Barrier methods of contraception.
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Contraceptive Devices, Female↗
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Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going?
Acceptability research is an important component of any product development process. As researchers move into a new, accelerated phase of vaginal microbicide development, it is important to take stock of the acceptability research conducted to date and determine future research priorities. In this paper, we review findings from acceptability research conducted to date in four categories: hypothetical product acceptability research, existing product research (spermicide acceptability studies), acceptability research within the context of clinical trials, and postmarketing acceptability research conducted around the female condom. Finally, we highlight areas where additional research is needed in light of recent progress in microbicide development and discuss a possible framework for the introduction and acceptability of new sexually transmitted disease (STD) prevention technologies.
Administration, Intravaginal↗
Adolescent contraception: an update.
Increased adolescent sexual activity in the past decade has resulted in corresponding increases in pregnancy, childbirth, and abortion, as well as a changing spectrum of sexually transmitted diseases. Contraceptive use in this age group remains limited and is subject to developmental, peer, family, and cultural influences. The most appropriate contraceptive methods may differ among adolescents when compared with older parous women based upon such factors as efficacy, availability, cost, side effects, reversibility, and the need for preplanning. This review updates changes in patterns of contraceptive use among adolescents, presents recent data on both the benefits and the potential risks of the oral contraceptive pill, and addresses the risk of complications with the intrauterine device. The possible teratogenicity of spermicides, the risk of toxic shock syndrome with barrier methods of contraception, and controversy about the use of depot medroxyprogesterone acetate are explored. Newly introduced methods such as the triphasic pill, vaginal sponge, cervical cap, spermicidal condom, and a simplified approach to postcoital contraception are discussed. Finally, recent compliance studies conducted among adolescents are reviewed.
Adolescent↗
Development and validation of an acceptability and satisfaction questionnaire for a contraceptive vaginal ring, NuvaRing.
OBJECTIVE: To validate an acceptability questionnaire for NuvaRing, a new combined contraceptive vaginal ring. METHODS: A 21-item questionnaire was developed covering: ease of ring use, ease of package use, clarity of instructions, sexual comfort, cycle-related characteristics, compliance and satisfaction. A total of 2145 women completed the questionnaire after 3, 6 or 13 cycles of NuvaRing use. The psychometric properties and predictive value of the questionnaire were assessed using cycle 3 data (n = 1950). The quality of completed questionnaires, item content analysis, construct validity, internal consistency reliability, known groups validity and predictive validity were evaluated. RESULTS: Excluding non-ordinal items, 0.6% of the data were missing. Principal component analysis of 15 ordinal items indicated that two hypothesised dimensions ('ease of package use' and 'clarity of instructions') were consistently linked and so were combined into a single 'ease of comprehension' scale. Item convergent validity (the degree of correlation between an item and its own scale) was 100% for 'ease of ring use' (r = 0.44) and 'satisfaction' (r = 0.58), 83% for 'ease of comprehension' (r = 0.25-0.62) and 67% (r = 0.38-0.54) for 'sexual comfort', but 0% for 'cycle-related characteristics' (r = 0.31). Item discriminant validity (the degree to which an item correlates with its own scale compared with other scales) was >/=96% for all dimensions. Internal consistency reliability was acceptable for all dimensions (adjusted Cronbach's alpha coefficient >0.70). Satisfaction was higher than in the complementary groups for respondents who had no adverse events, chose NuvaRing as the best method of contraception or completed the study; this indicated good known groups validity. Low satisfaction with the method was a good predictor of early discontinuation after cycle 3, indicating that the questionnaire had good predictive validity. CONCLUSIONS: The acceptability questionnaire has good psychometric properties and can predict early discontinuation of the NuvaRing vaginal ring method of contraception.
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↗
[Evaluation survey of the acceptability of the condom in Benin (Come district)].
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Africa↗
A polyherbal vaginal pessary with spermicidal and antimicrobial action: evaluation of its safety.
A polyherbal vaginal pessary (Praneem) has been formulated that has antimicrobial properties against genital pathogens in addition to spermicidal action. Thus, it has dual potential as a barrier method for contraception and for providing protection against some sexually transmitted infections. The present study reports the findings of a multicentre trial that was conducted to evaluate the safety of this product. Trials were carried out in 23 women in three centres in India: the Postgraduate Institute of Medical Education and Research, Chandigarh; Safdarjang Hospital, New Delhi; and Kamla Nehru Memorial Hospital, Allahabad. Thorough clinical and pelvic examinations were carried out as well as cervical cytology, blood biochemistry and haematology before and after use of the polyherbal pessary intravaginally once daily for 7 consecutive days. No toxicity was observed on clinical examination or by laboratory investigations. Daily intravaginal use of this pessary for 7 days had no adverse effects on cervical cytology or on metabolic and organ functions.
