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New female intravaginal barrier contraceptive device. Preliminary clinical trial.

The Fem Cap, a silicone rubber cervical cap, is shaped like a sailor's hat. While its dome covers the cervix, its rim fits snugly into the vaginal fornices, and its brim adheres and conforms to the vaginal walls. A spermicidal material is applied to the cap, then it is positioned over the cervix by hand or with a special applicator. The device is removed by hand up to 48 hours after insertion, but no sooner than eight hours after intercourse. Women chosen for the trial had contraindications to or were dissatisfied with the currently available contraceptive methods. Each woman was fitted with a cap of suitable size and instructed in its use. She was then asked to note any side effects and the dates of her menses in a diary. One-hundred-twenty-one women were enrolled in the study. Five became pregnant. Of those, two reported dislodgment of the cap during intercourse; the other three admitted to non-use of the cap on several occasions. This device has proven so far to be safe, effective and acceptable to women and men. It has several advantages over the currently available barrier contraceptive devices. The silicone rubber material from which it is made is non-allergenic, durable and easy to clean. Its design fits the anatomy and accommodates physiological changes. The Fem Cap is easy to insert and remove; an applicator facilitates insertion for some women. Instruction for use of the device requires short time from the health care provider.

Adolescent↗

Assessing the number of genital chlamydial infections in the United States.

The prevalence and incidence of genital infections with Chlamydia trachomatis have not yet been determined for broadly based populations within the United States. Largely on the basis of results of prevalence studies from sexually transmitted disease clinics, it has been estimated that C. trachomatis infections are the most common of all sexually transmitted infections and may number 3-5 million cases annually. C. trachomatis isolation rates range from 50% to 80% in certain diseases known to be caused by Chlamydia and from 10% to 30% in sexually active female adolescents and approximately 5% in college women. Cheaper, more-sensitive and widely available diagnostic tests are necessary to adequately define the epidemiology of genital Chlamydia infections in the U.S.

Adult↗

Internet availability of contraceptives.

OBJECTIVE: To measure the accessibility of contraceptive supplies over the Internet. METHODS: We performed an Internet search with the use of search engines and key words. We posed as consumers purchasing both prescription and over-the-counter contraceptive supplies. The number of clicks or web pages accessed, costs, shipping time, barriers to access, and prescription requirements were compared for selected birth control supplies. RESULTS: More than 200 web sites were visited to locate at least one site where we could purchase each selected product. Contraceptive supplies, including male and female condoms, spermicides, vaginal sponges, intrauterine devices (IUDs), diaphragms, and cervical caps, were easily obtained without a prescription from foreign web sites. Oral contraceptive pills (OCs) were readily available online in November 1999; some sites had discontinued sales by February 2000, but OCs could still be purchased with no prescription in August 2000. None of the four prescription sites supplied physician or prescriber credentials. The contraceptive costs varied by vendor and product. A type of copper IUD could be purchased for less than $50.00, whereas a single package of emergency contraceptive pills cost $141.00 from one vendor because of prescription and shipping fees. Some emergency contraceptive pills ordered arrived after 72 hours or did not arrive and the purchase was not refunded. A levonorgestrel IUD was shipped without difficulty in December 1999, but a second device, ordered in February 2000, was temporarily impounded by United States Customs. CONCLUSION: This method of contraceptive purchase is accessible, expensive, erratically regulated, and rapidly changing.

Contraceptive Agents↗

Knowledge about sexually transmitted diseases in rural and periurban communities of the Asaro Valley of Eastern Highlands Province: the health education component of an STD study.

Community health education played a major role in a study of sexually transmitted diseases (STDs) and other reproductive tract infections which we conducted in rural and periurban communities of the Asaro Valley near Goroka in the Eastern Highlands Province of Papua New Guinea. We found that most women had little knowledge about STDs, which they often did not realize were sexually transmitted. Even major signs and symptoms were thought to be normal and many women had not sought treatment until irreversible damage was done. Knowledge of the complications of STDs, such as infertility and stillbirth, was also slight in these women. It is apparent that there is a desperate need for more reproductive health education at the community level. In developing our health education methods, we found that simple line drawings of male and female reproductive organs and of people with different signs of STDs proved useful. These were quick and easy to produce from readily available materials. It was important to separate men and women into different groups with educators of the same sex, and to create a very informal atmosphere, encouraging free-ranging discussion. Following health education and sensitive interviewing, almost all the women selected for the community-based study of the prevalence of reproductive tract infections consented to vaginal examination, even if they were asymptomatic. Additionally, many nonselected women requested examination.

