This important article by James Wilton first appeared in Prevention in Focus on the CATE website here.

Une version française est disponible ici. 

Since the beginning of the HIV epidemic, condoms have been a cornerstone of our HIV prevention efforts—often promoted as the most effective way to prevent the sexual transmission of the virus. However, in the past few years the number of HIV prevention options has increased and some people are interested in, or are already using, newer strategies. As a result, frontline service providers are being asked challenging questions: Are condoms the most effective strategy available? How do they compare to other strategies? This article explores the evidence on how effectively condoms prevent HIV transmission and the implications for our HIV prevention messaging.

Condoms 101

Condoms are physical barriers used during sex to prevent parts of the body that are vulnerable to HIV infection (such as the penis, vagina, rectum and mouth) from coming into contact with fluids that may contain HIV and other infections. We currently have two main types of condoms: the male condom (also known as the external condom) and the female condom (also known as the internal or insertive condom).

What are they made of? Most male and female condoms are made from nitrile, latex, polyisopropene or polyurethane, all of which cannot be penetrated by the viruses and bacteria that cause sexually transmitted infections (STIs), including HIV.1 Lambskin condoms, which are made from sheep intestines, can be penetrated by bacteria and viruses and should therefore never be used to prevent the transmission of HIV.

To lube or not to lube? Sexual lubricants are commonly used in combination with condoms to increase pleasure. The use of lubricant is also recommended to decrease friction that can cause breakage, particularly during anal sex. Water- and silicone-based lubricants are safe to use with all condoms, but oil-based lubricants can compromise the integrity of latex and polyisopropene condoms and increase the risk of the condom breaking.

Using condoms correctly and consistently

Since condoms are impermeable to viruses, shouldn’t we expect them to be 100% protective against HIV? Unfortunately, it’s not that simple. As with any type of prevention strategy, condoms only work if they are used correctly and consistently. Inconsistent use can greatly decrease their ability to prevent HIV transmission.

Incorrect use of condoms can also compromise their effectiveness. For example, some people may use condoms that are too small or too large, damaged or expired; unroll condoms before putting them on; not pinch the tip when putting them on; use sharp objects to open condom packages; not use enough lubrication in combination with condoms or use oil-based lubrication with latex or polyisopropene condoms; or not hold the rim of the condom when pulling out. All of these can potentially increase the risk of HIV transmission by causing a condom to break, slip or leak.

Incorrect condom use can also take the form of putting on a condom late (after intercourse has started), removing the condom early (before ejaculation has occurred) or putting the condom on inside out and then flipping it over to use. If a condom is used incorrectly in these ways, then HIV transmission could occur even though the condom does not break, slip or leak.

A recent literature review of 50 studies revealed that the incorrect use of male condoms is surprisingly common.2 For example:

• Studies found that 17 to 51% of participants reported not putting on a condom until after intercourse had started.
• Some studies also reported high rates of condom problems, such as breakage (0 to 33%), slippage (0 to 78%) and leakage (0 to 7%), which could lead to HIV transmission. Errors in condom use may be partly responsible for these problems. For example, 24 to 46% of participants reported not pinching the tip of the condom and 16 to 26% reported using a condom that was not lubricated.

How often do condoms break, slip or leak when they are used perfectly in every possible way? We don’t know and probably never will. However, when condoms are used correctly, the rates of breakage, slippage, and leakage are likely quite low. Research shows that education and more experience using condoms can help lower rates of condom failure.3,4

So how effective are male condoms?

The best evidence we have on the effectiveness of male condoms comes from an analysis of 14 observational studies that enrolled heterosexual serodiscordant couples (where one partner is HIV-positive and the other is HIV-negative).5 The analysis compared the rate of HIV transmission between couples who said they always used male condoms to the rate among couples who said they never used male condoms. The analysis found that the rate of HIV transmission was 80% lower among couples who reported always using condoms.

For many people working in HIV prevention, an 80% effectiveness rate may be lower than you thought or have previously told clients and patients. However, it is important to consider the limitations of this analysis when interpreting its results. There are three reasons why this analysis may make condoms look less effective than they can be: 

Incorrect use. The couples who said they always used condoms may not have been using condoms correctly. This would have increased their risk of HIV transmission and reduced condom effectiveness.

Inconsistent use. The couples who said they always used condoms, in reality, may not always use them! Some of the couples may have had trouble remembering how often they used condoms or felt uncomfortable saying that they did not use condoms. This would have increased their risk of HIV transmission and made condoms appear less effective.

