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WHO recommends PrEP for MSM: Time for the UK to take note and act?

In a surprising move, the World Health Organisation has come out in support of Pre-Exposure Prophylaxis (PrEP), recommending Men who have Sex with Men (MSM) to consider its use for HIV prevention alongside the use of condoms. It will be a huge challenge for countries where resources are limited and where delivering drugs for treatment is already a challenge, but what does it mean for countries like the United Kingdom with its world class National Health Services and an epidemic characterised by half of new HIV infections diagnosed amongst gay men and where PrEP, despite proven efficacy, remains unavailable?

The problem with PrEP is not that we don’t if it works – it does, with a 42% risk reduction when compared to a placebo in trial with MSM and potentially more than a 90% risk reduction when taken strictly as indicated. It is not that we don’t know if PrEP is cost-effective – mathematical modelling as shown that for each case of HIV infection averted an estimated £280,000 – £360,000 in lifetime cost-treatment could be saved. It is not that we don’t know if PrEP has side effects or an impact on sexual behaviour – several studies have provided data on safety (it is safe) and behaviour change (no changes noted so far in trial) and drugs used of PrEP have been used successfully and safely for treatment for many years.

The problem is that the health commissioners have to be convinced that it is worth spending money providing PrEP on the NHS (In 2013 the cost of daily Truvada was £418.50 per month, not including care). And convincing the commissioners seems to rest on the results of the PROUD Trial.

PHE reaction to WHO on PrEP

So what is the PROUD trial and when will its results be available?

The PROUD trial comprises a pilot study which involved recruiting 500 gay men and other men who have sex with men in the UK to assess the feasibility of conducting a larger clinical trial of PrEP in the UK. The PROUD feasibility which is the one currently much talked about has completed enrolment in March 2014. Its results will be known late in 2015.

In the meantime, funding is being sought for conducting the much larger PROUD trial which aim to enrol 2,300 participants and would dovetail with the feasibility study running from January 2015 to end of June 2018.

Whilst the PROUD feasibility study will provide some information about PrEP effectiveness and cost effectiveness these are not its primary measure of outcomes. What the PROUD feasibility study will be looking at is the time it took to recruit 500 participants and the retention of participants in the study at 12 and 24 months. These will inform the design and conduct of the larger PROUD trial. Other secondary outcomes will also be measured (e.g. safety, STI, adherence, behaviour changes) but only the large PROUD trial will be able to assess willingness of gay men at risk to take PrEP, adherence to daily pill regimen, impact on sexual behaviour and efficacy in a high risk group on a scale required to draw meaningful conclusions.

But results will not be available until 2019 at best and that is if the study gets funded.

PrEP for HIV has been evaluated and continue to be evaluated in more than 10 studies which will have involved more than 10,000 participants, providing a wealth of data and information. Can we wait 5 more years before deciding if gay men should be given access to PrEP in the UK? Soon it will already be 5 years since the results of the seminal iPrEX trial have been published and here we are, waiting for the results of an hypothetical trial conducted just for the UK.

Meanwhile, the world, and the UK is moving and not necessarily in the good direction. For the past 5 years a debate has been raging in the US (where PrEP is available since 2012) between those who support its use for HIV prevention (162 organisations signed a statement in support of PrEP) and those who opposed it, the Don-Quixotic AHF. The debate though initially welcomed and valuable has nevertheless become a parody, with PrEP opponents failing to move on with the tide of scientific data supporting the intervention (see the most recent iteration in the New York Times).

Unfortunately, this debate has not taken place in the UK where PrEP has been kept under the curtain until recently. And while we did not talk about it, people, potential users who could benefit from it, started to forge their mind about it without much knowledge of it, as illustrated by some of the comments to the WHO announcement when reported on Pink News. These are not exception.

Reaction to WHO PrEP

There is a real risk that PrEP if ever available could suffer the same fate as Post Exposure Prophylaxis (limited public awareness, poor compliance). Have lessons been learned? Are lessons being ignored?

