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Effectiveness of the male latex condom: combined results for three popular condom brands used as controls in randomized clinical trials.

BACKGROUND: Although public health programs invest heavily in the male latex condom, its efficacy in preventing pregnancy and sexually transmitted disease has been based primarily on in vitro and retrospective studies. METHODS: We combine the results from two randomized, controlled contraceptive efficacy trials that used commercial latex condoms brands (Ramses Sensitol, LifeStyles, Trojan-Enz) in the control arms. Combining data from the two studies, we obtained longitudinal data covering 3526 menstrual cycles contributed by approximately 800 couples who used latex condoms exclusively for up to six menstrual cycles. Both trials also collected 3715 detailed breakage and slippage reports from the first five study condom uses. The second trial also tested 243 postcoital vaginal samples collected after the first study condom use for the presence of prostate-specific antigen (PSA) and spermatazoa. RESULTS: The combined clinical breakage rate for the first five condom uses was 0.4% for the three latex brands and the combined clinical slippage rate was 1.1%. The combined six-cycle typical-use pregnancy rate for the latex condoms was 7.0% (95% confidence interval 5.0-9.0). The combined six-cycle consistent-use pregnancy rate was 1.0% (95% confidence interval 0.0-2.1). PSA was detected in only 1.2% of postcoital vaginal samples collected after the first use of an intact study condom. There were no differences in performance or efficacy among the three latex brands tested. CONCLUSIONS: The male latex condoms rarely broke or slipped off during intercourse and provided high contraceptive efficacy, especially when used consistently. Risk of semen leakage from intact condoms was very low.

Adolescent↗

Structural integrity of the female condom after multiple uses, washing, drying, and re-lubrication.

Establishing the safety of re-using the female condom could significantly increase women's access to barrier methods especially in poorer countries. In this study, the structural integrity of female condoms was tested (n = 295) after multiple acts of vaginal intercourse. Fifty women were recruited to the study. Each woman re-used one condom up to eight times and washed, dried, and re-lubricated between each use. Structural integrity was measured using standard quality control testing; water-leakage, air-burst, and seam tensile strength. All results were compared to the United States Food and Drug Administration (US FDA) standards for an unused female condom. The results of the structural integrity tests for all cycles were above the FDA minimum standards for seam strength and burst tests. There was no deterioration detected in condoms used 8 times when compared to new female condoms in these tests. Five holes were detected by the water leakage test across all cycles, of which three were detected by the subjects themselves and reported to the investigators, therefore, giving a breakage rate of 1.7%. The holes were not associated with increased number of uses. This study provides further evidence that suggests the structural integrity of the female condom after multiple use is still within FDA minimum standards, although random holes resulting from handling occur infrequently with the re-use procedure.

Coitus↗

Does penile size in younger men cause problems in condom use? a prospective measurement of penile dimensions in 111 young and 32 older men.

OBJECTIVES: Young men often complain about problems with condom use, but very little information exists about the influence of men's age on penile dimensions and therefore on possible problems in the use of the most important means of contraception in the young. METHODS: We performed a prospective measurement of penile dimensions in 111 men,18 to 19 years old (group A), and in 32 men, 40 to 68 years old (group B). We measured penile length and width in the flaccid state and after visual and manual self-stimulation in group A and after intracavernous injection of prostaglandin E(1) in group B. RESULTS: The mean flaccid length in group A (8.60 cm) and group B (9.22 cm) was significantly different. The mean erect length in group A (14.48 cm) and group B (14.18 cm) was not significantly different. The mean flaccid width at the base was significantly different between group A (3.08 cm) and group B (2.87cm), but the mean flaccid width at the glans was not (group A, 3.02 cm; group B, 3.01 cm). The mean erect width at the base (group A, 3.95 cm; group B, 3.50 cm) and the erect width of the glans (group A, 3.49 cm; group B, 3.32 cm) were significantly different. CONCLUSIONS: Our assumption that the problems young men experience with condom use may be because of smaller penises could not be proved. To address the problems in condom use in younger men, a larger variety of condom sizes and better information about condom use may be useful.

Adult↗

Ineffective use of condoms among young women in managed care.

Condoms must be used effectively in order to prevent pregnancy and the spread of HIV/STD. This study investigated two types of ineffective condom use, delayed condom use (initiated after penetration has occurred) and condom slippage and/or breakage. We estimated prevalence and identified predictors of ineffective condom use among young women at risk of STDs. The study used baseline survey data from a randomized trial of women 18-24 years old at two managed care sites; 779 participants who were recent condom users were included in this analysis. Forty-four per cent of the sample reported delayed condom use in the past three months and 19% reported condom slippage and/or breakage. In multivariate logistic regression, younger age, primary partner, lack of partner support, multiple recent sexual partners and using condoms for contraception were positively associated with delayed condom use. Correlates of condom slippage and/or breakage were non-white race/ethnicity and history of any STD. Greater frequency of condom use independently predicted both outcomes. Ineffective condom use was common in this sample of experienced condom users and predictors were different for each outcome. HIV/STD prevention interventions must address more specific aspects of condom use than have previously been their focus, especially when condom use is already high.

