ArticleEClinicalMedicine2019
Levels of clinical condom failure for anal sex: A randomized cross-over trial.
Article in EClinicalMedicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02753842 (A Double-Blind, Single Center, Randomized 3-way Crossover Trial to Determine Pleasure for Fitted, Thin and Standard Condoms, and to Assess Clinical Failure for Vaginal and Anal Sex), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Single Center, Randomized 3-way Crossover Trial to Determine Pleasure for Fitted, Thin and Standard Condoms, and to Assess Clinical Failure for Vaginal and Anal Sex
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Lubricants for the promotion of sexual health and well-being: a systematic review.Sexual and reproductive health matters · 2021Pooled it
- Adding a Prevention Intervention to an Established App: The Blued+ HIV Prevention Pilot Study in Beijing and Chengdu, China.Journal of the International AIDS Society · 2026Article
- Pleasurable and problematic receptive anal intercourse and diseases of the colon, rectum and anus.Nature reviews. Gastroenterology & hepatology · 2024Review
- Preferences for HIV prevention strategies among newly arrived Asian-born men who have sex with men living in Australia: A discrete choice experiment.Frontiers in public health · 2023Article
- "I'd Rather Use a Refuse Bag:" A Qualitative Exploration of a South African Community's Perceptions of Government-Provided Condoms and Participant-Preferred Solutions.Archives of sexual behavior · 2021Article
- Protocol for a national probability survey using home specimen collection methods to assess prevalence and incidence of SARS-CoV-2 infection and antibody response.Annals of epidemiology · 2020Article
- Time for the US food and drug administration approval of condoms for anal intercourse.EClinicalMedicine · 2019Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundMen 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.
methodsWe 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.
findingsWe 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,
interpretationIn 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.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.