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Safety and tolerability of the new contraceptive sponge Protectaid.

OBJECTIVE: This study was undertaken to assess the efficacy, safety and acceptability of two different-dose regimens of the Protectaid contraceptive sponge. METHODS: The toxic effects of two forms of the new vaginal contraceptive sponge, Protectaid, in the cervical and vaginal tissues were studied. Both types were impregnated with F-5 gel containing different doses of nonoxynol-9 (NX9; 0.5% and 0.125%). The sponge was used by 35 women aged 20-35 years (mean 28.7 years) randomly allocated into two groups (Group A: 0.5% NX9, n = 20; Group B: 0.125% NX9, n = 15). RESULTS: During a 12-month period both regimens demonstrated a 91.4% overall contraceptive efficacy. Colposcopic examinations showed no significant cervical or vaginal lesions in either group, except for two cases at the 2-week and 3-month examinations in Group A women. In the former, inflammatory changes of little clinical significance were seen and the colposcopic appearance of the vagina was non-specific. In this case, the focal lesions were accompanied by dilated capillaries (hyperemia). In the second case, degenerative inflammatory changes, with the inflammatory foci varying in shape and distribution, were observed. Cervical cultures taken 6 months after the start of treatment showed the presence of Mycoplasma hominis and Candida albicans in one and two cases, respectively, in Group A. In Group B, cervical cultures taken at 3 months showed Gardnerella vaginalis and beta-hemolytic streptococci group B in one and two cases, respectively. CONCLUSION: The potent spermicidal and protective properties of this new contraceptive sponge may be of benefit to the sexually active female. Since the sponge was very well accepted by both the study participants and their sexual partners, it can be considered as a valuable barrier method.

Administration, Intravaginal↗

Use of nonoxynol-9 and reduction in rate of gonococcal and chlamydial cervical infections.

The spermicide nonoxynol-9 (N-9) has been used as a contraceptive for over 30 years, but the use of a vaginal spermicide and condoms for the prevention of sexually transmitted infections has not been examined in randomised studies. We report a single-blind randomised field trial to assess the effect of N-9 film on the rate of gonococcal and chlamydial cervical infection in women at high risk of these diseases. 343 women were randomly assigned to use either condoms and N-9 (186 women) or condoms and a placebo (157). Compliance with condom use was much the same in the two groups. Overall, N-9 reduced the rate of cervical infection by 25% (rate ratio [RR] 0.75, 95% confidence interval [Cl] 0.5-1.1); in women who used N-9 for more than 75% of their coital acts the infection rate was reduced by 40% (RR 95% Cl 0.3-1.0). The rate of yeast vulvovaginitis or genital ulcers was not higher in N-9 users than in placebo users, but the rate of symptomatic irritation was increased by 70% (RR 95% Cl 1.1-2.6) among N-9 users. Condom use was more protective against cervical infection than N-9 use. The rate of infection was 50% (RR 95% Cl 0.3-0.7) lower with 75% than with 0-50% condom compliance. The use of a vaginal N-9 spermicide with condoms whenever possible seems to be a better strategy than the use of condoms only for prevention of gonococcal and chlamydial cervical infection.

Administration, Intravaginal↗

Applying the theory of planned behaviour to pharmacists' beliefs and intentions about the treatment of vaginal candidiasis with non-prescription medicines.

