The primary objective of this project is to build on prior Phase 1 research to improve product sensitivity properties, to refine and test modifications of the Origami Male Condom 1 (OMC 1), and develop a more consumer-acceptable device exclusively for vaginal-penile intercourse, the Origami Male Condom 3 (OMC 3). Made of custom formulated biocompatible, viral-impermeable silicone, the OMC 3 is intended to: 1. Facilitate a more pleasurable and safer sexual experience for both partners, 2. Increase the sensitivity and acceptability of male condoms among those at risk of HIV/STIs, and 3. Encourage and increase motivation for consistent and correct condom use. Two revised product designs of the OMC 3 prototypes will be injection-molded to conduct pre-clinical testing for structural integrity. Upon completion of pre-clinical structural testing and identification of safe prototypes, we propose to conduct two human volunteer studies: 1. A User Preference (UP) Study, to identify a preferred prototype, comparing measures of improved sensitivity and user preference of two prototypes among 10 couples, and 2. A Couples Acceptability &Performance (CAP) Study to investigate the acceptability, and performance of the ""preferred"" prototype among 36 couples.
Public Health Relevance: We propose clinical research to develop and refine the OMC 3 for vaginal-penile intercourse in a feasibility study with human volunteers and pre-clinically tested for structural integrity. New features, including telescopic folding for easier donning, longitudinal ribs, lose fitting design, and a clitoral stimulation feature will be introduced to provide improved sensation and increased consumer acceptability and performance for both partners.
Thesaurus Terms: Aids Virus;Acquired Immune Deficiency Syndrome Virus;Acquired Immunodeficiency Syndrome Virus;Adverse Experience;Adverse Event;Behavioral;Biocompatible;Clinical;Clinical Evaluation;Clinical Research;Clinical Study;Clinical Testing;Couples;Custom;Devices;Esthesia;Evaluation;Extravasation;Feasibility Studies;Filamentous Fungi;Future;Hiv;Htlv-Iii;Heterosexuals;Home;Home Environment;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;Intention;Lav-Htlv-Iii;Loinc Axis 2 Property;Latex;Leakage;Liquid Substance;Lymphadenopathy-Associated Virus;Male Condoms;Measures;Modification;Molds;Motivation;Orgasm;Performance;Phase;Phase I Study;Price;Property;Recommendation;Reporting;Research;Ribs;Risk;Sbir;Sbirs (R43/44);Safety;Sensation;Sexual Climax;Silicones;Small Business Innovation Research;Small Business Innovation Research Grant;Spillage;Tensile Strength;Testing;Vagina;Vaginal;Variant;Variation;Viral;Virus-Hiv;Clinical Test;Condoms;Design;Designing;Experience;Fluid;Improved;Liquid;Male;Phase 1 Study;Pre-Clinical;Preclinical;Preference;Pressure;Pricing;Prototype;Research Clinical Testing;Rib Bone Structure
