Self-reported mechanical problems during condom use and semen exposure. Comparison of two randomized trials in the United States of America and Brazil.
ABSTRACT To compare self-reported condom use problems and objectively determined semen exposure in 2 populations.
Two randomized crossover trials in the United States and Brazil compared the failure rates of the female condom (FC) and male condom (MC). Participants used both condom types, completed condom-specific questionnaires to report problems, and collected precoital and postcoital samples of vaginal fluid. Prostate-specific antigen (PSA) was detected by immunoassay.
Problems with condom use were reported less frequently in the Brazilian study (rate difference: FC = 24%, P <0.0001, MC = 5%, P = 0.003). By contrast, the PSA detection rates were similar for both the FC and the MC (rate difference: FC = 2%, MC = 1%, not significant). These results suggest that the PSA detection rate was similar in the 2 study groups and that self-reported problems may be a less reliable measure of condom failure.
Use of biomarkers of condom failure like PSA may help to strengthen the validity of studies promoting behavior change for the prevention of sexually transmitted diseases.
Article: A phase I randomized placebo controlled trial of the safety of 3% SPL7013 Gel (VivaGel®) in healthy young women administered twice daily for 14 days.[show abstract] [hide abstract]
ABSTRACT: To assess the safety of VivaGel® used vaginally twice daily for 14 days among healthy, sexually-abstinent women, aged 18-24 years in the USA and Kenya. Randomized placebo controlled trial. Participants were randomized 2∶1, VivaGel to placebo. Safety was assessed by comparing genitourinary (GU) adverse events (AEs), colposcopy findings, vaginal lactobacilli and laboratory abnormalities by arm. Fifty-four women were enrolled; 35 in the VivaGel arm and 19 in the placebo arm. Twenty-six (74%) and 10 (53%) women reported taking all doses of VivaGel and placebo, respectively. No grade 3 or 4 AEs, or serious AEs occurred. Twenty-five (71%) participants in the VivaGel arm compared to 10 (53%) participants in the placebo arm had at least one grade 1 or 2 GU AE associated with product use (RR = 1.4, 95% CI 0.8-2.2). All seven grade 2 GU AEs associated with product use occurred among four women in the VivaGel arm. Vulvar and cervical erythema, cervical lesions, symptomatic BV, urinary frequency and metrorrhagia were more common in the VivaGel arm than the placebo arm. Twenty-nine (83%) participants in the VivaGel arm had a colposcopic finding compared to 10 (53%) participants in the placebo arm (RR = 1.6, 95%CI = 1.0-2.5). Two women in the VivaGel arm prematurely discontinued product use themselves due to a reported GU AE. Persistence of H₂O₂-producing and non-producing lactobacilli did not differ by study arm. GU AEs and colposcopic findings consistent with mild epithelial irritation and inflammation occurred more commonly among women in the VivaGel arm. ClinicalTrials.gov NCT003311032.PLoS ONE 01/2011; 6(1):e16258. · 4.09 Impact Factor