BACKGROUND: It is important to understand health professionals' attitudes and beliefs about practice and the barriers to achieving best practice. The theory of planned behaviour (TPB) has been widely used to understand behaviour. In this study, TPB was used to explore the psychological variables that influence community pharmacists and the supply of non-prescription medicines. OBJECTIVES: The objectives of the study were to: (i) apply the TPB to community pharmacy behaviour; (ii) identify barriers to/facilitators of evidence-based practice; (iii) describe psychological variables and responses to written scenarios of patients presenting in community pharmacies for non-prescription antifungals for the treatment of vulvovaginal candidiasis; and (iv) to examine the relationships between beliefs and behavioural intention. METHODS: A questionnaire survey was constructed using the TPB and disseminated to pharmacies in Grampian, Scotland. The purpose of the study was to explore community pharmacists' attitudes, beliefs and intentions about the supply of non-prescription antifungals for the treatment of vulvovaginal candidiasis. RESULTS: Of the 121 questionnaires disseminated, 76 (63%) were returned. Behavioural intention to sell antifungals to women with vulvovaginal candidiasis symptoms was strong. Attitude towards recommending these medicines was positive. However, only half of the sample responded appropriately to all four patient scenarios (n=42, 54%). Most pharmacists felt that they were able to recommend antifungals if they wished, but did not feel under social pressure to recommend them. Local doctors did not appear to be influential with respect to selling antifungals. If a customer was elderly, pregnant or if the pharmacist was uncertain of the diagnosis of candidiasis, an antifungal was less likely to be recommended. CONCLUSION: TPB provides a valid and useful summary of the key psychological variables influencing practice. There is more to pharmacy practice than the knowledge and attitudes of the pharmacist.

Antifungal Agents↗

Intimacy and women with type 2 diabetes: an exploratory study using focus group interviews.

PURPOSE: This study explored if and how women perceived diabetes as affecting their social and sexual intimacy and if they wished to receive professional attention for any sexual disturbances that they experience. METHODS: A series of five focus group interviews were conducted with 33 women with type 2 diabetes, ages 44 to 80 years, who also completed a questionnaire on sexual functioning: Two thirds were married and one third were sexually active. RESULTS: Categories resulting from the qualitative analysis were guilt and embarrassment in diabetes; female intimacy and shame; sexual dysfunction, an invisible problem; and the female patient. Asking women about intimacy revealed self-blame and embarrassment regarding their diabetes and sexual functioning. Several women who had experienced sexual dysfunction described barriers that made it difficult to obtain optimal care and/or self-care measures to cope with vaginal dryness, pain during intercourse, and decreased desire. Many of the women had the social and emotional resources to cope with their disease. Nonetheless, they experienced guilt, shame, and embarrassment, which are potentially oppressive features of having type 2 diabetes. CONCLUSIONS: Asking women with type 2 diabetes about intimacy in a contextually adequate way at routine follow-up visits could give them a chance to discuss both sexual and social intimacy concerns related to their diabetes.

Adaptation, Psychological↗

Assessment of knowledge, attitudes, and behaviors relative to cervical cancer and the Pap smear among adolescent girls in West Virginia.

BACKGROUND AND METHODS: Questionnaires assessing knowledge of, attitudes toward, and behaviors relative to cervical cancer and its prevention were administered to 279 tenth-grade girls. RESULTS: Eighty-four percent had heard of cervical cancer, and 83% had heard of the Pap smear. Sexual intercourse with multiple partners and cigarette smoking were risk factors identified by 65% and 40% of these students, respectively. Forty-eight percent reported being sexually active. This group, compared with those not sexually active, was more likely to 1) identify the Pap test as a test involving a vaginal examination, 2) use tobacco products, and 3) be exposed to tobacco smoke. The most common barriers to obtaining a Pap test reported by those sexually active were embarrassment (64%), pain/discomfort (57%), fear of cancer (27%), fear of parents discovering sexual activity (25%), and cost (13%). CONCLUSIONS: Based on the information obtained in this study, the authors recommend changes in school health programs that target adolescent girls: 1) risk factors and behavior should receive more emphasis, and 2) the pelvic examination and Pap test should be described in sufficient detail to address the issues of embarrassment, pain, and discomfort.

Adolescent↗

Nasal immunization with diphtheria toxoid conjugated-CD52 core peptide induced specific antibody production in genital tract of female mice.

