Terri L Walsh1, Margaret C Snead2, Breione J St Claire3, Jill L Schwartz4, Christine K Mauck4, Ron G Frezieres3, Diana L Blithe5, David F Archer6, Kurt T Barnhart7, Jeffrey T Jensen8, Anita L Nelson3, Michael A Thomas9, Livia S Wan10, Mark A Weaver11. 1. Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010. Electronic address: twalsh@essentialaccess.org. 2. Division of Reproductive Health, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. 3. Essential Access Health (formerly California Family Health Council), 3600 Wilshire Blvd., Ste. 600, Los Angeles, CA 90010. 4. CONRAD/EVMS, 1911 N. Fort Myer Drive, Ste. 900, Arlington, VA 22209. 5. Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Dr, Bethesda, MD 20817. 6. Obstetrics & Gynecology, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501. 7. University of Pennsylvania Medical Center, 3701 Market St., Ste. 800, Philadelphia, PA 19104. 8. Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR 97239. 9. Department of Obstetrics & Gynecology, University of Cincinnati Medical Center, 234 Goodman St., Cincinnati, OH 45219. 10. Department of Obstetrics & Gynecology, New York University,462 First Ave., New York, NY 10016. 11. Department of Mathematics and Statistics, Elon University, Elon, NC 27244.
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.
RCT Entities:
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.
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