Adolescent↗

The next generation of HIV prevention for adolescent females in the United States: linking behavioral and epidemiologic sciences to reduce incidence of HIV.

Given the increasing numbers of new HIV infections among adolescent females and limitations of the current generation of HIV interventions, a new generation of interventions is needed to prevent HIV and other infections in this population. Interventions available today are limited by their focus on single behaviors that have little epidemiologic significance, such as condom use, and their failure to be tested among the highest risk females. Recent advances in epidemiologic sciences suggest that the next generation of interventions should focus on parenting and parenting skills, sexual risk networks in which drug use and other high-risk behaviors are prevalent, and neighborhoods where these networks exist. Future research should include formative and observational studies to inform new intervention trials that reach the highest risk female youth.

Adolescent↗

Human papillomavirus: a highly prevalent sexually transmitted disease agent among female sex workers from Mexico City.

BACKGROUND: Cervical cancer, a human papillomavirus (HPV)-caused neoplasia, is highly prevalent in Mexico. GOAL: To determine the prevalence of HPV infection in female sex workers (FSW) from Mexico City and to assess the association between HPV infection and the characteristics of these women. STUDY DESIGN: A questionnaire was applied to 495 FSW. Cervical cell specimens were obtained for DNA amplification and hybridization to detect 27 HPV types. A risk factor analysis was performed. RESULTS: The overall prevalence of HPV infection was 48.9%. The prevalence of high-risk HPV types was 43%, whereas that of low-risk types was 24.6%. A total of 18.8% of study participants was infected with both high-risk and low-risk HPV types, and 28.5% were infected with two or more HPV types. Younger age and failure to use a condom were independently associated HPV risks (odds ratio, 7.3 and 2.3; 95% CI, 3.5-15.0 and 1.2-4.4, respectively). CONCLUSIONS: Infection with high-risk and multiple HPV types is high among Mexican FSW. This study corroborated a higher infection rate in younger women. A higher risk of HPV infection is also observed in women who have been involved with sex work for less than 1 year. However, condom use showed a protective effect against HPV infection.

Adolescent↗

Study of condom integrity after brief exposure to over-the-counter vaginal preparations.

BACKGROUND: Latex condoms are used as contraceptives and as preventives against sexually transmitted diseases. Latex rapidly and significantly deteriorates when exposed to pure mineral oil and vegetable oil. We wanted to determine if short exposures to readily available over-the-counter (OTC) intravaginal preparations could affect latex condom integrity. METHODS: We compared the mean burst time of test latex condoms, which had 5-minute exposure to various OTC vaginal products, with the mean burst time of control (unexposed) condoms during pressurized air inflation. RESULTS: Baby oil reduced the mean burst time from nearly a minute to just over 11 seconds. One intravaginal moisturizer and two intravaginal antifungal preparations also adversely affected latex condom integrity. Products that weakened latex condoms contained either mineral oil or vegetable oil. CONCLUSIONS: Women who rely on latex condoms should exercise caution if using OTC vaginal products containing either mineral oil or vegetable oil. Such products apparently can decrease condom strength and potentially jeopardize efficacy.

Condoms↗

Virus transmission through compromised synthetic barriers: part I--effect of unsteady driving pressures.

Although synthetic membranes such as gloves, condoms, and instrument sheaths are used in environments with highly time-varying stresses, their effectiveness as barriers to virus transmission is almost always tested under static conditions. In this paper it is shown how a previously developed mathematical model can be used to transform information from static barrier tests into predictions for more realistic use conditions. Using a rate constant measured for herpes adsorption to latex in saline, and an oscillatory trans-membrane pressure representative of coitus, the amount of virus transmitted through a hole (2 microm diameter) in a condom is computed. Just beyond the exit orifice of the pore, transport is dominated by the rapidly dissipating viscous jet of virus suspension, which results in an accumulation of viruses roughly 20 pore radii from the barrier surface during each cycle. Due to virus adsorption to the barrier surfaces, the simulations reveal a gradual decrease in virus flow with increasing number of cycles, and thus a slow divergence from predictions based upon steady-state conditions. Still, over the 500 cycles simulated, steady-state predictions approximate the net number of viruses transmitted to within 25 percent error.

Biomechanical Phenomena↗

Virus transmission through compromised synthetic barriers: part II--influence of pore geometry.

