(Scanned from the applicant's description): 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 (KwikezeTM) will offset universal reluctance toward condom usage and mitigate associated health risks. Specific Objectives Phase II: A) Finalize production scale quantities from existing optimized prototype. B) Test production scale applicators/condoms at independent labs following FDA requirements (ASTM D3492-99). C) Conduct experiments/clinical trials (incorporating Phase I findings) at three separate sites coordinated through Center for Contraceptive Research at University of Alabama Medical School. D) Three experiments total 240 couples: 1) 96 married heterosexual, 2) 96 unmarried heterosexual and 3) 48 male homosexual couples. Research Design: 10 trial alternating treatment repeated measures with random assignments to determine applicator effectiveness plus deriving from gender, age (3) and race (4). E) Rates of condom slippage/breakage will be determined/norms generated for independent variable subgroups. Benefits: 1) Expected to maintain condom integrity including minimizing slippage and breakage. 2) KwikezeTM will increase condom usage thus minimizing disease transmission and unwanted pregnancies. (Research results should allow for the commercialization of a cost effective and safe KwikezeTM with greater appeal to populations choosing to practice safe sex and/or birth control.)
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