Siegler Aaron J, Rosenthal Elizabeth M, Sullivan Patrick S, Christina Mehta C, Moore Reneé H, Ahlschlager Lauren, Kelley Colleen F, Rosenberg Eli S, Cecil Michael P
Department of Behavioral Sciences and Health Education Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, United States of America.
Department of Epidemiology Rollins School of Public Health at Emory University, United States of America.
EClinicalMedicine. 2019 Oct 31;17:100199. doi: 10.1016/j.eclinm.2019.10.012. eCollection 2019 Dec.
Men who have sex with men (MSM) face a 28-fold higher risk of HIV acquisition than men who have sex with women (MSW). Condoms are the most accessible prevention method, with billions produced annually. Due to potentially high clinical failure, international regulatory agencies do not approve condoms for anal sex. This trial sought to provide data regarding approval of condoms for anal sex.
We conducted a blinded, crossover randomized trial among MSM and MSW in Atlanta, Georgia, USA. Crossover conditions were standard condoms, thin condoms, and condoms fitted to each user's penile dimensions. The primary outcome was total clinical failure (slippage and/or breakage), assessed using an intention-to-treat analysis. A mixed methods model assessed differences in odds of failure. The study is registered with ClinicalTrials.gov, NCT02753842, and is completed.
We enrolled 252 MSM and 252 MSW between May 19, 2016 and May 2, 2017. Participants reported a total of 4884 anal or vaginal sex acts using study-provided condoms. For all crossover conditions, clinical failure was lower for anal sex (0•7%, 16/2351) than for vaginal sex (1•9%, 48/2533), (odds ratio 0•40, 95% confidence interval 0•21, 0•75, < •001)00. There was no difference in odds of failure for anal sex acts between the different types of condoms. Due to study design, nearly all anal sex acts used condom-compatible lubricant (98•3%), yet only a minority of vaginal sex acts (41•6%) used lubricant. Sex acts for which lubricant was used had lower failure for both anal and vaginal sex, with no difference in odds of failure between them.
In the largest trial of effectiveness of condoms for anal sex to date, we found remarkably low levels of failure. Condoms should be approved by regulatory agencies for anal sex. Clinicians may recommend condoms as a highly efficacious HIV and STD prevention tool for anal sex. Differences between failure for anal and vaginal sex were likely due to differential use of lubricant. Condom promotion programs should consider providing additional lubricant for all condoms distributed.
与男性发生性关系的男性（男男性行为者，MSM）感染艾滋病毒的风险比与女性发生性关系的男性（异性性行为男性，MSW）高28倍。避孕套是最容易获得的预防方法，每年生产数十亿个。由于临床失败率可能较高，国际监管机构未批准将避孕套用于肛交。本试验旨在提供有关批准避孕套用于肛交的数据。
我们在美国佐治亚州亚特兰大的男男性行为者和异性性行为男性中进行了一项双盲、交叉随机试验。交叉条件为标准避孕套、超薄避孕套以及根据每位使用者阴茎尺寸定制的避孕套。主要结局是总临床失败（滑脱和/或破裂），采用意向性分析进行评估。混合方法模型评估失败几率的差异。该研究已在ClinicalTrials.gov注册，编号为NCT02753842，且已完成。
我们在2016年5月19日至2017年5月2日期间招募了252名男男性行为者和252名异性性行为男性。参与者报告使用研究提供的避孕套共进行了4884次肛交或阴道性行为。对于所有交叉条件，肛交的临床失败率（0.7%，16/2351）低于阴道性行为（1.9%，48/2533），（比值比0.40，95%置信区间0.21，0.75，P<0.001）。不同类型避孕套的肛交失败几率没有差异。由于研究设计，几乎所有肛交行为都使用了与避孕套兼容的润滑剂（98.3%），而只有少数阴道性行为（41.6%）使用了润滑剂。使用润滑剂的性行为在肛交和阴道性行为中失败率都较低，两者之间的失败几率没有差异。
在迄今为止最大规模的避孕套用于肛交有效性试验中，我们发现失败率极低。监管机构应批准避孕套用于肛交。临床医生可推荐避孕套作为用于肛交的高效艾滋病毒和性传播感染预防工具。肛交和阴道性行为失败率的差异可能是由于润滑剂使用情况不同。避孕套推广项目应考虑为分发的所有避孕套额外提供润滑剂。
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