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 fIrst appeared on aidsmap.com here. 

A study from Amsterdam found that gay men who had used post-exposure prophylaxis (PEP) in the past were four times more likely than non-users to subsequently become infected with HIV.

PEP failure does not appear to be the cause of their HIV infection, but rather ongoing risk behaviour following a course of PEP. Self-reported adherence to the PEP regimen was high, at 94%.

The investigators compared HIV infection rates between 2000 and 2009 in 355 men, who had in total received 385 courses of PEP, with infection rates over the same period in 782 gay men entering the Amsterdam Cohort Study. They measured HIV incidence three and six months after receiving PEP in the former group and after cohort entry in the latter.

HIV incidence, translated into infections per man per year, was 6.4% in men who had taken PEP and 1.6% in the cohort study. Three out of the eleven PEP users who acquired HIV were positive three months after PEP but the other eight were only found to be positive six months later, indicating that few - if any - infections were acquired while actually taking PEP.

“Our study showed a high incidence of HIV among MSM [men who have sex with men] who used PEP, an indication of ongoing risk behaviour,” write the investigators. “This implies that PEP alone for this group is not sufficient to prevent HIV infection, and a combination of other more comprehensive preventative strategies is needed.”

Comment: It is important not to interpret this study as a failure of PEP. Instead, it indicates that gay men who come forward for PEP rightly see themselves as being at high risk of HIV, but find that PEP is not a strategy they can use often enough for it to be protective. Previous studies of PEP have also found that, while it has an efficacy of about 80% for individual infections, its use makes no difference to infection rates on a population level. The high HIV incidence in PEP seekers suggests that they might be ideal candidates to be offered an ongoing course of PrEP (pre-exposure prophylaxis). At present, PrEP is still regarded as an experimental prevention technique and access to it is limited to unlicensed or clinical trial-based use.

This article was originally posted December 14, 2012 on the blog of Positive Women’s Network here.  

Last week was Canada’s official day to remember and take action on violence against women. Did you hear anything about HIV?

Likely not. The connections between HIV and gender-based violence are discussed mainly by women engaged in HIV work and rarely by anyone outside the field.

Yet the connections are strong. More than one study has shown that personal histories of trauma increase the likelihood of infection for women, and women with HIV experience higher rates of partner abuse. In other words, the relationship runs both ways: violence can lead to HIV, and HIV can lead to violence.

One way that violence can lead directly to HIV is through sexual assault resulting in infection. There is a way to prevent infection immediately after an assault, using what is called post-exposure prophylaxis. Post-exposure means after possible contact with the virus. Prophylaxis refers to a protective or preventive treatment. Post-exposure prophylaxis involves giving anti-HIV drugs to a person right after possible exposure to the virus, for instance after a woman is raped. If the person starts the drugs soon enough and continues to take them as recommended, there is a good chance HIV infection can be avoided.

Given that the virus doesn’t discriminate (anyone who’s had unprotected sexual intercourse could have it) and that approximately one quarter of people in Canada with HIV don’t know they have it—the rationale behind the recent push in British Columbia to implement routine HIV testing—it would make sense to offer post-exposure prophylaxis to any woman who has been sexually assaulted.

But look at the guidelines on post-exposure prophylaxis after assault put out by one hospital in British Columbia. They circumscribe the dispensing of drugs to prevent HIV, granting them only when a sexual assault is deemed “significant risk.” The risk depends on either of two parts: (1) the “source” (i.e., the perpetrator of the assault) or (2) the “setting” (i.e., the place where the assault took place):

(1)    A woman who’s been raped qualifies for the drugs if she knows the rapist has HIV.

  She qualifies for the drugs if she knows the rapist uses injection drugs.

  She qualifies for the drugs if she knows the rapist has sex with men.

  Or she qualifies for the drugs if she was raped by multiple people.

(2)    She can also qualify for the drugs if the rape occurred in a “setting considered high risk for HIV.” An example given of such a setting? The Downtown Eastside.

