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

Terri L. Walsh, Margaret C. Snead, Breione J. St. Claire, Jill L. Schwartz, Christine K. Mauck, R. G. Frezieres, Diana L. Blithe, David F. Archer, Kurt T. Barnhart, Jeffrey Jensen, Anita L. Nelson, Michael A. Thomas, Livia S. Wan, Mark A. Weaver

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalContraception
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Female Condoms
Condoms
Semen
Biomarkers
Contraceptive Agents
Self Report
Pregnancy
Antigens

Keywords

  • Condom clinical failure
  • Contraceptive efficacy
  • Female internal condom
  • Prostate-specific antigen (PSA)
  • Semen biomarkers
  • Sexually transmitted infection

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Walsh, T. L., Snead, M. C., St. Claire, B. J., Schwartz, J. L., Mauck, C. K., Frezieres, R. G., ... Weaver, M. A. (Accepted/In press). Comparison of self-reported female condom failure and biomarker-confirmed semen exposure. Contraception. https://doi.org/10.1016/j.contraception.2019.07.143

Comparison of self-reported female condom failure and biomarker-confirmed semen exposure. / Walsh, Terri L.; Snead, Margaret C.; St. Claire, Breione J.; Schwartz, Jill L.; Mauck, Christine K.; Frezieres, R. G.; Blithe, Diana L.; Archer, David F.; Barnhart, Kurt T.; Jensen, Jeffrey; Nelson, Anita L.; Thomas, Michael A.; Wan, Livia S.; Weaver, Mark A.

In: Contraception, 01.01.2019.

Research output: Contribution to journalArticle

Walsh, TL, Snead, MC, St. Claire, BJ, Schwartz, JL, Mauck, CK, Frezieres, RG, Blithe, DL, Archer, DF, Barnhart, KT, Jensen, J, Nelson, AL, Thomas, MA, Wan, LS & Weaver, MA 2019, 'Comparison of self-reported female condom failure and biomarker-confirmed semen exposure', Contraception. https://doi.org/10.1016/j.contraception.2019.07.143
Walsh, Terri L. ; Snead, Margaret C. ; St. Claire, Breione J. ; Schwartz, Jill L. ; Mauck, Christine K. ; Frezieres, R. G. ; Blithe, Diana L. ; Archer, David F. ; Barnhart, Kurt T. ; Jensen, Jeffrey ; Nelson, Anita L. ; Thomas, Michael A. ; Wan, Livia S. ; Weaver, Mark A. / Comparison of self-reported female condom failure and biomarker-confirmed semen exposure. In: Contraception. 2019.
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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.",
keywords = "Condom clinical failure, Contraceptive efficacy, Female internal condom, Prostate-specific antigen (PSA), Semen biomarkers, Sexually transmitted infection",
author = "Walsh, {Terri L.} and Snead, {Margaret C.} and {St. Claire}, {Breione J.} and Schwartz, {Jill L.} and Mauck, {Christine K.} and Frezieres, {R. G.} and Blithe, {Diana L.} and Archer, {David F.} and Barnhart, {Kurt T.} and Jeffrey Jensen and Nelson, {Anita L.} and Thomas, {Michael A.} and Wan, {Livia S.} and Weaver, {Mark A.}",
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AU - Walsh, Terri L.

AU - Snead, Margaret C.

AU - St. Claire, Breione J.

AU - Schwartz, Jill L.

AU - Mauck, Christine K.

AU - Frezieres, R. G.

AU - Blithe, Diana L.

AU - Archer, David F.

AU - Barnhart, Kurt T.

AU - Jensen, Jeffrey

AU - Nelson, Anita L.

AU - Thomas, Michael A.

AU - Wan, Livia S.

AU - Weaver, Mark A.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - Condom clinical failure

KW - Contraceptive efficacy

KW - Female internal condom

KW - Prostate-specific antigen (PSA)

KW - Semen biomarkers

KW - Sexually transmitted infection

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