Origami MALE CONDOM-3: Feasibility & Acceptability Study, Phase 1 Clinical Resear

折纸男用避孕套-3：可行性

• 批准号: 8302261
• 负责人: Daniel Resnic
• 金额: $ 29.4万
• 依托单位: STRATA VARIOUS
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-15 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8302261
• 关键词: Adverse event; Behavioral; Biocompatible; Clinical; Clinical Research; Couples; Custom; Devices; Esthesia; Evaluation; Extravasation; Feasibility Studies; Future; HIV; Heterosexuals; Home environment; Human Volunteers; Injection of therapeutic agent; Intention; Latex; Liquid substance; Male Condoms; Measures; Modification; Molds; Motivation; Orgasm; Performance; Phase; Price; Property; Recommendation; Reporting; Research; Risk; Safety; Silicones; Small Business Innovation Research Grant; Tensile Strength; Testing; Vagina; Variant; Viral; condoms; design; experience; improved; male; phase 1 study; pre-clinical; preference; pressure; prototype; research clinical testing; rib bone structure

DESCRIPTION (provided by applicant): The primary objective of this project is to build on prior Phase 1 research to improve product sensitivity properties, to refine and test modifications of the Origami Male Condom 1 (OMC 1), and develop a more consumer-acceptable device exclusively for vaginal-penile intercourse, the Origami Male Condom 3 (OMC 3). Made of custom formulated biocompatible, viral-impermeable silicone, the OMC 3 is intended to: 1. Facilitate a more pleasurable and safer sexual experience for both partners, 2. Increase the sensitivity and acceptability of male condoms among those at risk of HIV/STIs, and 3. Encourage and increase motivation for consistent and correct condom use. Two revised product designs of the OMC 3 prototypes will be injection-molded to conduct pre-clinical testing for structural integrity. Upon completion of pre-clinical structural testing and identification of safe prototypes, we propose to conduct two human volunteer studies: 1. A User Preference (UP) Study, to identify a preferred prototype, comparing measures of improved sensitivity and user preference of two prototypes among 10 couples, and 2. A Couples Acceptability & Performance (CAP) Study to investigate the acceptability, and performance of the "preferred" prototype among 36 couples.

描述（由申请方提供）：本项目的主要目标是在之前的1期研究的基础上，改善产品敏感性，完善和测试Origami男性避孕套1（OMC 1）的改良，并开发一种更受消费者接受的专用于阴道-阴茎性交的器械，Origami男性避孕套3（OMC 3）。OMC 3由定制配方的生物相容性、病毒渗透性硅胶制成，旨在：1.促进双方更愉快和更安全的性体验，2。提高艾滋病毒/性传播感染风险人群对男用避孕套的敏感性和可接受性;鼓励和提高坚持正确使用避孕套的积极性。将对OMC 3原型的两种修订产品设计进行注塑成型，以进行结构完整性的临床前试验。在完成临床前结构测试和安全原型的鉴定后，我们建议进行两项人体志愿者研究：1.一个用户偏好（UP）的研究，以确定一个首选的原型，10对夫妇之间的两个原型的改进的敏感性和用户偏好的比较措施，和2。一个夫妇可接受性和性能（CAP）的研究，以调查的可接受性，和性能的“首选”原型之间的36对夫妇。