Ban on home testing for HIV in UK `is not justified`, says a researcher

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The UK ban on HIV self-testing should be reviewed, according to an opinion piece from a public health researcher at Liverpool University. The author, Lucy Frith, argues that the current prohibition on self-testing, introduced in 1992, is outdated, does not take account of new testing technologies, is preventing the detection of undiagnosed infections, and denies patient autonomy.

In late 2005, the US Food and Drug Administration convened a meeting to discuss the issues raised by a self-test for HIV using oral fluids. The meeting was called because the manufacturers of the test indicated that they would be seeking over-the-counter approval for this test. Frith notes that there was substantial support at this meeting for self-testing.

Legalising self-testing in the United Kingdom would, Frith argues, reduce the number of undiagnosed HIV infections. It is currently estimated that as many as a third of people with HIV in the UK are unaware that they are infected with the virus. She argues that evidence from the US suggests that there is a demand for self-testing.

Glossary

self-testing

In HIV testing, when the person testing collects their own sample and performs the whole test themselves, including reading and interpreting the result. 

oral

Refers to the mouth, for example a medicine taken by mouth.

consent

A patient’s agreement to take a test or a treatment. In medical ethics, an adult who has mental capacity always has the right to refuse. 

false positive

When a person does not have a medical condition but is diagnosed as having it.

anxiety

A feeling of unease, such as worry or fear, which can be mild or severe. Anxiety disorders are conditions in which anxiety dominates a person’s life or is experienced in particular situations.

Self-testing would also, according to the author, “enhance patients’ choice”, providing people with “more say over where, how, and when they would be tested for HIV.” She believes that arguments of “patient autonomy” are central to the legalisation of self-testing. Restricting HIV testing to healthcare settings, Frith argues, “is unwarranted, because it prevents individuals from fully exercising their autonomy.”

Arguments against self-testing are dismissed by Frith. She believes that the requirement for testing in a healthcare setting is a hangover from the days of HIV’s “exceptionalism.” She notes that face-to-face pre-test counselling is no longer recommended by the British Association for Sexual Health and HIV. Furthermore, only pregnant women assessed as having a moderate or high risk of HIV are offered counselling as part of the opt-out HIV testing offered to all pregnant women in the UK.

Frith is not persuaded by arguments that individuals who test positive using a self-test “would suffer greater stress and anxiety than those receiving their results in a healthcare setting.” Support and counselling would be available to people self-testing via telephone helplines and individuals testing HIV-positive would be referred to the NHS where they would have confirmatory HIV blood test and, if appropriate, counselling.

“Although it is a possibility that some individuals would not arrange a second test, this situation might also apply in medical settings”, writes Frith.

Frith notes that concerns have been expressed about the accuracy of the OraQuick HIV test after its use for home-collected oral samples for HIV tests yielded an unacceptably high number of false positive in the UK. Frith notes these concerns, but believes “other methods will be developed and we can reasonably predict that a test will soon meet required accuracy.” She believes that the law needs to change before an acceptable test becomes available so “the process of scrutinising self-tests can begin.”

Research quoted by the author suggests that individuals can perform self-tests with the same accuracy as laboratory testing, and therefore “people’s ability to use self-testing kits need not be a major obstacle to their introduction.”

Frith dismisses concerns about the abuse of self-tests. Legislation could make testing without consent illegal. However, she adds, “although such a law could not prevent testing, it would stop the results being used illegally (e.g. for employment dismissal). The use of self-tests leading to domestic violence would need to be monitored during piloting, writes Frith.

“When the appropriate self-test kits become available, the UK needs to be in a position to benefit from their use.”

References

Frith L et al. HIV self-testing: a time to revise current policy. The Lancet 369: 243 – 245, 2007.