Bold policies can deliver bold resultssaid Dr Rachel Baggaley, from WHO’s HIV Department.

The WHO noted that “Failure to provide adequate HIV services for key groups – men who have sex with men, people in prison, people who inject drugs, sex workers and transgender people – threatens global progress on the HIV response, warns WHO.

The Melbourne Declaration calls for making HIV pre-exposure prophylaxis available and to “establish demonstration projects that provide access to HIV pre-exposure prophylaxis to people at high risk of HIV infection” (Action Area 3).

In the US, the Public Health Service released the first comprehensive clinical practice guidelines for PrEP in May 2014 and the New York State Governor Andrew Cuomo has made PrEP a key part of his anti-HIV Strategy.

AIDES, the leading French HIV/AIDS organisation has called for immediate and effective access to PrEP based on the daily use of Truvada, a call supported by a group of French HIV Experts.

In the UK, we are PROUDLY waiting

A participant waves a Union flag during the annual Pride London parade

And while we wait, the HIV epidemic remains unabated among gay men in the UK with more than 2,500 new diagnosed infections year on year since 2001 despite increased testing and increased uptake of treatment. Gay men are denied an opportunity that if provided in a controlled environment and through clever implementation programmes, would protect some of them from becoming infected with HIV.

~rjt

This content is published under the Attribution-Noncommercial-No Derivative Works 3.0 Unported license.

 

Is a Pill Enough to Fight HIV?

The New York Times started a debate on Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV infection by asking five prominent researchers and HIV advocates to discuss whether promoting the use of antiviral drugs was a good public health strategy, or if it will encourage more to have unprotected sex.

Beside being over-simplistic, the framing of the question sets the tone, direction and probably outcome of the debate. The question could have been whether PrEP will reduce the number of new HIV infections but instead it sets the intervention against a backdrop of moral and behavioural choices, that of good, responsible worth to be encouraged and supported pubic health interventions (read condoms), versus encouraging bad, irresponsible, reprehensible unprotected sex. Can the two really be part of the same question?

Unsurprisingly, AHF Michael Weinstein, a fierce opponent of PrEP from the start – when little was known about it, embarked on a diatribe based on incorrect facts, stating that PrEP “has failed to protect the majority of men in every clinical trial”. A statement that is both incorrect since the Partners PrEP study showed an 84% efficacy of Truvada among men (P<0.001, not different from that in women) and the CDC Botswana study an 80% efficacy in men (P=0.03); but also a statement that does not make much sense, as it suggests that more than half of the men participating in clinical studies would have been infected during their course (there was 7 infections recorded among 662 male participants in the Partners PrEP study for example).

Whatever the scientific evidences, or that he clearly does not understand research, or that evidence in support of PrEP’s efficacy has been growing since he took a stand, Weinstein prefers to misrepresent and disregard science and PrEP for HIV prevention in favour of the promotion of good old condoms, which “remains the best strategy we have to protect our community” as ongoing rates of new HIV infections demonstrate and which people and particularly young one care to hear about as much as “listening to their elders talk about the “bad old days” resonates about as well as our parents talking about how poor they were during the Great Depression.

Larry Kramer, who also opposes PrEP, prefers not to deal with the issue of sex, which is a bit odd when discussing the prevention of a sexually transmitted infection. He  instead prefers to focus its attention on the long term side effects of the drugs used for PrEP. Though these are real, are they as bad as Kramer says they are? Better ask this question to the thousands of HIV positive people taking Truvada daily or read the reports coming out of clinical studies. But again, who needs evidence when personal anecdotes can fill the gaps.

Both Weinstein and Kramer are out of touch with reality, ignoring evidences, twisting facts and misrepresenting the proposed used of PrEP (which is not for life for instance). It is even questionable that they are aware of who are the current users of PrEP in the US, women.

Thankfully others are focusing their contributions on more burning and relevant issues. Looking forward rather than backward.

