Original research articleShort-term acceptability of the PATH Woman's Condom among couples at three sites
Introduction
A female condom that is highly acceptable to women and their partners could make a significant public health impact on the prevention of unwanted pregnancy and sexually transmitted infections (STIs). Research with the FC Female Condom® (manufactured by the Female Health Company) has shown substantial interest in the concept of a female condom but mixed acceptability due to design and user related issues [1]. PATH, a nonprofit, nongovernmental, international health organization dedicated to improving health in low-resource settings has worked for 6 years with couples from four regions to develop a woman's condom that would be:
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easy to handle and insert,
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easy to use (especially for new users),
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stable during use,
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comfortable for both partners,
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easy to remove,
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and less expensive than current options, with a target price of 25 cents per device.
After 3 years of iterative prototype development where the condom design was modified to address user needs in each region, PATH selected the most promising condom design and used it to conduct a nonrandomized, nonblinded, nonsignificant risk, multisite study to determine user acceptability among couples in Mexico, South Africa and Thailand.
Section snippets
Materials and methods
The PATH Woman's Condom (Fig. 1) evaluated in this study is a single-size, nonlubricated, single-use device consisting of a plastic pouch that is inserted in the vagina prior to intercourse and stays in the vagina during intercourse, providing a physical barrier between partners' genitalia. It is packaged with water-based lubricant that is applied before intercourse.
The condom is composed of a pouch made of 0.003-mm-thick urethane film, a urethane ring and four small elliptical pieces of
User characteristics
Each site enrolled 20 couples. Most women in Mexico and Thailand were married, and most women in all sites were parous (Table 1). Of the 60 couples enrolled, 34 had prior experience with PATH female condom prototypes and 26 had no prior experience. As a result, 57% (102/180) of the product uses were completed by experienced users, and 43% (78/180) of product uses were completed by new users.
Stability during use
As per the couples' reporting, the condom pouch remained stable during use in 97% (175/180) of product
Discussion
Results of this user evaluation suggest that the PATH Woman's Condom is easy to use, stable during use, comfortable and satisfactory during sex among users from diverse populations and cultures. This is not surprising given that this study is the culmination of a 6-year research and development process aimed toward developing such a device.
This device met or exceeded all but one of the primary product specification requirements used to establish success criteria by the product development team.
Acknowledgment
PATH would like to acknowledge the effort and commitment of our research partners, Dilys Walker of the National Institute of Public Health in Cuernavaca, Mexico; Mags Beksinska of the Reproductive Health Research Unit, University of Witwaterstand in Durban, South Africa; and Earmporn Thongkrajai of the Department of Community Nursing, Khon Kaen University in Khon, Kaen, Thailand; and the women and men who have willingly shared their experience and ideas. This study was supported by the CONRAD
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New female condoms in the pipeline
2012, Reproductive Health MattersCitation Excerpt :It comes with a sachet of water-based lubricant that is applied by the user. Acceptability trials have shown it is acceptable to users.18,19 The performance has also been found to be similar to FC2.20