The primary objective of this grant is to refine and test a prototype of the Comfort Condom(tm): a new condom made from silicone, a material that may offer better sensation and be less prone to breakage than latex or plastic. The Comfort Condom will feature several technological innovations, including: 1) strong, heavy- gauge material that feels like human tissue, creating sensation instead of acting as a filter to it, 2) a loose fit for greater comfort, 3) a discrete scrotal retention band to reduce the likelihood of slippage, and 4) highly stretchable material for better fit and comfort. There are five specific aims: 1. Fabricate three prototypes of the Comfort Condom(tm) from silicone using liquid injection molding. 2. Confirm that the Class VI medical grade silicone used in the Comfort Condom(tm) remains biocompatible after the manufacturing process. The completed condoms will undergo laboratory testing for cytotoxicity, sensitization, irritation, and systemic toxicity. All three prototypes will be tested. 3. Assess the structural integrity of the Comfort Condom(tm) by measuring tensile properties, leakage, permeability, airburst volume, and airburst pressure. All three prototypes will be tested. 4. Compare the safety, acceptability, and performance of the three Comfort Condom(tm) prototypes. A """"""""Feasibility and Design"""""""" study will be conducted with ten heterosexual couples. Each couple will use six condoms (two of each prototype), rate various subjective features of each condom, and report on any breakage, slippage, or adverse events they may experience. 5. Compare the safety, acceptability, and performance of the best Comfort Condom(tm) prototype with a commercial male latex condom. A """"""""Performance and Acceptability"""""""" study will be conducted with thirty-six couples. Each couple will use three Comfort Condoms(tm) and three latex condoms, rate various subjective features of each condom, and report on any breakage, slippage, or adverse events they may experience. For sexually active couples, condoms used correctly and consistently are the most effective method available to reduce the risk of transmitting HIV and other sexually transmitted infections (STI). Unfortunately, many individuals find latex condoms unacceptable. The development of new and improved condoms is a key component in combating the HIV/AIDS crisis. ? ? ?