Administration, Intravaginal↗
Anogenital warts contributing to the risk of squamous intraepithelial lesions among HIV-positive women of São Paulo, Brazil.
Unsafe sexual practices may expose HIV-positive women to high-grade squamous intraepithelial lesions (SIL) and to infection with oncogenic human papillomavirus (HPV) types. A cross sectional study of 141 HIV-positive women was designed to evaluate risk factors for the development of cervico-vaginal SIL and HPV-DNA detection/typing. Uni- and multivariate forward stepwise analysis was used to determine the relationship between risk variables and HPV infection and between risk behaviour, HPV and HIV infection with development of SIL. Univariate analysis showed that HPV-DNA infection was related to previous and recurrent anogenital warts, male genital warts and cytological alteration. For final multivariate analysis, both HPV type (undetermined- and high-risk, OR=29.3 and 112.0, respectively) were statistically associated (P=0.019) with high-grade cervico-vaginal SIL. The presence of anogenital warts as well as high- and undetermined-risk HPV infection may alert to cyto/histopathological alterations. These results point out the importance of the use of barrier methods and routine early genitoscopy/treatment for HIV-infected partners.
Adult↗
Female-controlled methods to prevent sexual transmission of HIV.
UNLABELLED: THE NEED FOR PREVENTION: Women throughout the world face a growing risk of infection with HIV. Consistent condom use, one cornerstone of primary prevention strategy, is not always feasible for many women. Consequently, women urgently need infection prevention technology that is within their personal control. METHODS: This session will review current efforts to develop and test female-controlled methods for preventing sexual transmission of HIV and other sexually transmitted pathogens. Both physical and chemical methods will be summarized, including recent findings concerning the efficacy and acceptability of the vaginal pouch (female condom), as well as an overview of research on vaginal microbicides. Data from studies of existing over-the-counter spermicides will be reviewed. The wide range of novel microbicidal products currently being evaluated in the laboratory and early clinical trials demonstrate the breadth of possibilities presented by chemical barrier methods. However, formidible challenges face public and private sector research and development efforts. This session will conclude by highlighting several issues related to the clinical evaluation and introduction of female-controlled prevention technology.
Contraception↗
[Contraception in perimenopause].
Perimenopausal women are still potentially fertile and pregnancy is attended with increased maternal and perinatal mortality. Several contraceptive methods can be used therapeutic for the treatment of climacteric symptoms like menstrual irregularities, flushes and vaginal dryness. Low-dose oral contraceptives (OC) prevent climacteric symptoms and additionally protect from perimenopausal bone loss. However, the individual cardiovascular risk increases with age and is even higher in perimenopausal women using OCs. Therefore for women with cardiovascular risk factors sterilization, barrier methods, progestin-only methods and intrauterine devices (IUD) are the better choice. Prolonged and heavy menses can be treated with the levonorgestrel-releasing IUD or injectable progestogens. If estrogen replacement is necessary, a low-dose treatment with natural estrogens can be combined with barrier methods, the levonorgestrel-releasing IUD and injectable progestogens. The variety of contraceptive options available to perimenopausal women allows individual counseling and thus may enhance compliance.
Adult↗
Effect of Replens gel used with a diaphragm on tests for human papillomavirus and other lower genital tract infections.
OBJECTIVE: Little is known about effects of vaginal lubricants with barrier contraceptives on detection of sexually transmissible infections. We hypothesized that Replens gel used with a diaphragm would neither inhibit human papillomavirus (HPV) detection in cervical samples and chlamydia (CT) and gonorrhea (GC) detection in urine samples, nor affect cervical cytology quality. MATERIALS AND METHODS: After a clinician-collected cervical sample and a self-collected vaginal sample for HPV detection ("pregel" specimens), women placed a diaphragm containing Replens gel into the vagina. Participants (n = 77) removed the diaphragm after 6 hours and performed vaginal HPV self-sampling at several time points thereafter. Clinicians performed cervical cytology sampling and HPV testing ("postgel" specimens) 24 hours after diaphragm removal. Pregel and postgel specimens were analyzed with and without added SiHa cells (source of defined numbers of HPV16 genomes). HPV was detected by polymerase chain reaction using MY09/11 primers. Urine samples were obtained for CT and GC testing. Proportions of samples testing positive were compared using relative risk (RR) regression models. RESULTS: Proportions with detectable HPV in the clinician-collected cervical pregel and postgel samples were not statistically different for samples with added SiHa cells (88.3% vs 93.2%, RR = 1.06, 95% confidence interval = 0.96-1.14) or for native HPV infection (32.9% vs 28.2%, RR = 0.87, 95% confidence interval = 0.71-1.06). In self-collected vaginal postgel samples, there was no trend for decreased HPV detection after gel exposure. Gel affected neither urine tests for CT and GC nor cytological quality. CONCLUSIONS: Recent Replens gel use with a diaphragm does not inhibit cervical HPV testing, urine testing for CT and GC, or cervical cytology quality.