Differences in behaviour. The risk-taking behaviours of the couples who said that they always used condoms may have been different from those couples who said they never use condoms. For example, couples who reported always using condoms may have engaged in behaviours that increased their risk of HIV transmission, such as having sex more often or engaging in higher-risk types of sex. If this was the case, these behaviours would have increased their risk of HIV transmission, making condoms appear to be less effective. It’s also possible that people who reported never using condoms may have engaged in behaviours that put them at lower risk of HIV transmission, such as having sex less often or only engaging in lower-risk types of sex (such as oral sex). If this was the case, this would make it appear as though there was less of a difference in HIV transmission rate between the two groups and make condoms appear less effective.

Given these limitations, the estimate of 80% likely does not reflect how effective condoms can be in preventing heterosexual HIV transmission. If used consistently and correctly, condom effectiveness is likely much higher.

Is the same true for men who have sex with men?

Are male condoms also effective at reducing HIV transmission when used by gay men or other men who have sex with men? Several studies have explored this question and estimated a similar effectiveness rate of 70 to 80% for consistent condom use during anal sex.6,7,8 However, these studies are affected by the same three limitations as studies of heterosexual couples—incorrect use, inconsistent use and differences in behaviour. So the effectiveness rate for consistent and correct condom use during anal sex is likely higher.

What about female condoms?

No studies have evaluated the effectiveness of female condoms in preventing HIV transmission during vaginal sex or anal sex. However, research shows that they are as effective as male condoms at preventing other STIs.9,10,11

The expanding HIV prevention toolkit

In the past decade the number of HIV prevention options available to reduce the risk of HIV transmission has increased. Some of these strategies are generating a lot of excitement because they may provide an option for people who don’t want to, or are unable to, use condoms. These include the following:

Antiretroviral treatment – which reduced the risk of HIV transmission by 96% among heterosexual serodiscordant couples in a randomized controlled trial (RCT).12

Pre-exposure prophylaxis (PrEP) – which reduced the risk of HIV transmission by 40 to 70% for gay men13 and heterosexual men and women14,15 in RCTs. Further analysis suggested that PrEP may have reduced HIV risk by up to 90% among those who always took their pills.13,14

Post-exposure prophylaxis (PEP) – which reduced the risk of HIV transmission by up to 80% in an observational study of healthcare workers exposed to HIV in the workplace.16

Observational studies suggest that behavioural strategies such as serosorting, strategic positioning and withdrawal may slightly reduce the risk of HIV transmission.17

People who want to use, or are already using, these strategies may want to know how effective they are compared to condoms. These questions can be challenging to answer and it’s important that, in our responses, we don’t compare apples and oranges. For example, comparing results from different types of studies can be problematic. Some of the new prevention strategies were evaluated using an RCT while condoms were evaluated using observational studies. Comparing the results from these two kinds of studies can be problematic for a number of reasons:

• In RCTs the two groups are randomized to ensure that there are no differences between the groups other than whether or not they received the intervention. This is important because we know that each group should have similar risk behaviours and that neither group should be more or less likely to get HIV. However, in observational studies (such as those used to assess condoms), one group could be having sex more often or engaging in riskier sex. This could impact the results and make a strategy, such as condoms, appear to be less effective than they actually are.
• RCTs create “ideal” conditions that can make a strategy appear more effective than it would be in the “real world.” For example, RCT participants are supported to ensure they use the strategy correctly and all participants are provided with a comprehensive package of prevention services, including STI testing and treatment, free condoms, and intensive adherence and risk-reduction counselling. By contrast, observational studies, such as those used to evaluate condoms, generally do not provide participants with additional supports. Therefore, these results may not be directly comparable to the results of RCTs.

When it comes to comparing the effectiveness of two prevention strategies, we need to pay attention to the research design used to measure that effectiveness. Most new prevention strategies, such as PrEP or treatment as prevention, have been evaluated using RCTs, which can tell us about the effectiveness of the strategy under “ideal conditions.” Unfortunately, we don’t know how effective condoms would be under the ideal conditions of an RCT; however, we have good reason to believe that they would be more than 80% effective when used consistently and correctly.

Implications for HIV prevention messaging

Safer sex messaging and prevention counselling need to emphasize that the correct and consistent use of condoms is a very highly effective method of preventing the sexual transmission of HIV.

