Behavioral and Manufacturing Science to Commercially Develop Fitted Condoms

描述（由申请人提供）：世界卫生组织的一项政策声明指出，“男用乳胶避孕套是减少艾滋病毒和其他性传播感染的唯一、最有效、可用的技术。“不幸的是，尽管几十年来一直在努力推广避孕套，但避孕套的使用率仍然低得令人不安。三分之一到二分之一的男性报告避孕套不合适，这些男性更有可能放弃使用避孕套。TheyFit有限责任公司试图通过生产“定制”避孕套来解决这个问题，根据用户确定的长度和周长测量，有95种不同的尺寸可供选择。目前，由于管理制造和测试程序的监管准则要求针对狭窄范围的避孕套尺寸设计的破裂测试，因此在美国仅可获得狭窄范围的避孕套尺寸。我们努力进行实验室避孕套测试，以增加采用新的国际标准草案的证据基础，这些标准建立了一个爆破测试标准模型，允许对更广泛的避孕套尺寸进行测试。采用扩大的测试标准对于在美国提供更大范围的避孕套尺寸至关重要。我们还试图通过验证TheyFit测量工具来改进传统的阴茎测量自我报告机制。这将解决一个关于有效措施的重要研究问题，并提供关于使用者是否有足够的能力准确确定其定制避孕套尺寸的信息。为了给将来的临床试验提供参考数据，我们将分析以前从全国男男性行为者样本中收集的数据，以确定肛交时的避孕套破损率。这项分析将提供创新，允许进一步的研究将避孕套推向规范的肛交医疗器械。在这两笔赠款中，TheyFit将与埃默里大学流行病学系的教师合作，他们拥有在性少数群体中进行艾滋病毒/艾滋病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NIH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 by manufacturing 'custom-fitted' condoms, with 95 different sizes available based on user-determined length and circumference measurements. Currently, only a narrow range of condom sizes are available in the United States due to regulatory guidelines governing manufacturing and testing procedures that require burst tests designed for a narrow range of condom sizes. We seek to conduct laboratory condom testing to increase the evidence base for adopting new draft international standards that establish a model of burst test standards allowing a broader range of condom sizes to be tested. Adoption of expanded testing standards is critical to enabling a wider range of condom sizes to be available in the United States. We also seek to improve upon traditional self-report mechanisms of penis measurement by validating the TheyFit measuring tool. This would address an important research question regarding validated measures and supply information on whether users have sufficient proficiency to accurately determine their custom condom size. To provide reference data for a future clinical trial, we will analyze data, previously collected from a national sample of men who have sex with men, to establish condom breakage rates for anal sex. This analysis will provide innovation by allowing further research to move condoms towards being regulated medical devices for anal sex. On both grants, TheyFit will work in collaboration with faculty in Emory University's Department of Epidemiology, who have extensive expertise conducting research regarding HIV/AIDS among sexual minority 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.