From *Family Health International, Research Triangle Park, North Carolina, and the †Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, Prevention Services Research Branch, Atlanta, Georgia
Support for this work was provided with funds from the United States Agency for International Development (USAID) cooperative agreement #AID/CCP‐3079‐A‐00‐5022‐00 and NIH contract NO1AI35173. The views expressed in this document, however, do not necessarily reflect those of the funding agencies.
Correspondence: Markus J. Steiner, Family Health International, P.O. Box 13950, Research Triangle Park, NC 27709. E‐mail: email@example.com.
WHEN USED CORRECTLY and consistently, male latex condoms are the most effective method to reduce the risk of sexually transmitted disease (STD)/human immunodeficiency virus (HIV) transmission during sexual intercourse.1,2 Rigorous prospective studies of HIV transmission among discordant couples provide compelling evidence that male latex condoms are highly effective only when used during every act of intercourse.3–5 But even then they are not perfect. Two of these serodiscordant studies4,5 and other prospective studies6,7 have documented transmission of HIV or STD during self‐reported consistent use of male latex condoms (hereafter referred to simply as condoms).
The article by Macaluso et al. in this issue of Sexually Transmitted Diseases suggests that condom breakage and slippage may be one cause of the observed failure of condoms to prevent STD/HIV transmission.8 In this large prospective study of high‐risk patients in STD clinics, condoms broke or slipped off in approximately 4% of coital acts. These findings are consistent with the most recent review of prospective studies that presented a range of breakage during vaginal intercourse from 0% to 6.7% (with most study rates <2%) and a range of complete slippage from 0.6% to 5.4%.2 Recent studies have documented that a minority of users are responsible for a disproportionate amount of breakage and slippage.9–13 As a result, for most condom users, breakage and slippage is a more infrequent event than the above average figures would suggest. Moreover, many condom breaks and slips do not place the user at risk of transmission because they occur before intercourse or during removal (nonclinical breakage and slippage).14 Most importantly, condom users who report more frequent condom breakage and slippage can be counseled to develop skills to avoid behaviors that may be placing them at increased risk.13
In addition to condom breakage and slippage, a possible explanation for the observed failure of condoms to protect against STD/HIV transmission despite self‐reported consistent condom use is that respondents did not provide valid information about their consistency of use. In other words, they did not consistently use condoms even though they reported doing so. A recent study finding no association between self‐reported condom use and overall incident STDs7 was debated in Sexually Transmitted Diseases.15–18 The most recent analysis of the original data concluded that the primary reason for the lack of an association between self‐reported consistent condom use and incident STDs was the fallibility of the self‐report.19 A randomized controlled trial that empirically assessed the association between prevalent HIV in female sex workers and different methods of measuring condom use found little or no relationship between level of self‐reported condom use and HIV prevalence.20 All condom‐use measures were most strongly associated with infection when limited to intercourse with partners who were not clients. Much research still remains to be done on how best to elicit accurate responses about condom use through improved data collection instruments. The use of biomarkers such as prostate specific antigen (PSA) to detect evidence of semen in the vagina shows promise in making condom effectiveness trials less reliant on self‐reported behavior.21
A second alternative explanation for documented cases of STD/HIV transmission during self‐reported consistent condom use is that respondents did not use condoms during the entire act of intercourse. This behavior has been associated with gonorrhea transmission in at least one study.22 In one recent cross‐sectional study of 47 university students, participants reported that 6% of acts resulted in breakage or slippage, while 10% were not protected with condoms throughout vaginal intercourse (put on after intercourse had started or removed during intercourse).23
A third, but highly unlikely, explanation for the documented cases of STD/HIV transmission during self‐reported consistent condom use is the transmission of pathogens through microscopic holes in the latex. Two laboratory studies tested the permeability of latex condoms and documented minute amounts of HIV‐sized particles passing through some of the latex condoms tested.24,25 Fortunately, the small amount of ejaculate estimated to pass through the latex would most likely be virus‐free in a man infected with HIV, and the authors calculated the risk of HIV transmission to be reduced 10,000‐fold with the use of condoms.24 This transmission risk may increase further with the improved quality of currently manufactured condoms.26
The types of condom and user failure we discussed earlier contribute disproportionately to the overall risk of STD/HIV transmission (Fig. 1). To create this figure, we used four imprecise assumptions: 1) 7.5 billion condoms used annually worldwide,27 2) 16.5 billion additional at‐risk acts not protected by condoms annually worldwide,27 3) 10% of condoms not used during entire act of intercourse,23 and 4) 3% of condoms break or slip off during intercourse or withdrawal.2 Condom failure caused by microscopic holes was too insignificant to appear on the graph if we assume the 10,000‐fold reduction in transmission risk offered by intact condoms.24 Despite the imprecision of these estimates, we can draw three conclusions that are robust even to significant changes in the earlier assumptions.
