HIV Home Testing: A cautious welcome
The much awaited Department of Health announcement of the “Modernisation of HIV rules to better protect public” is finally available online.
In this statement Chief Medical Officer Professor Dame Sally Davies announced that “outdated rules designed to combat the threat of AIDS in the 1980s […] will be modernised in line with the most recent science.” (emphasis mine).
The modernisation first targets the repeal of the ban on doctors, nurses and other skilled healthcare workers with HIV but who are receiving treatment, to take part in certain medical procedures. This is in line with recent randomised trials among which HPTN 052 that have shown that HIV infected people receiving treatment and with an undetectable viral load, had a greatly reduced risk of transmitting HIV to their partner. It also comforms with the 2008 Swiss statement on the infectiousness of HIV people on ART. So far, so good.
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| Some of the difficulties associated with HIV Home Testing from Deutsch AIDS Hilfe |
HIV Home Testing regulation will also be “modernised”, which is a welcome move, but not for the reasons mentioned (See previous posting in this subject, here and here).
The response to the announcement has been a cautious welcome. Notably, the position of BHIVA, the leading UK professional association representing professionals in HIV care, was not accompanying the DoH statement but released separately.
Indeed BHIVA issued a response in which the Chair David Asboe welcomed “the availability of regulated HIV self-testing kits, while noting two important caveats” related to the accuracy of the test and emphasising both falsely reassuring negative results and unduly worrying false positive. Whichever necessitated confirmation in a traditional setting.
Accuracy of testing in an unsupervised environment is a critical factor to the success of the approach. A modelling paper presented at the CROI 2013 Conference in Atlanta showed that the introduction of the OraQuick home test could led to an increase in HIV prevalence among San Francisco MSM[i] (as always, all models are wrong but some are interesting).
The BHIVA Chair also warned against HIV Home Testing being used “as a substitute for the expanded testing currently available in healthcare and other settings, and that the transfer into high quality, specialist care of someone who tests positive is monitored.”
The statement from the BHIVA Chair then concluded that “it is crucial that we evaluate the effectiveness of this policy in reducing undiagnosed infections without unwanted effects on behaviour, psychological wellbeing, and uptake of broader sexual health services.”
One would have thought that if the change in law were indeed based on “the most recent science”, data on the effectiveness of home self-testing would already be available.
Positively UK, a charity championing the rights of people living with HIV also welcomed the change adding that “It is vital that people testing for HIV have access to help in coming to terms with their diagnosis, coping emotionally, and managing their medications. While its good news that home testing will be available, the Government needs to understand the importance of those testing kits providing accurate information and signposting, and for support services to be in place for those who do test positive.”
In this regard, it should be common sense to listen to people who went through it.
Signposting will indeed be critical as the first step for newly diagnosed to enter care. At this stage it is very unclear what this signposting will consist in and we should keep in mind what happened with NHS 111.
In their response to the DoH announcement, The National Aids Trust, one of the charities that was lobbying for the change in the law with The Terence Higgins Trust wrote that,
“We will be working closely with the Government to ensure that all tests introduced are of a high quality and provide accurate results; that the test comes with in-depth and relevant information about HIV and that there are clear processes to ensure that those diagnosed are effectively linked into HIV support and care.”
To its credit NAT, has produced a very useful report into Home Testing in 2008 which is still very much up-to-date.
The Terence Higgins Trust only issued a sibylline statement from its departing Chair Nick Partridge to say that “So long as the right safeguards are in place, there is now no reason […] why people who would prefer to test at home should be denied that chance.”
So long.
But there was no real need to add to the waxing lyrical statement of a THT Senior Executive published a few days before the official announcement.
The tail wagging the dog
When asked on Twitter to provide evidence supporting the repeated statement that if home self-testing was available more people would get tested, more HIV infections would be detected and more infections would be prevented, Professor Kevin Fenton (Director of Health and Wellbeing at Public Health England, PHE), referenced “THT research” in this area.
First, I would like to very warmly thank Prof Fenton to engage on Social Media. The same cannot be said of a number of those who have been challenged on this matter and have remained silent. Maybe they forgot that Social Media, which they are prompt to promote as the answer to all our problems, are a two-way communication system.
