From The Associated Press via CTV News 

WASHINGTON —  U.S. drug regulators on Tuesday affirmed landmark study results showing that a popular HIV-fighting pill can also help healthy people avoid contracting the virus that causes AIDS in the first place. While the pill appears safe and effective for prevention, scientists stressed that it only works when taken on a daily basis.

The Food and Drug Administration will hold a meeting Thursday to discuss whether Truvada should be approved for people who are at risks of contracting HIV through sexual intercourse. The agency's positive review posted Tuesday suggests the daily pill will become the first drug approved to prevent HIV infection in high-risk patients.

FDA reviewers conclude that taking Truvada pre-emptively could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment."

Despite the positive results, reviewers said that patients must be diligent about taking the pill every day. Adherence to the medication was less than perfect in clinical trials, and reviewers said that patients in the real world may forget to take their medication even more than those in clinical studies.

First announced in 2010, Truvada's preventive ability was hailed as a breakthrough in the 30-year campaign against the AIDS epidemic. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 per cent, when accompanied by condoms and counselling. Another study found that Truvada reduced infection by 75 per cent in heterosexual couples in which one partner was HIV infected and the other was not.The FDA's panel of advisers will take separate votes on whether Truvada should be approved for:

• gay and bisexual men
• men or women in relationships with HIV-positive partners
• other people at risk of acquiring HIV through sexual activity

The FDA is not required to follow the advice of its panels, though it usually does.

An estimated 1.2 million Americans have HIV, which overwhelmingly affects men who have sex with other men, according to the Centers for Disease Control and Prevention. HIV attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off foreign infections.

Because Truvada is already on the market to manage HIV, some doctors currently prescribe it as a preventive measure. FDA approval would allow the U.S. drugmaker Gilead Sciences to formally market its drug for the new use.

But support for FDA approval is not unanimous. Some researchers stress that condoms remain the best weapon against AIDS, and a prevention pill is not the chemical equivalent.

"We know that if the person doesn't take the medication every day they will not be protected," said Dr. Rodney Wright, director of HIV programs at Montefiore Medical Center in New York. "So the concern is that there may not be adequate adherence to provide protection in the general population."

Wright, who is also chairman of the AIDS Health Foundation, added that some upcoming medications may be more effective at preventing infection than Truvada.

Researchers also worry about Truvada's mixed success rate in preventing infection among women. Last year a study in women was stopped early after researchers found that women taking the drug were more likely to become infected than those taking placebo. Researchers speculated that women may need a higher dose of the drug to prevent infection. They also said the disappointing results may have resulted from women not taking the pills consistently.

Still, many HIV patient advocacy groups say the drug should be a prescribing option to prevent HIV, alongside condoms, counselling and other measures.

"If we're going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people," said Ronald Johnson, vice-president of AIDS United. He added that more studies are needed to determine the drug's effectiveness in women and other patient subgroups.

"The current state of the data warrants going forward, but we believe additional clinical trials should also go forward to broaden the use of Truvada."

Last month, AIDS United and more than a dozen other advocacy groups sent a letter to the FDA, urging approval of Truvada.

California-based Gilead Sciences Inc. has marketed Truvada since 2004. The drug is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe the medications as part of a drug cocktail that makes it harder for the virus to reproduce. Patients with low viral levels are far less likely to develop AIDS. Side effects with Truvada include diarrhea, dizziness, nausea and vomiting. More serious problems can include liver toxicity, kidney problems and bone thinning. 

“Even if the rate of HIV infection among MSM remains at the current level, by the time a group of young MSM (18 years old) reach the age of 40, 41% of them will be HIV-positive. We cannot make any progress in fighting the HIV/AIDS epidemic in the U.S. unless we find ways to lower rates of HIV transmission among MSM.”

Positively Aware 

Ed pulls out a condom from his pocket and says to the crowd, “We’ve always had the answer all along. We couldn’t figure out how to use them.” As an international HIV/AIDS educator and one of five subjects of the award winning AIDS documentary, We Were Here. Ed Wolf reminds us that waving our finger at each other to use condoms never worked and never will. 

This is the second interview to inquire how the film impacted younger gay men.

