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Original article| Volume 99, ISSUE 6, P357-362, June 2019

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Acceptability of the Woman's Condom in a phase III multicenter open-label study

      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.

      Keywords

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      References

        • Beksinska M.
        • Smit J.
        • Mabude Z.
        • Vijayakumar G.
        • Joanis C.
        Performance of the reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among south African women.
        Contraception. 2006; 73: 386-393
        • Smit J.
        • Beksinska M.
        • Vijayakumar G.
        • Mabude Z.
        Short-term acceptability of the reality polyurethane female condom and a synthetic latex prototype: a randomized crossover trial among South African women.
        Contraception. 2006; 73: 394-398
        • Wanyenze R.K.
        • Atuyambe L.
        • Kibirige V.
        • Mbabazi S.
        • Tumwesigye N.M.
        • Djurhuus K.
        • et al.
        The new female condom (FC2) in Uganda: perceptions and experiences of users and their sexual partners.
        Afr J AIDS Res. 2011; 10: 219-224https://doi.org/10.2989/16085906.2011.626289
        • Beksinska M.
        • Smit J.
        • Joanis C.
        • Potter W.
        New female condoms in the pipeline.
        Reprod Health Matters. 2012; 20: 188-196https://doi.org/10.1016/S0968-8080(12)40659-0
        • Daniels K.
        • Mosher W.D.
        Contraceptive methods women have ever used: United States, 1982–2010.
        Natl Health Stat Report. 2013; 14: 1-15
        • UN Joint Programme on HIV/AIDS (UNAIDS)
        Prevention Gap Report.
        Geneva, Switzerland, 2016
        • Peters A.
        • Jansen W.
        • van Driel F.
        The female condom: the international denial of a strong potential.
        Reprod Health Matters. 2010; 18: 119-128https://doi.org/10.1016/S0968-8080(10)35499-1
        • Minnis A.M.
        • Padian N.S.
        Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions.
        Sex Transm Infect. 2005; 81: 193-200https://doi.org/10.1136/sti.2003.007153
        • Chatterjee K.
        • Markham Shaw C.
        Media portrayals of the female condom.
        J Health Commun. 2012; 17: 1138-1150https://doi.org/10.1080/10810730.2012.665423
        • Ventura-DiPersia C.
        • Rodriguez K.
        • Kelvin E.A.
        Failure of many United States Department of Health Web sites to provide accurate information about the female condom.
        Contraception. 2015; 92: 40-45https://doi.org/10.1016/j.contraception.2015.03.009
        • Anonymous
        The female condom: still an underused prevention tool.
        Lancet Infect Dis. 2008; 8: 343https://doi.org/10.1016/S1473-3099(08)70103-8
        • Peters A.
        • van Driel F.
        • Jansen W.
        Acceptability of the female condom by sub-Saharan African women: a literature review.
        Afr J Reprod Health. 2014; 18: 34-44
        • Beksinska M.E.
        • Piaggio G.
        • Smit J.A.
        • Wu J.
        • Zhang Y.
        • Pienaar J.
        • et al.
        Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the cupid female condoms: a randomised controlled non-inferiority crossover trial.
        Lancet Glob Health. 2013; 1: e146-e152https://doi.org/10.1016/s2214-109x(13)70054-8
        • Beksinska M.
        • Greener R.
        • Kleinschmidt I.
        • Pillay L.
        • Maphumulo V.
        • Smit J.
        A randomized noninferiority crossover controlled trial of the functional performance and safety of new female condoms: an evaluation of the Velvet, Cupid2, and FC2.
        Contraception. 2015; 92 ([S0010-7824(15)00220-6 pii]): 261-267https://doi.org/10.1016/j.contraception.2015.05.008
        • Schwartz J.L.
        • Barnhart K.
        • Creinin M.D.
        • Poindexter A.
        • Wheeless A.
        • Kilbourne-Brook M.
        • et al.
        Comparative crossover study of the PATH Woman's Condom and the FC Female Condom.
        Contraception. 2008; 78: 465-473https://doi.org/10.1016/j.contraception.2008.07.020