Adolescent↗

Sex in Australia: safer sex and condom use among a representative sample of adults.

OBJECTIVE: To provide reliable estimates of the frequency of condom use and correlates of condom use among Australian adults. METHODS: Computer-assisted telephone interviews were completed by a representative sample of 10,173 men and 9,134 women aged 16-59 years. The response rate was 73.1% (69.4% men, 77.6% women). RESULTS: Although the majority of respondents had used a condom at some time in their lives, fewer than half of the respondents who were sexually active in the year before being interviewed had used a condom in the past year. Condom use in the past year was associated with youth, greater education, residence in major cities, lower incomes, white-collar occupations, being a former smoker, and having more sexual partners in the past year. In the six months prior to interview, 7.1% of respondents always used condoms with regular cohabiting partners, 22.5% always used condoms with regular non-cohabiting partners, and 41.4% always used condoms with casual partners. Approximately 20% of respondents used a condom the last time they had vaginal intercourse, and one in eight of these condoms were put on after genital contact. Condom use during the most recent sexual encounter was associated with youth, living in a major city, having a lower income, having sex with a casual partner, and not using another form of contraception. CONCLUSION: As in other studies, condom use was strongly associated with partner type and use of other contraception. IMPLICATIONS: People with multiple sexual partners need to be aware that non-barrier methods of contraception (and condoms applied late) do not protect against sexually transmitted infections.

Adolescent↗

[Breast feeding: which contraceptive method?].

Contraception during breast feeding must take two points into account: the first physiological contraception due to anovulation which disappears at around the 9th week of lactation); the second pharmacological: any substance ingested by the mother during breast feeding is excreted in milk, chiefly by passive diffusion. All pharmacokinetic studies have shown that the transfer of progesterone or of estrogen when taking a contraceptive pill is extremely slight, being of the same order as that of natural hormones. When it is decided to use hormonal contraception, this should be started after the 6th week of lactation, when lipid profile has returned to normal and thromboembolic risk is identical to that of the population in general. As with all prescription during lactation, the drug should be taken as far as possible from the next feed. Barrier techniques (combining condoms and spermicides) are an elegant alternative to drug methods.

Amenorrhea↗

Evaluation of dry and wet transported intravaginal swabs in detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in female soldiers by PCR.

Screening women for sexually transmitted diseases (STD) in nonclinic settings is highly desirable because many infections are asymptomatic. This is especially true for military women, for whom logistical, social, and other job-related obstacles present barriers to accessing medical care. We assessed the accuracy of intravaginal swabs transported by mail in a wet versus a dry state for PCR (Amplicor CT/NG test) detection of chlamydia and gonorrhea infections in a cross-sectional study of 793 active-duty military women attending an STD clinic. PCR tests of vaginal swabs (wet and dry) were compared to local clinical methods used on cervical swabs. Standard wet vaginal swab PCR testing detected more chlamydia (11.6%) than cervical enzyme immunoassay (9.3%). For detection of chlamydia using wet swabs, the sensitivity and specificity compared with adjudicated true positives were 94.6% (87 of 92) and 99.3% (696 of 701), respectively. Comparing dry swabs to true-positives for chlamydia, the sensitivity was 91.3% (84 of 92) and the specificity was 99.3% (696 of 701). Standard wet vaginal swab PCR detected more gonorrhea (3.3%) than routine cervical culture (2.1%). The sensitivity and specificity of PCR testing of wet swabs compared to true-positives (infected patients) were 96.3% (26 of 27) and 98.2% (752 of 766) for gonorrhea, respectively. For gonorrhea, the sensitivity and specificity of dry swabs compared to true-positives (infected patients) were 88.9% (24 of 27) and 98.3% (753 of 766), respectively. PCR testing of wet and dry transported intravaginal swabs to detect chlamydia and gonorrhea infections was an accurate diagnostic method for military women.

Adolescent↗

Understanding the unprotected sexual behaviors of gay, lesbian, and bisexual youths: an empirical test of the cognitive-environmental model.