Roy is 25, bright, reads Nietzsche and graphic novels and spends most of his time in the cyber-sphere from where he predicts a future he can get behind. He’s an artist saddled with a student loan he says he’ll never pay back from an arts program he never finished. After washing dishes in Toronto he’s moved to our place on a small west coast gulf island for several weeks to work in our quarter acre garden. On the surface the exchange was a few hours of daily labour for room and board. The inter-generational mentorship will last a lifetime.  For now he’s planning to live in a tent tucked away in the woods for the summer, read and make art. A reasonable choice considering how disconnected much of his cohort has become from the natural world. 

My husband and I are the first out poz men he’s got to know. He was only peripherally aware of the history of AIDS. From the beginning of our time together we have ruminated over the relationship between gay past and queer future. Today we talk about the documentary, chaos and condoms. 

Birch: Having seen the documentary on the SF history of AIDS what questions emerged for you? 

Roy: It was more of an exposition of what happened. No questions. It showed people reacting with their best from a crisis. I got to hear their stories of their triumph and suffering. I’m trying to relate it to now.  The audience was made up of people who care about the subject already - because they are emotionally attached, mostly people who had history with it. I came because I was told to come. I love stories and I love stories that paint people as human beings. It was about authentic stories. Later, I went to my friend’s house to tell him about how great the film was. We realized we have no contact with people who lived through it or are willing to talk about it. It is important for young men to see this film early on before being introduced to the disease-focused sex education in high school. It’s important to hear stories of the people who have HIV before you scare them about it.  

My friend said, “Maybe they shouldn’t all have had sex with each other.” I reminded him that it was a completely different time. The condom is taught in school because of what happened, and yet it creates such a naïve outlook (without the context of what happened). It has created an us vs. them rationality (especially in gay culture) because we are not exposed to people who are positive and their stories. It is no surprise then that there is so much prejudice within the gay community toward positive men, especially in younger generations. 

Birch: Do you think younger gay men blame positive men for having to wear a condom today themselves? 

Roy: No, lots of them just do it because we were taught to do so. It depends on your upbringing. Some of them go bareback, they see it in porn, or someone fucked them bareback. It depends on what version of sex ed. you got. Some of us were imprinted; as a teenager I heard ‘always put it on’…and now that I’m here (at 25) it is more to do with the guys I’ve been with…. 

Birch: How would you describe the sexual culture you have inherited as a younger gay man? 

Roy: Sex is more clinical. It’s not just about the condom anymore. Sex is very fearful now - in every regard. It is not about connection in the way it should be. Not on a level that makes people feel good. A temporary thrust, bam and quick see if the condom broke or not. Gasp. Fear. It is clinical. I look to porn to see where guys are having great sex. Mr. Steeds Bareback blog. He just talks about all his bareback connections. Maybe it’s all fiction. He’s a good writer. It’s entertaining. Maybe it’s not all fiction. It is fascinating. He makes it sound a lot more fun – a lot more connective. 

Birch: How do you relate to condoms?

Roy: The condom represents boring sex. Every sexual encounter that started off potentially great, the ones that felt more connected, always wanted to go bareback. Then I told them to put on a condom. I always have the fantasy to go there (raw sex), even drunk as a mess…so, sex ed. did a good job. But when I told them to wear a condom the sex always became more lacklustre, putting order on chaos. 

Birch: What is it about ‘chaos’ you desire? 

Roy: It’s more free. More connection. It’s not antiseptic. It’s sweating. It’s nasty. It is so scary to try. The ‘order’ is so…I have a condom on my subconscious, on my being. When the fear is so ingrained the bodies are manipulated into ‘over-thinking’ and then (by default) we end up masturbating on each other. I’ve only had mutual masturbation. I’ve never had bareback sex which I equate with real sex. Condom sex, at least the mentality that comes with it, is like two people masturbating – we’re so caught up in our heads. I’m talking about my fantasy world. I’m not going to say you can’t have great sex with a condom. 

The people who risk themselves will fuck you. There are not there to masturbate. It’s not just about condoms and bareback. Its what the whole thing represents. It’s all about order and chaos. Dionysus has always had a big hand up. You know what I’m saying, darling. The maenads fuck better than the congressmen - unless of course the congressmen are a little crazy. Never mind - congressmen are probably all fucking bareback. 

Birch: So how would you describe the culture of raw sex?

