Dataset Information

Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.

ABSTRACT: OBJECTIVE:To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy. STUDY DESIGN:We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/penile misdirection) study and women in the contraceptive efficacy study completed condom self-reports and collected precoital and postcoital vaginal samples for up to four uses of the WC. Both studies used nearly identical self-report questions and the same self-sampling procedures and laboratory for prostatic specific antigen (PSA), a well-studied semen biomarker. We compared condom failure and semen exposure proportions using generalized estimating equations methods accounting for within-couple correlation. RESULTS:Ninety-five (95) efficacy substudy participants used 334 WC and 408 functionality participants used 1572 WC. Based on self-report, 19.2% WC (64 condoms) clinically failed in the efficacy substudy compared to 12.3% WC (194 condoms) in the functionality study (p=.03). Of the 207 WC efficacy uses with evaluable postcoital PSA levels, 14.5% (30 uses) resulted in semen exposure compared to 14.2% (184 uses) of the 1293 evaluable WC functionality study uses. CONCLUSIONS:When evaluating the ability of an experimental condom to prevent semen exposure, the rate of clinical condom failure reported by participants risking pregnancy in an efficacy substudy was significantly higher than the rate reported by participants not risking pregnancy in a functionality study. The rate of semen exposure, assessed by an objective biomarker was nearly identical for the two studies. IMPLICATIONS:Our results suggest that an objective marker of semen exposure in functionality studies could provide a reasonable alternative to contraceptive efficacy studies in evaluating risk of unintended pregnancy and inferring protection from sexually transmitted infection than condom failure rates based on self-report.

SUBMITTER: Walsh TL

PROVIDER: S-EPMC6875637 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.

Walsh Terri L TL Snead Margaret C MC St Claire Breione J BJ Schwartz Jill L JL Mauck Christine K CK Frezieres Ron G RG Blithe Diana L DL Archer David F DF Barnhart Kurt T KT Jensen Jeffrey T JT Nelson Anita L AL Thomas Michael A MA Wan Livia S LS Weaver Mark A MA

Contraception 20190802 5

<h4>Objective</h4>To investigate whether rates of self-reported Woman's Condom (WC) clinical failure and semen exposure from a functionality study are comparable to results from a contraceptive efficacy substudy.<h4>Study design</h4>We structured our comparative analysis to assess whether functionality studies might credibly supplant contraceptive efficacy studies when evaluating new female condom products. Couples not at risk of pregnancy in the functionality (breakage/slippage/invagination/pen ...[more]

PMID: 31381878

Similar Datasets

Project description:BackgroundLittle is known about actions taken by female sex workers (FSWs) after male condom failure during male-female sexual intercourse. The objective of this study was to investigate the actions taken by FSWs after condom failure among FSWs in semi-urban, Blantyre in Malawi.MethodsA cross sectional, qualitative study was conducted among FSWs in Blantyre, Malawi between May and July 2019. Snowballing technique was used to recruit study participants in four purposively selected study sites. Focus group discussions and in-depth interviews were conducted by trained research assistants among 40 FSWs. Data were analyzed using thematic content analysis.ResultsStudy participants reported having taken different actions after condom failure. Out of 18 FSWs who experienced condom failure, 10 reported to have stopped sex immediately and changed the condom and then resumed afterwards. They reported to have douched, urinated, and/or squatted to prevent pregnancy, sexually transmitted infections (STIs) and HIV acquisition. Five study participants reported to have asked for extra pay from the client; 10 FSWs didn't seek medical care. They thought the actions taken were enough for HIV and pregnancy prevention. Out of the 18 FSWs, only 3 stopped sexual intercourse completely and sought medical care which included post-exposure prophylaxis for HIV, STI treatment, and emergency contraceptives. Another 3 reported that they did not stop the sexual intercourse but only squatted and/or douched after sexual intercourse. The remaining 2 FSWs reported not to have stopped sexual intercourse and no any other actions were taken after the condom failure.ConclusionWe report some inadequate behaviors among FSWs after condom failure. Health programs should develop interventions and support the performance of safer sex and actions after condom failure among FSWs to prevent STIs including HIV, and unplanned pregnancies. Interpersonal, structural and policy factors hindering FSWs' access to perform effective interventions need to be addressed.

Dataset Information

Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.

Publications

Comparison of self-reported female condom failure and biomarker-confirmed semen exposure.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets