SBIR/STTR Research Award

A study to improve the fit of HIV prevention methods

Award identifier 49e02d6414929396cf08e0f1f64e44e2cc9bd177da00b3d46a6fb95742b21c47Awarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$1,490,788

Program and phase

SBIR · Phase II

Award year

2014

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
THEYFIT, LLC
Proposal award date
2014-09-25
Contract end date
2016-07-31
UEI
Not reported
Solicitation number
PA14-071
Topic code
NICHD

Research abstract

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 problem by manufacturing fitted condoms with 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 Universityandapos 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 donandapos 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

Technology keywords

Not reported

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Agency intelligence

Department of Health and Human Services

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