PROBLEM: The common mucosal immune system (CMIS) has developed as a barrier for the numerous encounters between the host and various pathogens. It is possible to exploit this system to induce secretion of IgA antibody which inhibits sperm penetration in the female genital tract. In this study, the immunogenicity of a human sperm surface antigen (CD52) introduced by intranasal immunization was investigated with a view to developing a contraceptive vaccine. METHOD OF STUDY: A synthetic peptide corresponding to CD52 core peptide (GQNDTSQTSSPS) was prepared and conjugated with diphtheria toxoid (DT) as a carrier protein. The immunogen was given to mice with DOTAP:cholesterol liposome adjuvant intranasally, followed by determination of Ig and IgA class antibody levels in the sera and vaginal washes. RESULTS: The CD52 core peptide elicited IgA class as well as Ig antibodies both in the sera and vaginal secretions after intranasal immunization. An additional nasal inoculation after decrease of the antibody titer raised the antibody level to its highest level during the experiment. CONCLUSIONS: These results indicate that the CMIS could induce Ig and IgA class antibodies reactive to CD52 core peptide in the female genital tract. Intranasal immunization of a sperm-specific antigen would be a promising regimen for a safe and easy contraceptive vaccine.

Animals↗

Future directions in contraception.

Although contraceptive research has markedly decreased in the United States, it has continued in other countries. The emphasis has been on the development of long-acting, noncoitally related contraceptives, including the progestogen-only and progestogen-estrogen vaginal rings. The levonorgestrel-releasing intrauterine device is highly effective and, like other contraceptives, may contribute to a decrease in the incidence of pelvic inflammatory disease. There is a great need for more effective, acceptable barrier contraceptives. The vaginal condom does not appear to be acceptable to many couples. Studies continue to demonstrate couples' lack of adherence to plans for abstinence and poor utilization of the present barrier contraceptives. The potential for the development of a male contraceptive utilizing gonadotrophin hormone-releasing hormone agonists or antagonists in conjunction with testosterone may hold promise in the future.

Contraception↗

A survey of female prostitutes at risk of HIV infection and other sexually transmissible diseases.

OBJECTIVE: To determine risk factors for the transmission of human immunodeficiency virus (HIV), including injecting drug use (IDU), sexual behaviour and other sexually transmissible diseases (STDs), in female prostitutes who attended the Sydney Sexual Health (previously STD) Centre. DESIGN: We surveyed by questionnaire 231 (47%) of 491 female prostitutes who visited the Centre over a 19 month period from 1986 to 1988. All were tested for HIV antibody. MAIN OUTCOME: All the women were seronegative for HIV but a number of major risk factors for infection were identified. RESULTS: Seventeen of 26 (65%) current injecting drug users had shared needles in the previous 6 months. Nineteen per cent of those surveyed had bisexual non-paying partners and 21% had partners who injected drugs. Sixty nine per cent always used condoms for vaginal intercourse with paying clients, but they were rarely used with non-paying partners. Condom use was also rare for anal intercourse with clients and/or partners by those (18%) who practised it. Seventeen per cent used condoms alone for contraception and 48% relied on oral contraceptives. We found a reduction in gonorrhoea, herpes and trichomoniasis when compared with a 1985 study conducted at the same Centre. However, there was an increase in reported abnormal cervical cytology. CONCLUSION: In spite of behaviour change by some, there are still many women working as prostitutes in Sydney who remain seriously at risk of HIV infection. We recommend more widespread use of barrier methods of contraception, intensified efforts to prevent the sharing of intravenous needles, closer monitoring of the health of prostitutes, and scientific study of their paying and non-paying sexual partners.

Adolescent↗

A prospective study of psychological distress and sexual risk behavior among black adolescent females.

