Long-Term Objectives: Determine effectiveness and safe utilization of small innovative device which, attached to partially unrolled condom, will facilitate and increase usage while maintaining condom integrity (including minimizing slippage and breakage). This dependable applicator and condom system (Kwikeze TM) will offset universal reluctance toward condom usage and mitigate associated health risks. Specific Objectives Phase I: 1) Finalize optimization of existing functional applicator prototype. 2) Test optimized prototypes at independent lab following FDA requirements (ASTM D3492-97). 3) Conduct 9 focus groups (10 participants each) on Kwikeze TM benefits and behavioral aspects on usage. 4) Refine instruments based on above. 5) Conduct clinical trials on 32 adult couples using cross sectional repeated measures design with alternating treatments. 6) Conduct data analysis. 7) Develop enlarged Phase II controlled design based on above to scientifically evaluate Kwikeze TM effectiveness. Phase I will explore feasibility/reliability of proposed design and assess Kwikeze TM physical characteristics and attitudes towards it s use. Benefits (see page 11): 1. Expected to maintain condom integrity including minimizing slippage and breakage. 2. Kwikeze TM will increase condom usage thus minimizing disease transmission and unwanted pregnancies. (Research results should allow for the commercialization of a cost effective and safe Kwikeze TM with greater appeal to populations choosing to practice safe sex and/or birth control.
The benefits of Kwikeze TM (patent pending) are expected to significantly increase condom use at a minimal cost of (4 cents over exiting condoms). With 27-30 million users, 1 billion condoms (650 million dollar market) are sold annually in the U.S. If only a small percentage of occasional condom users were to use Kwikeze TM more often and some non-condom users begin to use it, the contribution to the U.S. and World healthcare system would be immense.
