Beatrice A Chen1, Diana L Blithe2, Gitonga R Muraguri3, Audrey A Lance4, Bruce R Carr5, Jeffrey T Jensen6, Thomas D Kimble7, Amitasrigowri S Murthy8, Courtney A Schreiber9, Michael A Thomas10, Terri L Walsh11, Carolyn Westhoff12, Anne E Burke13. 1. Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA, USA; Magee-Womens Research Institute, 204 Craft Avenue, Pittsburgh, PA, USA. Electronic address: chenba@upmc.edu. 2. Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Dr, Bethesda, MD 20817, USA. 3. Health Decisions Inc., 2510 Meridian Parkway, Durham, NC 27713, USA. 4. Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, 300 Halket Street, Pittsburgh, PA, USA; Northland Family Planning, 35000 Ford Road, Westland MI 48185, USA. 5. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75390, USA. 6. Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. 7. Department of Obstetrics and Gynecology, Eastern Virginia Medical School, 601 Colley Ave, Norfolk, VA 23323, USA. 8. Department of Obstetrics and Gynecology, NYU School of Medicine, Bellevue Hospital Center, 462 First Ave, New York, NY 10016, USA. 9. Department of Obstetrics and Gynecology, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA. 10. Department of Obstetrics & Gynecology, University of Cincinnati Medical Center, 234 Goodman St, Cincinnati, OH 45219, USA. 11. Essential Access Health, 3600 Wilshire Blvd, Suite 600, Los Angeles, CA 90010, USA. 12. Department of Obstetrics & Gynecology, Columbia University, 622 West 168th St, PH 16, New York, NY 10032, USA. 13. Department of Gynecology & Obstetrics, Johns Hopkins University, 4940 Eastern Ave, Baltimore, MD 21224, USA.
Abstract
OBJECTIVE: This study aimed to evaluate the acceptability of the Woman's Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a US-based multicenter open-label phase III contraceptive efficacy trial. STUDY DESIGN: We assessed acceptability via written questionnaire at visit 2 (after the third cycle) and visit 3 (after the sixth cycle or >183 days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions. RESULTS: Most women [327/405 (81%)] had limited or no previous experience with female (internal) condoms. Of 405 evaluable women, 346 women completed questionnaires at visit 2 and 303 women at visit 3; 282 women attended both visits. Of women attending both visits, 165/282 (59%) reported at visit 2 that WC insertion was easy/very easy; this increased to 195/282 (69%) at visit 3 (p=.03). Many women [166/281 (59%)] preferred the WC [105/281 (37%)] or were neutral [61/281 (22%)], while 115/281 (41%) preferred male condoms. Women attending visit 3 felt confident that the WC could prevent pregnancy [246/303 (81%)] and STIs [217/303 (72%)]. Many women expressed empowerment with having control over their contraception; some disliked the design, esthetics and insertion process. Most women (254/299 (85%)] would recommend the WC to a friend. CONCLUSION: The WC's acceptability and ease of use is promising for wider dissemination as a female-controlled method that can protect against both pregnancy and STIs. IMPLICATIONS: The WC's overall acceptability and ease of use is promising for a new female-controlled barrier contraceptive option that can protect against both pregnancy and sexually transmitted infections.
OBJECTIVE: This study aimed to evaluate the acceptability of the Woman's Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a US-based multicenter open-label phase III contraceptive efficacy trial. STUDY DESIGN: We assessed acceptability via written questionnaire at visit 2 (after the third cycle) and visit 3 (after the sixth cycle or >183 days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions. RESULTS: Most women [327/405 (81%)] had limited or no previous experience with female (internal) condoms. Of 405 evaluable women, 346 women completed questionnaires at visit 2 and 303 women at visit 3; 282 women attended both visits. Of women attending both visits, 165/282 (59%) reported at visit 2 that WC insertion was easy/very easy; this increased to 195/282 (69%) at visit 3 (p=.03). Many women [166/281 (59%)] preferred the WC [105/281 (37%)] or were neutral [61/281 (22%)], while 115/281 (41%) preferred male condoms. Women attending visit 3 felt confident that the WC could prevent pregnancy [246/303 (81%)] and STIs [217/303 (72%)]. Many women expressed empowerment with having control over their contraception; some disliked the design, esthetics and insertion process. Most women (254/299 (85%)] would recommend the WC to a friend. CONCLUSION: The WC's acceptability and ease of use is promising for wider dissemination as a female-controlled method that can protect against both pregnancy and STIs. IMPLICATIONS: The WC's overall acceptability and ease of use is promising for a new female-controlled barrier contraceptive option that can protect against both pregnancy and sexually transmitted infections.
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