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.
Thesaurus Terms: Aids Virus; Aids Prevention; Aids/Hiv Prevention; Acquired Immune Deficiency Syndrome Virus; Acquired Immunodeficiency Syndrome Virus; Address; American; Biocompatible; Clinic; Clinical; Clinical Research; Clinical Study; Condom; Condoms, Unspecified; Couples; Cross-Over Studies; Cross-Over Trials; Crossover Studies; Crossover Trials; Data; Devices; Esthesia; Extravasation; Fda; Feasibility Studies; Female; Female Condoms; Food And Drug Administration; Food And Drug Administration (U.S.); Genital System, Female, Vagina; Guidelines; Hiv; Hiv Prevention; Hiv/Aids Prevention; Htlv-Iii; Heterosexuals; Human Immunodeficiency Viruses; Human T-Cell Leukemia Virus Type Iii; Human T-Cell Lymphotropic Virus Type Iii; Human T-Lymphotropic Virus Type Iii; Human Volunteers; Injection Of Therapeutic Agent; Injections; Lav-Htlv-Iii; Latex; Leakage; Legal Patent; Liquid Substance; Lymphadenopathy-Associated Virus; Materials Testing; Measures; Methods; Nitriles; Ostamer; Participant; Patents; Pellethane; Performance; Permeability; Phase; Plastics; Polyisocyanates; Polyurethanes; Pressure; Pressure- Physical Agent; Property; Property, Loinc Axis 2; Protocol; Protocols Documentation; Randomized; Research Design; Resistance; Risk; Sbir; Sbirs (R43/44); Std; Safety; Selection Criteria; Semen; Seminal Fluid; Sensation; Sexually Transmitted Diseases; Sexually Transmitted Disorder; Sexually Transmitted Infection; Shapes; Silicones; Small Business Innovation Research; Small Business Innovation Research Grant; Societies; Spillage; Study Type; Tensile Strength; Testing; Usfda; United States Food And Drug Administration; Unwanted Pregnancy; Vagina; Vaginal; Venereal Diseases; Venereal Disorders; Venereal Infections; Viral; Virus; Virus-Hiv; Viruses, General; Woman; Condoms; Design; Designing; Experience; Experiment; Experimental Research; Experimental Study; Fluid; Improved; Liquid; Male; Novel; Pre-Clinical; Preclinical; Preference; Pressure; Prospective; Prototype; Public Health Relevance; Randomisation; Randomization; Randomly Assigned; Research Study; Resistant; Sex; Study Design; Technological Innovation; User-Friendly