Renato Barucco, a public health and LGBT health advocate, acknowledges that “Truvada is not a realistic option for many people at risk, including teenagers and young adults” but accepts that PrEP works, and that “Any prevention tool that limits the spread of H.I.V. in communities at risk has intrinsic value”.

Being aware and acknowledging the limitations of PrEP is key to its successful implementation. In particular that individual adherence is critical to its effectiveness and keeping in mind that scientific and clinical studies have shown time and again that “the protective effect of daily PrEP may exceed 90 percent when used consistently” as Ken Mayer wrote. It will be by pointing at the weaknesses and addressing them that we will build strong and successful prevention programme.

Debating PrEP versus condom is missing the point completely, as PrEP is not for those who use condoms, but for those who do not use them. And what if those who use condoms stop using them because they prefer or want to use PrEP instead? Well, as a number of studies are showing, when taken consistently PrEP works, it works as well as condoms when used consistently (and remember that there are no clinical trial of condom’s effectiveness!)

In a debate with dinosaurs, I find it is interesting to look at the language used by PrEP opponents versus that used by PrEP supporters. The two Wordle below were built using Weinstein and Kramer’s text and then Barucco, Ackworth and Mayer’s text. Two small pictures are worth a thousand words.

What Kramer and Weinstein say about PrEP

PrEP Opponents say

What Mayer, Barucco and Ackworth say about PrEP

PrEP Supporters say

~rjt

 

This content is published under the Attribution-Noncommercial-No Derivative Works 3.0 Unported license.

 

Clinical Research: I am HIV positive and very much healthy, thank you.

The participation and contribution of healthy human volunteers in clinical research is key to the successful development of new approaches to HIV prevention. But what is a “healthy volunteer”?

The successful development of a HIV vaccine or of a New HIV Prevention Technology (NPT, such as microbicides, or Pre-Exposure Prophylaxis) as well as behavioural interventions rely on volunteers’ willingness to participate in research studies, giving and committing their time, and sometimes putting themselves at risk, for their benefit but also for that of others.

Early stage HIV vaccine research is one of the areas of clinical research where the immediate benefits from participating in a study is far to be obvious. Indeed, Phase I vaccine research is mostly concerned with the safety of new vaccine candidates and their ability to trigger an immune response, rather than with their effectiveness. Human participation in this type of research is one of the most altruistic, as ethical guidelines proscribe remunerating volunteers who engage in research for more than the time they give and discomfort they may experience during the course of the research.

These early phase studies typically recruit “healthy volunteers” into trials that are often long and demanding and with outcomes and benefits that may not materialise before many years. Recruitment is then an ongoing challenge which is more demanding than recruiting volunteers for research conducted with people affected with a disease, more accessible through care and for whom there may be a more direct and immediate benefit if the research is successful.

There are currently a number of early phase HIV prevention studies recruiting in the UK (especially in London) which are struggling to recruit “healthy volunteers”. Many organisations have realised that Social Media offer an opportunity to publicise clinical research and to extend recruitment beyond the traditional spheres of hospital staff and students. But the use of Social Media is still in its infancy and an uncharted territory for many and whilst sites likes Twitter and Facebook may facilitate the engagement with the public, they can also highlight the divide between research and the public.

Not so long ago, a tweet from Help Make History, a website set up to build a network of volunteers who would, in principle, be willing to participate in HIV prevention trials triggered a public response that led to some interesting and challenging discussions.

Healthy Volunteers

Are you unhealthy if you are HIV positive? Or is clinical language further obstructing social and prevention interventions that strive to convey the message that being infected with HIV is no longer a death sentence or associated with being unhealthy?

Healthy?

The Royal College of Physicians defines a healthy volunteer as an “individual who is not known to suffer of any significant illness relevant to the proposed study, who should be within the ordinary range of body measurements, such as weight, and whose mental state is such that he is able to understand and give valid consent to the study”. It is accepted that a healthy person who agrees to participate in a clinical trial is doing so for non-medical reasons and will receive no direct health benefit from participating.