These stipulations leave a lot of gaps and fuel a lot of stigma. The burden falls to the woman to know the rapist intimately: to know whether he has HIV (when he may not even know), to know whether he uses injection drugs, to know whether he has sex with men. This goes against current messaging in British Columbia that everyone should be tested because HIV affects all kinds of people. And singling out the Downtown Eastside as a place filled with HIV and rapists further stigmatizes a maligned and misunderstood community, while implicitly erasing the violence that goes on in all sorts of communities.

Being raped is no small thing. Part of me just shriveled up from having to write that, but I think sometimes we really need to remind ourselves of this fact. Women respond to assault in different ways, as they cope and figure out how to survive. I have done support work for survivors of violence and can attest that for many women, even years down the road, engagement with the medical system remains one of the most challenging and revictimizing experiences. After being raped, women don’t necessarily want to see a doctor or nurse immediately or at all—imagine how traumatic an exam is for someone whose bodily autonomy and integrity have been violated.

Yet the window for accessing post-exposure prophylaxis is just 72 hours. Imagine making it to a hospital after you’ve been assaulted and putting yourself in a vulnerable position physically and emotionally. You decide you want post-exposure prophylaxis since you feel you’re at risk or you just want peace of mind—because how can you really know if someone has HIV?—but you’re subjected to a series of questions about the rapist and the setting of the rape. Are these things you’re ready to talk about, especially with strangers? You don’t have a choice if you want to access anti-HIV drugs. So you manage to answer the questions, as best you can at this time. But you’re told you can’t have the preventive treatment because your rape wasn’t high-risk enough.

To deny post-exposure prophylaxis to a woman who’s been raped on the basis that she hasn’t provided sufficient proof that the rape was “significant risk” is to deny her control over her physical, sexual, and emotional health. To allow her to decide for herself if she wants anti-HIV drugs after a sexual assault is to provide an opportunity for her to reassert control over her body.

On World AIDS Day, Dalya Israel of Women Against Violence Against Women published a must-read blog entry laying out some of the links between HIV and violence. She concluded, “We can’t live in silos anymore, we have to see the connection between the HIV/AIDS movement and the feminist anti-violence movement.” The overlaps in our work can open up spaces of possibility—we’re all in this together, and a convergence of movements is long overdue.

- Erin

Follow Positive Women’s Network on twitter @PWN_BC

This article first appeared on the website of Pacific AIDS Network here. Republished with permisision of the author. Folllow PAN on twitter at @PAN_CBR 

Moving research on new “biomedical” HIV prevention technologies into practice

By James Wilton

Recent research findings have improved our understanding of HIV transmission and prevention and could change the landscape of our response to the HIV epidemic. In the past few years, several new HIV prevention approaches, such as post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP), and the use of antiretroviral treatment as prevention, have been found to reduce the risk of HIV transmission. These new strategies are often referred to as new “biomedical” HIV prevention technologies, or NPTs.

If moved into practice in an appropriate way, these new approaches could have a dramatic impact on the HIV epidemic in Canada and other parts of the world. However, translating this research into a reduction in new HIV infections within the communities we work with will be challenging. Community-based organizations (CBOs) – through programming and research – will have an important role to play in understanding these challenges, overcoming them, and effectively implementing these approaches.

Engaging people and communities in new HIV prevention approaches

At the most basic level, we know that the more people in a population who use a specific strategy, the more HIV transmissions they can potentially prevent. The number of people who use a strategy, often referred to as uptake or adoption, will depend on a number of factors, such as awareness (do people know about it?), acceptability (do people want to use it?) and availability (can people access and afford the technology if they want to use it?).

The impact of these strategies will also depend on “who” in a population uses them. More HIV transmissions will be prevented if the strategies are adopted by individuals who are at highest risk of HIV transmission, such as those who don’t use condoms consistently or share injection drug use equipment.

Focusing uptake among those at highest risk may be important for another reason. There is a concern that some people using these new approaches may feel a false sense of security and increase their risk behaviour, such as using fewer condoms or having sex with more partners (a concept known as risk compensation or behavioural disinhibition). Since none of these new strategies are 100% protective, this could potentially offset some of the benefit of NPTs and limit the number of HIV infections they prevent. However, the potential impact of risk compensation will be lower when used by people who are already at higher risk of HIV transmission.

