Do condoms work?

In recent years condoms’ ability to stop HIV has been questioned by people opposed to their use on religious or moral grounds.  Therefore questions of condom efficacy have to be addressed.

In one of the most highly-publicised statements, in October 2003, the President of the Vatican's Pontifical Council for the Family, Cardinal Alfonso Lopez Trujillo, said: "The AIDS virus is roughly 450 times smaller than the spermatozoon. The spermatozoon can easily pass through the 'net' that is formed by the condom. These margins of uncertainty...should represent an obligation on the part of the health ministries and all these campaigns to act in the same way as they do with regard to cigarettes, which they state to be a danger." (Vatican: Condoms don't stop Aids, The Guardian, 9 October 2003.)

These statements are quite simply untrue. Consistently-used condoms provide significant protection against HIV, pregnancy and sexually transmitted infections (STIs). The degree of protection they offer against HIV and STIs is significantly better than any other single prevention method, taken in isolation, other than sexual abstinence or complete mutual monogamy between two people who have tested negative for HIV.

Summary of key findings

Finding out the degree to which condoms protect against HIV is important both for HIV-negative people who want to protect themselves against HIV, and HIV-positive people who want to avoid transmitting it. Finding out their efficacy in protecting against other STIs is important for sexual health in general and may be particularly important for people with HIV, who may be more vulnerable to the effects of certain STIs.

A summary of findings we look at in more detail below goes as follows:

• Condoms used 100% of the time, though not necessarily 100% perfectly (i.e. with usual rates of breakage, slippage and so on) provide protection of about 80-85% against HIV (uncertainty range: 76%-93%). In other words for every 100 cases of HIV infection that would happen without condom use, about 15 (range: 7-24) would happen when condoms are used consistently.
• Condoms offer a similar degree of protection against gonorrhoea.
• They offer protection in the range of about 50-66% against syphilis, though this depends on factors such as the location of primary syphilis lesions.
• They provide protection against chlamydia and trichomoniasis of a similar or somewhat smaller degree, with different studies showing protection rates varying from 85% to 26%.
• Against genital herpes (HSV-2), estimates of efficacy range considerably; studies are hampered by the fact that people with herpes are only intermittently symptomatic and/or infectious. The best estimate we have is that using condoms more than three-quarters of the time halves the chance of acquiring HSV-2, and may reduce the chances of genital infection with the cold sore virus HSV-1 too.
• One study has demonstrated that consistent condom use offers women significant protection against HPV infection by men (in the region of 73%). Another has found that condom use helps to prevent HPV infection progressing to cervical or penile cancer in both women and men.

Challenges in determining condom efficacy

These degrees of protection may be lower than some readers expect, and rates of 98% reliability are still sometimes quoted for condoms. These are based upon observations of their use in contraception: studies have shown that 98% of women relying on condoms as their sole form of contraception remain pregnancy free if condoms are used perfectly, meaning that they are used consistently and correctly at every act of sexual intercourse. (Hatcher 2004)

However because they are not always used correctly even if they are used consistently, studies have found efficacy rates of 85-87% when young women use condoms as their sole form of contraception (Santelli 2007). This contraceptive efficacy compares with an estimated:

• 92.5% for contraceptive pills
• 96.5% for implants and intra-uterine devices
• 99% for the pill and condoms used together
• 99.8% for vasectomy,

but only

• 77% for the rhythm method (calendar based method)
• 75% for withdrawal, and
• 72% for spermicides.

Condoms are, however, the only method on that list that has been shown to protect against STIs as well as pregnancy.

Laboratory studies and product testing have shown that reputable condoms tested in the laboratory are completely impermeable to micro-organisms as small as viruses. Research has also found that during vaginal intercourse condoms break less than 2% of the time (CDC 1999) and during anal intercourse less than 4% of the time.(Grady 1994)

However the same studies show that condoms come off the penis altogether 3-5% of the time but may slip down (but not off) up to 13% of the time. In these circumstances it is easy to see why condoms sometimes fail, even in consistent users.

