Female Condom-ORIGAMI FC Feasibility Study - Clinical Research

描述（由申请人提供）：迫切需要扩大有效的女性发起的艾滋病毒预防方案。该提案的目的是改进和测试ORIGAMI女用避孕套的原型，该避孕套由新开发的生物相容性硅树脂配方制成，硅树脂是一种较软的材料，与乳胶、丁腈或聚氨酯相比，可以提供更好的感觉，不易破裂，此外，它对比艾滋病毒小的病毒具有预先测试的不渗透性。 ORIGAMI女用避孕套”的目的是：（1）促进双方获得愉悦的性体验;（2）提高有艾滋病毒、其他性传播感染和意外怀孕风险的消费者对女用避孕套的接受程度;（3）鼓励坚持正确使用。该材料同时将提供最大的保护，防止断裂，滑动和病毒渗透。 该新型装置将具有以下技术创新：（1）专门为此装置开发的生物相容性、无毒、无过敏性硅胶的先进配方;（2）独特的形状保持、生物形态设计;（3）预先测试的病毒不可渗透材料;（4）出色的抗撕裂性和拉伸强度;以及（5）独特的专利储液器，旨在最大限度地减少精液回流。 我们将制造三个ORIGAMI女性避孕套的原型，并将进行结构完整性的临床前测试。接下来，我们将进行两项临床研究，如下所述。研究设计和方法：本方案中将进行两项人类志愿者研究：（1）女性用户偏好（FUP）研究，将评价三种ORIGAMI女性避孕套原型的设计偏好和非性交方面的可接受性和性能，并确定哪种避孕套最安全、最舒适，可接受30 D女性受试者插入/取出和佩戴;和（2）一项夫妇可接受性和性能（CAP）研究，将在40对异性夫妇阴道性交时比较ORIGAMI女用避孕套首选原型与市售女用避孕套的临床性能和可接受性。将从参与者中收集安全性和性能、偏好和可接受性数据，并进行分析，以进一步改进ORIGAMI女用避孕套的设计，并确定进入SBIR II阶段的可行性。 公共卫生相关性：为了满足扩大由女性主动采取的有效预防艾滋病毒办法的迫切需要，该项目提议改进“ORIGAMI女用避孕套”的原型，这是一种新的、生物相容的硅橡胶避孕套，旨在提高有艾滋病毒、其他性传播感染和意外怀孕风险的消费者对女用避孕套的接受和使用。其新颖的设计和新的材料旨在使其更加方便用户，并提高其可接受性，并始终如一地正确使用。

DESCRIPTION (provided by applicant): There is an urgent need to expand effective female-initiated HIV prevention options. The purpose of this proposal is to refine and test prototypes of the ORIGAMI Female Condom", made of a newly developed formula of biocompatible silicone, a softer material that may provide better sensation and be less prone to breakage than latex, nitrile, or polyurethane, in addition to its pre-tested impermeability to virus smaller than HIV. The ORIGAMI Female Condom" is intended to (1) facilitate a pleasurable sexual experience for both partners; (2) increase the acceptability of female condoms among consumers at risk of HIV, other sexually transmitted infections, and unwanted pregnancies; and (3) encourage its consistent and correct use. The material simultaneously will provide maximum protection against breakage, slippage, and viral permeability. The novel device will feature the following technological innovations: (1) an advanced formula of biocompatible, non-toxic, non-allergenic silicone, developed specifically for this device; (2) a unique shape- retaining, biomorphic design; (3) pretested viral-impermeable material; (4) excellent tear-resistance and tensile strength; and (5) a unique patented reservoir designed to minimize semen backflow. We will fabricate three prototypes of the ORIGAMI Female Condom", which will undergo pre-clinical testing for structural integrity. Next, we will conduct two clinical research studies, as described below. Research Design & Methods: Two human volunteer studies will be conducted in this protocol: (1) a Female- User Preference (FUP) Study, which will evaluate the design preferences and non-coital aspects of acceptability and performance of three ORIGAMI Female Condom" prototypes and identify which is the safest, most comfortable, and acceptable to insert/remove and wear to :30D female subjects; and (2) a Couples Acceptability and Performance (CAP) Study, which will compare the clinical performance and acceptability of the preferred prototype of the ORIGAMI Female Condom" to that of a commercial female condom during vaginal intercourse among 40 heterosexual couples. Safety and performance, preference, and acceptability data will be collected from the participants and analyzed to further improve the ORIGAMI Female Condom" design and establish feasibility to proceed to a SBIR II phase. PUBLIC HEALTH RELEVANCE: To address the urgent need to expand effective female-initiated HIV prevention options, this project proposes to refine a prototype of the ORIGAMI Female Condom", a new, biocompatible, silicone condom, intended to increase the acceptability and use of female condoms among consumers at risk of HIV, other sexually transmitted infections, and unwanted pregnancies. Its novel design and new material are intended to make it more user-friendly and to increase its acceptability, with consistent and correct use.