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预防方案。这项提议的目的是改进和测试“ORIGAMI女用避孕套”的原型，它由一种新开发的生物相容性有机硅配方制成，这种更柔软的材料可能提供更好的感觉，比乳胶、丁腈或聚氨酯更不容易破裂，此外，它还具有预先测试过的对比HIV小的病毒的不渗透性。ORIGAMI女用避孕套旨在(1)为双方提供愉快的性体验；(2)提高有感染艾滋病毒、其他性传播疾病和意外怀孕风险的消费者对女用避孕套的接受程度；(3)鼓励其一贯和正确使用。同时，该材料将提供最大限度的保护，防止破损，滑移和病毒渗透性。新设备将具有以下技术创新：(1)专门为该设备开发的生物相容性，无毒，非过敏性硅胶的先进配方；(2)独特的保持形状的生物形态设计；(3)预先测试的病毒不渗透材料；(4)优异的抗撕裂性和抗拉强度；(5)一个独特的专利储液器，旨在减少精液回流。我们将制作三个“ORIGAMI女用避孕套”的原型，它们将进行结构完整性的临床前测试。接下来，我们将进行两个临床研究，如下所述。研究设计与方法：两项人体志愿者研究将在本协议中进行：(1)女性用户偏好（FUP）研究，该研究将评估三种ORIGAMI女用安全套原型的设计偏好和非性方面的可接受性和性能，并确定哪一种是最安全，最舒适，可插入/取出和佩戴的：30D女性受试者；(2)夫妇可接受性和表现（CAP）研究，将在40对异性伴侣中比较“ORIGAMI”女用避孕套的首选原型和商用女用避孕套在阴道性交中的临床表现和可接受性。将从参与者那里收集安全性和性能、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。

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.