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Comparative contraceptive efficacy of the female condom and other barrier methods.

Because the research design for the clinical trial establishing the contraceptive efficacy of the female condom--a six-month life-table probability of failure of 15% (12% in the United States vs. 22% in Latin America)--did not include randomization with another method of contraception, no definite conclusion about its comparative efficacy is possible. Comparisons using other female barrier methods as historical controls, however, provide evidence that, among women in the United States, the contraceptive efficacy of the female condom during typical use is not significantly different from that of the diaphragm, the sponge or the cervical cap. The six-month probability of failure during perfect use of the female condom is 2.6% among U.S. women, similar to rates for the diaphragm and the cervical cap but significantly lower than that for the sponge. Meaningful comparisons with the male condom are not possible because of the lack of data from carefully controlled prospective clinical trials. Extrapolations from the results on contraceptive efficacy suggest that perfect use of the female condom may reduce the annual risk of acquiring the human immunodeficiency virus by more than 90% among women who have intercourse twice weekly with an infected male.

Clinical Trials as Topic↗

High speed cinematography of the initial break-point of latex condoms during the air burst test.

High speed cinematography of latex condoms inflated to burst under standard (ISO) conditions reveals that rupture of the condom typically is initiated at a small focal point on the shank of the condom and then rapidly propagates throughout the condom's surface, often ending with partial or full severance of the condom at its point of attachment to the air burst instrument. This sequence of events is the reverse of that sometimes hypothesized to occur, where initiation of burst was considered to begin at the attachment point and to constitute a testing method artifact. This hypothesis of breakage at the attachment point, if true, would diminish the value of the air burst test as a standard for assessing manufacturing quality control as well as for condom strength measurements and comparisons.

Air Pressure↗

Identification of allergenic proteins in condoms by immunoenzymatic methods.

BACKGROUND: A large increase of allergy to latex proteins has been observed lately probably as a result of a great use of latex-containing goods. At present these untoward reactions have led to consideration of this problem as a health and occupational hazard. It is therefore, necessary to identify the allergens contained in latex-manufactured products and to develop effective diagnostic tools to detect sensitized individuals. OBJECTIVE: The objective of this study is to identify antigenic and allergenic components in latex condoms by using chemical, immunochemical, and immunoenzymatic methods. METHODS: The protein content of extracts obtained from several brands of condoms was determined and characterized by using a modified Lowry method, a quantitative ELISA assay and SDS-PAGE. The allergenic behavior of these proteins was studied by IgE immunoblotting, EAST and ELISA techniques, using sera from subjects allergic to latex products, particularly to latex condoms. RESULTS: Wide variations in the protein content (38 to 740 microg/g product) and composition were observed. The SDS-PAGE protein profiles showed components ranging from 7 to 94 kD of relative molecular weights; most of them were also detected in natural rubber latex. The most prominent bands were revealed in the 14 and 30 kD zones. A strong band of 69 kD in the SDS-PAGE profiles would correspond to a neoantigen, since it was not observed in natural latex. The immunoblotting analysis employing sera from 5 patients allergic to latex condoms showed the presence of 4 components with IgE binding capacity (14, 30, 69, and 94 kD). The EAST and ELISA methods showed the presence of allergens in all the condom brands studied. CONCLUSIONS: The presence of allergenic proteins in several condom brands was demonstrated by different immunoenzymatic methods.

Adolescent↗

Use of penile prostheses to maintain external condom catheter drainage in spinal cord injury patients.

This is a retrospective analysis of 79 spinal cord injury patients who have had penile implants from one to 14 years. The primary indication for implants was the loss of condom catheter with a small retractile penis. Mean period after injury to when the implants were placed was 8.24 years (range 1-21 years). Mean total length of time the implants have been followed was 7.08 years (1-14 years). Sixty patients responded to our detailed questionnaire and they have been subjected to further analysis: prior to the implant 46 patients (77%) frequently lost their condoms. Fourteen of the patients (23%) had indwelling catheters, and 3 (5%) had a suprapubic cystostomy since they could not retain an external condom for urinary drainage because of retraction of a small penis. Post implant, 81% of patients had no accidents involving condom loss, while 19% still lost condoms. All indwelling catheters could be removed except for one patient who continued with a suprapubic catheter following transurethral sphincterotomy (TURS) and a penile implant. Sixty-eight percent used the implant for sex and felt their wives were satisfied. Patient satisfaction survey showed a markedly increased self esteem, increased mobility without fear of condom loss, and an improved sex life. Overall, the long term prosthesis failure rate was 8%. The specific infection complication rate was less than 2%. The Flexirod semirigid, hinged prosthesis proved ideal in meeting the requirements for these patients.