But the definition of being healthy is open to debate and depends on the study conducted. Different clinical studies have different selection criteria (called inclusion and exclusion criteria) even if seeking “healthy volunteers”.

In the case of an HIV preventative vaccine, a key element of the definition of  healthy(for the time being) is that the volunteer is HIV negative, but does not stop there. For example, one of the study currently seeking healthy participants requires individuals to have a Body Mass Index (BMI) between 19-28, to be at low risk of HIV infection, and is excluding pregnant women, people who had tanning sessions or excessive terminal hair growth, along the usual criteria supporting physiological body functions and mental capacity.

Accordingly, the clinically obese, sexually active gay men, those back from holiday under the sun and hairy people would not be eligible. As esoteric as these criteria may seem, there is a rational for each of them and there is no particular emphasis on being HIV negative, though it is a fundamental exclusion criteria.

However, despite good intentions, the use of “healthy” may fuel the myth that being HIV-positive means being unhealthy and may contribute to the stigma associated with living with HIV. Paul Clift, well-known and respected HIV/Health activist who reacted to the tweet kindly agreed to answer a few questions on the subject.

Incidence0: What triggered your reaction to the Help Make History website tweet seeking “healthy volunteers” for a HIV Vaccine Clinical Trial?Paul: I saw a Facebook message from a friend showing screenshots of a Twitter conversation outlining the issue, in which the term ‘healthy’ was being used to mean – or at least, to imply – HIV-negative. I objected to this because the term ‘healthy’ is used in this sense in wider social settings such as Grindr and helps to create and perpetuate a climate of opinion that HIV is somehow outside the bounds of ‘healthy’ and this in turn feeds into a discourse centred on purity/impurity.

Clinical study needs to have stringent inclusions and exclusions criteria. There is a rational for this and it is not possible to list all criteria in an advert (especially on twitter). Do you perceive the choice of “healthy” as unnecessary discriminating or stigmatizing?

All that an advert needs to say is that there are exclusion criteria and that these will be listed and explained on enquiry.

Do you think that if the tweet had mentioned other exclusion criteria (such as not being obese or hairy) you would have reacted to it?

Probably. Because a Tweet is so limited – 140 characters – I don’t think there’s a need to list specific exclusions at the Tweet stage beyond saying that some criteria or conditions apply.

Do think that for the public at large, being HIV positive means being unhealthy?

Undoubtedly. In fact, when I am brought in to support people who are newly diagnosed with HIV it is not uncommon to find that the first challenge is their belief that HIV is something worse than unhealthy, that it is a product of being ‘personally dirty’ and that the diagnosis is therefore one of contamination. The stigma and self-stigma flowing from this set of beliefs around purity/impurity as well as misperceptions about life expectancies can be considerable and extremely hard to overcome. This does not apply only to ‘the public’ by the way, but to some healthcare workers (nurses, doctors) as well.

This is a delicate question for me to ask because I understand very well your reaction. However, some people may think you are overreacting or being PC. What would your response be to that perception?

Depending on the person and on the situation, I might tell the person to f*** off or I might take a deep breath before going into an explanation (for what always feels the umpteenth time!). I guess the problem here is that the – any – social mainstream tends not to reflect on itself and on the way that it dominates society and societal values, and fails therefore to understand that individuals and groups outside the mainstream have always to explain (in order to claim) their social legitimacy; this includes challenging the unthinking use of value-laden vocabulary.

You studied Medical Anthropology, does this change or affect how you view clinical research?

Sort of. I already saw clinical research as necessary but also compromised by various factors. These include the ongoing under-inclusion of women and racial/ethnic minorities, and the sometimes questionable motives of Pharma companies more interested in promoting a product than in scrutinising the efficacy of a chemical compound.

Do you think the way the Tweet or the printed advert (if you saw it) was worded is symptomatic of not enough engagement of the research community with the public?