Adolescent↗
Use of intrauterine device in the setting of uterus didelphys.
BACKGROUND: Uterine anomalies are frequently diagnosed in reproductive-aged women and are generally considered a contraindication to the use of intrauterine contraception. We elected to offer this method to a woman with uterus didelphys and a poorly controlled seizure disorder who wished to avoid hormonal and barrier contraceptives. CASE: A 17-year-old woman (gravida 1, para 1) with a seizure disorder desired an intrauterine device (IUD). She was found to have uterus didelphys and a complete vaginal septum. After obtaining informed consent, an IUD was placed in each uterine horn. The patient retained both IUDs and was satisfied with the method 9 months after IUD insertion. CONCLUSION: Intrauterine contraception should be considered an option for women with uterine anomalies on a case-by-case basis.
Adolescent↗
Potential preventive strategies and therapies in urinary tract infection.
There are perhaps five strategies either presently advocated or under investigation for prevention of recurrent urinary tract infection (UTI): antibiotics, including natural peptides; functional foods; vaccines; probiotics; and miscellaneous, including avoidance of spermicides and maintenance of good hygiene. It is not possible to state the proportion of patients using antibiotics versus foods such as cranberry or using alternative approaches such as avoidance of spermicides. The majority of women who are referred to specialists will be prescribed long-term, low-dose antibiotics. However, given the magnitude of the problem, it is safe to state that large numbers of women are at least experimenting with alternative remedies such as drinking of cranberry juice or ingestion of herbal remedies with a view to enhancing their immune response. Vaccine development remains a long way from human use and has yet to be developed for organisms other than Escherichia coli. The use of probiotics of restore the normal vaginal flora and provide a competitive bacterial barrier to pathogens is close to becoming available as an alternative preventive approach. The next decade should see the introduction of new methods for reduction of the high incidence of UTI and better management of recurring urogenital infections.
Anti-Bacterial Agents↗
Barrier contraceptive use and HIV infection among high-risk women in Cameroon.
OBJECTIVES: To measure the association between spermicide use and HIV infection, adjusting for condom use, and to measure the association between condom use and HIV infection, adjusting for spermicide use. DESIGN: Prospective study of women using nonoxynol-9 (N-9) spermicides and latex condoms, with up to 12 monthly clinic visits for interviews, examinations and tests, and re-supply. METHODS: A total of 273 HIV-negative women with multiple sexual partners were enrolled, given latex condoms and N-9 vaginal spermicidal suppositories, and advised to use both every time they had sexual intercourse. Participants recorded data on sexual activity on pictorial coital logs. New HIV infections were detected and confirmed by quarterly enzyme-linked immunosorbent assays and Western blots, respectively. RESULTS: Nineteen HIV infections occurred during mean follow-up of 8.1 months (an incidence rate of 10.4 infections per 100 women-years). The adjusted HIV rate ratio (RR) was 0.1 [95% confidence interval (CI), 0.1-0.6] for more consistent compared with less consistent spermicide users; and 1.1 (95% CI, 0.4-2.9) for more consistent compared with less consistent condom users. Among the subgroup of experienced condom users, the RR for more versus less consistent condom use was 0.3. CONCLUSIONS: This is the first epidemiological evidence that N-9 spermicides can reduce the incidence of HIV infection. A more definitive randomized clinical trial is urgently needed.
Adolescent↗
Contraception during perimenopause.
Perimenopause marks the transition from normal ovulation to anovulation and ultimately to permanent loss of ovarian function. Fecundity, the average monthly probability of conception, declines by half as early as the mid-forties, however women during the perimenopause still need effective contraception. Issues arising at this period such as menstrual cycle abnormalities, vasomotor instability, the need for osteoporosis and cardiovascular disease prevention, as well as the increased risk of gynecological cancer, should be taken into consideration before the initiation of a specific method of contraception. Various contraceptive options may be offered to perimenopausal women, including oral contraceptives, tubal ligation, intrauterine devices, barrier methods, hormonal injectables and implants. Recently, new methods of contraception have been introduced presenting high efficacy rates and minor side-effects, such as the monthly injectable system, the contraceptive vaginal ring and the transdermal contraceptive system. However, these new methods have to be further tested in perimenopausal women, and more definite data are required to confirm their advantages as effective contraceptive alternatives in this specific age group. The use of the various contraceptive methods during perimenopause holds special benefits and risks that should be carefully balanced, after a thorough consultation and according to each woman's contraceptive needs.