Adult↗

Prevention strategies other than male condoms employed by low-income women to prevent HIV infection.

This study sought to determine HIV prevention strategies other than male condom use employed by low-income women who have sex with men (WSM) and to identify variables that predict use of these strategies. A cross-sectional survey of nearly 4,000 women receiving Women, Infants, and Children (WIC) benefits in 21 Missouri counties was conducted. The response rate was 58%, with 2,256 completed questionnaires returned. Women were asked to indicate one or more of nine methods they had ever used to prevent HIV infection. Women were also asked about their use of male condoms, preference for male condoms versus female condoms, and which partner usually made decisions about STD/HIV prevention. Of the 2,256 questionnaires returned, 1,325 WSM indicated use of at least one HIV prevention strategy other than condom use. Strategies were: being tested for HIV (68.2%), partner being tested for HIV (44.1%), asking partner about his sex history (41.1%), using oral contraceptives (18.8%), asking him if he has HIV (13.7%), douching (11.8%), withdrawal (9.4%), and having anal or oral sex (6.6%). Common predictors of these strategies were race, education, history of STD, condom use, and marital status. Basic misunderstandings about HIV prevention are common in specified subpopulations of low-income women. HIV prevention programs for low-income WSM should capitalize on women's efforts to prevent HIV by designing programs to help women replace ineffective prevention strategies with effective prevention strategies.

Adult↗

Discriminant attitudes and beliefs about condoms in young, multi-partner heterosexuals.

Four hundred and eight people aged 15-35 years who reported having more than one sexual partner of the opposite sex in the past year or who thought it likely that they would do so in the next year were surveyed about their sexual behaviour, concern about acquired immunodeficiency syndrome and sexually transmitted diseases and attitudes to condom use. Differences in concerns and attitudes between regular and non- or irregular condom users and between men and women are reported. Three conceptually coherent factors (condom use as positive action; condom use as cue to embarrassment; and condom use as antithetical to good sex) discriminated between users and non-users. Implications for health promotion campaigns designed to promote condom use are discussed.

Acquired Immunodeficiency Syndrome↗

Preventing AIDS and other STDs through condom promotion: a patient education intervention.

We report on two studies that assessed the impact of a soap-opera style videotape on inner-city STD (sexually transmitted disease) patients' knowledge about and attitudes toward condom use, and willingness to redeem coupons for free condoms. Subjects in the first study who viewed the videotape (and participated in a brief oral recall session) had higher knowledge scores and more accepting attitudes than subjects who did not (knowledge test means of 11.1 versus 7.9, attitude index means of 13.0 versus 11.3). The intervention was most effective among those who were relatively poorly educated and, to a lesser extent, among those who reported less frequent use of condoms and fewer sex partners. In the second study, intervention group subjects were more likely than control group subjects to redeem coupons. Both groups exhibited a high level of interest in the free condoms. We argue that education and accessibility to free condoms can increase condom use and that health care providers have a vital role in promoting this form of STD prevention.

Acquired Immunodeficiency Syndrome↗

Prior condom use and the risk of tubal pregnancy.