When stressed during normal use, synthetic barriers such as gloves and condoms can develop tears that are undetectable by the user. It is of considerable public-health importance to estimate the quantity of virus transmitted through the tear, in the event of viral contamination of the fluid medium. A mathematical model that accounts for virus adsorption to the barrier material was used to compute the quantity of virus transmitted through defects of various geometries. Slits were modeled as cylinders of elliptic cross section, and upper and lower bounds for the transmission rate of HIV and Hepatitis B virus (HBV) were calculated for barrier-use scenarios such as coitus and gripping of surgical instruments. For a 1-microm high slit, HIV transmission was found to be negligible for all likely use scenarios. HIV transmission became potentially significant for a 5-microm slit. Due to its high titer, HBV transmitted at potentially important levels even through the 1-microm slit. The dependence of the transmission rate upon pore aspect ratio was determined and found to be very strong for high-adsorption situations and near-circular pores. Numerical predictions of virus transport through a laser-drilled hole in a condom matched experimental measurements well, even when the tapered nature of the geometry is ignored.

Biomechanical Phenomena↗

Men with broken condoms: who and why?

OBJECTIVES: To identify (1) the prevalence of condom breakage, and demographic and sexuality-related differences among young men who have sex with women reporting and not reporting this event; (2) condom-specific behaviours associated with breakage. METHODS: Young men (n = 278) attending a clinic for treatment of sexually transmitted infections (STIs) responded to an anonymous questionnaire aided by a CD recording of the questions. The samples were screened to include only men who had used a condom during penile-vaginal sex at least three times in the past 3 months. Condom-specific behaviours (including breakage) were assessed using these last three acts of condom use as the recall period. Correlates achieving bivariate significance were subjected to multivariate analysis. RESULTS: Nearly one third (31.3%) of the men reported recent breakage. The breakage rate was 15%. Three correlates significantly distinguished between men who did and did not report breakage. Men who had past STIs were more likely to report breakage (adjusted odds ratio (AOR) 2.08), as were men who also reported condom slippage (AOR 2.72). Less self-efficacy for correct condom use was also significantly associated with breakage (AOR 1.07). Further, three condom-specific behaviours were significantly associated with breakage: allowing condoms to contact sharp objects (AOR 2.6), experiencing problems with the "fit or feel" of condoms (AOR 2.3) and not squeezing air from the receptacle tip (AOR 2.0). CONCLUSIONS: Breakage may be common and may occur in a larger context of difficulties with condoms. STI clinics could potentially benefit some men by providing instructions on the correct use of condoms.

Adult↗

Why do condoms break or slip off in use? An exploratory study.

Men attending 3 sexually transmissible disease clinics and a university health clinic in Sydney, Australia, were invited to complete a questionnaire on their use of condoms. Respondents were 108 male condom user volunteers aged 18 to 62 years; in the last five years 47 had had sex with men, 18 with both men and women and 43 only with women. They reported using a total of 4809 condoms in the previous 12 months (condoms worn by a male partner were not included). The overall breakage rate was 4.9% (including condoms breaking during application), while 3.1% of condoms reportedly slipped off. On a multivariate analysis, condom breakage correlated with: (1) male sexual partner(s), (2) infrequent condom use, (3) rolling the condom on as per conventional instructions (modified application methods appeared protective) and (4) having trouble with condoms partially slipping. Factors associated with condoms slipping off were (1) young age, (2) being circumcised, (3) having less life-time condom experience, (4) rolling the condom on conventionally, and (5) having trouble with condoms partially slipping. Few men used inappropriate lubricants and no association between lubricant type and breakage was found. Though common among our respondents, negative attitudes towards condoms, loss of erection during condom application or use, finding condoms uncomfortable, and prolonged sexual intercourse were not related to success in use. Almost half (49%) of the men reported having deliberately removed a condom after the beginning of intercourse; 17% had done so 3 or more times. Counselling protocols should acknowledge the complexity of condom use.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Correlates of condom breakage and slippage among university undergraduates.

An anonymous questionnaire was used to explore relationships between condom breakage, slippage and possible correlates in a sample of 428 single, never married college men and women. Specific condom use errors and problems that could lead to breakage and slippage were also examined. A three-month recall period was used. Breakage/slippage was found to be associated with never receiving instruction on correct condom use (P = 0.001), more than one sex partner (P = 0.001), more frequent use of condoms (P = 0.001), and partner(s) being less than highly motivated to use condoms (P = 0.02). Those reporting that condoms had contacted a sharp object were three times as likely to report breakage (P = 0.001). Those using condoms without proper lubrication (P = 0.006) and those experiencing loss of erection during sex (P = 0.001) were more likely to report slippage. Further research should investigate the efficacy of instruction addressing specific factors that may reduce the incidence of breakage/slippage, thereby enhancing condom effectiveness.

Adolescent↗