In addition, however, people are not consistent in their use of condoms, and may not even be consistent when they claim to be, or think they are. Research has shown that 40-70% of men who claim they use condoms 100% of the time in fact do not use them for every act of intercourse.

The first question we have to answer, then, in assessing condom efficacy, is whether we are talking about their efficacy in perfect use, consistent use, or typical use.

Perfect use sets too high a standard for individual behaviour, and measuring typical use is more about studying what motivates people to use condoms than whether they work, and is dealt with in following sections. Indeed there is a convention to use two different words when describing the effect of prevention interventions for these reasons. Condom efficacyis how well they work when people use them as indicated, i.e. consistently; condom effectivenessis how well they actually work to curb the spread of HIV in a given population, given actual levels of use.

The studies that have been done of condom efficacy have therefore largely contrasted HIV and STI incidence or prevalence in people who claim 100% consistent use and people who use them inconsistently or not at all. Because these studies involve private behaviours that investigators cannot observe directly, it is difficult to determine accurately whether an individual is a condom user and whether condoms are used consistently and correctly.

Challenges in study design

The next problem is deciding what kind of study provides truly reliable evidence. It would be unethical to mount a randomised trial of condom use because the control group would have to stop using them altogether. The evidence we have is based on three types of trials, and each has potential weaknesses.

For efficacy against HIV and other chronic STIs, studies of the incidence of HIV (or HSV or HPV) in monogamous serodiscordant couples provides the best evidence. These can be done in individuals whose characteristics are known and can be controlled for, and if the relationship truly is monogamous then infections by acute STIs and from outsiders can be ruled out.

One disadvantage is that condom use in long-term relationships, even in serodiscordant couples, is relatively rare. Another is that the HIV-positive partner will be chronically infected and so will not have the very high viral load characteristic of acute HIV infection. Thirdly, in long-term serodiscordant relationships, studies have shown that the HIV-negative partner can acquire a degree of immunity to their partner’s HIV. For these reasons, HIV transmission within long-term serodiscordant relationships, especially heterosexual ones, may be rarer than it is between casual sex partners. For all these reasons, large studies may be needed to establish differences in HIV (and HSV and HPV) incidence between condom users and non-users.

Another kind of study is to conduct a prospective cohort study, looking at differences in HIV incidence between two groups of people according to their usage of condoms. This cannot be a randomised controlled study, but participants’ HIV and STI incidence can be related to their condom use either at baseline or preferably (because behaviours change over time) by means of regular questionnaires and monitoring. There is opportunity for qualitative research too, contrasting attitudes and drivers of behaviour between people who catch HIV or other STIs and those who do not. Condom efficacy against acute STIs can also be measured, if people have multiple partners, or their partners do.

The weaknesses of this kind of study include the fact that condom use cannot be corroborated by partners, so self-report is likely to be even more unreliable. Because behaviours change over time, it can be challenging to decide whether people really are ‘consistent’ users and the pool of consistent users will shrink over time; and like all cohort studies, results are prone to be confounded by participant characteristics that were not monitored. A study that measures HIV incidence in condom users and non-users will be confounded, for instance, if one group has substantially fewer sexual partners than the other.

For this reason and because HIV seroconversion even in high-risk populations is a relatively uncommon event, prospective cohort studies have to be large and can be quite costly.

A third kind of study is to conduct a retrospective cohort study, asking people about their condom use and contrasting HIV and STI prevalence in users and non-users. Retrospective cohort studies are subject to greater limitations that prospective ones. Participants’ recall of behaviour is often inaccurate; the studies may rely on medical records that may omit significant demographic and medical information; and it can be difficult to determine retrospectively people’s degree of STI exposure.

For all these reasons, measuring the efficacy of condoms (or indeed other established prevention methods and strategies such as serosorting) can be challenging. Nonetheless, a number of carefully conducted studies have demonstrated that consistent condom use is a highly effective means of preventing HIV transmission.

When it comes to STIs other than HIV, most epidemiologic studies of these are characterised by methodological limitations, and thus, the results across them vary widely - ranging from demonstrating no protection to demonstrating substantial protection. However we now have enough evidence to demonstrate that condoms offer at least some and in some cases excellent protection against most STIs.

Review by NIAID

Given that condoms have been promoted as the first line of defence against HIV since the beginning of the epidemic, at least in the developed world, it is perhaps surprising that a really rigorous review establishing their efficacy against HIV and STIs was not conducted till June 2000 (NIAID 2001), when the US National Institute of Allergy and Infectious Diseases (NIAID) conducted a review of the evidence for their efficacy, spurred on partly by a political climate in the USA which at the time was turning against the promotion of condoms and contraception, and towards abstinence and monogamy as the favoured method of protecting against STIs and pregnancy.

The US Centers for Disease Control (CDC) had previously issued a fact sheet(CDC 1999) that stated that “several studies provide compelling evidence that latex condoms are highly effective in protecting against HIV infection when used for every act of intercourse.” After the NIAID review, they withdrew this fact sheet and issued another(CDC 2002) which also stated that “Epidemiologic studiesthat are conducted in real-life settings, where one partner is infected with HIV and the other partner is not, demonstrate conclusively that the consistent use of latex condoms provides a high degree of protection.” This fact sheet also stated that condoms could protect against gonorrhoea, chlamydia and trichonomiasis, but that there was not enough evidence to say whether they were effective against Genital Ulcer Diseases such as syphilis, herpes and HPV infection.

It also prefaced this with the following warning, in bold print:

“The surest way to avoid transmission of sexually transmitted diseases is to abstain from sexual intercourse, or to be in a long-term mutually monogamous relationship with a partner who has been tested and you know is uninfected. For persons whose sexual behaviors place them at risk for STDs, correct and consistent use of the male latex condom can reduce the risk of STD transmission. However, no protective method is 100 percent effective, and condom use cannot guarantee absolute protection against any STD.”

This rewording was interpreted at the time as a move away from the promotion of condoms and an attempt to appease the pro-abstinence lobby, but is an accurate statement of the protection condoms offer.

The NIAID review first determined the risks of exposure to semen due to condom breakage and found that this, given that breakage is quite rare, was a low risk: about one chance per 166 sex acts using a condom.

It also reviewed patterns of condom use amongst people in the USA. It found that condom use amongst women aged from 15 to 45 had increased from 12% in 1982 to 20% in 1995 (Piccinino 1998). It found that 33% of young men aged 15-19 reported using condoms in 1988 and that that proportion had gone up to 45% in 1995 (Sonnenstein 1998). The Youth Risk Behavior Survey, an annual survey conducted by CDC, also found that condom use had increased from 55% to 62% in young men between 1991 and 1997 and from 38% to 51% in young women(CDC 1998). However these studies did not report rates of slippage and breakage.

NIAID: Condoms' efficacy against HIV

HIV is the only STI for which formal meta-analyses of condom efficacy have been published, though only for heterosexual couples (Davis 1999, Weller 2003) and NIAID evaluated what was then the most recent analysis, by Davis and Weller (Davis 1999). This analysis, in which only longitudinal or cohort studies were included, used the following criteria to select studies related to condom use and HIV/AIDS prevention:

• The sample only included serodiscordant, sexually active, heterosexual couples
• HIV status was determined by serology (so that exposure to HIV was known)
• Data collection included self report about condom use
• The study design afforded longitudinal follow-up of HIV uninfected partner.

Davis and Weller found twelve studies that met these criteria. The meta-analysis noted the direction of transmission (male-to-female, female-to-male, and unstated) and date of study enrolment. Condom usage was classified into the following three categories: always (100% use), sometimes, and never.

Among participants who reported always using condoms, the summary estimate of annual HIV/AIDS incidence from the twelve studies was 0.9 seroconversions per 100 person years (0.9%). Among those who reported never using condoms, the summary estimate of annual HIV/AIDS incidence from the seven studies was 6.7%. Overall, Davis and Weller estimated that condoms provided an 85% reduction in HIV/AIDS transmission risk when infection rates were compared in ‘always’ versus ‘never’ users, though the confidence intervals meant that the ‘true’ efficacy could be as low as 60% or as high as 96%.

To cite one of the twelve studies in more detail, (Saracco 1993) researchers looked at Italian serodiscordant couples in which the male partner was HIV positive. Among 171 couples who used condoms consistently, three women (2%) became infected with HIV whereas among 134 couples who used condoms inconsistently or not at all, 16 women (12%) became infected, a relative risk of 6.6 indicating a condom efficacy of about 84%. Annual HIV incidence was 7.2% among women not using condoms and 1.1% among consistent condom users. This study also found that reported anal sex raised the risk to women by another 40%, but only if they did not use condoms.

Davis and Weller subsequently published another meta-analysis in 2003(Weller 2003), this time of 14 studies. These included 13 cohorts of ‘always’ users that yielded an annual HIV incidence estimate of 1.14%, with a confidence interval ranging from 0.56% to 2.04%. There were 10 cohorts of ‘never’ users. The studies with the longest follow-up time, consisting mainly of studies of partners of haemophiliac and transfusion patients, yielded an HIV incidence estimate of 5.75% with a confidence interval of 3.16% to 9.66%. Overall effectiveness, the proportionate reduction in HIV seroconversion with condom use, was approximately 80%, a downward revision from 1999.

The only other meta-analysis of condom efficacy that satisfied NIAID’s criteria was in 1997(Pinkerton 1997). In this analysis by Pinkerton two sets of studies were evaluated employing two different standards of ‘consistent’ use. For the less rigorous standard, in which ten studies compared ‘users’ with ‘non-users’, the estimated condom efficacy rate was 79%. For the more rigorous standard, nine studies compared ‘always’ users with ‘never or inconsistent’ users (note this is different from Davis and Weller, who compared ‘always’ with ‘never’ users.)

In these nine studies there were only four seroconversions reported among 277 (1.4%) steady partners of HIV-positive men and women who consistently used condoms. In contrast, when condoms were used inconsistently or not at all, 171 of 867 (19.7%) sexual partners seroconverted. This led to an efficacy estimate of 93% effective when condoms are used consistently as opposed to inconsistently.

This is about the highest standard of proof we can expect from studies of condom efficacy. Taking Davis and Weller and Pinkerton together, one can say that the best efficacy estimates we have for the use of condoms in preventing HIV are:

• “Almost always” versus “never”: 79%
• “Always” versus “never”: 80-85%
• “Always” versus “sometimes”: 93%

Condom efficacy in gay men

What about condoms’ efficacy against HIV in sex between men? Remarkably, despite gay men being the first and still the largest at-risk population in the developed world, and themselves largely responsible for the ‘safer sex’ movement, there has been no similar meta-analysis of the extent to which using condoms actually prevents HIV infection in gay men. This may be because the majority of HIV transmission amongst gay men occurs in casual sex situations, where the HIV serostatus of partners cannot be assessed, and so the degree of HIV exposure risk cannot be ascertained.

NIAID: Condoms' efficacy against sexually transmitted infections

WHO review of condoms' efficacy against STIs

Irregular use sometimes no better than no use

One factor we have been stressing here is the importance of consistentcondom use when it comes to ensuring these levels of efficacy. Studies show that as soon as condom use falls off and becomes irregular, then the degree of protection they offer rapidly declines. Indeed, just as taking some but not all doses of your HIV drugs is worse than taking none at all, so in some circumstances using condoms sometimes can be worse than using them never – possibly because of the false reassurance this provides.

To take one study from Rakai, Uganda (Ahmed 2001), Ahmed found that 79% of a large sample of people never used condoms, 16.5% did so irregularly, and only 4.4% always did. He found that annual HIV incidence in non-users was 1.7% a year and in consistent users 0.4% a year – a 76% reduction in risk, concordant with other studies. But he found that HIV incidence in inconsistent users was 2.1% - in other words, very similar to that in non-users (the difference was not statistically significant). Consistent condom users had half as many cases of gonorrhoea or chlamydia as non-users – again, broadly in line with other studies. But inconsistent users had 44% more gonorrhoea and chlamydia than non-users – and this was statistically significant.