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Self-reported condom use is a commonly collected statistic, yet its use in research studies may be inaccurate. We evaluated this statistic among women in HIV-discordant couples enrolled in a clinical trial in Nairobi, Kenya. Vaginal swabs were acquired from 125 women and tested for prostate-specific antigen (PSA), a biomarker for semen exposure, using an enzyme-linked immunosorbent assay. Ten (10%) of 98 women who reported 100% use of condoms in the previous month tested PSA positive. In a bivariate logistic regression analysis, among women who reported 100% condom use in the previous month, those with ≤8 years of school had significantly higher odds of testing PSA-positive (odds ratio [OR] = 8.39, 95% confidence interval [CI] 1.02-69.13) than women with more schooling. Our estimate may be conservative, as the ability to detect PSA may be limited to 24-48 hours after exposure. Less educated women may be a target group for counselling regarding reporting sexual behaviour in clinical trials.

Abstract: Objectives: Comparison of male condom (MC) vs. female condom (FC) with respect to self-reported mechanical and acceptability problems and semen exposure using prostate-specific antigen (PSA) as an objective biological marker and evaluation of the effect of an educational intervention on self-reported problems and semen exposure, by condom type. Design: Randomized crossover trial. Methods: Four hundred women attending a family planning clinic in Brazil were randomized and either received in-clinic instruction or were encouraged to read the condom package insert; all used two FCs and two MCs. We measured the rates of self-reported user problems with MC and FC use and the rates of semen exposure during use (assessed by testing vaginal fluid for PSA). Results: The educational intervention group reported fewer problems with either condom as compared with the control group (p=.0004, stratified by condom type). In both groups, self-reported problems were more frequent with FC use than with MC use (p<.0001, stratified by intervention). The educational intervention did not significantly reduce semen exposure. Overall, semen exposure occurred more frequently with FC use (postcoital PSA, >1 ng/mL; 22%) than with MC use (15%); the difference, however, was small and nonsignificant for high PSA levels (≥150 ng/mL; 5.1% for FC vs. 3.6% for MC). Conclusions: In this study, the FC was less effective than the MC in preventing semen exposure during use and led more frequently to self-reported user problems. Both devices were highly protective against “high-level” semen exposure, as measured by postcoital PSA levels in vaginal fluid. In-clinic education may reduce user problems and increase acceptability and use of both devices. [Copyright &y& Elsevier]