The cognitive-environmental model (CEM; M. Fishbein et al., 1991) was used to understand the unprotected sexual behaviors of 156 gay, lesbian, and bisexual youths. Unprotected anal sex among the males was associated directly with poor protection skills (e.g., incorrect use of barrier methods, such as condoms), poor intentions to use barrier methods, and poor norms by sexual partners concerning barrier methods. Furthermore, the association between low self-efficacy and increasing unprotected anal sex was attributed to poor intentions. Direct associations of unprotected oral sex with poor intentions and poor partner norms also emerged, as did an indirect relation between unprotected oral sex and low self-efficacy via poor intentions. These last 3 findings were replicated when examining unprotected oral or vaginal-digital sex among the females. Relations among the CEM factors supported some CEM-theoretical propositions.

Adolescent↗

HIV prevention: the need for methods women can use.

Efforts to prevent heterosexual transmission of HIV (human immunodeficiency virus) infection have thus far focused on modifying sexual behaviors and the use of condoms. While the experience of family planners, particularly in those countries most threatened by heterosexual HIV transmission, has shown that the most effective measures of pregnancy prevention have relied on women, little attention has been given to barriers to HIV transmission that depend on the woman and are under her control. Tactics which interrupt transmission of the virus should be considered in their own right and separated from those that interrupt pregnancy, for insurance, the diaphragm. Greater emphasis is urged for research on preventive methods women could use, including the possibility of a topical virucide that might block transmission through the vaginal route.

Adult↗

The external urethral barrier for stress incontinence: a multicenter trial of safety and efficacy. Miniguard Investigators Group.

OBJECTIVE: To assess the efficacy and safety of an external urethral barrier for the management of mild to moderate stress urinary incontinence in adult women. METHODS: Four hundred eleven women with the symptom of stress urinary incontinence in 12 United States centers participated. Additional inclusion and exclusion criteria were applied before protocol device use, and ultimately 390 subjects began device use. Outcome measures for efficacy and safety were assessed. Efficacy was evaluated by the number of leakage episodes using a voiding diary, subjective urinary leakage severity, incontinence impact scores, and pad testing. Safety was evaluated by symptom assessment, urinalysis, urine culture, measurement of postvoid residual urine volume, vulvar cytology, vaginal culture, and (n = 81) cystometric testing. RESULTS: Efficacy was indicated by statistically significant reductions in the number of leakage episodes, subjective leakage severity scores, incontinence impact scores, and pad-test loss during device use. The data also indicated that the device was safe, as evidenced by the lack of statistically significant changes in the percentage of subjects with urinary tract infections during device use or in postvoid residual urine volume and cystometric indices. Symptoms of vulvar irritation or lower urinary tract discomfort occurred in a small percentage of subjects but were generally transient, and only three women discontinued using the device. CONCLUSION: The external urethral barrier appears to be a safe nonsurgical alternative to absorbent products for the management of mild to moderate stress urinary incontinence in adult women.

Adolescent↗

Contraception after heart surgery.

This study represents the different methods of contraception used by women having cardiac surgery at Ain Shams University Hospital. The study comprised of 250 women having had mitral commissurotomy, 77 women having had valve replacement including one case of triple valve repair and 3 women having had cardiac surgery for congenital heart disease. An IUCD was used by 170 women (51.5%), vaginal tablets by 4 women (1.2%), oral contraceptive pills by 7 women (2.1%), "safe period" by 7 women (2.1%), tubal ligation was performed in 10 women (3%). The husbands of 33 women (10%) used condoms, and 99 women (30%) did not use contraceptive methods. The IUCD was tolerable and was associated with bleeding in 60 women (35.2%) and leucorrhoea in 55 (32.3%). The IUCD was removed from only one woman due to severe bleeding. Three pregnancies occurred with condom users in two women who had had mitral commissurotomy and one having had valve replacement. There was no case of bacterial endocarditis in the study group.

Abortion, Spontaneous↗

Condom use and breakage among women in a municipal hospital family planning clinic.

