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Results for “Female Condom”

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At least 91 records · Page 5Linked to original sources
PubMed2003

Female-condom use in a gender-specific family planning clinic trial.

OBJECTIVES: We evaluated female-condom use among women participating in an HIV/STD intervention designed to reduce unprotected sex and expand prevention strategies. METHODS: Women (n = 360) were recruited from a family-planning clinic and were randomized into an 8- or 4-session intervention group or a control group. We conducted follow-up interviews at 1, 6, and 12 months. RESULTS: At 1 month, the odds ratios of first-time female-condom use were 9.49 (95% confidence interval [CI] = 4.01, 22.20) in the 8-session group and 4.39 (95% CI = 1.84, 10.49) in the 4-session group relative to controls. Repeated use (n = 21) was predicted by perceived ability to use, by self and partner satisfaction, by dislike of male condoms, and by previous diaphragm use. CONCLUSIONS: Gender sensitive cognitive-behavioral interventions can influence women to try the female condom. To increase long-term use, interventions may need to include self-insertion practice and involvement of male partners.

Single-Use Internal Condom↗
PubMed1994

Contraceptive efficacy and acceptability of the female condom.

OBJECTIVES: The purpose of the study was to determine the contraceptive efficacy of the female condom and to provide data about the device to the US Food and Drug Administration. METHODS: The clinical trial was conducted at six US sites and three sites in Latin America. Eligible subjects were in mutually monogamous relationships and agreed to use the female condom as their only means of contraception for 6 months. RESULTS: A total of 328 subjects contributed to the analysis of contraceptive efficacy. Twenty-two US subjects and 17 Latin American subjects became pregnant, yielding 6-month gross cumulative accidental pregnancy rates of 12.4 and 22.2, respectively. During perfect (consistent and correct) use of the method, the 6-month accidental pregnancy rates were 2.6 and 9.5 for the US and Latin American centers, respectively. There were no serious adverse events related to the use of the method. CONCLUSIONS: The female condom provides contraceptive efficacy in the same range as other barrier methods, particularly when used consistently and correctly, and has the added advantage of helping protect against sexually transmitted diseases.

Adult↗
PubMed2003

Acceptability and technical problems of the female condom amongst commercial sex workers in a rural district of Malawi.

A study was conducted among commercial sex workers (CSWs) in rural southern Malawi, in order to (a) assess the acceptability of the female condom and (b) identify common technical problems and discomforts associated with its use. There were 88 CSWs who were entered into the study with a total of 272 female condom utilizations. Eighty-six (98%) were satisfied with the female condom, 80% preferred it to the male condom and 92% were ready to use the device routinely. Of all the utilizations, the most common technical problem was reuse of the device with consecutive clients, 6% after having washed it, and 2% without any washing or rinsing. The most common discomfort that were reported included too much lubrication (32%), device being too large (16%), and noise during sex (11%). This study would be useful in preparing the introduction of the female condom within known commercial sex establishments in Malawi.

Adult↗
PubMed2003

Use of the female condom among sex workers in China.

OBJECTIVES: To introduce the female condom (FC) among sex workers (SWs) in China. METHODS: We adopted the intervention study method. The 315 participating SWs were randomly assigned to an intervention group (155 SWs) or a control group (160 SWs). RESULTS: The rate of SWs who reported liking FC increased from 60.0% pre-intervention to 93.5% post-intervention, and the rate of SWs who considered that their clients could accept FC increased from 27.1% to 92.3%. After the intervention, 93.5% expressed that their sexual satisfaction had increased with their familiarity with FC and 97.4% expressed that they would use it in the future. CONCLUSIONS: The understanding and use of FC can be greatly improved through active intervention-i.e. medical workers providing SWs with FC.

Adolescent↗
PubMed2000

Obstetrical and gynecological devices; classification of female condoms. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is classifying the preamendments female condom intended for contraceptive and prophylactic purposes. Under this rule, the preamendments female condom is being classified into class III (premarket approval). This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.

Single-Use Internal Condom↗
PubMed2000

The female condom and STDs: design of a community intervention trial.

