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In this statement Chief Medical Officer Professor Dame Sally Davies announced that “outdated rules designed to combat the threat of AIDS in the 1980s […] will be modernised in line with the most recent science.”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.
|Some of the difficulties associated with HIV Home Testing from Deutsch AIDS Hilfe|
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.”
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, 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.”
[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 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,
|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.