Yes, up to a point. Thing is, with HIV specifically there is a preference from People Leaving With HIV for the term ‘positive’ and rejection of the term ‘infected’ precisely because of the negative connotations of the latter. This has been taken on board by BHIVA to a significant degree, which is why BHIVA Standards and Guidelines often use the term ‘positive’ where they possibly can rather than ‘infected’ throughout. I would therefore expect something more human/less clinical whenever HIV research is being discussed. The research community with which I deal from time to time (i.e. as member of Steering Committee or some other advisory position) tends to be more or less up to speed on this, or receptive to comment from public/patients.

What would you have like the tweet or advert to say?

Something along the lines of: We are currently enrolling people into a study into [subject]. If you are interested please contact us to how you might take part…. Or something like that.

In that regards, and as noted by Paul, recruiting and selecting volunteers would benefit from being entirely separate processes. This would help creating comprehensive registers of volunteers that could participate to different studies.

It is worth noting that to ensure that all advertising materials and methods used to recruit human subjects are appropriate, organisations conducting clinical studies need to submit these to an ethics review committee and obtain its approvals. This does not yet extend to how social media such as Twitter and Facebook are used as recruitment tool, though their proposed use should be stated and approved when applying to ethics review committees. However there is no need to do so with a bit of common sense; the same principles should apply to Twitter and Facebook as would apply to a printed advertisement.

Words Matter – ask the Public

Language is not neutral but laden with preconceived ideas and associated meanings. Exclusion and inclusion criteria can be perceived as arbitrary and enrollment in clinical studies is known to be biased (for example often excluding women ). Though there may be an immediate or practical rational for making such choices and formulating them in a particular way fitting a particular study and communication medium, it is not always in the best interest of the research.

Raising awareness that words have negative connotations, even amongst those familiar with HIV research, is not being overly sensitive but is contributing to a global effort to get rid of inappropriate use of language. It is not about political correctness or about banning the use of words which meaning is ever-changing, but about nurturing mindfulness that some words may better not be used in particular contexts. This is where engaging with the public in the design of advertisement campaign could prove useful.

It is nowadays accepted that research would progress much faster if the public is involved from an early stage. This is why Patient and Public Involvement (PPI) is becoming an integral component of research, one encouraged by the National Institute for Health Research (NIHR). Public involvement in research can be defined as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. This includes, for example, working with researchers to plan studies, offering advice as members of a project steering group, commenting on and developing research and communication materials.

The emergence of new social technologies is affecting the interaction between researchers and the Public (See for example crowd-funded research and its recent use to raise fund for a HIV vaccine) and offers an opportunity and an instrument – though not a solution, to redefine and foster this relationship and to make it a better two-way process.

And because it is a two-way process it does not have to start from the Research side but can very well start from the Public side. So, where to start? Why not by participating in an HIV vaccine study? Just check the Help Make History Website, find out if you are eligible for a study and get involved with the researchers.

~rjt

Further reading:G. Pasqualetti, et al. Healthy volunteers and early phases of clinical experimentation. European Journal of Clinical Pharmacology 66, 7 (2010) 647-653.

NIHR. Involving users in the research Process. A”how to” guide for researchers.

AVAC. Stakeholder Engagement Toolkit for HIV Prevention Trials.

 

This content is published under the Attribution-Noncommercial-No Derivative Works 3.0 Unported license.

 

HIV testing: Home Sampling vs. Home Testing, a primer for users (and others)

Home testing and home sampling are not one and the same and it is important for potential users  and their providers to understand the key differences between the two.

HIV home testing is coming. Not right now, because none of the non-clinical commercial testing kits currently available are approved in the UK 1. However, “home testing” is already broadly advertised, though it is not currently home testing but home sampling 2. Both aim at detecting HIV infections but they differ on a number of points.

  • Home sampling requires the individual to collect and send a sample of blood or saliva to a laboratory for analysis. Sampling has been legal for a number of years and can be a successful approach. Testing is performed by qualified laboratory personal, in a controlled and monitored environment.
  • Home testing requires the individual to perform the test themselves and to read and interpret their own results. As of April 6, HIV home testing is legal. The approach has not been tested thoroughly in the UK and there is little data about its potential uptake and benefits 3.