When answering questions about the effectiveness of condoms, it’s important to emphasize that they have several advantages over other options. Key messages include the following:

• If a condom is used correctly and it doesn’t break, slip or leak, then it is virtually 100% protective. However, there is a still a possibility that condoms will break, slip, or leak even when used correctly. Condoms do not eliminate the risk of HIV transmission.
• Condom effectiveness does not rely on accurate knowledge of a person’s HIV status, as opposed to serosorting, which requires accurate knowledge of the HIV status of both partners—something that is often difficult to know for certain.
• Whereas the goal of some other strategies—such as PEP, PrEP or having an undetectable viral load— is to reduce the risk of an exposure leading to an infection, condoms prevent an exposure to HIV from occurring in the first place.
• Other prevention options may be less effective if either partner has an STI, a higher viral load or other biological factors that affect HIV risk whereas condom effectiveness is not affected by these.
• If they don’t break, slip or leak, condoms can reduce the risk of HIV transmission for both anal and vaginal sex to the same level. However, the risk of HIV transmission while using PrEP or when the viral load is undetectable may be higher for anal sex than for vaginal sex. (This is because anal sex has a higher baseline risk of HIV transmission than vaginal sex.18)
• Condoms also reduce the risk of other STIs, such as gonorrhea, chlamydia, herpes and syphilis.19 Although other strategies may reduce the risk of HIV transmission, they do not reduce the risk of STI transmission. This is important because STIs can increase a person’s risk of HIV transmission.20
• Condoms can reduce the risk of unintended pregnancy.
• Condoms are less expensive, more readily available and less toxic than strategies that involve antiretroviral medications, such as PEP and PrEP.

Despite the advantages of condoms, we can’t ignore the important role that other prevention strategies may play in helping someone reduce their risk of HIV transmission. Condoms are not without their disadvantages and these can make it difficult for people to use them consistently and correctly. For example, condom use can be difficult to negotiate, condoms can decrease sexual pleasure and intimacy, they need to be available at the time of intercourse, they may be difficult to use when under the influence of alcohol or drugs, and they do not allow a woman to conceive. For these reasons, some people may choose to reduce their risk of HIV transmission in other ways.

Conclusion

HIV prevention efforts need to focus on helping people adopt prevention strategies that are appropriate to their circumstances and will be most effective for them. If people are having difficulty using condoms or are having problems with condom breakage, slippage or leakage, counselling may help them use condoms more consistently and correctly.

At the same time, alternative strategies for reducing the risk of HIV transmission may need to be discussed with these clients. When exploring other prevention options, it’s important to clearly explain their limitations, factors that may decrease their effectiveness and how a person can keep their risk of HIV transmission as low as possible while using these strategies. No strategy—including condoms—is 100% effective; all have their limitations and can fail in different ways. Since condoms provide less than 100% protection, using other strategies in combination with condoms will help decrease a person's overall risk of HIV transmission. However, if a client or patient decreases their condom use in favour of a less protective strategy, they may be increasing their overall risk of HIV transmission.

Resources

AIDSMAP – Do condoms work?

CATIE News – High prevalence of condom use errors and problems – implications for HIV prevention messaging

Canadian HIV/AIDS Legal Network – HIV non-disclosure and the criminal law: Implications of recent Supreme Court of Canada decisions for people living with HIV: Questions & Answers

References

1. Lytle CD, Routson LB, Seaborn GB, Dixon LG, Bushar HF, Cyr WH. An in vitro evaluation of condoms as barriers to a small virus. Sex Transm Dis. 1997 Mar;24(3):161–4.

2. Sanders SA, Yarber WL, Kaufman EL, Crosby RA, Graham CA, Milhausen RR. Condom use errors and problems: a global view. Sex. Health. 2012 Feb 17;9(1):81–95.

3. Lindberg L, Sonenstein F, Ku L, Levine G. Young men’s experience with condom breakage. Family Planning Perspectives. 1997 Jun;29(3):128–31.

4. Steiner MJ, Taylor D, Hylton-Kong T, Mehta N, Figueroa JP, Bourne D, et al. Decreased condom breakage and slippage rates after counseling men at a sexually transmitted infection clinic in Jamaica. Contraception. 2007 Apr;75(4):289–93.

5. Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane Database Syst Rev. 2002;(1):CD003255.

6. Vittinghoff E, Douglas J, Judson F, McKirnan D, MacQueen K, Buchbinder SP. Per-contact risk of human immunodeficiency virus transmission between male sexual partners. Am. J. Epidemiol. 1999 Aug 1;150(3):306–11.

7. Golden M. HIV serosorting among men who have sex with men: implications for prevention. 13th Conference on Retroviruses and Opportunistic Infections. 2006;Abstract 163.

8. Detels R, English P, Visscher BR, Jacobson L, Kingsley LA, Chmiel JS, et al. Seroconversion, sexual activity, and condom use among 2915 HIV seronegative men followed for up to 2 years. J. Acquir. Immune Defic. Syndr. 1989;2(1):77–83.

9. Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect. 2005 Jun;81(3):193–200.

10. French PP, Latka M, Gollub EL, Rogers C, Hoover DR, Stein ZA. Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sex Transm Dis. 2003 May;30(5):433–9.

11. Kelvin EA, Mantell JE, Candelario N, Hoffman S, Exner TM, Stackhouse W, et al. Off-label use of the female condom for anal intercourse among men in New York City. Am J Public Health. 2011 Dec;101(12):2241–4.

12. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N. Engl. J. Med. 2011 Aug 11;365(6):493–505.

13.a. b. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N. Engl. J. Med. 2010 Dec 30;363(27):2587–99.

14.a. b. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N. Engl. J. Med. 2012 Aug 2;367(5):399–410.

15. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N. Engl. J. Med. 2012 Aug 2;367(5):423–34.

16. Cardo DM, Culver DH, Ciesielski CA, Srivastava PU, Marcus R, Abiteboul D, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N. Engl. J. Med. 1997 Nov 20;337(21):1485–90.

17. Vallabhaneni S, Li X, Vittinghoff E, Donnell D, Pilcher CD, Buchbinder SP. Seroadaptive Practices: Association with HIV Acquisition among HIV-Negative Men Who Have Sex with Men. PLoS ONE. 2012;7(10):e45718.

18. Boily M-C, Baggaley RF, Wang L, Masse B, White RG, Hayes RJ, et al. Heterosexual risk of HIV-1 infection per sexual act: systematic review and meta-analysis of observational studies. Lancet Infect Dis. 2009 Feb;9(2):118–29.

19. Holmes KK, Levine R, Weaver M. Effectiveness of condoms in preventing sexually transmitted infections. Bull. World Health Organ. 2004 Jun;82(6):454–61.

20. Ward H, Rönn M. Contribution of sexually transmitted infections to the sexual transmission of HIV. Curr Opin HIV AIDS. 2010 Jul;5(4):305–10.

About the author: 

James Wilton is the Coordinator of the Biomedical Science of HIV Prevention Project at CATIE. James is currently completing his master’s degree of Public Health in Epidemiology at the University of Toronto and has completed an undergraduate degree in Microbiology and Immunology at the University of British Columbia.

This article by Gus Cairns first appeared in aidsmap.com here.  

An analysis by Dawn Smith of the US Centers for Disease Control (CDC) reported at the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013) on 4 March has provided the first estimate of the efficacy of condoms in preventing HIV transmission during anal sex since 1989. It found condoms stop seven out of ten anal transmissions – the same efficacy found by the 1989 study.

However, it also found that sometimes using condoms is not effective at preventing HIV infection, and that long-term 100% condom use is a minority behaviour: only one-in-six gay men actually managed to maintain it over the three- to four-year time frame of the analysis.

One ongoing problem in assessing the effectiveness of different HIV prevention methods is that anal sex is under-studied. We do not have enough data on rectal viral loads and their effect on transmission, or on whether HIV treatment reduces transmission via anal sex as well as it does for vaginal sex.

We are also unclear about to what extent condoms actually prevent HIV transmission in anal sex. This last fact may seem surprising, given that condoms have been recommended since the mid-1980s as the only effective HIV prevention method for gay men who have anal sex.

In fact, there is only one large study in gay men, dating from 1989. In this study of 2914 gay men, HIV incidence among those who said they used condoms 100% of the time was 70% lower than in men who did not use them at all. There has been one small study in the era of antiretroviral treatment (ART), which found an efficacy of approximately 75%.

Amongst all men having anal sex, men who said they used condoms 100% of the time were 70% less likely to acquire HIV than men who never used condoms.

These are somewhat lower than efficacies computed for vaginal sex, which is in the order of 80 to 85%, and may reflect both that HIV is at least ten times more easily transmitted via anal than vaginal sex, and also that condoms may be more likely to fail during anal sex.

So a new study estimating condom efficacy in anal sex is very overdue and, given the need to compare condom efficacy against newer, biomedical prevention methods, very useful.

The studies analysed

Researchers from the US Centers for Disease Control retrospectively analysed condom use and HIV infection data from two different studies of US HIV-negative gay men: the VAX004 study, the first efficacy trial of an HIV vaccine, conducted between 1998 and 1999, and EXPLORE, one of the largest studies ever conducted of a behavioural intervention in HIV, conducted between 1999 and 2001.

There were some differences between the trial populations. Men in EXPLORE were twice as likely to be black and 50% more likely to have a college or university degree, and were younger, with fewer than half of the men in VAX004 aged 35 or under but nearly two-thirds in EXPLORE.

There were 1323 out of 3102 men in EXPLORE who said that they had had at least one episode of unprotected sex with an HIV-positive partner (43% of the men in the trial) and 2167 out of 4264 in VAX004, or 51% of all men in that trial. Altogether then, the CDC studied 3490 men who had had serodiscordant unprotected anal sex out of a total of 7366. There were 154 HIV infections in men in VAX004 and 71 in EXPLORE.