Second, it is rather surprising to see (very) grey literature being referenced as the basis for such an important change whilst scientifically collected evidence is available on the subject (see here and here and here and here). But let’s look at the evidence quoted to support the decision to change the law (hopefully only in part, Prof Fenton also referenced Lord Fowler’s Report) .
In 2010, THT conducted an online survey which is summarised here as follow (full report here):
“In 2010, Terrence Higgins Trust surveyed 657 people via newsletters, social media, and other online media. Of the 490 respondents that had not tested HIV-positive, 63% said they would consider using HIV self-testing kits if they were legalised and 51% thought legalisation would make them test more often. Among gay men, one of the groups most at risk of HIV in the UK, 60% thought legalisation would make them test more often.”
It is worth noting that this study was a survey advertised on social media and conducted via Survey Monkey. How representative this survey is, is without a doubt questionable. There is a non-negligible potential for a selection bias both because of the medium chosen to conduct the survey but also by selecting respondents who are more inclined to use or be interested in home testing. That half of the respondents where MSM points towards such selection bias, and that is only one of the possible bias (geographical location being another one, but the data is not available).
There are causes for great concerns if changes in law that may have a huge impact on Public Health are based on this kind of evidence, i.e. on 309 unrepresentative people saying that “they would consider using HIV self-testing kits if they were legalised”.
However, there could be new data available if THT and Public Health England were to make them available. Since January 2013, THT claims to have distributed 9,000 self-sampling kits (which are not to be confused with self-testing kit). How many have been returned? How many new infections have been diagnosed? What percentage of newly diagnosed have been linked to care? THT and PHE have the data and can publicise them anytime.
So, let’s be clear.
There is no doubt that the legalisation of HIV Home Test Kits is the right thing to do. The main reasons are threefold:
- First, kits are already available.
- Second, it is an opportunity to regulate the market and the MHRA will have an important role to play.
- Third, people who know their status tend to change their sexual behaviour and may enter clinical care more quickly.
But what cannot be said is that the legalisation of HIV home testing will:
- Be a good thing just because it makes sense to do it,
- Increase the number of HIV tests to a level that will make a difference in reducing onward transmission,
- Lead to earlier detection of HIV infections (actually it would probably lead to identifying older infections at first),
- Contribute to a identify a large number of the 25,000 or so infections that remain undiagnosed,
- Increase the number of patients linked to care and,
- Play an important role in the control of the epidemic.
And the reason none of the above can be said or claimed is very simple: there is simply no data arising from “the most recent science” to support any of these statements (happy to be proven wrong). And I’d like to conclude by quoting again a 2013 scientific survey of the literature on self-testing:
“Both supervised and unsupervised testing strategies were highly acceptable, preferred, and more likely to result in partner self-testing. However, no studies evaluated post-test linkage with counselling and treatment outcomes and reporting quality was poor. Thus, controlled trials of high quality from diverse settings are warranted to confirm and extend these findings.”
~rjg
[i] Katz DA, Cassels SL, Stekler JD: Replacing Clinic Testing with Home-Use Tests May Increase HIV Transmission among Seattle MSM: Evicence from a Mathematical Model. CROI, Atlanta, March 2013, Paper 1064.
UPDATE: As I thought we would be done with HIV Home Testing for the week, Aidsmap newsreel brought this to my attention. This will require some time to digest but the summary is reproduced below. Remarked absence of representation from the UK outside academics from the LSHTM and of GNP+
Report on the First International Symposium on Self-Testing for HIVReport on a symposium convened to discuss the legal, ethical, gender, human rights and public health implications of HIVST scale-up. It brought together ethicists, policymakers, practitioners, researchers, activists and donors to present their experiences and research findings on HIVST. The aim of the meeting was to develop a consensus statement and to publish a framework and series of papers to catalyse and support policy change regarding HIVST. |
| UPDATE: Follwing an email to Sir Nick Partridge at THT, in which I raised my concersn, I received the follwoing response: |
| Thank you for your email. Like you, I welcome the announcement about legalising the sale of HIV self test kits.THT is working hard to ensure that all the concerns you raise are addressed. Specifically, we are working with the Medicines and Healthcare Products Regulatory Agency to ensure that over the counter HIV tests comply with regulations and are accurate, reliable diagnostic kits with appropriate support and guidance for those with either a negative or reactive result. This should include access to a free telephone helpline as well as web based support on HIV prevention for those with a negative result and to ensure prompt linkage to a confirmatory test and access to care for those with a positive result.I recognise your concern over coercive misuse, however I doubt a legal framework can address this. THT has been unable to find either anecdotal or research evidence of coercive misuse in the UK, even though self tests kits have been available over the internet for many years now.As far as I am aware, there is no intention for the sale HIV self test kits to be supported by public funds or to replace free HIV testing in clinical settings. As you know, Local Authorities are mandated to commission sexual health services and these will continue to offer free HIV testingTHT will continue to address HIV stigma and is keen to minimise the risk of this being an obstacle to people entering and staying in care.I hope this answers your concerns and that things are progressing well with the UK HIV Vaccine consortium.
With best wishes, Nick |
| To which I responded: |
| Thank you for your response, rest assured it is very much appreciated. I am glad to read that you are considering how to address the concerns I have raised. We are living through changing times and though we need to recognised that today’s epidemics is very much different than 30 years ago, HIV remains an issue shrouded in stigma and ignorance. HIV Home testing has a role to play in the taming of the epidemics, but which one and to what extent, will depends on how it is implemented. I trust you will look carefully into making the best of it. |
I think it has to be said that the decision to lift the ban on healthcare professionals where there was a risk resulting from “exposure prone procedures” was based on much more evidence than the HTPN052 study & similar partner studies. The report that concluded the risk to be less than negligible took several yrs to compile.
It seems very clear that the author here is at odds with THT & appears to be using the lifting of the ban on home testing as a beating stick to have a pop at the charity.
In my view we are in danger of discrediting this change long before the tests become available, which will only add to uncertainty & anxiety for those who believe home testing would be appropriate for them.
I find it quite disheartening to read some of these blog entries as home testing is one way to help reduce the fear & stigma that many people have about going for an HIV test & HIV itself.
There have been two good decisions this week in my view that can help change the public perception about HIV. We really need to have some balance here & realise that for some a home test is as good as it is going to get as they would never use more traditional & community testing options.
With change & progress comes a degree of risk – the DoH must invest in an educational campaign to support the use of these tests when they become available. For the record I think this needs to be a DoH produced campaign rather than leave it to the HIV charity sector which in all cases are desperately trying to protect vital services – even the larger organisations.
Thank you for engaging in this very important debate.
I fully support the decision to lift the ban on health care professionals with HIV who are on treatment. There is plenty of evidence to support this decision.
There is much less evidence to support lifting the ban on home testing and the decision to do so is a pragmatic one. HIV Home Testing Kits are available, and we better regulate them now.
Now, I reject the suggestion that it is an opportunity for charity-beating. First if it was the case, Charities and here I guess you mean THT would have to blame themselves for putting forward wild and unfounded statements about the role and importance of HIV Home Testing. In this regard, I think that I have provided ample evidence to support a cautious approach. A cautious approach that is also proposed by professionals working in the field and by charities that supports or care for HIV positive people.
There is a lot of Home Sampling taking place, which offers the safety and support that Home Testing may not. It will all depends on how home testing will be implemented and we know very little about that. Legalisation without an implementation and governance framework is putting the cart before the horse. As another example you could look at what is done with Pre-Exposure Prophylaxis and in particular at the PROUD trial which is investigating the effectiveness in the UK of a prevention strategy that has already been proven successful elsewhere.
In my view, the issue of stigma around testing is a moot one. Figures from the HPA/PHE clearly show that a growing number of HIV Tests are being taken in classic settings. Testing also occurs in other less conventional settings. Testing at home will not necessarily remove the stigma from having to go to a clinic to either confirm your home-made diagnostic or enter care. Testing alone may even increase this stigma, and here again the recent WHO report highlights this issues. There are many simple things to do to increase conventional testing, from friendly clinics, to distributing more Home Sampling test, and community testing. Keep in mind that there is one thing that we don’t know for sure, that is who and where are those with an undiagnosed infection, and would Home Testing improve them taking a test? No data available, and to assume that Home Testing will make a difference is just, well, an assumption. In fact, many undiagnosed HIV infections could be diagnosed by improving current practices and removing exiting barriers.