This primer explores key differences between HIV home sampling and HIV home testing and put them in perspective with HIV testing in clinical or community settings. It will also offer a perspective to HIV testing for potential users, with a focus on gay men undecided about what options to go for when home testing will be available.

Three key factors should be taken into consideration when deciding to go for a HIV test: Accessibility, reliability and support. The table below compares these features and more for the three type of testing soon available.

Affordability should also be taken into consideration. Remember that HIV testing is free in the NHS and price as hefty as £300 have been seen for the very same test being performed in private settings. These are excluded from the table below (click to enlarge or download as PDF)

HIV Testing v5

A point of view on HIV testing

wanderer-above-a-sea-of-fogThe decision to take a HIV test is not always an easy one, but not necessarily a difficult or thorny one. It is often motivated by an interest in one’s personal health or because people believe they have been exposed to a risk of infection. Once the decision to go for HIV testing is taken, it is important to consider the options available and to be confident with the settings, technology and process of going through testing.

More than 900,000 HIV tests were performed in the UK in 2012, a number growing year-on-year. The very large majority of HIV testing is performed in clinical settings in particular in genitourinary medicine (GUM) clinics where it is highly acceptable (85% acceptability recorded). GUM clinics offer an environment which aim to provide safety, reliability and accurate testing and to maximise linkage to care for those who test positive. It is also an opportunity to provide further information to those who test negative to stay negative, and to perform testing for other sexually transmitted infections and more.

If you do not have any problem with visiting a GUM clinic and assuming one is easily accessible to you, then this is where you can get the best service available and for free. Alternatively, consider home sampling.

If for whatever reason you decide to opt for home testing, then consider carefully the following (adapted from the MHRA website)

When thinking about self-testing…

You can get free access to high quality tests through GUM clinics across the country. In London, 1 in 4 gay men test in a single GUM clinic, confirming the popularity of testing in clinical settings. Though still not enough, HIV testing is high amongst gay men and testing is a critical point of entry into care, which saves life. An HIV specialist or your GP can help you make decisions about testing and help you access further treatment or advice.

A negative home testing results can rarely completely exclude a HIV infection and may not be as helpful as a visit to a GUM clinic which will include further testing for other sexually transmitted infections.

Think about the possible results of the test and what you are going to do when you have the result – whether it is positive or negative.

If you decide to self-test, you should still follow-up with conventional testing to confirm the results and discuss your options if positive.

Before buying an HIV self-testing kit…

  • Whether buying from the high street or online, only buy a test from a source that you trust.
  • If possible ask a healthcare professional e.g. a pharmacist, practice nurse, GP to help you select the best test for you.
  • Do not buy or use the test if it looks damaged or the seals are broken.
  • Make sure the test has a CE mark. A CE mark means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.
  • But remember – a CE Mark alone is no guarantee that a home test will be suitable for your needs.
  • No test is 100% reliable.

Before using a HIV self-test…

  • Be sure that the kit contains everything you need and make sure you have everything else you need.
  • Don’t rush.
  • You don’t have to test on your own if you are worrying about the outcome.

Read the instructions carefully:

  • Make sure you perform the test according to the instructions.
  • Make sure you know how the test should be stored if you don’t use it immediately.
  • Make sure you know how to read the test result.
  • Make sure you know what the results mean.
  • Make sure you know how to dispose of the test after use, especially if you are concerned with privacy issues.
  • Know who to consult for help if you need it when you know the result.

After using the test…

  • Don’t rush (yes, again)
  • Remember that no test kit is 100% reliable or accurate.
  • Regardless of the result, you will need to seek confirmation of the result by attending a clinical service and have a confirmatory test performed by a laboratory.
  • A negative result is not a license for unprotected sex.