The total follow-up period in VAX004 was three years, and four years in EXPLORE. Participants were tested for HIV every six months and asked whether they had always used a condom for anal sex in the previous six months, sometimes used one, or never used one.

Condom efficacy with 100% use

Amongst all men having anal sex, men who said they used condoms 100% of the time were 70% less likely to acquire HIV than men who never used condoms, and 68% less likely than men who said they sometimes used them.

Condom efficacy was consistently higher in EXPLORE:  it was 86% for all anal sex, 87% for receptive anal sex and 76% for insertive anal sex compared with 59, 63 and 55% in VAX004.

Why the big difference? One possibility is that because EXPLORE was a behavioural intervention, it may have helped participants use condoms better and have fewer ‘accidents’ than in VAX004, which monitored condom use but did not intervene.

These figures are derived by comparing HIV incidence in men who said they always used condoms with men who never used them. What about the men who sometimes used them?

Condom efficacy with intermittent use

This analysis also shows that sometimes using condoms is no better than not using them at all. Overall, men who said they sometimes used condoms were only 4.4% less likely to acquire HIV than men who never used them. This difference was statistically insignificant; the margin of uncertainty means that, statistically, the 'true' efficacy of 'sometimes' versus 'never' using condoms could be anything between 29% fewer infections to 29% more infections, which is as good as saying that intermittent condom use essentially has zero efficacy.

There were 26% fewer infections in EXPLORE in men who used condoms intermittently than in men who never used them, but this was not statistically significant.

In VAX004 ‘sometimes’ using condoms was, if anything slightly less effective than never using them, with nearly 10% more infections in ‘sometimes’ versus ‘never’ users. How could this be? In the 1989 study, gay men who said they 'sometimes' used condoms were no less than 70% more likely to acquire HIV than men who said they never used them. The researchers at the time hypothesised that this because men who never used condoms might be more likely to be in monogamous relationships.

The researchers are now going to do further research to split ‘sometimes’ into different frequencies of use to find out below which level condom use ceases to be protective.

Consistency of condom use

How consistent was consistent condom use? Over the whole length of the studies, not very.  Two-thirds of men reported using condoms 100% of the time for at least one six-month slot during the two trials: but only 16.4% reported using them in every single six-month slot, i.e. truly consistently. Conversely, while only 5% of men reported never using condoms for the whole length of the studies, 40% reported never using them for at least one six-month period.

In the same session, Bob Grant, lead investigator of the iPrEx PrEP trial, showed an interesting slide showing selected ‘condom careers’ in individual trial participants and showed a whole variety of different use patterns over time, with the only consistent factor being no consistency.

There are a couple of important considerations to apply the CDC study’s conclusions. One is that social desirability bias almost certainly means that men's reported use of condoms was higher than it really was. This would mean the figures would tend to underestimate condom efficacy in the men who really did use condoms 100% of the time.

On the other hand, since only a minority of men in the studies did use condoms 100% of the time, these computed efficacy figures for condoms have to be divided by the fraction who actually did use them, resulting in lower effectiveness than this in actually preventing HIV on a population level.

Reference

Smith D et al. Condom efficacy by consistency of use among MSM: US. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, abstract 32, 2013.

View abstract 32 on the conference website.

A webcast of the session in which this research was presented, HIV prevention: ARV, counseling, contraception, and condoms, is available on the conference website.

The Conference on Retroviruses & Opportunistic Infections (CROI) focusses mainly on biological sciences. What can we learn about prevention? 

Nothing is more likely to whip the media into a frenzy over HIV than the word ‘cure’. Over these past few days, reports from a conference in Atlanta of the ‘cure’ of a baby from HIV fuelled numerous media headlines. Since the initial reports, it has become obvious why the ‘cure’ was qualified by the ambiguous ‘functional’, and why inverted commas punctuated the science. Conference attendees now suggest that whilst worthy of further investigation, report of a ‘cure’ is premature.

Less prominent in the media were discussions on the prevention of HIV. On the basis that ‘prevention is better than cure’ I have followed this conference theme from my laptop in the comfort of my Edinburgh living room. For one thing, I prefer to leave complex virology and pharmacology to the scientists. For another, Atlanta is about as grey and cold as ‘Auld Reekie’.

Mixed results

Last summer’s grand and political International AIDS Conference in Washington heralded ‘An End to AIDS’, supplying journalists with a catch-phrase. An exploration of the theme of prevention at the Atlanta conference yields unexciting headlines. It does, however, provide helpful insights.

In the context of what is one of the best conferences focused mainly on HIV science, it is possible to compare biomedical responses with behavioural interventions to prevent HIV transmission. Biological sciences often claim a significant breakthrough, as in the introduction of ground-breaking anti-retroviral therapies. In the behavioural science of prevention you’re up for the long haul of education, engagement, and understanding HIV and protection from a community and individual perspective.