For those who choose to be sexually active, condoms are the best available means of protection against sexually transmitted diseases including the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). Condoms are also an effective method for preventing pregnancy. Unfortunately, condoms are not 100% effective at preventing pregnancy or the spread of infection, in part because condoms do break. In order to gain insight into condom breakage, a questionnaire was administered to women attending a municipal hospital family planning clinic. Thirty-six percent of the 106 subjects had experienced at least one condom breakage. Condom breakage occurred in approximately 1 out of 100 acts of intercourse using condoms, with a lifetime breakage rate of 10 per 1000 condom uses and a past year breakage rate of 8 per 1000 condom uses. Breakage rates did not differ substantially by age. Five percent of the women's unplanned pregnancies were attributed to broken condoms. The results of this study corroborate previously reported rates. Factors associated with these women's most recent breakage experiences included: vaginal intercourse, minimal foreplay, and breakage prior to ejaculation. Controlled studies will be needed to determine how the condom can be used to reduce the likelihood of breakage.

Contraceptive Devices, Male↗

College students' high-risk sexual behavior following alcohol consumption.

This study is a follow-up to a previous study assessing the relationship of alcohol consumption as a disinhibitor to high-risk sexual behavior. Results are based on survey data from 1,902 students attending 12 colleges. Sexual behaviors occurring after people had "let themselves drink more than normal in order to make it easier for them to have sex with someone" were assessed. At least once in the past year, 33.2% of the men and 17.4% of the women had met this criterion. In those instances, 76.3% of the men and 77.1% of the women initiated condom use for vaginal intercourse. Results are discussed in relation to partners' compliance following condom initiation and preventing the spread of HIV disease.

Alcohol Drinking↗

Preventing the heterosexual spread of AIDS: what is the best advice if compliance is taken into account?

It has been recently advocated that avoiding partners who may be at high risk of carrying HIV provides 5000-fold better protection against HIV infection than usage of condoms [1]. In this paper, it is demonstrated that this guideline is largely based on unrealistic assumptions. If the sensitivity of identifying high-risk partners, realistic estimates of the efficiency of mechanical and chemical barrier methods, and the compliance in following either strategy are taken into account, use of condoms and/or suppositories containing nonoxynol-9 might be more effective than the attempt to avoid high-risk partners. Thus, both barrier methods should be strongly recommended for casual sexual heterosexual contacts.

Acquired Immunodeficiency Syndrome↗

Contraceptive use in women with bacterial vaginosis.

The aim of the study was to investigate if bacterial vaginosis (BV) is associated with use of specific contraceptives. Women at family planning and youth clinics (n = 956), among whom 131 had BV, were subjects for structured in-depth interviews including current and previous contraceptive use. Variables measuring sexual risk-taking were ascertained. Current users of contraceptives were compared with non-users. Both oral contraceptive (OC) and condom use showed a significant protective effect against BV, adjusted for possible confounders (odds ratios were 0.4 and 0.3, respectively). Intrauterine device use (IUD) showed no association with BV. Women with BV had less often used any contraceptives, including condom, at their sexual debut than the women in the comparison group. In this study, OC and condom use seemed to exert a protective effect against BV, whereas no effect for IUD use was found.

Adult↗

HIV risk behavior among Peace Corps Volunteers.

OBJECTIVE: To describe HIV risk behaviors among Peace Corps Volunteers (PCV) and to examine correlates of sexual risk behaviors. METHOD: Cross-sectional data were collected from 1242 randomly selected PCV serving in 28 countries in 1991. PCV reported the frequency of specific risk behaviors in self-administered questionnaires, which were completed anonymously and returned to the Centers for Disease Control and Prevention. RESULTS: Non-sexual HIV risk behaviors were rarely reported by PCV. Sixty-one per cent of the 1080 PCV who answered questions about sexual behavior during their Peace Corps service reported having at least one sex partner. Sixty per cent of PCV had another PCV partner, 39% had a host-country national partner, and 29% had a non-PCV expatriate partner. Overall, less than one-third (32%) of unmarried PCV used condoms during every episode of sexual intercourse; more frequent use was reported in relationships with non-steady and (for male PCV) host-country national partners. Among male PCV, condom use was positively related to lower alcohol use and the belief that HIV was a problem in the host country. Female PCV reporting more condom use with male partners were younger and had fewer partners than those reporting less use. CONCLUSION: These data indicate that PCV are at risk for acquiring HIV through unprotected vaginal intercourse. All persons who become sexually active with new partners while travelling or living abroad should be encouraged to use condoms consistently.

Adult↗