Roy: The whole thing represents more masculinity to go bareback. It just comes with that. The straight community never wears condoms. So you have to wrap yourself to go have sex? It feels cheated. Like we’re not having sex. Straight guys can fuck at the party. Being a gay man we are seen as disease carrying vessels. With a straight guy, it’s just a guy fucking. You have no condom-tations with it. Wrapping ourselves up as clinical specimens - it’s not sexy. AND we hear stories of the 70s where gay men were having sex: breakfast, lunch and supper, sex, sex, sex. How orgiastic. Then the pendulum swung back to order. Now we want to swing back, it’s just that natural swing of things and we want an orgy. We never had that. 

A topic that you might expect to enter into HIV education more frequently than it does is risk management. How do people make decisions around managing risk? It’s a topic that I know very little about, and I certainly hear very little about it in this field.

While we put a fair amount of effort towards understanding social and cultural nuances that affect sexual decision making, a part of me wonders if we could be drawing on the body of knowledge that exists around how people interpret and manage risks in their daily lives. This occurred to me today, during an early morning conversation about HIV transmission. I say “early morning” because, at quarter past 8, as I was taking the first few sips of my coffee, I found myself explaining to a friend, visiting from out of town, what particular sex acts are at higher risk for HIV transmission and why.  (Innocent questions about my job quickly transition into talking about vaginal lining or anal mucus… hence my previous post on how the job never ends).

 My friend asked an interesting question – do different at-risk groups pay more or less attention to the nuances of different levels of risk? Specifically, he wondered about sero-discordant couples. My response was that partners who make a decision to engage in a sero-discordant sexual relationship would likely be interested in learning about the different levels of risk; a more relevant issue is that many people tend to take a completely “hands-off” approach when it comes to risk management around HIV infection, attempting to avoid dealing with sexual risk completely.

I do, unfortunately, often encounter HIV negative people who seem to believe that having sex only with only HIV negative people is the best solution to protecting themselves from HIV. Of course this avoidance of risk is an illusion; they fail to recognize that they may be having sex with HIV positive people without knowing it (because not everybody knows their status, nor will they necessarily always disclose it) and this false impression may lead people to increase their level of risk by failing to use condoms, for example.

But this led me to a question. Why do people make such severe judgements about risk when it comes to sex and not when it comes to many other aspects of our lives?  Everyday many of us get in the car and drive to work, even though there is a significant risk that we get into a car accident.  In fact, the risk of an accident likely trumps the risk of acquiring HIV by unprotected sex. The number of car accidents per year far exceed HIV infections, yet people get into their cars every day, buckle their seatbelt as a matter of harm reduction, and go ahead with their day without thinking, calculating, or questioning these risks, let alone judging others who also put themselves at risk by being on the road.  But many of these HIV negative car drivers would not carry this same approach to sero-discordant sex, even though it could be argued that a car accident could potentially have worse consequences than HIV acquisition and that missing out on a great love or even great sex would be a tremendous loss.

So what are the psychological or sociological factors that make people behave so illogically when it comes to decisions around risk taking?  As we work to address stigma, disclosure, condom use and other issues, it may be information worth knowing.

This article by Roger Pebody first  appeared on aidsmap. 

The First Study

Pre-exposure prophylaxis (PrEP) would be an acceptable HIV prevention strategy for large numbers of gay, bisexual and other men who have sex with men in major UK cities, according to two studies presented to the British HIV Association (BHIVA) conference in Birmingham this week.

The conference also heard details of a small pilot PrEP study, likely to start recruiting later this year.

A cross-sectional survey of 842 HIV-negative gay and bisexual men, recruited at bars, clubs and saunas in London, suggested that half the respondents would be interested in taking PrEP.

Respondents were given information about pre-exposure prophylaxis and asked: “If PrEP were available, how likely is it that you would take a pill (oral dose) on a daily basis to prevent HIV infection?”.

Half said yes, with 16% saying they were likely to take PrEP and 34% saying they were very likely to. Men interested in PrEP were slightly more likely to be under the age of 35 (AOR adjusted odds ratio 1.58), have attended a sexual health clinic in the past year (AOR 1.59) and to have previously taken post-exposure prophylaxis (PEP) (AOR 1.96). After statistical adjustment, various measures of risky sex were no longer associated with interest in PrEP.

In this survey, 17 men (2.1% of those answering the question) said that they had previously taken antiretroviral drugs to reduce their risk of HIV infection.

Secondly, clinicians at the Manchester Centre for Sexual Health surveyed HIV-negative men attending their service who reported unprotected receptive anal intercourse. Of the 121 men who responded, 36% said they would be “very willing” to take PrEP while only 14% said they would not take the treatment. Daily dosing was perceived as a better option by four fifths of respondents – just one fifth would prefer taking a dose before sexual activity.

These data confirm and reinforce findings from a study reported in November 2011, which found that half the gay men surveyed would consider taking PrEP. Once again, daily dosing was preferred to taking a dose before sex. In the qualitative data, men commented that sex is often spontaneous and that they felt daily dosing would facilitate adherence.

However these data are all based on giving men a few key facts about PrEP and presenting it as a hypothetical option. In real-life circumstances, where men think more seriously about PrEP as an option and hear friends’ experience of taking it, actual uptake and sustainability may be very different.

While the Manchester respondents largely assured the researchers that they would take all their doses of PrEP and wouldn’t have more risky sex, real-life experience needs to be tested in research.

To this end, the Medical Research Council are seeking funding for a 5000-participant, two-year study which would randomise HIV-negative gay men who report unprotected anal intercourse to either take PrEP (Truvada) and attend motivational interviewing (intervention group) or to be put on a one-year waiting list for PrEP and to have motivational interviewing in the meantime (control group).

For the researchers, it is crucial that this is an open label but randomised study, in which participants know whether they are receiving the actual drug. This unusual research design would, they argue, tell us more about the real-world effectiveness of PrEP than a blinded study as it would take into account the possible impact of participants taking more sexual risks because they felt that PrEP afforded some protection. (Researchers call this ‘risk compensation’ or ‘behavioural disinhibition’).

Rather than test efficacy in artificial conditions, the study would therefore test effectiveness in more realistic UK conditions.

So far, however, the potential funders of this costly study have not been persuaded by this argument and it is unclear whether the study will be able to go ahead.

What will, however, start recruiting later this year is a pilot version of the same study, aiming to include 500 men who attend one of around twelve sexual health clinics.

As well as allowing the researchers to have a dry run of the main trial and identify teething problems with its strategy, it should also provide valuable information on the number of men who actually follow through on a clinician’s offer of PrEP. Data on the characteristics of men who seek PrEP, drop-out rates and risk compensation will also be collected.

The researchers intend to take some of these data back to the main study’s potential funders, in order to support a revised application.

Acceptability of taking HIV treatment for prevention purposes

As well as asking people hypothetical questions about PrEP, researchers have also been asking people waiting for an HIV test result hypothetical questions about treatment as prevention.

Individuals from high-risk groups attending the Jefferiss Wing at St Mary’s Hospital for HIV testing were given an explanatory paragraph about treatment, infectiousness and safer sex. They were then asked: “If you were diagnosed with HIV would you consider taking treatment to reduce the risk of passing on infection (even if you did not need to take treatment for your own health)?”.

Four out of five respondents said ‘yes’. Encouragingly, gay men who reported unprotected anal intercourse in the past three months were more likely than others to be interested in the idea. Less encouragingly, people who had had a sexually transmitted infection or who had previously taken PEP were slightly less likely to say that they would take treatment for prevention.

The researchers suggested that the latter factor may be associated with PEP users’ experience of side-effects. It contrasts with the findings of the London PrEP attitudes study described above which found people who had previously taken PEP more likely to be interested in PrEP.

References

Aghaizu A et al. Who would use PrEP? Predictors of use among MSM in London. 18th Annual Conference of the British HIV Association, Birmingham, abstract O23, 2012. See abstract here.  

Thng C et al. Acceptability of HIV pre-exposure prophylaxis (PrEP) and associated risk compensation in men who have sex with men (MSM) accessing GU services. 18th Annual Conference of the British HIV Association, Birmingham, abstract P233, 2012. See abstract here.

Jones C et al. Treatment as prevention: the views of high risk patients attending an outpatient GUM clinic. 18th Annual Conference of the British HIV Association, Birmingham, abstract P234, 2012. See abstract here.

This article is copyright © NAM Publications, 2012. All rights reserved

There has been a flurry of articles recently with headlines like “Undetectable Viral Load? Not Necessarily in Semen” like this one in POZ.  Discovery of this connection isn’t the least bit new, of course, but what’s drawn attention is new research from Boston which furthers our understanding of the associated risk a little more. More on what that research says in a moment.

The headlines may sound alarming for those who thought, because they’d reached undetectable, they were much less infectious because of low levels of virus in their blood. But if there is in fact virus in the semen, are we back to square one, the walking time bombs we’ve always been? Certainly the headlines seem to imply that. And certainly the headlines seem to reinforce the message for poz guys everywhere “wear a condom, whatever your viral load”.  But do the headlines reveal the full picture?

