RAI CONDOM: Feasibility & Acceptability Study, Phase 1 Pilot Clinical Research

描述(申请人提供)：这个项目的目的是研究、改进和测试折纸RAI避孕套的三个原型，RAI(接受性肛交)避孕套由生物兼容、不透病毒的硅胶制成，可能比乳胶产品提供更好的感觉和更少的破裂，并提供最大限度的病毒传播保护。三个原型将进行注射成型，并进行生物兼容性和结构完整性的预临床测试。折纸RAI避孕套的目的是：1.促进双方愉快和安全的RAI性行为体验；2.提高那些进行肛交并有感染艾滋病毒/性传播疾病风险的人对避孕套的接受度；3.鼓励和增加那些进行肛交的人持续和正确地使用避孕套；4.提供一种由接受伴侣控制的艾滋病毒预防策略。在完成临床前测试和确定安全和生物相容的原型后，我们建议进行两项人类志愿者研究：1.用户偏好研究，确定首选原型，比较30名志愿者在非性交环境下三种原型的用户偏好测量；2.夫妇可接受性和性能研究(CAP)，以调查24对夫妇在肛交过程中首选原型的可接受性和性能。公共卫生相关性：为了介绍一种迫切需要的、有效的RAI(接受性肛交)艾滋病毒预防策略，本研究的主要目标是研究折纸RAI避孕套的可行性和可接受性：一种新型的生物相容、病毒不渗透、硅胶、直肠插入式避孕套，旨在提供男性乳胶避孕套的替代品，并提高艾滋病毒/性传播感染风险消费者的接受度和依从性。其用户友好的设计旨在引入一种令人愉快的、更可接受的、由合作伙伴控制的障碍，并鼓励其使用。

DESCRIPTION (provided by applicant): The purpose of this project is to research, refine and test three prototypes of the ORIGAMI RAI CONDOM, an RAI (receptive anal intercourse) condom made of a biocompatible, viral-impermeable silicone, which may provide better sensation and less breakage than latex products and provide maximum protection against viral transmission. Three prototypes will be injection-molded and pre-clinically tested for biocompatibility and structural integrity. The ORIGAMI RAI CONDOM is intended to: 1. Facilitate a pleasurable and safe RAI sexual experience for both partners, 2. Increase the acceptability of condoms among those who practice anal intercourse and are at risk of HIV / STIs, 3. Encourage and increase consistent and correct use for those who practice anal intercourse and 4.Provide a receptive-partner-controlled strategy for HIV prevention. Upon completion of pre-clinical testing and identification of safe and biocompatible prototypes, we propose to conduct Two human volunteer studies will be conducted: 1. A User Preference Study, to identify a preferred prototype, comparing measures of user preference of the three prototypes among 30 volunteers, in a non-coital context and 2. a Couples Acceptability & Performance Study (CAP) to investigate the acceptability and performance of the preferred prototype during anal intercourse among 24 couples. PUBLIC HEALTH RELEVANCE: To introduce an urgently needed, effective HIV prevention strategy for RAI (receptive anal intercourse), the primary objective of this Study is to research the feasibility and acceptability of the ORIGAMI RAI CONDOM: a new biocompatible, viral-impermeable, silicone, anorectally inserted condom, intended to provide an alternative to male latex condoms and increase acceptability and compliance for consumers at risk of HIV/STIs. Its user-friendly design is intended to introduce a pleasurable, more acceptable, receptive- partner-controlled barrier and to encourage its use.