Female Condom-ORIGAMI FC Feasibility Study - Clinical Research

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 and 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.