It’s clear we’ve made good progress towards quantifying what IS the risk of virus in the semen, and in the associated risk of HIV transmission. Today I want to look at what we’ve learned and what are the implications for people living with HIV.

Semen – the traditional view

The virus in the blood vs. virus in the semen debate is a complicated and technical one. As a result, there has been a tendency for prevention experts to try and make things simple for us. Here’s how CATIE, for example, answers the question “If my viral load is undetectable, can I still pass HIV to others?”  

“Yes. While HIV may not be detectable in the blood, there might still be enough to infect someone. Also, there may be higher levels of HIV in semen or vaginal secretions. So, even if you have an undetectable viral load, you might still infect someone if you share needles or have unprotected sex.”

There is nothing here that isn’t absolutely correct.  But the answer doesn’t help quantify the risk for us – and quantifying risk, or trying to, is exactly what informed decisions are built on. In this particular case, we need to know what science tells us about three key questions:

• What is the likelihood of virus appearing in the semen if it can’t be detected in the blood?
• Where virus is detected in semen, what are the likely concentrations?
• Are those concentrations likely to cause HIV transmission?

All three questions are answerable, albeit with provisos, from research. That research suggests, in a nutshell, that while a quarter of ‘undetectable’ gay men have HIV in semen, the risk of transmission is likely quite low.

The research on “undetectable” gay men’s semen.

The Boston research has helped quantify the likelihood of both virus being present in the semen in "undetectable" men and the likelihood of it causing transmission. This study involved 101 gay/bi men. This AIDSmeds article summarizes the results. Eighty-three of the 101 men had undetectable levels of HIV in their blood samples. Though most also had undetectable HIV in their semen samples, 25% of those had detectable seminal viral loads. This is in the range that previous studies have confirmed.

What’s interesting is that the men who had an STI were 29 times more likely to have viral discordancy. The implication is that without an STI, undetectable in the blood means, way more often than not, undetectable in the semen.

Now let’s look at those 25% of undetectable men where virus was detected in their semen, because it’s important to understand how much virus was present.  The median level in the semen was 200 - in other words, unlikely to infect anyone.  A viral load below 1,000 has in fact, rarely been associated with HIV transmission.

So let’s summarize what we’ve learned from Boston: if you have an undetectable viral load there is a one-in-four chance of virus being measurable in your semen, considerably smaller if no STIs are present. And if that virus in your semen reflects median levels found in the study, the chances of transmission are tiny.

The problem is that median levels are just that – some men will in fact have higher levels of seminal virus, thus increasing the risk of transmission.  So, while the median range for measurable semen may have been 200, the actual range was 80 to 2,560 copies. We need to look at other research to find out whether those higher levels of seminal virus are likely to cause transmission.

It’s not as clear cut as one would like, but AIDSmap reports a small 2008 study from San Francisco found that the median seminal viral load in men transmitting HIV to partners was 4,300 and the lowest was 110. A larger (1,199 gay men) 2009 study from the UK found that two out of 41 transmissions of HIV (5%) were from men with an apparently undetectable viral load, as measured in their blood.

BUT as AIDSmap  qualifies “studies of the link between viral load and transmission suffer from it being difficult to pin down transmitters in a cohort of gay men with multiple partners and where viral load may be measured months after the transmission.”  In other words, it is wrong to conclude the men had undetectable virus (in the blood) at the time of transmission.

What does all this mean? It’s hard not to suggest that in “undetectable” men, virus in semen at levels likely to result in HIV transmission represents anything other than a small but nevertheless potential risk.

How we process risk.

It’s notoriously difficult to turn research data like this in to helpful risk guidelines, a topic which was explored in some depth in my recent interview with CATIE’s James Wilton here. 

What is clear is that the risk associated with semen in otherwise undetectable men is low, but cannot be expressed as zero.

But what risk CAN be expressed as zero? Certainly not with  condoms, the cornerstone of our HIV prevention programs.  A recent literature review reported in CATIE concluded condoms can be highly unreliable. CATIE summarizes “The review found that there is a variety of ways in which condoms are being used incorrectly and the prevalence of incorrect condom use is surprisingly high.”  That and breakages, even when condoms are used properly, present an alarming  picture.  Breakage and slippage or complete failure of the condom to afford protection was reported in 25-45% of those studied, with an event rate of up to 8%.  (“Fit or feel” issues, by the way, were reported in 7-30% of those  studied and in up to 45%  of events, with erection difficulties reported by 19-20%  and up to 20% of events.)