Overall, I think home testing is being discussed on an emotional basis rather than on an evidence-based one. But the evidence are here (or not in many cases). You need to exercise judgement on the quality of the research put forward. One question you have to ask yourself is, do you want healthcare to be decided on a Survey of 400 or so people? Or do you want it based on peer-reviewed evidence?
Finally, will or should the DoH lead the implementation? If so, the NHS would have to pay for the distribution of free kits. To date there is no indication they would do so. Which leave you with the question of who will pay for these kits if the DoH does not and who will make money out of them?
There are many issues to look into, and we all need to be involved.
Sincerely.
I agree that there is a great deal of emotion attached to the debate on home testing – for me it is all about safety & regulation of the product first & foremost as I am of the opinion that those who already purchase unregulated tests are also the ones likely to purchase the tests when they are available over the counter.
I agree that there have been no randomised controlled trials on the use of home testing kits, and therefore there is very little data available. One would assume that the MRHA has reviewed what evidence there is & made a decision based on balance or risk v benefit, and concluded that the benefit outweighs the risk.
I am not sure why there is a view these test kits should be provided free of charge, and perhaps there in lays the rub for some – maybe there is a view that these testing kits are no more than a money spinner for the manufactures?
I guess this is where the convenience & choice argument comes in – we often have to pay for convenience, which after all is a personal choice an individual has to make, either pay to go private for healthcare or use the NHS – does the same principle apply to these test kits in the wider sense? I am aware that some people will pay to go to a private physician to get an HIV test rather than use the NHS because they still believe that testing for HIV has an effect on their ability to get a mortgage.
I think we should also be clear that it is not my expectation that home testing kits will make a bit dent in undiagnosed HIV / late presentations, & I am not sure where those claims have been made if I am honest.
There certainly are lots of things to think about & as with many things this Government are doing they provide the policy & build in the framework at a later date.
My personal view is the that the added safety & reliability of the approved tests, somewhat outweighs the potential for greater harm to occur than is already potentially there – perhaps I will be proven incorrect in the fullness of time.
You are raising an interesting question when asking if these kits should be provided free of charge. Current home sampling is providing free of charge and I guess many would expect that home testing kits would also be provided free of charge. Cost will affect uptake. Interestingly, and again, data about uptake if test kits where not free is lacking, something “THT research” did not look into (I am not having a go at THT here, just echoing language use here and there).
Will the sale of these kits be a money spinner? I can’t answer that but I would really hope that it won’t be the case, thought I know the manufacturers are waiting in the aisle and some of them have been vocal about the need to change the law, without very clearly dicslosing their interests in the change.
One thing I need to clairify from your message: the MHRA does not conduct trial. The role of the MHRA is to authorise the sale of the kits in accordance with existing regulations, in particular the Medical Devices Directive 93/42/EEC and the In Vitro Diagnostic Medical Devices Directive (98/79/EC). Trials, if they were to take place, would have to be conducted and paid for by the NHS or other organistions who can act as sponsor of a study.
The truth is, there are contexts with high HIV prevalence and limited resources where the introduction of Home Testing has shown a positive impact. For example in Malawi, self-testing and home treatment initiation triples uptake of HIV treatment. The context is very different there but there is proper research and reliable data to assess the value of the approach and guide its implementation.
Here is worth remembering Lord Fowler’s full recommendation:
The ban on HIV home testing kits, as laid out in the HIV Testing Kits and Services Regulations 1992, is unsustainable and should be repealed. A plan should be drawn up, in consultation with clinicians, patients, voluntary organisations and professional associations, to license kits for sale with appropriate quality control procedures in place. The licensing regime must make sure that the tests are accurate, and that the process gives comprehensive advice on how to access clinical and support services in order that those who test positive get the care that they need.
We will have the ban lifted (note that it is because it is “unsustainable”). What about the plan and the consultation?