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

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 and 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.