OBJECTIVES: The main purpose of this study is to compare sexually transmitted disease (STD) prevalence in cohorts of women with and without access to female condoms. METHODS: Six matched pairs of communities were identified from Kenya tea, coffee and flower plantations. One community within each pair was randomly selected to receive the female condom intervention. Approximately 160 eligible women were enrolled at each site. Female condom communities underwent an education program on use of female and male condoms and STDs, comprising group meetings, puppetry and other folk media, and training of clinic service providers and community outreach workers. Control communities received similar information on use of male condoms (freely available at all sites). At baseline, participants were tested for cervical gonorrhea and chlamydia and vaginal trichomoniasis, to be repeated at 6 and 12 months. The study has 80% power to detect a 10% prevalence difference, assuming an aggregate STD prevalence of 20% with 25% loss to follow-up and intracluster correlation of 0.03. RESULTS: Among 1929 women at baseline, the mean age was 33.1 years; 78% had never used a male condom. The prevalences of gonorrhea, chlamydia and trichomoniasis were 2.6%, 3. 2% and 20.4%, respectively (23.9% overall). The intracluster correlation based on these data was near zero. CONCLUSIONS: Comparable pairs of study sites have been selected. STD prevalence is sufficiently high, and the variation between sites is acceptably low. The study is feasible as designed.

Adolescent↗
PubMed2003

Partner characteristics, intensity of the intercourse, and semen exposure during use of the female condom.

The objective of this study was to assess how characteristics of the intercourse and the couple relate to semen exposure during use of the female condom. From 1996 to 1998, 210 women in Birmingham, Alabama, were trained to use the female condom and follow study procedures during a group session and individually practiced inserting the device. The outcome was semen exposure as defined by comparing pre- and postcoital prostate-specific antigen levels in vaginal fluid. Women who had high income levels had lower rates of semen exposure (odds ratio (OR) = 0.3, 95% confidence interval (CI): 0.2, 0.7), while those in a relationship of less than 2 years were at greater risk (OR = 2.4, 95% CI: 1.3, 4.1). Couples with a large disparity in vaginal fundus size and penis size were at increased risk of semen exposure (OR = 2.7, 95% CI: 1.2, 6.0). Engaging in very active intercourse also increased the risk (OR = 1.7, 95% CI: 1.1, 2.6). Thus, the protective effect of the female condom appears to be a function of user- and intercourse-specific characteristics. Future studies of male condom efficacy should focus on collecting detailed data about the users and characteristics of intercourse to predict failure accurately.

Adult↗
PubMed2001

Female condom introduction and sexually transmitted infection prevalence: results of a community intervention trial in Kenya.

OBJECTIVE: To measure the impact on sexually transmitted infection (STI) prevalence of a female condom introduction and risk-reduction program at Kenyan agricultural sites. DESIGN: We conducted a cluster-randomized trial to determine whether a replicable, community-level intervention would reduce STI prevalence. METHODS: Six matched pairs of tea, coffee and flower plantations were identified. The six intervention sites received an information/motivation program with free distribution of female and male condoms, and six control sites received only male condoms and related information. Participants were tested for cervical gonorrhea and chlamydia by ligase chain reaction on urine specimens, and vaginal trichomoniasis by culture, at baseline, 6 and 12 months. RESULTS: Participants at intervention (n = 969) and control sites (n = 960) were similar; baseline STI prevalence was 23.9%. Consistent male condom use was more than 20% at 12 months. Consistent female condom use was reported by 11 and 7% of intervention site women at 6 and 12 months. Unadjusted STI prevalence was 16.5 and 17.4% at 6 months, and 18.3 and 18.5% at 12 months, at the intervention and control sites, respectively. Logistic regression models confirmed the null effect of the female condom intervention. CONCLUSIONS: Female condom introduction did not enhance STI prevention at these sites. It is unclear which aspects of the intervention -- STI education, condom promotion, case management -- were associated with decreased STI prevalence from baseline to follow-up.

Adult↗
PubMed2005

Acceptability studies have important role in microbicide clinical trials. Researchers also look to improve female condom use.

Long before a proof of concept is achieved, even before Phase I trials begin, investigators were designing and considering acceptability studies that would be integrated into the microbicide study process. Now that five microbicides are in Phase III clinical trials, that early foresight has helped ensure there will be a ready audience when an effective microbicide is available.

Anti-Infective Agents↗