Community-based organizations will play a key role in engaging individuals and communities and facilitating the appropriate uptake of these technologies. This will involve:

• Community mobilization to build readiness for new approaches and address barriers that may affect their acceptability, such as stigma and social, cultural, and political norms.
• Outreach and educational campaigns to improve awareness of these strategies, including information on who they are appropriate for and where they can be accessed, particularly among those at highest risk for HIV transmission.
• Accurate risk assessments for those who are interested in using these approaches and, if appropriate, referral to locations where they can be accessed.
• Community planning to ensure NPTs are provided in a way that respects human rights and supports informed decision making by the people using them.
• Advocacy to ensure the technologies are available and affordable.

Community-based research (CBR) will be essential to gain a better understanding of the acceptability, awareness and availability of these technologies in the community, the barriers to adopting them, and the characteristics of those who are using them.

Packaging new approaches with other strategies and supports

Among those who do use these strategies, what will influence the effectiveness of NPTs at reducing HIV incidence?

How consistently and correctly these strategies are used will be important. Research shows that these new approaches – such as post-exposure prophylaxis (PEP), pre-exposure prophylaxis (PrEP), and the use of antiretroviral treatment as prevention – are much less protective if not used consistently. Correct use means different things for different strategies. However, as none of these new approaches are 100% protective, correct use generally means that these new approaches are combined with, instead of replace, existing HIV prevention strategies.

Furthermore, the presence of certain biological factors that are known to increase HIV risk, such as sexually transmitted infections (STIs), may reduce the effectiveness of these new approaches. Therefore, correct use of these strategies also means combining them with STI prevention, testing, and treatment services.

In research studies and clinical trials, these NPTs have been credited with dramatic reductions in HIV incidence and this has generated a lot of excitement. For example, the HPTN 052 study found that antiretroviral treatment reduced HIV incidence among heterosexual serodiscordant couples by 96%.

However, we may not see the same large reductions in incidence in populations using these strategies in the “real world,” outside of a clinical trial. In clinical trial settings, participants are provided with ongoing prevention and support services including free condoms, HIV testing, STI testing and treatment, and intensive adherence and risk-reduction counselling. All of these services help to create “ideal” conditions that can maximize the impact of an HIV prevention strategy on HIV incidence. These new approaches may be less effective outside of a clinical trial if they are not provided in combination with these additional support services.

Community-based organizations will play an important role in packaging new prevention approaches with additional strategies and supports. This will include:

• Adherence support to help people integrate these strategies into their daily lives and use them consistently.
• Education on how to use the strategies correctly, including information on their advantages and disadvantages compared to existing approaches and the factors that may reduce their effectiveness.
• HIV prevention and risk-reduction counselling to help people understand their HIV transmission risk while they are using a prevention technology and to help them adopt additional HIV and STI prevention strategies. This will also need to include linkages and referrals to other services needed by people at risk of HIV infection and transmission.

Again, community-based research can play an important role in providing  insight into how people are using these strategies in the “real world” and the barriers to using these strategies consistently and correctly.

The role of CBOs and CBR in the changing HIV prevention landscape

The HIV prevention landscape is changing and CBOs have an important role to play in ensuring NPTs are used by the “right” people, at the “right” time, in the “right” context, and in the “right” way.

However, there is an increasing concern that the introduction of these technologies, particularly those based on antiretrovirals, will “medicalize” HIV prevention and reduce the role of CBOs in the response to the HIV epidemic. This is because most “biomedical” NPTs can only be obtained from a healthcare provider and need to be combined with ongoing medical services, such as laboratory and clinical monitoring, HIV testing (in the case of PEP and PrEP), and STI testing and treatment. Therefore, the worry is that these new “biomedical” approaches will shift the setting of HIV prevention from the community to the clinic.

In reality, it’s clear that these new prevention approaches are not exclusively “biomedical” and need to be packaged with several non-clinical services in order to prevent risk compensation, promote their appropriate uptake and sustained use, and ensure they are effective outside of a clinical trial setting. These are services that many healthcare providers do not have the time, knowledge, or expertise to provide effectively and, therefore, represent a gap that CBOs need to fill.

