THEYFIT, LLC — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): A policy statement by the World Health Organization n

Description

DESCRIPTION (provided by applicant): A policy statement by the World Health Organization notes that, the male latex condom is the single, most efficient, available technology to reduce the transmission of HIV and other sexually transmitted infections. Unfortunately, despite decades of condom promotion efforts, condoms usage rates remain disappointingly low. Between one-third and one-half of men report poor condom fit, and these men are more likely to forego condom use. TheyFit LLC seeks to address this bymanufacturing 'custom-fitted' condoms, with 95 different sizes available based on user-determined length and circumference measurements. Currently, only a narrow range of condom sizes are available in the United States due to regulatory guidelines governing manufacturing and testing procedures that require burst tests designed for a narrow range of condom sizes. We seek to conduct laboratory condom testing to increase the evidence base for adopting new draft international standards that establish a model of burst test standards allowing a broader range of condom sizes to be tested. Adoption of expanded testing standards is critical to enabling a wider range of condom sizes to be available in the United States. We also seek to improve upon traditional self-report mechanisms of penis measurement by validating the TheyFit measuring tool. This would address an important research question regarding validated measures and supply information on whether users have sufficient proficiency to accurately determine theircustom condom size. To provide reference data for a future clinical trial, we will analyze data, previously collected from a national sample of men who have sex with men, to establish condom breakage rates for anal sex. This analysis will provide innovation by allowing further research to move condoms towards being regulated medical devices for anal sex. On both grants, TheyFit will work in collaboration with faculty in Emory University's Department of Epidemiology, who have extensive expertise conductingresearch regarding HIV/AIDS among sexual minority populations. The proposed research has potential to inform efforts aimed at reducing HIV-related disparities and reducing new HIV infections, meeting two priority areas identified in the Strategic Plan of the NIH Office of AIDS Research. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Condoms are the most efficient and available technology for preventing HIV transmission, but many men don't use condoms and report problems with poorly fitting condoms. The proposed research seeks to contribute to tools and standards development that would allow for a larger range of condom sizes to be available to men in the United States. Having an expanded range of condom sizes made available is a promising strategy in increasing condom usage, particularly in high-risk populations.