The relationship between prior condom use and tubal pregnancy was assessed in a population-based case-control study at Group Health Cooperative of Puget Sound during 1981-86. We interviewed 227 women with a tubal pregnancy who had no clinical indication of infertility and no history of sterilization and 674 similarly defined controls who were matched to the cases on age and county of residence. A history of condom use for more than one year was associated with a decreased risk of subsequent tubal pregnancy (RR = 0.74, 95% CI = 0.44, 1.26) adjusted for the effects of age, current use of contraceptive methods, educational level, and age at first intercourse. The effect was more pronounced when condoms had been used during five-year periods with more than one partner (RR = 0.38, 95% CI = 0.15, 1.0) than during five-year periods with one partner (RR = 0.89, 95% CI = 0.45, 1.76). Condom use for less than one year was unrelated to risk of ectopic pregnancy. Since the use of condoms offers protection against sexually transmitted diseases, one or more of which are likely to be causally related to tubal pregnancy, the observed negative association plausibly represents a protective influence of long-term condom use on the occurrence of tubal pregnancy.

Adult↗

Barrier contraceptives and sexually transmitted diseases in women: a comparison of female-dependent methods and condoms.

INTRODUCTION: Most efforts at sexually transmitted disease (STD) protection center on condom use, but little is known about how condoms compare with other barrier methods, particularly those controlled by women. METHODS: To evaluate the effect of different barrier contraceptives on the prevalence of STDs and other vaginal infections, we retrospectively studied 5681 visits by women to an urban STD clinic. RESULTS: As compared with women using no contraceptive or with tubal ligations, women using the contraceptive sponge or diaphragm had at least 65% lower rates of infection with Neisseria gonorrhoeae and Trichomonas vaginalis, while condom users had 34% and 30% lower rates, respectively. For Chlamydia trachomatis, the reduction was 13% among sponge users, 72% among diaphragm users, and 3% among condom users, although these differences were not significant. When compared with women using condoms, women using female-dependent methods (sponge or diaphragm) had significantly lower rates of both gonorrhea and trichomoniasis. Vaginal candidiasis was more common among women using diaphragms but not other barrier methods, while rates of bacterial vaginosis were similar among all groups. CONCLUSIONS: Women using the contraceptive sponge or diaphragm experience protection from STDs to a greater extent than those relying on condoms. Female-dependent barrier contraceptives should receive more attention in STD risk-reduction programs.

Adult↗

"Female condom" approved.

The Food and Drug Administration approved the first so-called female condom on May 7. Despite limited data on the effectiveness of the Reality Vaginal Pouch in sexually transmitted diseases (STDs) and a relatively high pregnancy rate among users, the device was approved because it is the first barrier contraceptive for women that provides some protection against STDs. The label will be required to emphasize that for "highly effective protection" against STDs, including AIDS, latex condoms for men are the best choice. The panel must also compare the pregnancy rate for the female condom--approximately 26%/year--to rates for other barrier contraceptives, which are lower. For example, the pregnancy rate for male latex condoms is approximately 15%/year. The females condom consists of a lubricated polyurethane sheath with a flexible polyurethane ring on each end. One ring is inserted into the vagina much like a diaphragm; the other remains outside, partially covering the labia. In addition to the labeling restrictions, FDA is also requiring the manufacturer of the product, Wisconsin Pharmacal of Jackson, Wis., to take part in additional effectiveness studies for the product. FDA's decision to approve the female condom was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of the agency's Obstetrics and Gynecology Devices Advisory Panel at its meeting on December 10, 1992. Wisconsin Pharmacal studies 200 women who used the device for 6 months. The estimated pregnancy rate of 26%/year in the study is believed to have been due in part to improper use of the device by some of the subjects. (The expected rate of pregnancy among women not using any contraceptive method is 85%). Women who use the device correctly each time they have intercourse can expect a lower pregnancy rate.

Americas↗

Protocol for changing condom catheters in males with spinal cord injury.

A five year study was conducted to determine the appropriate frequency for routine changing of condom catheters in males with spinal cord injury. One hundred and thirteen outpatient subjects participated in a non-randomized study. Eighty subjects changed their condom catheters on a daily basis, and 33 changed their condom catheters every other day. The subjects were questioned and the clinic record was reviewed by a nurse clinician about the incidence of skin and urinary complications occurring in the previous year. The most common skin complication found in both groups was redness, followed by excoriation. The most common urinary complication reported by both groups was urinary tract infection, followed by bladder and renal stones. There was no significant difference found in the incidence of skin or urinary complications between the subjects who changed their condom catheters daily and those who changed their condom catheters every other day. It is recommended that selected patients can change their condom catheters every other day as long as appropriate guidelines are followed.