OBJECTIVE: The purpose of the study was to examine the association between adolescents' psychological distress and their sexually transmitted disease/human immunodeficiency virus (STD/HIV)-associated sexual behaviors and attitudes. METHOD: Sexually active black adolescent females (N = 522) completed, at baseline and again 6 months later, a self-administered questionnaire that assessed sexual health attitudes and emotional distress symptoms (using standardized measures, alpha =.84), a structured interview that assessed STD/HIV-associated sexual risk behaviors, and a urine screen for pregnancy. RESULTS: In multivariate analyses, controlling for observed covariates, adolescents with significant distress at baseline were more likely than their peers, after 6 months, to be pregnant (adjusted odds ratio [AOR]: = 2.0), have had unprotected vaginal sex (AOR = 2.1), have nonmonogamous sex partners (AOR = 1.7), and not use any form of contraception (AOR = 1.5). Additionally, they were also more likely to: perceive barriers to condom use (AOR = 2.2), be fearful of the adverse consequences of negotiating condom use (AOR = 2.0), perceive less control in their relationship (AOR = 2.0), have experienced dating violence (AOR = 2.4), feel less efficacious in negotiating condom use with a new sex partner (AOR = 1.6), and have norms nonsupportive of a healthy sexual relationship (AOR = 1.7). DISCUSSION: The findings suggest that psychological distress is predictive over a 6-month period of a spectrum of STD/HIV-associated sexual behaviors and high-risk attitudes. Brief screening to detect distress or depressive symptoms among adolescent females can alert the clinician to the need to conduct a sexual health history, initiate STD/HIV-preventive counseling, and refer for comprehensive psychological assessment and appropriate treatment. Among adolescents receiving STD treatment, those with even moderate emotional distress may be at heightened risk for further unhealthy outcomes. STD/HIV interventions should also consider psychological distress as one potential risk factor that may impact program efficacy.

Adolescent↗

Commentary: the quest for women's prophylactic methods--hopes vs science.

The companion article by Rosenberg and Gollub in this issue summarizes data from 10 observational studies and concludes that female-controlled contraceptive methods, under typical conditions, are comparable to condoms in preventing sexually transmitted diseases and should be merchandized as such. While we agree that chemical and mechanical contraceptives provide protection against some sexually transmitted diseases, we think the authors have overstated the scientific case for these methods, especially in comparison with the condom. We think the current data remain inconclusive regarding the absolute protection of spermicides against the human immunodeficiency virus and their level of protection--relative to that of the condom--against other sexually transmitted diseases. Three reasons account for our differences: the limitations in the comparative data; the reported adverse effects of spermicides on vaginal conditions, including genital ulcers; and the relative value of condoms, even under typical conditions, in preventing sexually transmitted diseases. For these reasons, we would currently counsel both women and men who practice high-risk sexual behaviors to use condoms as their first line of defense. If this is unacceptable, the female barriers become a fallback position to protect against bacterial sexually transmitted diseases.

Condoms↗

[Sexually transmitted diseases (STD) and their relationship with sexual behaviour and condom use, in a cohort of teenagers referring to a STD centre. A nine-year, prospective study].

In order to assess the relationship between a diagnosis of sexually-transmitted disease (STD), sexual behaviour, condom use, and other social, demographic, and epidemiological variables in a cohort of young adults who referred to a STD centre during a 9-year period, all patients aged 13-20 years were prospectively evaluated, with special attention paid to sexual behaviour, and use of condom or other contraceptive techniques. The 284 assessed young adults represented 6.1% of all patients with a diagnosis of STD: an increasing temporal trend was noticed (from 3. % in 1991, up to 10.4% nel 1999: p<.0001). On the whole, 70.1% of subjects aged 20 years or less never used a condom during the 6 months preceding the diagnosis of STD: only 21.8% of patients reported regular condom use, and 4.9% more subjects referred occasional use, while in the remaining 3.2% of cases other contraceptive methods were employed. Among under age patients (10.6% of study population), the rate of condom use was 3.3% only, while male homosexuals always denied the use of barrier methods. Although a progressive increase in condom use was observed through the study time (from 0% encountered in 1991-1994, to 57.6% of 1999: p<.0001), this phenomenon proved linked only to the massive increase of immigrant sex workers, which occurred since 1997. When excluding from analysis any probable female prostitutes, lack of condom use tested related to the male gender (p<.05), and a low education (p<.04). Over 50% of patients reported 0-1 partners during the last 6 months, even though an increase in sexual promiscuity was observed during the last three years, compared with 1991-1996 (p<.02). Among the 297 different STD episodes (mostly nongonococcal cervicitis-vaginitis and urethritis, and HPV infection), an increasing incidence of nongonococcal STD and syphilis was found, but no correlation was observed between the spectrum of diagnosed STD, sexual behaviour, and condom use. In particular, in 69.9% of the 103 episodes nongonococcal disease occurred despite regular (65 cases), or occasional (7 episodes) condom use. Moreover, no significant relationship was disclosed between STD occurrence, condom use, and other analyzed social, demographic, epidemiological, and clinical variables. According to our survey, an increased risk of STD seems to involve young adults, and to be related to the variation of multiple demographic, epidemiological, and behavioral features. While immigration and prostitution had the major impact during the last three years, sexual promiscuity and infrequent condom use represent persistent; risk factors in this age population. Besides their diagnostic and therapeutic role, STD centres are able to carry out permanent monitoring of STD, as a starting point to plan adequate information campaigns and specific prevention strategies.