Moving forward

Dr. Kevin Fenton of the Centers for Disease Control and Prevention (CDC) in the United States gave a presentation at the 2012 International AIDS Conference in Washington where he discussed the implications of this new research for CBOs. He called upon CBOs to adapt to the changing HIV prevention landscape by:

• Learning new skills (improving their science base and understanding of clinical trial results).
• Developing new clinical alliances (improving their ties with organizations and institutions where these prevention technologies can be obtained).
• Providing new clinical and prevention services (offering HIV and STI testing, adherence support, and risk-reduction support).
• Promoting the uptake and correct use of these technologies (developing accurate, tailored, context-specific information; ensuring messages reach their target populations through a variety of different mechanisms, such as peer–peer outreach).

James Wilton is the Coordinator of CATIE’s Biomedical Science of HIV Prevention Project, he can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it. .

This article first appeared on the website of CATIE  here.  

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Recent advancements in our understanding of HIV transmission, treatment, prevention and testing are changing the landscape of our response to HIV and generating a significant amount of optimism. The buzz at the International AIDS Conference this past July in Washington D.C. was that we may now be able to achieve an ‘AIDS-free generation’ where first, no one will be born with the virus; second, that as people age, they will be at a far lower risk of becoming infected than they are today; and third, that if they do acquire HIV, they will get treatment that keeps them healthy and prevents them from transmitting the virus to others.

Similarly, the United Nations AIDS organization has launched a ‘Getting to Zero’ campaign for this World AIDS Day, December 1, signifying the aim of getting to zero new infections, zero AIDS-related deaths, and zero discrimination.  

There are many reasons why we should feel these commendable goals can be achieved. But there are also significant challenges that need to be addressed before we get there.

New understanding about HIV

First, a word about those things that give us confidence.

We now have newer medications for people living with HIV that are easier to take and have fewer side-effects, thereby making HIV treatment more manageable. These medications also allow people living with HIV to have a near-normal life expectancy. We also have a much better understanding of the importance of starting treatment earlier in order to achieve better health outcomes.

Treatment can also help prevent the transmission of HIV. Research shows that people living with the virus who are on successful antiretroviral therapy and have a fully suppressed viral load (undetectable) are less likely to pass HIV onto others.

Due to these advancements in our understanding of the virus, treatment guidelines now recommend that people living with HIV begin antiretroviral therapy as soon as they are ready after diagnosis.

The importance of early detection

To complement the uptake of early treatment, we have also made progress in developing new testing technologies and strategies that allow us to detect HIV earlier and faster than ever before, allowing HIV-positive people to learn about their status much sooner after becoming infected. 

Early diagnosis is crucial to our success in preventing HIV transmission for three major reasons.  First, it may help identify people during the first few months after HIV infection when their viral load and risk of HIV transmission is at an all-time high. Second, it gives newly diagnosed individuals the option to start treatment earlier. And lastly, the majority of people diagnosed with HIV take active measures to reduce their risk of passing HIV on to others.

New prevention approaches

Although condoms and clean needles are the backbone of our prevention efforts, we are learning about additional prevention tools that can also be used. We now know that the same drugs used to treat HIV can be used by HIV-negative people to help reduce their risk of an HIV infection. These preventative approaches are known as post-exposure prophylaxis (PEP) and pre-exposure prophylaxis (PrEP). While PEP is the standard of care for occupational exposure to HIV, its availability for non-occupational exposures and its cost vary greatly across Canada. Although PrEP is not currently approved for use by Health Canada, some doctors may already be prescribing it to their patients (known as ‘off-label’ use).These new prevention approaches are promising options for HIV-negative people who are at a high risk of getting HIV.

HIV drugs, in combination with other strategies such as not breastfeeding can also help eliminate the transmission of the virus from an HIV-positive mother to her newborn child.

Challenges we still face

Despite these advancements, translating them into a generation without AIDS or without new HIV infections remains challenging. The hurdles we continue to face include limited financial resources applied to HIV prevention and treatment, and the barriers people living with and at-risk of HIV face when accessing HIV-related services.

Additionally, people living with HIV can be criminally prosecuted for not disclosing their HIV status to their sexual partners, which can discourage them from wanting to know their status, and thereby opting out of getting tested.