How do condoms stack up to undetectable viral load as a means of affording protection?  Some prominent advocates have suggested that the use of condoms in people living with HIV affords LESS protection than having an undetectable viral load.  Respected POZ magazine founder Sean Strub said that here. Even Canada’s most prominent AIDS researcher, BC’s Dr Julio Montaner said in a PositiveLite.com interview “I’m very comfortable that HAART is at least as protective – or more – than condoms.”

Overall though, we’ve been slow to acknowledge the risk from unprotected sex amongst sero-discordant partners has changed radically since the advent of undetectable viral load.  But here’s a recent exception. The ever-progressive Heath Initiative for Men (HiM) said just this month ”Most of the time, guys with undetectable blood viral loads who are taking treatment as prescribed, and get tested regularly for STIs (and treated if need be), also have undetectable viral loads in cum and rectal secretions.”

They go on, very significantly, that “for some gay men, if their partner is on treatment as prescribed by his doctor, has an undetectable blood viral load that is monitored regularly and is getting tested (and treated if need be) for STIs regularly, their risk of picking up HIV is greatly reduced, even without condoms. This may be something you want to talk about with your partner, together with his doctor.”

Conclusion

Given the evidence, even with its gaps, it’s not unreasonable to suggest that  the risk of transmission associated with semen when your blood viral load is undetectable has been over emphasized and overstated.  Why? It’s hard not to think it’s connected with our desire to see condom use maintained.

Not that this desire isn’t well founded. Condoms may not be 100% effective, or even close, but they are the best prevention technology we have right now.  So let’s be clear; it’s inappropriate for people living with HIV to stop using condoms, whatever their viral load, without carefully reviewing the risk to themselves and their partners.  That, as HiM suggests, may involve discussion with your partner and your doctor, hopefully an informed one.

But ultimately it depends, as does life in general, on what risk you consider reasonable. You make similar informed decisions every time you cross the road.

PositivelIte.com writer Michael Bouldin said “It’s not that we don’t know what constitutes risky behavior; it’s that it’s simply not possible to always avoid it, or in a given moment even desirable. Walking a red light can get you killed; it can also get you to a job interview on time.”

How we process risk is fluid too.  It depends on the context – the time, the place, the partner – and to what extent we are informed.  And to be frank, there are problems here. Canadian Treatment Action Council (CTAC) chair  Alex McLelland recently said on PositiveLite.com “As a community, we have not developed or even responded with relevant guidelines on how to incorporate the new reality that people living with HIV who are on treatment and have viral suppression do not always need to use condoms.”   

So risk is a very fluid concept for us consumers, isn’t it? It’s less so for HIV educators, who need to ensure that anything less than zero risk constitutes a warning shot across our bows.

Warning shots are fine and we need them. But we need to interpret them, try to qualify the degree of risk that might apply to us, just as we hover on the curb before crossing the road. In the case of the danger of virus in semen in those of us who are undetectable, the warning shot doesn’t pack a lot of punch for me, if you peel its skin away and look at the underlying research. But your experience may vary. In the context of informed decision making, you really need to make up your own mind.

It seems these days that one can't read an article about HIV prevention without running into references to the "Test and Treat" approach and its possibilities of ending the HIV pandemic. I'm not going to examine the whole of that issue here, but I hope to open a can of worms at one end of it. That end is the beginning: testing and what we might do to revolutionize the accessibility of testing to those who might have been exposed to a chance of HIV transmission.

Our cousins in France (as we like to refer to them here in Québec), at the Warning, are now raising the once (and still?) taboo issue of home testing for HIV. I think it's worth exploring the possible advantages and disadvantages of that approach and whether it might be helpful in some way to add it to our basket of testing options.

No jurisdiction currently allows testing without the involvement of health care professionals. There are some openings to the involvement of community health workers, notably in France, where an exception has been made to allow for community-based testing efforts, particularly in the gay community. This doesn't mean, however, that it is impossible to obtain your own rapid testing kit: a colleague of mine managed to order two test kits that were delivered in the mail from Malaysia, and you can't miss the internet ads that offer rapid test kits. (Ediitor's note: see video below illustrating use of one such test.) The problem is that they are not currently legal, not even for self-use.

