluation of prostate-specific antigen as a quantifiable indicator of condom failure in clinical trials.

The ability of condoms to retain all elements of semen during intercourse has been assessed by postcoital visual inspection and in vitro permeability studies. Yet, these observations may not be sufficiently precise or realistic. This pilot study evaluated prostate-specific antigen (PSA) as a semen marker of inapparent failure of the condom barrier under conditions of actual use. Twelve couples collected samples from the vagina and surfaces of the condom using sterile cotton swabs. We obtained precoital and postcoital samples for 24 acts of unprotected intercourse, 54 acts of intercourse using intact condoms, and 40 acts of intercourse using condoms that had been deliberately punctured. We used electrophoresis to determine the amount of PSA present in the samples. PSA was detected in 100% (24/24) of vaginal samples collected immediately after unprotected intercourse and in none of the vaginal samples collected more than 24 h after intercourse (0/90). PSA was also present in 98% (83/85) of the samples collected from the inside of the condom that had failed during intercourse. Excluding uses where the condom failed during intercourse, PSA was detected in 2% (1/47) of the postcoital vaginal samples collected after use of intact condoms and in 41% (14/34) of the samples collected after use of condoms with known 1-mm punctures. We conclude that PSA shows great promise as a semen biomarker in clinical trials of barrier methods. We recommend that future studies further investigate the ability of this biomarker to identify condom failures and quantify the extent of semen exposure associated with various types of condom failures.

Adolescent↗

Use of prostate-specific antigen (PSA) to measure semen exposure resulting from male condom failures: implications for contraceptive efficacy and the prevention of sexually transmitted disease.

Accurate measurement of semen exposure resulting from condom failures can refine public health messages and improve predictions of condom efficacy in preventing pregnancy and HIV transmission. Eight hundred and thirty couples enrolled in a condom efficacy study were asked to collect a baseline sample of ejaculate from the inside of the first study condom they used and to collect a postcoital vaginal sample whenever a study condom broke or slipped off during intercourse. All samples were quantitatively tested for prostate-specific antigen (PSA), a substance found only in human semen, using rocket immunoelectrophoresis, and inspected microscopically for presence of sperm. Sixty-eight baseline ejaculate samples collected from the inside of the first study condom by couples who subsequently experienced a condom failure averaged 13.4 microg PSA per swab and 79% of the samples averaged one or more sperm per high power field (hpf). Seventy-nine postcoital vaginal samples obtained after a condom break averaged 5.7 microg PSA per swab and only 38% averaged one or more sperm per hpf. The PSA results indicated a 50% reduction in semen exposure compared to baseline levels (p = 0.0001). Seventeen samples obtained after a condom slip-off averaged 2.5 microg PSA per swab and none of the samples averaged one or more sperm per hpf. The PSA results indicated an 80% reduction in semen exposure compared to baseline levels (p = 0.0001). Our results suggest that even condoms that fail reduce the risk of pregnancy and the transmission of sexually transmitted disease compared to unprotected intercourse. We also used PSA results to adjust a model designed to predict consistent-use pregnancy rates from condom breakage and slippage data.

Coitus↗

Can condom users likely to experience condom failure be identified?

A study based on a convenience sample of 177 couples who each used 11 condoms found that 103 condoms (5.3%) broke before or during intercourse and 67 condoms (3.5%) slipped off during sex. Couples who had not used a condom in the past year were almost twice as likely to experience condom failure as were couples who had used at least one during that period (p < .001). Of the couples who had used a condom in the previous year, the failure rate among those who reported at least one condom break during that period was more than twice the failure rate among those who reported no breaks (p < .001). Among couples who had used condoms in the past year without breaking any, those who did not live with their partner and those who had a high school education or less were at increased risk of condom failure (adjusted odds ratios of 3.2 and 2.7, respectively).

Adolescent↗

Prostate-specific antigen in vaginal fluid as a biologic marker of condom failure.

Forty women participated in three clinic visits during which they were exposed to their partner's semen (10 microL, 100 microL, and 1 mL). At each visit they took vaginal fluid samples before exposure to their partner's semen, immediately after, and at 1, 24, and 48 h after exposure. PSA was measured with an enzyme-linked immunoassay. The mean PSA level for preexposure swabs ranged between 0.43 and 0.88 ng/mL. The mean PSA levels were 193 immediately after exposure to 10 microL, 472 after 100 microL, and 19,098 after 1 mL. The PSA levels declined within 1 h, and returned to background at 48 h. The findings confirm that our procedure is a sensitive and specific method for detecting recent semen exposure, and indicate that PSA levels depend on exposure intensity and time since exposure. Application of this method in condom efficacy studies provides objective evidence of condom failure that enhances the interpretation of self-report.

Adult↗

Noninferiority testing in crossover trials with correlated binary outcomes and small event proportions with applications to the analysis of condom failure data.

Regulatory agencies may require demonstrating a new therapy or device as noninferior to an existing method. For example, a new condom type must demonstrate noninferiority to existing latex condoms before consideration as an equivalent method of pregnancy prevention. Studies designed to assess condom effectiveness typically measure experimental and standard condom failure in a crossover trial, resulting in unbalanced correlated binary outcomes with low event proportions. We used simulations to evaluate the test size of a simple population average approach to noninferiority testing with the small event proportions, intracluster correlations, and sample sizes frequently found in condom studies. Results emphasize the importance of considering test accuracy when designing any study.

Binomial Distribution↗

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.

Adolescent↗

Condom failure among homosexual men.

Following a postal questionnaire survey of 262 homosexual men carried out to investigate condom use during sexual activity, a sample of 97 men who used condoms during anogenital sex was identified. Thirty-one percent of those who had used a condom during anal intercourse reported at least one incident of condom breakage. When looked at in terms of frequency of individual condom use, it was found that 1 in 27 condoms break during this activity. Examination of the reasons for breakage and a review of the literature indicated that physical stress on the condom is likely to be a major factor in these incidents.

Adult↗