Background Men who have sex with men (MSM) face a 28-fold higher risk of HIV acquisition than men who have sex with women (MSW). 0.75; SA OR: 0.37, 95%CI 0.19, 0.72). Fitted condoms did not have different levels of failure than standard condoms for vaginal and anal acts (PA 1.67, 95% CI 0.83C3.83) or for anal sex acts only (PA OR: 0.93, 95% CI: 0.27, 3.26), suggesting rejection of the a priori hypothesis that fitted condoms would fail at lower rates than standard condoms for anal sex. Thin condoms IDH1 Inhibitor 2 were associated with higher failure rates in both models relative to standard condoms (PA OR: 2.17, 95%CI: 1.11, 4.25; SA OR: 2.25, 95%CI 1.12, 4.51). In the SA model, higher levels of clinical failure were associated with baseline characteristics of having experienced condom failure in the previous 6 months, not having used condoms in the 30 days prior to study initiation, and having bigger self-measured condom width. Among factors assessed after every sex event, using condom lubricant was connected with higher probability of failure incorrectly. Due to research design, almost all anal sex works included condom-compatible lubricant (2307/2347, 98.3%) and a minority of vaginal sex works included condom-compatible lubricant (1053/253, 41.6%). A post-hoc evaluation among genital IDH1 Inhibitor 2 sex acts that research or additional condom-compatible lubricant was utilized indicated medical failing of just one 1.1% (12/1053) for these works (data not displayed in dining tables). Conversely, genital sex acts with either nonuse useful or lubricant of condom-incompatible lubricant had failure prices of 2.5% (36/1467). When managing for usage of condom-compatible lubricant, there is no difference in the chances of failing for anal versus genital sex (OR 0.83 95% CI ?0?3, 2.2, p?=?0.70). 4.?Dialogue In the biggest clinical trial of condoms for anal intercourse to date, total clinical failure for anal sex was less than 1% for fitted, thin, and standard condoms. Previously, regulatory agencies have approved non-inferiority applications for vaginal sex based on a less than 5% IDH1 Inhibitor 2 failure rate [21,25]. We therefore anticipate that our findings will allow for international regulatory agencies to provide a label indication for each of these types of condoms for anal sex. Our previous survey found that 69% of MSM reported they would be more likely to use condoms more frequently if the condoms were FDA label-indicated for anal sex, so a label indication may provide public health utility [26]. A label indication could have utility for women as well, and we see no reason to anticipate biological differences in failure levels for anal sex due to the sex (male or female) of the receptive partner. A label indication will clarify the high efficacy of condoms for anal sex when used properly, potentially promoting their use in combination prevention strategies that encourage choice of efficacious interventions. In our trial, clinical failure was significantly lower for anal sex than for vaginal sex. This confirmed our hypothesis that condoms would fail at an acceptable level for anal sex, but was contrary to our expectation that condoms might fail more often for anal sex. In Rabbit polyclonal to GLUT1 multivariate analyses that controlled for potential confounders such as past failure experiences, the effect of lower failure for anal sex remained significant. This finding is contrary to previous research that discovered higher failing for anal intercourse than for genital sex. One most likely reason behind the difference between your present and earlier results requires provision of lubricant. The FDA website records that condoms may fail even more for anal intercourse than for genital sex because of higher degrees of friction [18]. We offered all scholarly research individuals with water-based, condom-compatible research lubricant,.