HIV Home Testing: Not a free cuddly toy
As a follow up on yesterday’s posting about the forthcoming legalisation of HIV home testing, I’d like to look into a French study investigating access to and use of unauthorised online HIV self-test by Internet-using French-speaking MSM. The study was conducted in 2009 and the results were published in March 2012, which make them slightly out of date but still rich in lessons to learn.
As in the UK, the distribution and sale of HIV self-tests is not authorised in France. However, HIV self-tests are readily available online. This is the one reasons why legalisation is in itself justified, so that their sale can be regulated to ensure that the products are providing accurate and reliable results. But how this is done and what it will achieve remains unanswered questions.
The study was conducted by Tim Greacen and its results are summarised in the figure below. Briefly a survey was conducted over 12 weeks early in 2009 and promoted though an online banner and/or emails. Respondents who clicked on the banner or email link were redirected to an online questionnaire comprising 93 questions that took on average 23.2 minutes to answer. This is a long time and requires some dedication from the respondents.
First, that the researchers have been able to advertise this study online so broadly is a remarkable and worthy achievement. Access to the questionnaire, i.e. visitors clicking on the banner or email link, was relatively low but comparable with other similar initiatives. The researchers acknowledged a potential bias toward selecting visitors interested in self-testing.
Awareness of self-testing for HIV was limited with 30% of the respondent knowing about it, but this may be explained by a study conducted 4 years ago and to language limitations (Sites offering testing kits are predominantly in English).
Of the 14,022 who accessed the questionnaire only 2,370 were eligible for the study after exclusion of incomplete questionnaires, of those HIV positive and of those who did not know about self-testing.
82 of these 2370 had obtain a self-test and of the 69 who self-tested 62 returned a negative result that was confirmed for 29 of them, leaving 33 unconfirmed results. Remarkably confirmation was sought mostly by traditional testing.
But it is the 7 cases of “unsure” and positive results that are cause for concerns.
Firstly because of the 3 positive cases only 1 was confirmed. One positive test turned out to be negative suggesting the test had not been used properly and the other was never confirmed. Secondly, of the 4 unsure, 3 did not understand how to read the test and 1 though he had not used it correctly. Only 2 sought confirmation and only 1 had a negative result confirmed, leaving 3 participants unaware of their status, 4 including the positive one who called the hotline but who was lost to the study.
Of the three that were initially positive, none talk to a doctor about the result, emphasising the importance of managing linkage to care, which in this case did not took place.
Overall, with the participation of 18 organisations and websites and out of 2,370 eligible participants issued from a population that was considered at risk, the outcome of the study was the identification of 1 HIV infection. One.
Of course the context of this study is different than one in which HIV Home Tests would be legal but the issues raised are the same and the outcomes similar to that of a UK prospective study in which 4,500 people were invited through a gay dating site, 132 HIV test kits were requested and 73 were returned leading to 4 new HIV diagnoses.
In the UK, the number of HIV tests taken yearly in clinical settings has been going up constantly since 2009. Amongst MSM in England, HIV test coverage in GUM clinics between 2009 and 2012 increased from 42,855 to 72,706 (84% coverage) and HIV test uptake from 52,701 to 90,698 (94% uptake). If there is still some stigma attached to taking an HIV test, these numbers clearly indicate that taking the test in a GUM clinic is acceptable and becoming more so. This is an area where there is still room for improvements but there are other settings where HIV testing can be and is performed (Gym, sauna, MSM events) and which may be less stigmatizing than a GUM clinic.
Around 25% of PLWH in the UK do not know that they are infected with the virus. How many will be identified through home testing? Can other strategies, such as community based initiatives, deliver better outcomes?
In absence of a clear and explicit framework for delivering safe, accurate and accompanied HIV home testing, and in a context of budget cuts and decentralisation of HIV prevention services to local authorities, the question of the value, effectiveness and return of HIV home testing is a burning one.
More worrying is the unpalatable thought that home testing would come to replace part of testing in clinical settings as a cost saving measure both locally and nationally. If HIV testing “in the comfort of your home” is just one option amongst others, it will be important that it does not become the main option for HIV testing.
