Can Condom Users Likely to Experience Condom Failure Be Identified?

A study based on a convenience sample of 177 couples who each used 11 condoms found that 103 condoms (5.3%) broke before or during intercourse and 67 condoms (3.5%) slipped off during sex. Couples who had not used a condom in the past year were almost twice as likely to experience condom failure as were couples who had used at least one during that period (p

The rapid spread of the human immunodeficiency virus (HIV) and other sexually transmissible diseases (STDs) during the last decade has led to increased research on the male condom. Because condom breakage during intercourse or withdrawal seriously undermines this protection, numerous studies have examined the frequency of this problem.(1) Data from these studies suggest that breakage rates range from less than 1% to 12% of condoms used.(2)

Does this wide range in condom breakage rates result from chance, from differences in the material integrity of condoms or from variations among individual users in their likelihood of breaking condoms? Anecdotal evidence suggests that a relatively small proportion of condom users are responsible for a disproportionate number of breaks. If this is the case, the proportion of these "condom breakers" in a study could affect the study's overall breakage rate. Because so little is known about the characteristics of such individuals, we cannot predict accurate condom breakage rates for a given user. If simple methods of identifying condom breakers existed, service providers could maximize the impact of their educational interventions by targeting the cohort of users who experience the majority of breaks.

The analysis presented in this article examines possible explanations for the wide range of breakage rates presented in the literature and attempts to provide a basis for identifying condom users who are at increased risk of breaking condoms. This analysis uses a subset of data from a study conducted by Family Health International (FHI) to assess the value of laboratory tests in predicting condom breakage.(3)

In the original study, breakage and slippage data were collected for 20 different lots of condoms. Four lots were new condoms from four U.S. manufacturers; the remaining 16 were recovered from warehouses in Tanzania, the Dominican Republic, Egypt, Mexico, Kenya, Jamaica and Barbados. All recovered condoms were made by a single U.S. manufacturer and were distributed by the Commodities Procurement and Support Division of the U.S. Agency for International Development.

Three hundred couples were recruited for the study from professional organizations and institutions in the Research Triangle Park area of North Carolina (Raleigh, Durham and Chapel Hill) via fliers and word of mouth. Couples who expressed interest in participating were sent a fact-sheet outlining the purpose of the study and a list of criteria for participation. The study protocol required participants and their partners to be in a monogamous heterosexual relationship, at least 18 years old, protected against pregnancy, not practicing behaviors that would put them at risk of STDs (including HIV), and free from known sensitivities to latex. Further, each participating couple agreed to use 20 condoms during the four-month study period and to complete a self-administered questionnaire. FHI's Protection of Human Subjects Committee approved the study protocol and informed consent forms.

The 20 study condoms--one from each lot--were equally divided into four packets, which were mailed to participating couples along with the study questionnaire, a one-page form on which respondents answered a series of questions on slippage and breakage for each condom and filled in an identifying code from the condom packaging. The participants were asked to use the five condoms in each packet in random order. This scheme was devised to reduce potential bias from the order in which the condoms were used. When the investigators received the completed questionnaires, they paid the participating couples for each condom used.