Contraception↗
Structural integrity of the female condom after a single use, washing, and disinfection.
The Reality(R) female condom is approved for use during a single act of intercourse, but is expensive relative to other barrier methods. Re-use is a potential strategy to reduce its per-use cost. We tested the structural integrity of female condoms (n = 318) after a single act of vaginal intercourse. We also measured the impact of laboratory washing (1, 5, or 10 times) with and without disinfection on the structural integrity of unused condoms. Structural integrity was measured via 5 tests: seam tensile strength, water leakage, air-burst, tear propagation, and device dimensions. No degradation in device structural integrity occurred after a single use when compared to control for seam tensile (16.0 vs.15.7 mPa; p = 0.558); water leakage (1.9% vs. 0.9%; p = 0.618); air burst (3.9 vs. 3.6 kPa; p <0.001); or tear propagation (344.6 vs. 336.8 psi; p = 0.313). Mean length was slightly increased [single use vs. control (177.9 vs. 172.5 mm; p <0.001)]. No consistent pattern of structural degradation emerged across all wash/disinfection groups. Our data suggest the structural integrity of the female condom remains intact after a single use and cleaning.
Coitus↗
Invasive fungal dermatitis in the < or = 1000-gram neonate.
OBJECTIVE: In 1991, we noted the emergence amongst our extremely low birth weight neonates of a new clinical entity, invasive fungal dermatitis, characterized by erosive, crusting lesions and a high rate of subsequent systemic fungal infection. We sought to define this condition and examine potential risk factors. METHODS: Sixteen neonates with invasive fungal dermatitis were seen during a 2-year period in three Baylor College of Medicine affiliated intensive care nurseries. Seven were confirmed cases, with skin biopsy evidence of invasion beyond the stratum corneum. Nine had a consistent clinical course and a positive potassium hydroxide examination of skin scrapings or isolation of fungi from skin or systemic cultures. Three controls were matched to each case by hospital, date of admission, and birth weight. Data was collected by retrospective chart review. RESULTS: Invasive fungal dermatitis occurred in 5.9% of at-risk infants. Case patients had a mean birth weight of 635 g and developed skin lesions at a mean age of 9 days (range, 6 to 14). Candida albicans was the most commonly implicated pathogen, but other Candida species, Aspergillus, Trichosporon beigelii, and Curvularia were also seen. Disseminated infection occurred in 69%, all due to Candida sp. Case patients were significantly more premature than controls (mean gestation, 24.4 vs 25.9 weeks) and were more likely to be delivered vaginally (81% vs 50%). Postnatal steroids were administered to cases (81%) more often than controls (46%). Case patients had more prolonged hyperglycemia (as assessed by insulin administration) than controls (mean 4.3 vs 2.0 days). CONCLUSIONS: Invasive fungal dermatitis is a disease of the smallest, most immature neonates and is associated with vaginal birth, steroid administration, and hyperglycemia. We speculate that the skin serves as a portal of entry for colonizing fungal species and may thus lead to disseminated infection. Methods to improve skin barrier function may be useful in preventing this disorder.
Candidiasis↗
The protective effect of condoms and nonoxynol-9 against HIV infection.
OBJECTIVES: Whether or not spermicides can reduce the risk of human immunodeficiency virus (HIV) transmission remains an important question for the control of heterosexual HIV transmission. The authors provide estimates from a reanalysis of one of the few observational studies on the efficacy of condoms and spermicides, used separately and together, per vaginal contact. METHODS: In this reanalysis, three different models were used to assess the efficacy of spermicides and condoms: linear (Pearl index), exponential (maximum likelihood), and monotonic (marginal likelihood). RESULTS: Reported use of barrier methods among 27,432 contacts was as follows: condoms plus nonoxynol-9, 39%; condoms alone, 25%; nonoxynol-9 alone, 24%; and unprotected, 11%. Under all three models, the results indicate a strong protective effect for spermicidal suppositories. The Pearl index indicated that spermicide alone is apparently efficacious, but the efficacy per contact cannot be quantified with this approach. Maximum likelihood estimates for the efficacy of nonoxynol-9 alone and condoms (with or without nonoxynol-9) were 100% (95% confidence interval [CI95] = 43%, 100%) and 92% (95% CI95 = 79%, 100%), respectively. CONCLUSIONS: The data from this observational study suggest that spermicides may be efficacious in reducing the risk of HIV transmission.
Administration, Intravaginal↗