Adolescent↗

Heterosexual transmission of HIV in Haiti.

BACKGROUND: Despite the importance of human immunodeficiency virus (HIV) transmission through heterosexual contact, the incidence of HIV infection in heterosexual cohorts has not been well studied, particularly in the developing world. OBJECTIVE: To 1) determine the incidence of HIV infection in discordant heterosexual couples (couples in which one partner had HIV infection and the other did not) in Haiti and 2) assess risk factors for and methods of preventing HIV infection. DESIGN: Prospective study. SETTING: National Institute for Laboratory Research, Portau-Prince, Haiti. PARTICIPANTS: 475 HIV-infected patients and their noninfected regular sex partners. MEASUREMENTS: Patients and their partners were evaluated at 3- to 6-month intervals for HIV infection, sexually transmitted diseases, and sexual practices. The efficacy of counseling and provision of free condoms was also evaluated. RESULTS: Among the 177 couples who remained sexually active during the prospective study period, 20 seroconversions to HIV positivity occurred, for an incidence rate of 5.4 per 100 person-years (95% CI, 5.16 to 5.64 per 100 person-years). Thirty-eight couples (21.5%) discontinued sexual activity during the study. Only 1 seroconversion occurred among the 42 sexually active couples (23.7% of the 177 sexually active couples) who always used condoms. In contrast, the incidence in sexually active couples who infrequently used or did not use condoms was 6.8 per 100 person-years (CI, 6.49 to 7.14 per 100 person-years). Transmission of HIV was associated with genital ulcer disease, syphilis, and vaginal or penile discharge in the HIV-negative partner and with syphilis in the HIV-infected partner. CONCLUSION: Counseling and the provision of free condoms contributed to the institution of safe sex practices or abstinence in 45% of discordant heterosexual couples. However, 55% of couples reported that they continued to have unprotected sex, resulting in an incidence of HIV infection of 6.8 per 100 person-years.

Condoms↗

Adolescent contraception. Review and recommendations.

In the light of the increase in teenage sexual activity over the past decade, the authors review current social, psychological, and educational attitudes. Together with a summary of the legal ramifications, they provide recommendations for treatment of this patient group.

Adolescent↗

Contraception in the perimenopause.

Pregnancy in women aged 40 and above is frequently unplanned and the legal abortion rate is high in this age group. Contraception and fertility are shrouded in popular mythology and many women do not appreciate either their risk of conception or the range of methods available to prevent conception. Either hormonal or non-hormonal methods of contraception may be appropriate.

Contraception↗

Social characteristics and sexual behaviour of women at high risk of HIV infection in a town in Central Province of Kenya.

Forty seven women food handlers who were considered to be at high risk of HIV infection in Thika town of Central Province of Kenya were studied. The women were interviewed individually for information related to their social characteristics and sexual behaviour. The study showed that 91% were bar attendants, 58% had less than 7 years of formal education and 95% were either unmarried or divorced. All the women had at least one child. One of them practised anal sex but the rest practised vaginal sex. Their opinions on condom use revealed that they lacked knowledge on the advantages of condom use. Certain issues have been raised by this study, which call for in depth studies or incorporation into ongoing studies.

Contraceptive Devices, Male↗