Crunch time

More gay men need to test for HIV and they also need to test more regularly and more often. The decision is yours but once you have made it most of the hard work is done. There is a lot of support available out ether and you won’t be alone.

Useful links

Non exhaustive list of services offering free sampling kits

If you have suggestions to improve this article please get in touch.

~rjt

Update
07 apr 14: revised table (v2 & v3). Thanks to Roger Peabody for important feedback.
07 apr 14: revised table (v4 & v5) with added information.

Notes:The lack of preparedness of both Department of Health and NGOs working in the field of HIV prevention resulted in HIV home testing being legal before being available. Medical tests are subject to an EU Directive called the In Vitro Diagnostic Medical Devices Directive. Self-test kits cannot be sold within the UK or the EU unless they have been CE but there is little indication that the MHRA is prepared to approve a test very quickly.Regrettably, NGOs are conflating Home Sampling and Home Testing, a decision which will most certainly lead to confusion amongst users.Early in April 2014, Public Health England finally produced a guidance document on HIV Testing and Self-Testing – Answers to frequently asked questions.

This content is published under the Attribution-Noncommercial-No Derivative Works 3.0 Unported license.

 

The PARTNER study, a licence to bareback?

Absence of evidence is not evidence of absence. Does the PARTNER study signal the death of condoms or should we curb our enthusiasm, and carry on pretending we use them?

Partners Study Results

The preliminary results of the PARTNER study were one of the most talked about data presented at the CROI 2014 conference held in Boston this year. This multicentre study conducted across 75 centres in the EU was and still is looking at the risks of HIV transmission within couples where one partner is HIV-negative and the other is HIV-positive on treatment.

So far, the study has enrolled over 1,100 couples and based on an interim analysis including 16,400 occasions of sex in gay men and 28,000 in heterosexuals couple, no case of HIV transmission has been observed between an HIV positive person with a viral load below 200 copies/ml and their HIV negative partner (Read the Aidsmap report for more details and watch a video about the study).

Does this mean that gay men can finally ditch condoms with their HIV positive sexual partners on treatment? Well, it is not that simple.

We need to acknowledge that the results of the PARTNER study are preliminary but also that they are another stepping stone in a series of studies demonstrating that antiretroviral treatment can reduce the risk of HIV transmission, otherwise known as Treatment as/for Prevention (TasP). Before PARTNER, the HPTN 052 study conducted among heterosexual couples in Sub-Saharan Africa had already shown a 96% reduction in the risk of transmission. Other studies in KwaZulu Natal and Malawi have also showed reduced risk of HIV transmission even with limited treatment coverage. Further back in time, the 2008 Swiss Statement had already indicated that within specific circumstances, HIV infected individual could be considered as not infectious.

As always, it takes time for scientific results to diffuse from the scientific community to the public, and when it does, one can be sure it will trigger all kind of debates and arguments more than often entrenched in beliefs and prejudices than facts.

One of the key facts in the PARTNER study is that being on treatment is not good enough to prevent HIV transmission. Viral load of the HIV infected must be below 200 copies/ml, and the statistical analysis leading to the much publicised conclusion actually specifically excluded people with a viral load above 200 copies/ml, as were couples in which HIV-negative partners took PEP or PrEP or couples in which people did not attend follow-up visits. It also showed that infections could happen and often be attributable to sexual encounters outside an established relationship.

Nevertheless, taken together, existing study results support a conclusion that the Swiss Statement suggested 5 years ago. So what to make of it?

Whilst most of the community welcomed the news for its potential to affect the course of the epidemic, other have adopted a more prudent and critical approach. Kristian Johns, writing for GMFA is one of those for whom being on treatment for HIV is not a licence to bareback (He is not alone and his column for FS is only used here as a case in point).

“Lads, lads, lads. Let’s just rein in our penises and hold fire on the condom-burning for a cotton-picking second. No transmissions doesn’t mean there’s a zero risk of transmitting HIV, it just means there were no transmissions. Granted, it’s encouraging, but only as encouraging as playing Russian Roulette with a loaded gun and getting away with your head intact after multiple tries. There’s still a bullet in the gun, my friends. ” write Johns in the issue 141 of FS magazine.

