ACT UP is Watching: HIV self-test rollout fails to meet WHO guidelines

Mylan ‘Autotest VIH’ rollout fails to meet WHO guidelines for HIV self-testing

ACT UP Dublin expresses serious concerns about the HIV self-testing kit (“Autotest VIH”) Mylan has brought to market in Ireland. In this statement, we highlight ways that the product fails to meet World Health Organization (WHO) standards in this area, and we make suggestions regarding how the product should be improved.

Increasing access to HIV testing is a critical part of Ireland’s response to HIV and we believe HIV self-testing (HIVST) holds considerable promise for increasing rates of HIV testing, for connecting people living with HIV to care, and therefore also for reducing new infections. However, it is important that it be properly implemented, in particular, ensuring that consumer and patient interests are protected. We are concerned about a number of serious shortcomings in the way that Autotest VIH is being packaged and brought to market.

Recently, ACT UP Dublin conducted a review of current policy guidelines with respect to HIVST in anticipation of the possible widespread availability of this type of product in Ireland. There are currently no Irish national policy guidelines regarding HIVST.  The HSE Sexual Health and Crisis Pregnancy Programme has informed us that it is awaiting guidance from ECDC on a new set of HIV testing guidelines for Europe, which will include guidance specific to HIVST. This means that Mylan’s product is being brought to market in Ireland in the absence of a coherent and well-thought out national strategy encompassing HIVST.

In the absence of relevant national guidelines, we reviewed WHO guidance on HIVST.  We looked carefully at the packaging and instructional insert for the Autotest VIH in order to understand how or whether the product fits with current international best practice, as specified by WHO. 

Overall, WHO strongly recommends that “HIV self-testing should be offered as an additional approach to HIV testing services”. By increasing the options available, self testing can help increase uptake of HIV testing, particularly among people who are less likely to avail of conventional testing services. 

WHO emphasises that to maximise the benefit while reducing potential harms, HIV self testing programmes “should adhere to the WHO 5 Cs: Consent, Confidentiality, Counselling, Correct test results and Connection (linkage to prevention, care and treatment services).” Here we highlight two of particular concern in the Irish context: “counselling” and “connection.”


Regarding counselling, WHO advises:  “All HIV testing must be accompanied by appropriate and high-quality post-test counselling, based on HIV test results.  Quality assurance (QA) mechanisms, as well as supportive supervision and mentoring systems, should be in place to ensure the provision of high-quality counselling.”

In regard to Autotest VIH for Ireland, for the purposes of counselling, users of this product are directed to contact GOSHH 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.  When we contacted GOSHH outside of office hours, we heard a recording that made no mention at all of HIVST.
  • 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. Moreover, if this additional resource is to be provided to users, it should be included in the packaging of the test itself (otherwise it is liable to being misplaced).

We have some additional questions and concerns:

  • What training or information will be made available to dispensing pharmacists regarding HIV, HIV testing, or how to access HIV care and services? Will pharmacists be able to provide appropriate and accurate support and advice to users of this product?
  • Because the counselling services offered with the test are not always accessible, it is extremely important that information regarding living with HIV today be included in the product itself.  Users should be clearly informed that today HIV is treatable with medications with very few side effects, that people living with HIV have a normal life expectancy, and that people with HIV who are effectively treated cannot transmit the virus.  This is especially important in Ireland, where knowledge about HIV is very low, especially in hard to reach populations. It is not unlikely that those receiving a reactive test result will believe that they (a) have AIDS and are (b) likely to die from it.  It is absolutely vital that Mylan guard against this misapprehension and the extremely harmful psychological consequences.
  • WHO advises that HIVST product users be directed to websites and video demonstrations of a product.  Autotest VIH directs users to a French-based website and video demonstration. This website and this video should be recreated in a culturally- and market-specific way for Ireland.
  • Although HSE has no specific guidelines about HIV self testing, the HSE Sexual Health and Crisis Pregnancy Programme did distribute a short statement that noted that because of the 3-month window period “this test is NOT suitable for monitoring individuals taking HIV PrEP.” SHCPP recommends that PrEP users “engage with services for appropriate monitoring and follow up.” This information should also be included in the packaging.


Regarding connection to clinical care, WHO advises: “Linkage to prevention, treatment and care services should include the provision of effective and appropriate follow-up. Providing {HIV testing} in situations where there is no access or poor linkage to care, including ART, has limited benefit for those with HIV. In the context of HIVST, connection also includes linkage to further HIV testing in a stigma-free community- or facility-based setting, where test results can be confirmed and an HIV diagnosis given by a trained provider.”   

  • It is vital that information about the treatability of HIV be included in information provided with the test kit. It should also be made explicit that care and treatment for HIV is available for free to anyone living with HIV in Ireland.
  • We insist that Mylan 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.  This should include details on where and when clinical services are available at various sites across the country. It should also inform users that HIV care and treatment in Ireland is free.

What’s next?

ACT UP Dublin believes that HIV self-testing is a promising new way to increase HIV testing and to overcome some of the barriers to testing and treatment that lead to, among other things, a high rate of late diagnosis in Ireland.  We believe a comprehensive and properly instituted national strategy for HIV testing should include national 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, whether in Dublin or in Donegal.  ACT UP Dublin will continue watching.

[An earlier version of this post included questions regarding the services available to self-test users. We were contacted by GOSHH who provided additional information that addressed those specific concerns and we have removed those questions from the post.]