A reality check on ‘End to AIDS’ rhetoric provided useful background to the conference’s assessment of interventions such as Pre-Exposure Prophylaxis, treatment as prevention, and the conditions essential to their success in the long term. By way of comparison, detailed analyses of what drives the HIV epidemic especially among gay men, and community studies suggest a direction for HIV prevention.

A road-test for science

One of the most telling comments was an aside from Thomas Coates of the University of California when he referred to Los Angeles where his research team is based as “like a third world country ….. I kid you not”. In response to a question about how to spend the next few billion dollars, the same speaker quipped, “I think our Congress has decided that the money is not going to be available”. Asides maybe, but another aspect of the reality within which scientific research and prevention are subject to a ‘road-test’.

 “Community-led reductions”, a study presented by Thomas Coates, was a deep disappointment. Reporting on three study sites, the packages tried were little more than the standard community approaches we operate in Scotland. It is true that the interventions applied over three years from 2006-2009 and assessed between 2010 and 2011, yielded a 25% increase in HIV testing and a fourfold increase in detection of previously undiagnosed HIV, as well as reductions in risk especially among those diagnosed positive. These successes are not significant in comparison to experience of the effect of policy and practice changes over a similar period in Scotland.

What Coates called a ‘modest reduction of 14% in incidence’ based on new statistical calculations, however, is worth more investigation. Perhaps one interesting aspect of the intervention was use of mobile outreach and testing buses, similar to that used by the ROAM team in Edinburgh and by the Hepatitis Trust across the UK. His conclusion that his team must ‘achieve the penetration of the community’ should not be misinterpreted.

A drug-based study into use of Tenofovir in a vaginal microbicide and in Pre-Exposure Prophylaxis (PrEP) reported that those receiving the intervention did no better than those on the placebo. Thus, one of the largest trials of HIV drug-based prevention had to be discontinued before it had completed its course. The VOICE study recorded an almost statistically significant greater likelihood of the women on the study becoming HIV positive.

The main reason for trial futility was not drug-related, but on account of low adherence to the regimen. This mirrors results of the Fem-PrEP study and a similar study with young gay men.

Adherence to any intervention, be it condom use or drug-based, is crucial. As mentioned in an earlier report of CROI, intermittent use makes sense for when you’re planning sex, but is ineffective if the power of the intervention depends upon there being sufficient level of drug in the blood-stream to prevent establishment of the infection. Whilst results of broad community-wide, drug-based interventions are disappointing, there might be scope for their use along with intensive support with individuals at greatest risk.

Condom use

was the subject of another detailed longitudinal study, which sought to estimate the efficacy of condom use for HIV prevention among men who have sex with men. Dawn Smith reported a 70% efficacy in condom use, similar to that reported in 1989 by Weller and Ahmed. Of additional interest were the levels of adherence to condom use over time. Long-term, only a minority 16% reported ‘always’ using condoms. Intermittent, ‘sometimes’ condom use, was reported to have no significant effect in preventing HIV. The longer the time-frame studied, the lower the consistency of condom use. This finding attracted a fair bit of interest in conference reports. One must question why.

First of all, the study took no account of the context of condom use, for example, the type of relationship, concurrency, numbers of sexual partners, settings or networks. Secondly, the range used for ‘sometimes’ using condoms went from 1% to 99% with no stratification. It is obvious that the longer one risks ‘sometimes’ not using a condom, say in a fairly representative 50% of per act use, the more likely that infection will occur. It will rise further if 50% ‘sometimes’ shows a further 25% reduction. However, it remains true that ‘always’ is better than ‘sometimes’, and ‘sometimes’ is better than ‘never’ using condoms.

How we report statistics to our communities and their underlying message requires care. Reports of a baby ‘cure’ have resulted in phone lines busy with anxious parents asking when the elusive ‘cure’ will be made available. If we report statistics, and we ought to, we have a responsibility to add sound analysis and relevance to the readership’s real life experience. Meantime, condom use is 70% effective in preventing HIV.

Greater promise in the field of prevention was woven into other studies on which I will comment separately. Meantime, the big message of these studies is that if biomedical science is to be the harbinger of a prevention break-through, it will take time, it has to be in the real world, and it will succeed only in combination with behavioural science and alongside structural and political change. I will also consider these factors and what we might learn.

This article originally appeared on Roy's own blog scottfreehiiv here.

This story by Keith Alcorn first appeared on aidsmap.com here. 

PositiveLite.com says: Since this report was released earlier this month there has been much skepticism/caution in the press as to the significance, or even reality, of this "functional cure", such as this analysis in the Huffington Post or this one in The Guardian.

