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

描述(由申请人提供)：该项目的主要目标是在之前第一阶段研究的基础上，提高产品的敏感性，改进和测试折纸男用避孕套1(OMC 1)的改进，并开发一种消费者更容易接受的专门用于阴道-阴茎性交的装置，折纸男用避孕套3(OMC 3)。OMC 3由定制的生物相容、不透病毒的硅胶制成，目的是：1.促进双方更愉快和更安全的性行为体验；2.提高艾滋病毒/性传播疾病风险人群对男用避孕套的敏感性和接受度；3.鼓励和增加持续和正确使用避孕套的动力。OMC 3原型的两个修改后的产品设计将进行注塑，以进行结构完整性的临床前测试。在完成临床前结构测试和确定安全原型后，我们建议进行两个人类志愿者研究：1.用户偏好(UP)研究，以确定首选原型，在10对夫妇中比较两个原型的提高敏感性和用户偏好的措施；以及2.夫妇可接受性和性能(CAP)研究，以调查36对夫妇中“首选”原型的可接受性和性能。 公共卫生相关性：我们建议进行临床研究，以开发和改进用于阴道-阴茎性交的OMC 3，这是一项与人类志愿者进行的可行性研究，并进行了结构完整性的预临床测试。新的功能，包括更容易穿上的伸缩式折叠，纵向肋骨，失去合身设计，以及阴蒂刺激功能，将为双方提供更好的感觉和更高的消费者接受度和性能。

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.