In this edition of the CBAS newsletter, we highlight two internal/female condom studies. These include a mystery shopper study of the retail availability of the internal/female condom in the southwestern United States, and an investigation of semen exposure in a functionality study of an internal/female condom as compared to semen exposure in a contraceptive efficacy study. Bibliographies of cervical barrier method research published through March 1, 2020, remain available on on the Completed Research page.
Hsu R, Tavrow P, Uysal J, Alterman AE. Seeking the female (internal) condom in retail pharmacies: Experiences of adolescent mystery callers. Contraception. 2020 Feb;101(2):117-121.
BACKGROUND: Female (internal) condoms could be viable alternatives to male (external) condoms. Our objective was to describe barriers that adolescent mystery callers encountered when trying to access female condoms in US pharmacies.
METHODS: In mid-2016, university students seeking "condoms for girls" called retail pharmacies in Arizona, California, New Mexico and Utah. We evaluated differences in product availability and callers' experiences by pharmacy type.
RESULTS: Of our final sample (n=1475), only eight outlets (0.5%), all national chains, definitely stocked female condoms. Of those not (or probably not) stocking female condoms, 11% tried to be helpful (e.g., offered to special order), 59% made no substantive comment, and 30% were unhelpful (e.g., dismissive, rude, gave wrong information). National chain employees were significantly more unhelpful (34% vs 22%, p< .01).
CONCLUSION: Almost no pharmacies in four southwestern states stocked female condoms in mid-2016. Pharmacy staff frequently were unhelpful, which could deter adolescent use of female condoms even if new types become available.
Walsh TL, Snead MC, St Claire BJ, Schwartz JL, Mauck CK, Frezieres RG, Blithe DL, Archer DF, Barnhart KT, Jensen JT, Nelson AL, Thomas MA, Wan LS, Weaver MA. Comparison of self-reported female condom failure and biomarker-confirmed semen exposure. Contraception. 2019 Nov;100(5):406-412
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.