Researchers in the United States say that they have identified a case of a 'functional' HIV cure in a child infected with HIV who began antiretroviral treatment within days of birth. The child has now been off treatment for a year, and although HIV DNA has been detected at very low levels in the child’s cells, the virus is not reproducing.

Further follow-up will be required to determine whether this state persists, or whether viral replication resumes, but researchers involved in the case are optimistic that what they have found represents a functional cure – a state in which HIV remains in the body, but no longer replicates. One functional cure in an adult has been reported previously – the so-called 'Berlin patient' (see below and related news story).

The findings were presented at a press conference on the opening day of the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, and further details were released on Monday 4 March in a conference session on 'HIV Eradication'.

Dr Deborah Persaud (below, right) of Johns Hopkins University School of Medicine, Baltimore, reported on the case of a child treated with antiretroviral therapy from 30 hours after birth, almost immediately after testing for HIV DNA and RNA on the second day of life. The child was born to a mother with detectable viral load at the time of delivery.

The child was delivered prematurely, at 35 weeks of gestation, and the mother underwent rapid antibody testing for HIV at the time of delivery. She had not been in HIV care previously. The child was tested for HIV at around 30 hours of life, and tests revealed detectable HIV DNA and HIV RNA of just under 20,000 copies/ml. RNA tests continued to be positive up until 20 days of life, indicating that this was not an isolated false positive result and that viral replication was taking place.

In line with recommended practice in cases where mothers have detectable viral load at the time of delivery, the infant was initiated on a regimen of AZT/3TC and nevirapine as prophylaxis against infection. In cases of prophylactic treatment to prevent infection in HIV-exposed infants, this regimen would be given for 4 weeks. In this case, because virus was detected and the infant had confirmed HIV infection, treatment continued until the age of 18 months (although lopinavir/ritonavir (Kaletra) was substituted for nevirapine at day 7). At 18 months of age, the child’s caregiver withdrew the child from treatment and the child was lost to follow-up for nearly six months.

Viral load tests were carried out at 7, 12 and 20 days of age that showed detectable virus after the initiation of treatment, before the virus became undetectable on a test with a lower limit of detection of 20 copies/ml at day 29. Subsequent testing until month 26 showed that viral load remained persistently undetectable after this point, despite the fact that treatment was stopped after 18 months.

When the child returned to care at 23 months of age and it became apparent that viral load was not detectable in the absence of treatment, clinicians at the University of Mississippi Medical Center sought advice from research groups outside the state, including Dr Katherine Luzuriaga at the University of Massachusetts.

Collaborating laboratories at the National Institutes of Allergy and Infectious Diseases and the University of California San Diego carried out ultrasensitive tests to determine whether HIV had been eliminated, or whether any traces of the virus persisted in any cell types. They found that viral RNA of 1 copy/ml could be detected in tests carried out when the child was two years of age and 2 copies/ml at 26 months. Co-culture of 22 million resting CD4 cells failed to identify any replication-competent HIV at 24 months.

However, testing at 24 and 26 months of age found a reservoir of presumably latently infected cells: HIV DNA was detected in peripheral blood mononuclear cells at a frequency of 37 and 4 copies per million cells. The investigators also looked for 2-LTR circles, fragments of unintegrated HIV DNA that might have the potential either to influence the way in which the infected cell evades immune surveillance, or to establish a prolonged state of latency. They found no 2-LTR circles within the cells containing HIV DNA, suggesting that HIV is completely quiescent, and not replicating – a functional cure of HIV infection.

Speaking at the press conference, Deborah Persaud rejected suggestions that the case might represent an episode of successful post-exposure prophylaxis, noting that several blood samples taken during the first week of life had tested positive for viral RNA, indicating that infection had already become established. However, further testing of these samples is not possible because the samples had not been stored, their future significance not being appreciated at the time the child was diagnosed.

Dr Persaud said that the findings represented a “proof of concept”. Referring to the case of a Berlin man who was declared cured of HIV infection following a bone marrow transplant from a donor with genetically conferred resistance to HIV infection, she said: “We believe this is our Timothy Brown moment.”

She said that trials to investigate whether a functional cure is possible for larger numbers of infants are now in design, and that, if successful, the challenge will be to replicate the results through the existing platform of services for prevention of mother-to-child transmission.

Reference

In a study published last week-end, the Health Protection Agency sets out their analysis of a well-documented epidemic.  Read it in full on Plos One or more briefly in the BBC news report. It answers a question many of us have been asking, “Why do HIV infections continue to rise in the face of high coverage of ART treatments and with a tripling of HIV testing?” 

The study compares two periods of time, 1990-1997, and 1998-2010.  HIV infections rose by 50%. During the same period, condomless sex rose by a ‘modest’ 26%. The benefits of treatment on preventing HIV transmission are being eroded by the fall in condom use. Facts and statistics take the shine off the ‘End to AIDS’ rhetoric.

