Behavioral and Manufacturing Science to Commercially Develop Fitted Condoms

行为和制造科学用于商业开发贴合避孕套

• 批准号: 8603309
• 负责人: Michael P Cecil
• 金额: $ 22.49万
• 依托单位: THEYFIT, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8603309
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adopted; Adoption; Agreement; Anal Sex; Area; Behavioral; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Custom; Data; Data Analyses; Data Collection; Data Element; Development; Education; Educational Background; Epidemic; Epidemiology; European Union; Faculty; Future; Grant; Guidelines; HIV; HIV Infections; Industry; International; Laboratories; Latex; Legal patent; Length; Marketing; Measurement; Measures; Medical Device; Modeling; NIH Office of AIDS Research; Outcome; Patient Self-Report; Performance; Phase; Policies; Population; Prevention strategy; Procedures; Public Health; Relative (related person); Reporting; Research; Role; Sales; Sampling; Science; Sexually Transmitted Diseases; Standardization; Strategic Planning; Syphilis; Technology; Testing; Time Study; United States; United States Food and Drug Administration; Universities; Ursidae Family; Width; Work; World Health Organization; base; condoms; design; evidence base; experience; high risk; improved; innovation; male; meetings; men; men who have sex with men; novel; penis; pressure; prevent; public health relevance; response; sexual minority; tool; transmission process

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.

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疾病传播的唯一、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致力于解决这一问题，他们生产“定制”避孕套，根据用户决定的长度和周长提供95种不同尺寸的避孕套。目前，由于管理制造和测试程序的监管指南要求为狭窄尺寸的避孕套设计爆裂测试，美国只有很小范围的避孕套可用。我们寻求进行实验室避孕套测试，以增加通过新的国际标准草案的证据基础，该草案建立了一个破裂测试标准模型，允许测试更广泛的避孕套尺寸。采用扩展的测试标准对于在美国提供更广泛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。这将解决关于有效措施的一个重要研究问题，并提供关于用户是否具有足够的熟练程度来准确确定其定制避孕套大小的信息。为了为未来的临床试验提供参考数据，我们将分析之前从全国男男性行为样本中收集的数据，以确定肛交的避孕套破损率。这一分析将提供创新，允许进一步的研究将避孕套转向受监管的肛交医疗器械。在这两笔赠款中，TheyFit将与埃默里大学流行病学系的教职员工合作，后者拥有广泛的专业知识，在性少数人群中开展关于艾滋病毒/艾滋病的研究。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。