Stigma, discrimination, and poverty can make it difficult for marginalized populations to access services, which explains why some populations are more strongly affected by the HIV epidemic. The reality is that a number of Canada’s communities have a high prevalence of HIV. According to the latest estimates (2008) by the Public Health Agency of Canada, gay men and other men who have sex with men represent a majority (51 per cent) of people living with HIV. People who use injection drugs represent 20 per cent, people from regions where HIV is endemic (such as Africa and the Caribbean) represent 14 per cent, and Aboriginal people represent eight per cent of the total HIV epidemic in Canada.  

Where do we go from here?

It’s clearer than ever that HIV prevention, testing, care and support, and treatment are all mutually reinforcing elements of an effective response to realizing an ‘AIDS-free generation.’ At CATIE, we feel these advancements call for an ‘integrated approach’ to HIV treatment and prevention. Such an approach will be discussed, for example, in September, 2013, when CATIE will host a forum that will explore the recent developments in HIV and determine ways to integrate HIV treatment and prevention for us to move forward in an effective way.

While we are still years away from an ‘AIDS free generation,’ we appear to be on the right path. It only takes a look back 30 years ago at the despair we once felt in the face of this unknown disease to see how far we’ve come. 

The year 2011, just ended, marked the thirtieth anniversary of the HIV/AIDS pandemic. Much has been achieved in those three decades, most notably advances in treatment that have changed the face of HIV for those who have access to antiretroviral (ARV) medication from a terminal illness to a chronic yet manageable disease.

But of late there’s been other good news to celebrate. Just last month, for example, researchers from the University of Western Ontario announced that clinical trials are about to begin on a new HIV vaccine they’ve developed. And it does seem that, increasingly, more and more experts are becoming convinced that appropriately treated HIVers with an undetectable viral load are much less likely to pass on the virus than people not on treatment. However, as PositiveLite editor Bob Leahy recently pointed out by how much and in what circumstances is still subject to debate.

The latest people to take the view that HIVers on treatment with undetectable viral loads are unlikely to infect their sexual partners are the two organizations that write the HIV treatment guidelines for the UK, the British Association for Sexual Health and HIV  and the British HIV Association. They’ve done this via their newly revised guidelines for the use of post-exposure prophylaxis (PEP).

PEP is an emergency measure aimed at preventing HIV infection after the possible exposure of an HIV negative person to the virus. The new UK guidelines are notable for no longer recommending that PEP be provided in a number of situations where the “source partner” is known to be HIV+ and to have an undetectable viral load. These situations include unprotected vaginal intercourse, unprotected insertive anal intercourse and oral sex. But PEP is still recommended following unprotected receptive anal intercourse.

The guidelines are also notable for not recommending PEP in any situation in which the source partner is thought not to belong to a social group in which HIV prevalence is high, such as gay men or people from high-prevalence countries (such as those in sub-Saharan Africa). The guidelines also clarify that, due to the very low risk of infection, PEP is unnecessary following human bites or contact with a discarded needle.

 (Unlike the UK and many other countries in the developed world, Canada has no national guidelines for the use of PEP for non-workplace exposure - such as unprotected sex, a condom breaking during sex, needle sharing or sexual assault -  although some provincial guidelines exist. As a result, PEP for non-workplace exposure is rarely promoted in Canada. On the other hand, PEP after workplace exposures - for example a health care worker who accidentally suffers a needle-stick injury - remains the “standard of care” and is widely used in this country.)

Yet, despite the growing body of evidence that having an undetectable viral load significantly reduces the likelihood of an infected person passing on the virus to an uninfected sexual partner, Canada has witnessed an escalation in the number of people prosecuted for allegedly exposing partners to HIV even if they had an undetectable viral load and/or were using protection such as condoms or engaging in a low risk activity such as oral sex. Ontario is home to the majority of HIV-related prosecutions in Canada and is also one of the leading jurisdictions in the world when it comes to such prosecutions.

Part of the problem is that the law around HIV disclosure has never been legally defined. Rather, it comes from a 1998 decision of the Supreme Court that HIV+ people have a legal duty to tell a sex partner that they have HIV before they have sex if there’s a “significant risk” that they’ll pass on the virus to that person. This lack of clarity on what constitutes significant risk has meant that the police, Crown attorneys and lower courts have been inconsistent in how they interpret what sex acts, and under what circumstances, pose a significant risk of HIV transmission.

