October 23, 2015
People concerned about their HIV status can order a kit online, and test themselves in the privacy of their own home. Although the first HIV self-testing kit went on sale in England, Scotland and Wales this year, they still remain illegal in Northern Ireland.
BioSURE uses finger-prick technology that gives a result in around 15 minutes. The test works by detecting antibodies produced by the body against the HIV virus. These antibodies may not reach detectable levels until three months after HIV has been acquired, which means that any negative results in this "window period" must be interpreted with extreme caution. After this the test is very sensitive (the manufacturer quotes 99.7%).
How it works.
Anyone who tests positive needs to attend a sexual health clinic to confirm the diagnosis and discuss treatment. Or if negative, should take heed of the "window period" and consider attending a sexual health clinic for more information.
HIV self-testing kits have only been on sale in the UK for a few months because regulations that prohibited the sale of such kits were not revoked until earlier in the year. The recent change in the law reflects social and medical changes that have taken place over the last few years.
Back in 1992 -- when the tests were originally banned -- treatment of HIV was still in its infancy and outcomes were often poor. Many people died prematurely and many more suffered terribly from drug side-effects. The situation today is very different, at least in high-income countries. If people are diagnosed quickly and start treatment early enough they can expect a normal life expectancy. While it would be wrong to claim that the stigma attached to this disease has entirely disappeared, social attitudes towards HIV and AIDS have changed significantly in the UK.
Despite this, it is still the case that outcomes are often poor if patients are diagnosed late -- these people are ten times more likely to die in the first year after diagnosis than those diagnosed earlier. This means that it is vital to try and diagnose HIV in its early stages so that treatment can start promptly. But this is easier said that done, partly because HIV often does not cause any symptoms in the early stages.
Indeed, an estimated one in four HIV-positive individuals in the UK (around 26,000 people) are tragically unaware of their infection. Trying to reduce this number is a public and ethical imperative because it could give these people a better chance of survival.
Early diagnosis benefits other people, too. This is because patients can modify sexual behaviour once they have been diagnosed. Treatment also lowers the level of virus in the blood, further reducing transmission rates. Early diagnosis also enables faster notification of past sexual partners and contact tracing so that others can benefit from early diagnosis and treatment, too.
There is concern that the availability of self-testing kits will allow people to go online, buy a kit, and find out that they have HIV without ever undergoing pre-test counselling. The need for lengthy pre-test counselling was historically considered necessary in order to ensure that people "fully" understood the implications of a positive HIV test. This was at a time when a lack of effective treatments and huge social stigma surrounding AIDS meant that a diagnosis could cause more harm than good.
But because the benefits of early diagnosis are now overwhelming and because lengthy pre-test counselling can act as an unnecessary barrier to testing, the British HIV Association has now published guidelines downplaying the need for such counselling. So the claim that self-testing kits should be prohibited because they might reduce the possibility of pre-test counselling is far less compelling that it used to be.
Nevertheless, the idea that someone might learn that they have HIV when they are home alone, rather than from a trained health professional remains troubling for many. Might those who test at home suffer greater distress or even harm themselves if they receive a positive result without having a professional on hand to break the bad news and offer immediate support?
The tests could also be misused. An abusive person could, for example, coerce a partner, child or other vulnerable adult to be tested against their will or without their consent. A negative result might also be used as a negotiating tool for unprotected sex.
These are undeniable risks associated with HIV self-testing. However, other countries have allowed their citizens to use such tests for years. For example, a saliva-based home test was approved by the US Food and Drug Administration in 2012. There is little evidence to suggest that liberalising the rules has caused serious harm or that the tests are being routinely abused.
A European study also found that a third of self-testers may not have had an HIV test were it not for self-testing. If this turns out to be true in the UK, too -- and in one study 91% of men in the UK said they would be willing to self-test -- it could improve the rates of early HIV diagnosis in this country, bringing with it the myriad benefits described above. These kits may also empower patients and promote autonomy by enabling people to choose when and how they wish to test themselves.
The removal of the ban on the sale of these HIV tests in England, Scotland and Wales was ethically defensible. But in order to determine whether the benefits really do outweigh the harms we still have to monitor their use and carefully collect and evaluate their impact. If things go awry, the kits could be banned again very quickly. If things go well, Northern Ireland could take note and follow suit.
Jonathan Youngs, a doctor in the Clinical Infection Unit at St George's Healthcare NHS Trust in London, contributed to this article.
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