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

项目描述（由申请人提供）：该项目的主要目标是建立在先前的第一阶段研究的基础上，以提高产品的敏感性，改进和测试折纸男避孕套1 （OMC 1）的改进，并开发一种消费者更接受的装置，专门用于阴道-阴茎性交，折纸男避孕套3 （OMC 3）。由定制配方的生物相容性，病毒不渗透的硅胶制成，omc3旨在：为双方提供更愉快、更安全的性体验；2 .提高男性避孕套在艾滋病毒/性传播感染风险人群中的敏感性和可接受性；鼓励并增强坚持正确使用避孕套的积极性。两个修改后的OMC 3原型产品设计将进行注射成型，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，我们建议进行两项人体志愿者研究：1。用户偏好（UP）研究，以确定首选原型，比较10对夫妇中两种原型的改进灵敏度和用户偏好的措施。一项夫妻接受度和表现（CAP）研究调查了36对夫妇的“首选”原型的接受度和表现。

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.