In last month’s Canadian Medical Association Journal, Julio Montaner, one of Canada’s and the world’s leading HIV medical doctors, along with colleagues from the British Columbia Centre for Excellence in HIV/AIDS called for the end of prosecutions for allegedly exposing sexual partners to the virus. “To put the burden on the person infected with HIV that they have to disclose when they may be on treatment or using a condom, or doing both, is really not appropriate,” Montaner told The Vancouver Sun. “Let me be clear, I think that people who behave irresponsibly, they need to be judged accordingly and there are laws to address those issues...but to have a policy that selectively targets HIV is discriminatory and discourages people from seeking out testing and treatment.”

All this will be coming under intense scrutiny next month, when the Supreme Court of Canada is to hear two appeals involving HIV non-disclosure. In both cases, one from Manitoba, the other from Québec, the accused are HIV+ and had consentual sex with their partners without disclosing their HIV status although they used condoms or were on ARV medication that kept the risk of transmission very low. In each case, the accused were acquitted by the provincial Courts of Appeal. However, prosecutors in both cases applied for an appeal before the Supreme Court.

So it was of particular concern that in September 2011, Ontario’s Attorney General indicated his government’s intention to file an application to intervene in the Supreme Court hearing. The government’s intent was to call on the Court to rule that people living with HIV must disclose their status before any sexual activity whatsoever - even in the case where there’s a negligible, effectively zero, risk of HIV transmission - and that not disclosing should be prosecuted as an aggravated sexual assault, which is one of the most serious offences in the Criminal Code.

It was especially troubling that the Ontario Attorney General's office took this position at the same time that it was engaged in ongoing discussions regarding the development of prosecutorial guidelines for allegations of HIV non-disclosure.

So it was good news to learn that, just before Christmas 2011, Ontario quietly withdrew its application to intervene before the Supreme Court. The government hasn’t released its reasons for this about-face, although it must be said that the governing Liberal party has just recently been returned to power following a provincial election where they gained a plurality of seats in the provincial parliament. The premier also appointed a new Attorney General who may have been instrumental in deciding against his predecessor’s decision to intervene.

However, the appeal before the Supreme Court will still be going ahead - it starts on February 8, 2012 - at which time the Court will be asked to define “significant risk”. Hopefully, in reaching a decision on the two cases before it, the bench will take into account current medical and scientific research about the risk of transmission and make a decision that’s compatible with scientific, medical, public health and community efforts to prevent the spread of HIV and to provide care, treatment and support for people living with HIV.

You can listen to an excellent debate about the current law - and recommended changes to it - in a podcast of the CBC Radio current affairs program The Current that was broadcast on December 21, 2011. In it Anna Maria Tremonti talks with Tim McCaskell, a long-time AIDS activist and person living with HIV, and Carissima Mathen, an associate professor of law at the University of Ottawa.

Sources:

Peabody, R.: PEP guidelines for the UK revised to take account of undetectable viral load. London: NAMaidsmap (December 2011): http://www.aidsmap.com/PEP-guidelines-for-the-UK-revised-to-take-account-of-undetectable-viral-load/page/2186929/ Accessed December 29, 2011

Wilton J.: Post-exposure prophylaxis fact sheet. Toronto: CATIE (2011) http://www.catie.ca/fact-sheets/prevention/post-exposure-prophylaxis-pep Accessed December 29, 2011

Wilton, J.: Enhancing the potential benefit of PEP. Toronto: CATIE (June 2011) http://www.catie.ca/en/catienews/2011-06-23/enhancing-potential-benefit-pep Accessed December 29, 2011

HALCO News Fall 2011. Toronto: HIV & AIDS Legal Clinic Ontario http://www.halco.org/wp-content/uploads/2011/11/HALCO_Newsletter_Fall_2011.pdf Accessed December 29, 2011

Salerno, R.: Ontario withdraws intervention in HIV criminalization cases. Toronto: Xtra! (December 2011) http://www.xtra.ca/public/National/Ontario_withdraws_intervention_in_HIV_criminalization_cases-11273.aspx Accessed December 29, 2011