Kristian raised here the very valid point that no observed transmission does not mean no transmission at all and later that viral load must be controlled and that some people did become infected by people outside their relationship, finally adding that “until we have a cure for HIV, or at the very least, a vaccine, there is no ‘new negative’.”

There aren’t, but there are HIV positive people who are very closed to be “new negative” and some sexual intercourses much closer to no risk of transmission than anything else abstinence or condom can offer. Data from clinical trials not only prove it but epidemiological records also confirm it.

What optimism and its counter-reaction (much less publicised and Kristian Johns can be praised for voicing his concerns, as should GMFA for printing them) indicate, is that facts and all the facts needs and must be explained because gay men can decide, based on an informed choice (which is something I believe FS stands for) to ditch or not condoms or to no longer feel guilty for not using condoms with some of their partners (and why not, start to enjoy sex again).

The reality is that, as individual, with a minimum of educational intent and effort, we can take control of our sexual life, and relax those clenched cheeks that make us looks like an uptight condom brigade Janissary.

If condoms work for you then carry on with using them, but as fellow writer Gus Cairns wrote “[the PARTNER study] confirms that we gay men have to change our ideas about infectiousness and HIV radically if we are to stand a chance of reducing HIV infection in our community.”

The message of the PARTNER study is not to ditch condoms but to change our understanding and beliefs about our risk of getting infected by HIV. Whilst serosorting, seropositioning and negotiated safety have failed to show real effectiveness, whilst PrEP is not available in the UK, whilst PEP is underused, whilst condom use is on the decline, treatment as/for prevention has shown a string of successes in reducing HIV transmission.

What the PARTNER study should forces us to do is to rethink our relationship with HIV status; it should forces us to question our preferences for sexual partners with an alleged or declared HIV negative status and our discriminatory attitude toward those HIV positive (until we become one of them).

What PARTNER, HPTN 052 and other treatment as/for prevention studies should do is not to lead us to react against the possibility of an HIV-free generation but to revisit our HIV prevention messages and beyond our HIV prevention strategies.

What the PARTNER study should not do is to throw us back into dualist and outdated debates about HIV prevention.

Institutionalised HIV prevention tends to be monolithic, and why bother with it if “Bareback feels good and there’s no amount of health promotion that’s going to convince penis-owners of anything else”, as wrote Kristian. That statement is in need of qualification. True, most people, whether they are gay or not, whether it is about HIV or not, will remain impervious to prevention messages of all sorts as long as they do not feel they are at risk. Look at 48-year-old Rachel Dilley, who recalls finding out she was HIV positive and never thought she could be at risk because she believed HIV only affected Black people in Africa.

For organisations involved in messaging prevention it is also a strong signal that they should get up to date with  the science, that they should be wary of engaging in partisan debate, that they should built on evidence, engage with the research at much earlier stage of development and work hard(er) to make complex information intelligible facts.

There is no doubt that HIV transmission could occur from those on treatment with a perfect, undetectable viral load, even if we have not seen it yet. But an upfront dismissal of is neither justified nor justifiable. It only shows an inability to move along with clinical developments. It deprives men, particularly those who do not use condoms, of a prevention choice that could protect them from becoming infected, as long as they understand the limitations of treatment as/for prevention. It stigmatises HIV positive gay men who do not need to be reminded that they still have HIV as the pill(s) they take everyday does that for them.

Treatment for prevention is not a magic bullet. Until there is a HIV vaccine, there is no magic bullet, not even in that gun that some use to play “Russian Roulette” with; but there are guns that jam and TasP is the first prevention intervention to actually jam that gun.

~rjt

Edit 30/03: clarifications and (some) typos.

This content is published under the Attribution-Noncommercial-No Derivative Works 3.0 Unported license.

 
 

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