Adult↗

Influence of attitudes on the intention to use condoms in Quebec sexually active male adolescents.

PURPOSE: The purpose of this study was to determine the influence of attitudes and other variables on the intention to use condoms in sexually active male adolescents. METHODS: The survey was conducted from April to June 1989 on a sample of 433 sexually active boys aged 12-19 years registered in secondary schools in Laval, Quebec. RESULTS: Information on condoms provided by parents, peers, school, or media had no positive effect on male adolescents' intention to use condoms. Having a favorable attitude towards contraceptive responsibility, however, was significantly associated with the outcome variable. Endorsement of this responsibility seemed short-lived being replaced by the birth control pill in older adolescents. The study also found that in younger adolescents, intention to use condoms was significantly associated with supportive parental attitudes. CONCLUSIONS: The results of this study highlight the importance of developing strategies to encourage sexually active male adolescents to assume greater responsibility for using condoms, and suggest that in order for programs to be effective, STD and acquired immunodeficiency syndrome prevention should be done at younger ages while encouraging parents to take a greater role in sex education.

Adolescent↗

Women's satisfaction with birth control: a population survey of physical and psychological effects of oral contraceptives, intrauterine devices, condoms, natural family planning, and sterilization among 1466 women.

User satisfaction and the physical and psychological effects of five commonly used contraceptive methods were investigated in a population survey among 1466 West German women. The focus was on effects attributed by current and past users to these methods, rather than objectively assessed effects, to shed further light on personal experiences that are highly relevant to the user but often remain unknown to prescribers and unreported in the medical literature. Within the overall sample, 1303 women were surveyed concerning their current or past use of oral contraceptives (OC), 996 regarding condoms, 342 with respect to intrauterine devices (IUD), 428 in regard to natural family planning (NFP), and 139 in relation to sterilization (respondents completed questions about each method used). It emerged that satisfaction was greatest with sterilization (92% of users), followed by OC (68% of ever users), IUD (59%), NFP (43%), and condoms (30%). Almost one in three NFP users had experienced an unwanted pregnancy during use of this method, as compared with one in 20 OC and condom users. The majority of users reported no mood changes during use of the methods studied. The percentages reporting negative mood changes (various items were scored) were up to 16% among OC users, 23% among condom users, and 30% among NFP users. The latter observations suggested that subjective side effects of a contraceptive agent on mood generally reflected, at least in part, the user's sense of confidence in the method concerned (notably, with regard to efficacy and safety). Oral contraceptives, IUD, and sterilization had a broadly positive impact on sex life, whereas that of condoms was often negative. Whereas OC users often reported less heavy and painful menstruation (in up to 56% of cases), IUD were associated with heavier, prolonged, and more painful menstruation (in up to 65% of cases), as also was sterilization, although to a lesser extent (in up to 32% of cases). Overall, the study findings indicated that OC and sterilization had less negative impact on physical and psychological functioning than the other methods studied, in contrast to what the general public often believes.

Adult↗

Use of birth control pills, condoms, and withdrawal among U.S. high school students.

PURPOSE: To examine the use of contraception at last sexual intercourse among currently sexually active adolescents. METHODS: We analyzed data from national school-based Youth Risk Behavior Surveys (YRBS) conducted in 1991, 1993, 1995, and 1997. The YRBS is a self-administered, anonymous survey which uses a national probability sample of U.S. students in public and private schools from grades 9 through 12. RESULTS: From 1991 to 1997, condom use significantly increased (from 46% to 57%), birth control pill use decreased (from 21% to 17%), and use of withdrawal significantly decreased (from 18% to 13%). In 1997, although more students were using condoms, 13% reported using withdrawal and 15% reported using no method to prevent pregnancy at last sexual intercourse. In 1997, condom use among females was significantly lower in the 9th grade than in the 12th grade (p <.001), whereas birth control pill use was higher (p <.001) and use of withdrawal remained stable. Among males, condom use and withdrawal use remained stable from 9th to 12th grade, whereas birth control pill use by their partner increased (p <.001). CONCLUSIONS: Inadequate contraceptive use among sexually active adolescents continues to be a major public health problem in the United States. For young people who will not remain sexually abstinent, families, health care providers, schools, and other influential societal institutions should promote the correct and continued use of condoms as essential protection against sexually transmitted diseases and human immunodeficiency virus infection.