Various explanations are offered: it’s old infections being diagnosed, younger men take more risks, urban networks, and social networks. None of these offers an adequate explanation. Diagnosis of very recent infections, infections right across the age spectrum, a doubling of cases in some lower prevalence areas about eight years ago, and social network research run counter to these explanations. Condoms are free and, we’re told, increasingly available in lots of outlets on the gay scene and elsewhere.

In a thought provoking personal blog on the study published in SavingLivesUK, one of the positive advocates takes issue with one early response, which suggests that gay men are not complacent. This is based on the study’s hypothetical situation, that if gay men had given up condoms altogether, then the increase in HIV would have been measured in the tens of thousands. Alex disagrees with the ‘no complacency theory’ and points instead to the perception among many gay men of the effect of class, trusting posh middle class boys as opposed to council estate lads. Peer pressure especially on dating sites are not an explanation in themselves, but a platform on which gay men can be classist, succumb to peer pressure, and make hormonal, ill-considered decisions.

Alex speaks good sense when he says that many gay men are complacent. The study describes its calculation of the effect of a 100% abandoning of condoms as a ‘counter-fact’. An interesting aside admittedly, but we need to deal with hard-headed reality if we’re going answer the vital question, ‘What are we going to do about it? 

In addition to the ‘not complacent’ response, a stock answer is a plea for funding of local HIV prevention, followed with a lament about NHS reorganisation. The annual accounts don’t really hit the mark in terms of an effective message on rising rates of HIV. It provokes rather another question, ‘What exactly is the money being spent on?’

In another relevant blog, Australia’s Christopher Banks (aka ‘Bipolar Bear’) critiques a recent ‘test and treat’ campaign there, his conclusion being, ‘Wow. It makes HIV sound like a corporate life insurance plan rather than one of the most deadly and resilient viruses ever encountered. Nice reframing’. He berates the ‘cursory nod’ given to condoms as against HIV testing and ‘bizarre infection-avoidance methods’.

As an advocate for drug-related harm minimisation, I am interested in the effectiveness of ‘infection-avoidance methods’ and how they fit within our communications strategies. I am not convinced that the approach translates well from drugs to sex, especially if it dilutes, confuses or confounds a public health safer sex message.

The study released by HPA draws two practical conclusions that ‘much higher rates of testing combined with treatment and diagnosis would be likely to lead to substantial reductions in HIV incidence. Increased condom use should be promoted to avoid erosion of the benefits of ART and to prevent other serious sexually transmitted infections.’

Our health promotion messages and interventions need to take a lead. Gay men who are consistent in proper condom use need encouragement, knowing they’re part of a life-saving solution. There is a general risk that agencies tend to accommodate and mirror the problems of their ‘client group’. Without recognising it, has uncritical acceptance of some aspects of our ‘gay radicalism’ risked falling in behind the growing culture of ‘condomless sex’ (NB this includes but is not synonymous with ‘bareback’ culture)? Focus on Pre-Exposure Prophylaxis, and even, dare I say it gay marriage and HIV testing, can drown out safer sex messages.

How do we counter the hedonistic appeal of the commercial community in the form of dating sites, video production, drugs and alcohol dealers? One way of achieving this is through the eroticisation of condoms as part of safer sex, and reinforcement of sex for pleasure and of condoms for both safety and contraception (yes, gay men can make babies!).

How well do men understand condom ‘fit and feel’? If it fits better and feels better, there’s more chance it will be used. Men need to know this, rather than being left to a chance discovery.

Looking around for a response to the study, I found it on ‘Twitter’: it’s ‘education’. In a nod perhaps to the funding obsession, Richard Horton of the Lancet posted, ‘Make condoms a new national currency, from schools onwards’. He has a point. Separately, in a detailed response to an enquiry into teenage pregnancy, the Scottish Sexual Health Lead Clinicians Group, calls upon the Scottish Government to make condoms and contraception available in schools, Scottish Sexual Health Lead Clinicians Group, calls upon the Scottish Government to make condoms and contraception available in schools and asks, why a Government that’s prepared to take a stand on controversial issues like gay marriage, runs scared of making emergency contraception available in schools. Schools must be inspected rigorously on how well they meet the sexual health needs of young gay people who on average feel confident enough of their sexuality to talk about it to friends at the age of 16. Like all young people, they need support and information.

No one wants simplistic, single-stranded solutions to a complex problem. The current drowning of safe sex and condom messages, however, is symptomatic of funding fears and the priority of the organisation. This does not cut it with the gay or positive community.

This article originally appeared in Roy's own blog scottfreehiv here.