This official illegality leads to another concern: quality control. If these tests were legal to obtain, there would likely be some government oversight with respect to the quality of the tests. HIV tests generally require a high degree of sensitivity and specificity. These criteria can be explained in this simplistic fashion: sensitivity is the percentage of tests that will come back positive when HIV is present and specificity is the percentage of tests that will come back negative when HIV is not present. False positives and false negatives can cause big problems, so these measures of quality control are ongoing for the test kits that are used in the health care system. Clearly, this monitoring does not take place for products that are not approved for use.

One hurdle to get past in allowing home testing is ensuring that people understand the nature of the rapid test. It isn't rapid because you can use it the day after your exposure; it is rapid because it can give results quickly when testing after the traditional window period. The rapid tests measure antibodies, which take time to develop in the body. There are other options that can give results sooner after an exposure if that is a concern, such as fourth generation ELISA tests which include tests for certain other proteins that develop more quickly than HIV antibodies. These, however, are a little more technically complicated and not available in the form of easy-to-use test kits. This is all information that can be explained to anyone with a great degree of comprehension, so it shouldn't be a reason for forbidding home use of the rapid test.

Indeed, there are other forms of medical testing that are made available to people to use at home. Diabetics monitor their blood sugar levels with great regularity, and on the 'diagnostic' side of things, women have been able to obtain and use home pregnancy tests for quite some time. These things do have regulation, and therefore some degree of assurance of quality that ought to be applicable to HIV home tests, too.

Because of the stigmatization of HIV infection, we have set up some very strict guidelines regarding pre- and post-test counselling. Concerns include ensuring that people understand the nature and impact of the test before agreeing to it as well as ensuring that a test result is not disconnected from appropriate interventions — counselling and information regarding the person's personal practices in the case of a negative result and that plus connection to care in the case of a positive result. This is a little harder to envisage in the case of a self-administered test. Even if the test is technically appropriate (sufficient sensitivity and specificity), who will help the person to manage personal reactions to the result? Is there a risk of people concluding that they are somehow protected from HIV if they are negative after repeated exposures? What about the emotional crisis that might follow a positive result? There is already movement toward simplifying or streamlining some of these requirements, particularly for those who have previously tested, and that should help to speed up the process for many.

It's often easy for those of us on this side of a positive diagnosis (the positive side) to conclude that HIV has become a manageable chronic condition and not the drama that we once thought it was, but the home testing issue is no longer about us. It is about people with widely varying degrees of exposure to information about HIV and the impact of living with (or managing) HIV, and if a rule is to change it has to take into consideration the disparities of understanding in the whole population.

One possibility for opening the door without completely removing it from its hinges would be to make the home tests available to people we hope to test frequently (i.e.: those who have frequent and ongoing exposure to the risk of HIV transmission) by prescription, at least in the form of a pilot project. This approach would ensure that the initial information and counselling would be complete, that connections to care were already in place for future use, and might offer the possibility of lightening the burden on the health care system while simultaneously stepping up regular testing.

Keeping control of the door might be necessary for reasons other than just understanding the science of HIV testing, however. Some of our biggest problems in HIV, persisting after the development of effective treatment options, are human rights problems. What could be the human rights implications of home HIV testing? Think about employment discrimination or other forms of social exclusion. If home HIV tests were to be available over the counter or off the shelf, what would stop people from using them on others over whom they exercise some form of control? As a society, we have not been particularly effective and certainly not proactive at righting the wrongs of prohibited discrimination, so I have very little confidence that we could prevent home HIV test kits from being misused to discriminate and exclude if they were widely available.

This is the issue that really puts the brakes on home tests for me, even if I have been led to a place where I would be ready to accept home tests by prescription for frequent testers. I work with some brilliant people who have really helped to shape and re-shape my own opinions about this topic, and I like to think that my attitude is evolving.

I think we are ready to have this debate and we ought to get to it.

Post-script:

My colleague kindly allowed me to purchase one of his tests and helped me film myself testing. I thought it was important to do this to show that it could be done, it could be done with humour (particularly when the result is not in doubt!) and that undetectable viral load in the blood is not undetectable antibodies on an HIV antibody test. Since the usual “how-to” videos tend to show negative results, I also wanted to show what a positive result would look like. I’m itching to use the photo as my Facebook profile picture (after PositiveLite publishes this article, of course!)

So . . . first the test - then the test results!