The purpose of this project is to research, refine and test three prototypes of the ORIGAMI RAI CONDOM, an RAI (receptive anal intercourse) condom made of a biocompatible, viral-impermeable silicone, which may provide better sensation and less breakage than latex products and provide maximum protection against viral transmission. Three prototypes will be injection-molded and pre-clinically tested for biocompatibility and structural integrity. The ORIGAMI RAI CONDOM is intended to: 1. Facilitate a pleasurable and safe RAI sexual experience for both partners, 2. Increase the acceptability of condoms among those who practice anal intercourse and are at risk of HIV / STIs, 3. Encourage and increase consistent and correct use for those who practice anal intercourse and 4.Provide a receptive-partner-controlled strategy for HIV prevention. Upon completion of pre-clinical testing and identification of safe and biocompatible prototypes, we propose to conduct Two human volunteer studies will be conducted: 1. A User Preference Study, to identify a preferred prototype, comparing measures of user preference of the three prototypes among 30 volunteers, in a non-coital context and 2. a Couples Acceptability &Performance Study (CAP) to investigate the acceptability and performance of the preferred prototype during anal intercourse among 24 couples.

Public Health Relevance

To introduce an urgently needed, effective HIV prevention strategy for RAI (receptive anal intercourse), the primary objective of this Study is to research the feasibility and acceptability of the ORIGAMI RAI CONDOM: a new biocompatible, viral-impermeable, silicone, anorectally inserted condom, intended to provide an alternative to male latex condoms and increase acceptability and compliance for consumers at risk of HIV/STIs. Its user-friendly design is intended to introduce a pleasurable, more acceptable, receptive- partner-controlled barrier and to encourage its use.

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 #
1R43AI084145-01A1
Application #
7757091
Study Section
Special Emphasis Panel (ZRG1-AARR-G (15))
Program Officer
Sharma, Usha K
Project Start
2009-07-20
Project End
2011-06-30
Budget Start
2009-07-20
Budget End
2010-06-30
Support Year
1
Fiscal Year
2009
Total Cost
$828,188
Indirect Cost
Name
Strata Various
Department
Type
DUNS #
799212931
City
Marina Del Rey
State
CA
Country
United States
Zip Code
90292