A study to improve the fit of HIV prevention methods

 描述(申请人提供)：世界卫生组织的一份政策声明指出，男用乳胶避孕套是减少艾滋病毒和其他性传播感染传播的唯一、最有效的可用技术。不幸的是，尽管几十年来一直在推广避孕套，但避孕套的使用率仍然低得令人失望。三分之一到一半的男性报告避孕套适合性差，这些男性更有可能放弃使用避孕套。TheyFit LLC试图通过生产适合的避孕套来解决这个问题，该公司有95种不同的尺寸可供选择。潜在用户可以通过使用纸张测量工具来确定其长度和周长，从而客观地确定适合他们的避孕套尺寸，从而使避孕套的尺寸过程个性化。拟议的研究将涉及进行一项临床试验，以了解已安装的避孕套的安全性能(即避孕套破裂和滑脱)，以及探讨使用者是否认为已安装的避孕套可以增强快感。这项盲法试验将在不同人群中进行，以评估安全套对肛门和阴道性交结果的影响。这项提案将通过提供更多数据来提供创新，将避孕套推向受监管的肛交医疗器械。此外，据我们所知，这将是第一次明确评估快感作为主要终点的避孕套试验。为了最大限度地增加避孕套选择对公众健康的好处，我们还建议开发一种移动电话应用程序(APP)，用于自动确定合适的避孕套大小。他们将与埃默里大学流行病学、行为科学和健康教育系的教职员工合作，这些教职员工拥有在不同人群中进行艾滋病毒/艾滋病临床试验和相关流行病学研究的广泛专业知识。拟议的研究有可能为旨在减少艾滋病毒相关差异和减少新的艾滋病毒感染的努力提供信息，满足国立卫生研究院艾滋病研究办公室战略计划中确定的两个优先领域。

 DESCRIPTION (provided by applicant): A policy statement by the World Health Organization notes that, the male latex condom is the single, most efficient, available technology to reduce the transmission of HIV and other sexually transmitted infections. Unfortunately, despite decades of condom promotion efforts, condoms usage rates remain disappointingly low. Between one-third and one-half of men report poor condom fit, and these men are more likely to forego condom use. TheyFit LLC seeks to address this problem by manufacturing fitted condoms, with 95 different sizes available. Potential users can objectively determine their fitted condom size by using a paper measurement tool to determine their length and circumference measurements, thereby personalizing the condom sizing process. The proposed research will involve conducting a clinical trial to inform understanding of fitted condom safety performance (i.e. condom breakage and slippage), as well as addressing whether users perceive that fitted condoms enhance pleasure. This blinded trial will be conducted among diverse populations, allowing for assessment of condom performance for both anal and vaginal sex outcomes. This proposal will provide innovation by providing additional data to move condoms towards being regulated medical devices for anal sex. Additionally, this will be the first condom trial, to our knowledge, to explicitly assess pleasure as a primary endpoint. To maximize the public health benefits of increased condom options, we also propose to develop a mobile phone application (app) for automating the determination of fitted condom size. TheyFit will work in collaboration with faculty in Emory University's Departments of Epidemiology and Behavioral Sciences and Health Education, who have extensive expertise conducting clinical trial and related epidemiological research regarding HIV/AIDS among diverse populations. The proposed research has potential to inform efforts aimed at reducing HIV-related disparities and reducing new HIV infections, meeting two priority areas identified in the Strategic Plan of the NIH Office of AIDS Research.