Global pharmaceutical company Mylan have just launched an over-the-counter HIV self-test kit which can detect the presence of the virus in the blood, however, AIDS coalition ACT UP Dublin have released a statement of concern over the product’s failure to meet necessary guidelines.

While ACT UP welcomes increasing rates of HIV testing, they stress the importance of a self-test kit which is properly implemented with consumer and patient interests at the forefront.

The World Health Organisation, or WHO, recommends that a HIV self-test kit should adhere to the “5 Cs”, those being Consent, Confidentiality, Counselling, Correct test results and Connection (linkage to prevention, care and treatment services). ACT UP have concerns with the Mylan product on two of those issues – Counselling and Connection.

ACT UP describe how WHO states “All HIV testing must be accompanied by appropriate and high-quality post-test counselling, based on HIV test results. In regard to Autotest VIH (the self test kit), users of this product are directed to contact GOSHH (Gender, Orientation, Sexual Health, HIV) in Limerick. However:

• This GOSHH service is offered on a very limited, ‘office-hours’ basis. It is not even available over the lunch hour. Moreover, the hours of available counselling are not printed on the external packaging.  

• It is extremely likely that individuals will use this test not during normal business hours, but during evenings and weekends. The lack of availability of counselling during these times is serious and troubling.

• Users of Autotest HIV will be also be provided with information regarding HSE’s HIV helpline by pharmacists. This helpline also has limited hours of consultation.

ACT UP have the following questions and concerns:

• Will pharmacists be able to provide appropriate and accurate support and advice to users of this product?

• Information regarding living with HIV should be included in the product itself. Users should be clearly informed that HIV is treatable, that people living with HIV have a normal life expectancy, and with effective treatment cannot transmit the virus, in order to guard against misapprehension and extremely harmful psychological consequences.

• Autotest VIH directs users to a French-based website and video demonstration. It should be recreated in a culturally- and market-specific way for Ireland.

• The test is not suitable for monitoring individuals taking HIV PrEP. This information should be included in the packaging.

On the issue of connection, ACT UP state:

• Information about the treatability of HIV should be included in the test kit. It should be made explicit that care and treatment for HIV is available for free to anyone living in Ireland.

• Mylan should build a website for users of Autotest VIH in Ireland that provides specific, detailed information on where to seek care in the event of a positive test result including details on where and when clinical services are available.

The statement finished with: “ACT UP Dublin believes that HIV self-testing is a promising new way to increase HIV testing and to overcome some of the barriers that lead to a high rate of late diagnosis in Ireland. A comprehensive and properly instituted national strategy should include guidelines for self-testing and a programme for making self-testing kits freely available to the most vulnerable communities.  

Such a strategy should be part of a new commitment from the State and other stakeholders to ‘Get To Zero’: to make zero new HIV infections a realisable goal in the coming decade. Because Mylan stands to make more money from each new HIV diagnosis, government should encourage Mylan to underwrite subsidies to make the kits affordable and easily accessible.”