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 problem by manufacturing fitted condoms, with 95 different sizes available. Potential users can objectively determine their fitted condom size by using a paper measurement tool to determine their length and circumference measurements, thereby personalizing the condom sizing process. The proposed research will involve conducting a clinical trial to inform understanding of fitted condom safety performance (i.e. condom breakage and slippage), as well as addressing whether users perceive that fitted condoms enhance pleasure. This blinded trial will be conducted among diverse populations, allowing for assessment of condom performance for both anal and vaginal sex outcomes. This proposal will provide innovation by providing additional data to move condoms towards being regulated medical devices for anal sex. Additionally, this will be the first condom trial, to our knowledge, to explicitly assess pleasure as a primary endpoint. To maximize the public health benefits of increased condom options, we also propose to develop a mobile phone application (app) for automating the determination of fitted condom size. TheyFit will work in collaboration with faculty in Emory University's Departments of Epidemiology and Behavioral Sciences and Health Education, who have extensive expertise conducting clinical trial and related epidemiological research regarding HIV/AIDS among diverse 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

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 goal of this project is to allow potential users to select their best condom size, and to see if these condoms increase pleasure and performance. Having an expanded range of condom sizes made available is a promising strategy in increasing condom usage, particularly in high-risk populations.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HD078154-02A1
Application #
8846451
Study Section
Special Emphasis Panel (ZRG1-AARR-G (10))
Program Officer
Newcomer, Susan
Project Start
2013-08-01
Project End
2016-07-31
Budget Start
2014-09-25
Budget End
2015-07-31
Support Year
2
Fiscal Year
2014
Total Cost
$772,266
Indirect Cost
Name
Theyfit, LLC
Department
Type
DUNS #
015033081
City
Covington
State
GA
Country
United States
Zip Code
30014