Effectiveness of female and male condoms in preventing exposure to semen during vaginal intercourse: a randomized trial

Galvão, Loren W.; Oliveira, Laurione Cândido de; Dı́az, Juan; Kim, Dhong-Jin; Marchi, Nádia M.; Dam, Johannes van; Castilho, Roger F.; Chen, Michael; Macaluso, Maurizio

doi:10.1016/j.contraception.2004.08.008

Cited by 57 publications

(48 citation statements)

References 29 publications

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“…Thus, if the last exposure was to a large amount of semen, it is possible that the pre-coital and post-coital swabs will vary by up to 22 ng/mL by chance alone. This criterion was used in evaluating semen exposure in some studies [6,10], while other studies employed a 15 ng/mL difference [9,11]. Changing the minimum difference from 22 to 15 ng/mL would change the probability of a false-positive exposure assessment by a small amount.…”

Section: Resultsmentioning

confidence: 99%

“…Objective biomarkers of semen exposure, most notably prostate-specific antigen (PSA), are valid predictors of exposure to semen and may offer a reliable counterpart to user self-report for assessing condom performance during penile-vaginal intercourse [1]. An increasing number of clinical trials have incorporated testing for PSA levels to assess the performance of male and female condoms [2][3][4][5][6][7][8][9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

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Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

et al. 2012

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Background-Prostate-specific antigen (PSA), a biomarker for semen exposure, may provide a more objective measure of condom failure than subject self-reports. Methods for measuring PSA vary and their comparability with respect to assessing condom performance has not been adequately evaluated. This study compared results from three different PSA assays of vaginal samples collected by subjects in a randomized clinical trial which compared the performance of female condoms.Study Design-We selected 30 pairs of pre-and post-coital vaginal samples from subjects who reported condom functionality problems or whose original PSA assay was positive. Samples were retested using three different PSA assays [quantitative enzyme-linked immunoassay (EIA), rocket immune-electrophoresis (RIE) and chromatographic immunoassay (CIA)]. We compared the proportion of condom uses where the post-coital PSA result indicated semen exposure for each of the three assays.Results-Despite varying levels of sensitivity, the results from all three assays were remarkably consistent. Self-reported condom failures did not correlate well with positive PSA results, suggesting that exclusive reliance on either PSA or user self-report may be inadequate for assessing condom functionality. HHS Public Access Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptConclusion-In combination with user self-report of condom failure, PSA testing provides a reliable, objective marker of condom functionality. Studies based on PSA testing may improve on conventional contraceptive clinical trials by offering a more direct assessment of a condom product's ability to prevent semen exposure.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

et al. 2012

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“…Although the male partner is not unaware of the female condom, it does provide a prevention strategy that is less dependent on male willingness. Cost and mechanical difficulties have been cited as reasons for limited uptake (Galvao et al 2005), but newer designs are easier to use, can be reused (Thomsen et al 2006), and are made of materials that improve sensation with the promise of enhancing acceptability, uptake, and cost (Coffey et al 2006). There are increasing reports of female condoms being used for HIV prevention in anal sex (http://doh.dc.gov/doh/cwp/ view,a,1371,q,602647,dohNav_GID,1839,doh Nav, |33815|,,.asp).…”

Section: The Female Condommentioning

confidence: 99%

Behavioral and Biomedical Combination Strategies for HIV Prevention

Bekker

Beyrer

Quinn

2012

Cold Spring Harbor Perspectives in Medicine

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“…12 The most effective womaninitiated barrier method to prevent HIV and other STI as well as pregnancy is the female condom (FC), a vaginally inserted sheath worn during sex. 13,14 The FC has become widely used for prevention in several developing countries with high HIV incidence. [15][16][17][18][19][20] Studies around the globe have found positive results from introducing FC to women of all ages, including decreased STI incidence and increased protected sex.…”

Section: Introductionmentioning

confidence: 99%

Multilevel Social Influences on Female Condom Use and Adoption Among Women in the Urban United States

Weeks

Li²,

Coman³

et al. 2010

AIDS Patient Care and STDs

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Heterosexually transmitted HIV remains of critical concern in the United States and around the world, especially among vulnerable and disadvantaged women, complicated by socioeconomic circumstances, gender power, addiction, and experiences of abuse, among other conditions. Effective woman-initiated HIV prevention options, such as the female condom (FC), are needed that women can use in different sexual relationship contexts. We conducted a behavioral and attitudinal survey with 461 primarily African American and Latina (especially Puerto Rican) women in Hartford, Connecticut, to measure factors on the individual, partner relationship, peer, and community levels influencing their initial and continued use of FC (using the prototype FC1) for disease prevention. We used multivariate analyses and structural equation modeling to assess effects of multiple level factors on FC use and unprotected sex with primary, casual, and paying partners. Initial, recent, and continued FC use was associated with factors on the individual level (education, marital status, drug use, child abuse experiences, HIV status), partner level (number of sex partners, paying sex partner, relationship power), and peer level (more or influential peers saying positive things about FC). Community level factors of availability and support were consistently poor across all sectors, which limited overall FC use. Patterns differed between African American and Latina women in stages and contexts of FC use and unprotected sex. FC can make a valuable contribution to reducing heterosexually transmitted HIV among women in many circumstances. The greatest barrier to increased FC use is the lack of a supportive community environment for its promotion and use.

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Effectiveness of female and male condoms in preventing exposure to semen during vaginal intercourse: a randomized trial

Cited by 57 publications

References 29 publications

Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

Prostate-specific antigen as a biomarker of condom failure: comparison of three laboratory assays and self-reported condom use problems in a randomized trial of female condom performance

Behavioral and Biomedical Combination Strategies for HIV Prevention

Multilevel Social Influences on Female Condom Use and Adoption Among Women in the Urban United States

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