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

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。 公共卫生相关性：我们建议临床研究开发和完善OMC 3阴道阴茎性交的可行性研究与人类志愿者和临床前测试的结构完整性。新的功能，包括伸缩折叠更容易穿上，纵向肋骨，失去拟合设计，和阴蒂刺激功能将被引入，以提供改善的感觉和提高消费者的接受度和性能的合作伙伴。

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. PUBLIC HEALTH RELEVANCE: We propose clinical research to develop and refine the OMC 3 for vaginal-penile intercourse in a feasibility study with human volunteers and pre-clinically tested for structural integrity. New features, including telescopic folding for easier donning, longitudinal ribs, lose fitting design, and a clitoral stimulation feature will be introduced to provide improved sensation and increased consumer acceptability and performance for both partners.