First and most importantly, most STD/HIV transmission risk likely occurs because of condom nonuse. Thus, the highest priority for any STD/HIV prevention program must be to change those factors that lead to condom nonuse. Four recent randomized controlled trials28–31 have shown by level I evidence32 that social and behavioral interventions are effective in increasing self‐reported condom use and decreasing STD/HIV incidence.33 Each study used slightly different approaches to changing behaviors, but similarities exist: 1) increasing personal awareness of vulnerability to acquiring STD/HIV, 2) developing negotiation skills to discuss condom use and STD/HIV risk with sex partners, 3) emphasizing the importance to the individual of STD/HIV testing, 4) reducing drug and alcohol use associated with higher risk sexual behaviors, and 5) planning for situations in which “behavioral relapse” may occur. The programmatic applicability of these well‐controlled trials, especially in resource‐poor settings, is unknown. The large‐scale implementation of these approaches to increase condom use will be costly, but the economic and social cost of STD/HIV sequelae are larger.
Second, the transmission risk from not using condoms during the entire act of intercourse is minor compared to nonuse of condoms. However, the limited research done on this topic suggests that this problem may be at least as important as condom breakage and slippage in exposing the user to the risk of transmission.23 More systematic research is needed to better quantify this problem and to explore approaches to better encourage condom use from “start” to “finish” among persons at risk for infection.
Third, condom breakage and slippage poses a minor transmission risk compared to condom nonuse. Nevertheless, given our previously mentioned assumptions, breakage and slippage result in 225 million acts of intercourse per year in which condom users are at increased risk of STD/HIV transmission and pregnancy. Decreasing this large number of at‐risk acts must be a public health priority. Behaviors that may be associated with breakage and slippage of condoms, including 1) rough handling (e.g., opening package with teeth, scissors, or other sharp objects), 2) improper donning, 3) use of oil‐based lubricants, 4) use of vaginal drying agents, 5) lengthy or vigorous intercourse, 6) anal intercourse, 7) intercourse in certain positions (rear‐entry), 8) delayed withdrawal after ejaculation, 9) not holding the condom during withdrawal, and 10) reuse of condoms.13,34 We encourage incorporating these recent research findings into counseling messages to help reduce the risk of breakage and slippage.2 In addition, counseling needs to address the public's misunderstanding of the risk of condom breakage and slippage that may lead to distrust of condoms and subsequent nonuse.35–37 Such distrust leading to nonuse make the influence of breakage and slippage on transmission risk greater than Figure 1 would suggest.
The main problem with condoms is the high level of nonuse among couples at increased risk of STD/HIV (Fig. 1). The magnitude of this problem overwhelms less frequent problems with condoms, such as breakage and slippage. While breakage/slippage needs to be acknowledged as a potential problem for some condom users, public health messages need to be worded carefully to ensure that fear of breakage and slippage will not further amplify nonuse, which is our main target. We acknowledge that condoms are less than acceptable to many couples for a multitude of reasons, rendering condom promotion a difficult task at best. The four randomized controlled trials cited earlier provide some guidance on how to successfully encourage condom use, but additional resources are needed to increase our understanding and to apply this research programmatically.
A “female initiated” alternative to male condoms is microbicide containing nonoxynol‐9 (N‐9). Unfortunately, a recent study has raised serious concern about the effectiveness of N‐9 in preventing HIV transmission38 and U.S. Food and Drug Administration (FDA) approval of any new microbicide under development is unlikely to be granted in the next few years.39 A more promising alternative is the female condom, which has been shown to be acceptable to some couples in numerous small‐scale and short‐term introductions.40 However, the substantially higher price and certain product‐specific attributes of the female condom in comparison to the male condom may limit its use for other couples, especially in resource‐poor settings. Although far from perfect, the male latex condom is the most effective and least expensive prevention method for the time being and increasing its use must remain the highest priority for any STD prevention program. Concurrently, we urgently need to develop effective, inexpensive, and acceptable barrier alternatives to provide increased choice in the future.
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