        • Joanis C.
        • Beksinska M.
        • Hart C.
        • Tweedy K.
        • Linda J.
        • Smit J.
        Three new female condoms: which do South-African women prefer?.
        Contraception. 2011; 83: 248-254https://doi.org/10.1016/j.contraception.2010.08.002
        • Coffey P.S.
        • Kilbourne-Brook M.
        • Austin G.
        • Seamans Y.
        • Cohen J.
        Short-term acceptability of the PATH Woman's Condom among couples at three sites.
        Contraception. 2006; 73: 588-593https://doi.org/10.1016/j.contraception.2005.10.017
        • Wu J.
        • Huang Z.
        • Coffey P.S.
        • Kilbourne-Brook M.
        Short-term acceptability of the Woman's Condom among married couples in Shanghai.
        J Sex Transm Dis. 2016; 2016: 6201421https://doi.org/10.1155/2016/6201421
        • Barnhart K.T.
        • Rosenberg M.J.
        • MacKay H.T.
        • Blithe D.L.
        • Higgins J.
        • Walsh T.
        • et al.
        Contraceptive efficacy of a novel spermicidal microbicide used with a diaphragm: a randomized controlled trial.
        Obstet Gynecol. 2007; 110: 577-586https://doi.org/10.1097/01.aog.0000278078.45640.13
        • Beksinska M.
        • Joanis C.
        • Manning J.
        • Smit J.
        • Callahan M.
        • Deperthes B.
        • et al.
        Standardized definitions of failure modes for female condoms.
        Contraception. 2007; 75: 251-255https://doi.org/10.1016/j.contraception.2006.10.003
        • Beksinska M.
        • Smit J.
        • Greener R.
        • Piaggio G.
        • Joanis C.
        The female condom learning curve: patterns of female condom failure over 20 uses.
        Contraception. 2015; 91: 85-90https://doi.org/10.1016/j.contraception.2014.09.011
        • Guerra F.M.
        • Simbayi L.C.
        Prevalence of knowledge and use of the female condom in South Africa.
        AIDS Behav. 2014; 18: 146-158https://doi.org/10.1007/s10461-013-0580-3
        • Gollub E.L.
        The female condom: tool for women's empowerment.
        Am J Public Health. 2000; 90: 1377-1381
        • Coman E.N.
        • Weeks M.R.
        • Yanovitzky I.
        • Iordache E.
        • Barbour R.
        • Coman M.A.
        • et al.
        The impact of information about the female condom on female condom use among males and females from a US urban community.
        AIDS Behav. 2013; 17: 2194-2201https://doi.org/10.1007/s10461-012-0381-0
        • Artz L.
        • Macaluso M.
        • Kelaghan J.
        • Austin H.
        • Fleenor M.
        • Robey L.
        • et al.
        An intervention to promote the female condom to sexually transmitted disease clinic patients.
        Behav Modif. 2005; 29: 318-369
        • Maksut J.L.
        • Eaton L.A.
        Female condoms=missed opportunities: lessons learned from promotion-centered interventions.
        Womens Health Issues. 2015; 25: 366-376https://doi.org/10.1016/j.whi.2015.03.015
        • Mantell J.E.
        • Hoffman S.
        • Weiss E.
        • Adeokun L.
        • Delano G.
        • Jagha T.
        • et al.
        The acceptability of the female condom: perspectives of family planning providers in New York City, South Africa, and Nigeria.
        J Urban Health. 2001; 78: 658-668
        • Food and Drug Administration
        • Department of Health and Human Services
        Obstetrical and gynecological devices; reclassification of single-use female condom, to be renamed single-use internal condom. final order.
        Fed Regist. 2018; 83: 48711-48713
        • Nadler J.T.
        • Weston R.
        • Voyles E.C.
        Stuck in the middle: the use and interpretation of mid-points in items on questionnaires.
        J Gen Psychol. 2015; 142: 71-89https://doi.org/10.1080/00221309.2014.994590
        • Kramzer L.F.
        • Cohen J.
        • Schubert J.
        • Dezzutti C.S.
        • Moncla B.J.
        • Friend D.
        • et al.
        Assessing the potential of the Woman's Condom for vaginal drug delivery.
        Contraception. 2015; 92: 254-260https://doi.org/10.1016/j.contraception.2015.05.005