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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
5R43AI096908-02
Application #
8302261
Study Section
Special Emphasis Panel (ZRG1-AARR-G (10))
Program Officer
Deal, Carolyn D
Project Start
2011-07-15
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
2
Fiscal Year
2012
Total Cost
$294,000
Indirect Cost
Name
Strata Various
Department
Type
DUNS #
799212931
City
Marina Del Rey
State
CA
Country
United States
Zip Code
90292