NAT twitted today that those who tested positive will be sign-posted to care services. The French study show that this may not be enough and that a more structured support will be needed. THT also twitted to reassure those eventually coerced into testing that this was a crime that can be report to THT direct. The feeling here is that there is little readiness should the sale of HIV home tests be promptly made legal.
The French and other similar studies point towards the need for a very cautious and structured approach to home testing for HIV and for pilot studies that are culturally and contextually sensitive to be conducted before national roll-out of what could be a costly and lame intervention.
~rjt
Ed 14/08 for clarity.
In addition tot the rationale that legalising HIV home testing kits will prevent abuse and allow control, other arguments are fed in along the way. The HIV home testing campaign has based its recommendations on a claim that clinics are overcrowded, too busy, and lacking in privacy, some even claiming concerns about confidentiality. If so, then these problems need to be solved at source rather than through home testing which brings with it equally uncomfortable and substandard risk factors.
A key gap in the entire argument is an analysis of who it is that’s testing late. Focus on MSM and Africans ignores a serious problem of late diagnosis in non-African heterosexual individuals. It also fails to recognise, as suggested in this ‘Incidence0’ article, that significant improvements in rates of HIV testing have come about through various strategies, opt-out in antenatal, outreach community testing, normalising HIV tests in sexual health clinics, and an increase in GP testing. The case for home testing is that anything that will increase testing is good. As Prof Helen Ward pointed out in a tweet yesterday, more testing does not mean more diagnosis or linkage to care, and what we need is better engagement with and by existing services.
The demography of those with undiagnosed infections is highly diverse. Recommendations for proven strategies to improve HIV testing are not being driven forward, and though health policy and systems in Scotland as against the rest of the UK are diverging as a result of devolution, the picture is fairly common across the UK. The problem is not lack of policy or knowledge of what we ought to do, it is a lack of action and implementation.
It is relatively easy to pick holes in the HIV home testing proposals and these have already been well rehearsed. Questions need to be asked and answers are needed as to why we have reached this stage with no proper consultation or transparency as to processes. There is a question also as to potential conflicts of interest on the part of campaigners and lobbyists.
These are important issues. At least equally important in our discussions, however, is to take a positive line on HIV testing. How often have we heard of efforts to make the testing experience better for the patient? I use ‘patient’ advisedly as criticism is not all one way. Many campaigners are critical of healthcare and clinical standards, staff and facilities. It is worth noting that they and their work are seldom subject to anything like the scrutiny to which NHS partners are accustomed.
The greatest weaknesses in the argument for HIV home testing is firstly in the supporting material issued by the Orasure company itself, the only approved home test kit welcomed by campaigning groups like NAT and THT. One in twelve false positives, and a three month window period fall well below acceptable standards.
The second weakness is that abuse of the current system is likely to be replaced by abuse of a new legalised approach. The MHRA’s role is interesting in this regard as their remit is to approve the technology, whereas the provider is regulated by CQC. There is no clarity as to how legalised kits will be regulated, how risks will be assessed and dealt with, how customers (for such they will be) are to be protected, or how commercial company interests will be brought into line with national strategic priorities while they pursue commercial interests and target marketing in supermarkets, on youtube, and on dating sites, as currently in USA where the kits are already on sale.
Conflict of interest on the part of commercial companies who have lobbied for legalisation needs to be open and transparent. By the same token so also ought the interests of charities and campaigning groups whose role includes provision of services and possible contractual and financial benefit by way of sponsorship or contracts from sales of kits and the work that will be involved in follow-up.
The weakness which I find astonishing is that we are all busy debating home testing when in fact we ought to be debating home sampling. There is no need for home testing kits to be legalised. Those who framed the original regulation knew exactly what they were doing. They carefully hedged what was permissable and what was not so as not to restrict the very approach which campaigners advocate – an option which allows the individual to take a test in their own time and in their own space, but with a link to care.
The important safety and health imperative, however, is built in through protocols and access to clinical expertise and supervision. Only in that way will choice be made consistent with the goal of HIV testing. Not as an end in itself but a route into care and prevention services, with the patient at the centre of strategy, interests, and activity.