Adolescent↗

Evaluation of the validity of the condom use self-efficacy scale (CUSES) in young men using two behavioral simulations.

Assessment of behavioral skills remains critical to the evaluation of HIV prevention interventions; however, investigators often rely upon participant reports of self-efficacy to estimate such skills. We evaluated the relationship between self-efficacy beliefs for condom use and behavioral performance. Forty-three men completed the Condom Use Self-Efficacy Scale (CUSES) and participated in 2 behavioral assessments. Regression analyses indicated that the CUSES subscales relevant to negotiation of condom use did not account for a significant amount of variability in interpersonal skills; similarly, the CUSES subscale relevant to technical condom use skill did not account for variability in the condom application scores. We caution investigators against the assumption that higher self-efficacy reflects behavioral competence for HIV-risk reduction.

Adolescent↗

"Condom distribution in high school" -- a rebuttal.

To challenge the distribution of condoms on school campuses with accusations of immorality and "lack of good character" appears shallow at best. Considering the home situation of many young people and their immediate environment, the act of securing a condom could be totally consistent with "good character." Certainly, abstinence up to a certain stage in a youth's life is prudent, but who is to determine the age to which, and the environment in which, abstinence must be observed universally? The litany of virtues to which Gow refers (kindness, courtesy, the Golden Rule, and so forth) all could be attributed to the youth who obtains a condom at school and uses it in an effort to protect himself and his partner. Use of a condom even by a teenager is not an unvirtuous act. Gow refers to two "misguided assumptions." The first is that "it is the legitimate function of the schools to dispense contraceptives." He maintains that parents and physicians, not schools, constitute the proper source of medical information and medication. Granted, they are the most logical and desirable sources, but what if a student has incompetent or perhaps no parental guidance and has little if any access to a physician? Schools have acted in loco parentis ever since public education first evolved. Why should it stop now during a devastating health crisis? The second "misguided assumption"--that "teen sex and pregnancies result from ignorance"--happens to be true. Ignorance is a major cause of pregnancies and AIDS. Distribution of condoms on campuses will help to counteract ignorance because it leads to explanations and discussion, two essential components of education. I find no quarrel with Gow's call for reevaluation of values and methods of communication. His belief that institutions such as churches, families, social organizations, and so forth must assume a larger role in clarification of values is logical. But until that occurs, what institution other than a public school has a better chance to reach the greatest number of young people?

Americas↗

Barriers to condom use among heterosexual male and female college students.

The authors used a questionnaire to assess gender differences in barriers to condom use among 198 female and 89 male heterosexual undergraduate college students. Participants were divided into three groups--consistent users, inconsistent users, and nonusers--based on their reported condom use. Factor analyses on each gender revealed similar barrier factor structures, but the barriers explained more of the variance in condom use among women than among men. Of the 9 or 10 predictors assessed, the low perceived need barrier was the most powerful predictor of condom use for both genders. Male and female participants who were nonusers, in a current monogamous relationship, and using oral contraceptives were more likely to report a low perceived need to use condoms. Implications for future research are discussed.

Adult↗

Changes in condom use by gay men.

Cross sectional and longitudinal data on condom use among homosexually active men is presented. Data pertain to two waves of interviewing (1987/8 and 1991) from Project SIGMA, a large longitudinal study of male homosexual behaviour in the light of HIV. Aggregate changes across the time-period indicate an increase in condom use for both insertive and receptive anal intercourse, particularly with casual partners. Condom use is still much more prevalent with casual rather than regular partners. Longitudinal analysis show considerable changes at the individual level, with almost a third of men changing their practices. Half of those decreased their risk behaviours, whilst the other half increased them. Less than 1% used condoms for fellatio in the year preceding the 1991 interview, but 8.3% had used other barriers during sex, primarily for hygiene and fun reasons, rather than as disease prophylaxis. Some implications are drawn for condom promotion and HIV prevention.

Adolescent↗