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HIV testing: Home Sampling vs. Home Testing, a primer for users (and others)

Home testing and home sampling are not one and the same and it is important for potential users  and their providers to understand the key differences between the two.

HIV home testing is coming. Not right now, because none of the non-clinical commercial testing kits currently available are approved in the UK 1. However, “home testing” is already broadly advertised, though it is not currently home testing but home sampling 2. Both aim at detecting HIV infections but they differ on a number of points.

  • Home sampling requires the individual to collect and send a sample of blood or saliva to a laboratory for analysis. Sampling has been legal for a number of years and can be a successful approach. Testing is performed by qualified laboratory personal, in a controlled and monitored environment.
  • Home testing requires the individual to perform the test themselves and to read and interpret their own results. As of April 6, HIV home testing is legal. The approach has not been tested thoroughly in the UK and there is little data about its potential uptake and benefits 3.

This primer explores key differences between HIV home sampling and HIV home testing and put them in perspective with HIV testing in clinical or community settings. It will also offer a perspective to HIV testing for potential users, with a focus on gay men undecided about what options to go for when home testing will be available.

Three key factors should be taken into consideration when deciding to go for a HIV test: Accessibility, reliability and support. The table below compares these features and more for the three type of testing soon available.

Affordability should also be taken into consideration. Remember that HIV testing is free in the NHS and price as hefty as £300 have been seen for the very same test being performed in private settings. These are excluded from the table below (click to enlarge or download as PDF)

HIV Testing v5

A point of view on HIV testing

wanderer-above-a-sea-of-fogThe decision to take a HIV test is not always an easy one, but not necessarily a difficult or thorny one. It is often motivated by an interest in one’s personal health or because people believe they have been exposed to a risk of infection. Once the decision to go for HIV testing is taken, it is important to consider the options available and to be confident with the settings, technology and process of going through testing.

More than 900,000 HIV tests were performed in the UK in 2012, a number growing year-on-year. The very large majority of HIV testing is performed in clinical settings in particular in genitourinary medicine (GUM) clinics where it is highly acceptable (85% acceptability recorded). GUM clinics offer an environment which aim to provide safety, reliability and accurate testing and to maximise linkage to care for those who test positive. It is also an opportunity to provide further information to those who test negative to stay negative, and to perform testing for other sexually transmitted infections and more.

If you do not have any problem with visiting a GUM clinic and assuming one is easily accessible to you, then this is where you can get the best service available and for free. Alternatively, consider home sampling.

If for whatever reason you decide to opt for home testing, then consider carefully the following (adapted from the MHRA website)

When thinking about self-testing…

You can get free access to high quality tests through GUM clinics across the country. In London, 1 in 4 gay men test in a single GUM clinic, confirming the popularity of testing in clinical settings. Though still not enough, HIV testing is high amongst gay men and testing is a critical point of entry into care, which saves life. An HIV specialist or your GP can help you make decisions about testing and help you access further treatment or advice.

A negative home testing results can rarely completely exclude a HIV infection and may not be as helpful as a visit to a GUM clinic which will include further testing for other sexually transmitted infections.

Think about the possible results of the test and what you are going to do when you have the result – whether it is positive or negative.

If you decide to self-test, you should still follow-up with conventional testing to confirm the results and discuss your options if positive.

Before buying an HIV self-testing kit…

  • Whether buying from the high street or online, only buy a test from a source that you trust.
  • If possible ask a healthcare professional e.g. a pharmacist, practice nurse, GP to help you select the best test for you.
  • Do not buy or use the test if it looks damaged or the seals are broken.
  • Make sure the test has a CE mark. A CE mark means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.
  • But remember – a CE Mark alone is no guarantee that a home test will be suitable for your needs.
  • No test is 100% reliable.

Before using a HIV self-test…

  • Be sure that the kit contains everything you need and make sure you have everything else you need.
  • Don’t rush.
  • You don’t have to test on your own if you are worrying about the outcome.

Read the instructions carefully:

  • Make sure you perform the test according to the instructions.
  • Make sure you know how the test should be stored if you don’t use it immediately.
  • Make sure you know how to read the test result.
  • Make sure you know what the results mean.
  • Make sure you know how to dispose of the test after use, especially if you are concerned with privacy issues.
  • Know who to consult for help if you need it when you know the result.

After using the test…

  • Don’t rush (yes, again)
  • Remember that no test kit is 100% reliable or accurate.
  • Regardless of the result, you will need to seek confirmation of the result by attending a clinical service and have a confirmatory test performed by a laboratory.
  • A negative result is not a license for unprotected sex.

Crunch time

More gay men need to test for HIV and they also need to test more regularly and more often. The decision is yours but once you have made it most of the hard work is done. There is a lot of support available out ether and you won’t be alone.

Useful links

Non exhaustive list of services offering free sampling kits

If you have suggestions to improve this article please get in touch.

~rjt

Update
07 apr 14: revised table (v2 & v3). Thanks to Roger Peabody for important feedback.
07 apr 14: revised table (v4 & v5) with added information.

Notes:The lack of preparedness of both Department of Health and NGOs working in the field of HIV prevention resulted in HIV home testing being legal before being available. Medical tests are subject to an EU Directive called the In Vitro Diagnostic Medical Devices Directive. Self-test kits cannot be sold within the UK or the EU unless they have been CE but there is little indication that the MHRA is prepared to approve a test very quickly.Regrettably, NGOs are conflating Home Sampling and Home Testing, a decision which will most certainly lead to confusion amongst users.Early in April 2014, Public Health England finally produced a guidance document on HIV Testing and Self-Testing – Answers to frequently asked questions.

This content is published under the Attribution-Noncommercial-No Derivative Works 3.0 Unported license.

 

The PARTNER study, a licence to bareback?

Absence of evidence is not evidence of absence. Does the PARTNER study signal the death of condoms or should we curb our enthusiasm, and carry on pretending we use them?

Partners Study Results

The preliminary results of the PARTNER study were one of the most talked about data presented at the CROI 2014 conference held in Boston this year. This multicentre study conducted across 75 centres in the EU was and still is looking at the risks of HIV transmission within couples where one partner is HIV-negative and the other is HIV-positive on treatment.

So far, the study has enrolled over 1,100 couples and based on an interim analysis including 16,400 occasions of sex in gay men and 28,000 in heterosexuals couple, no case of HIV transmission has been observed between an HIV positive person with a viral load below 200 copies/ml and their HIV negative partner (Read the Aidsmap report for more details and watch a video about the study).

Does this mean that gay men can finally ditch condoms with their HIV positive sexual partners on treatment? Well, it is not that simple.

We need to acknowledge that the results of the PARTNER study are preliminary but also that they are another stepping stone in a series of studies demonstrating that antiretroviral treatment can reduce the risk of HIV transmission, otherwise known as Treatment as/for Prevention (TasP). Before PARTNER, the HPTN 052 study conducted among heterosexual couples in Sub-Saharan Africa had already shown a 96% reduction in the risk of transmission. Other studies in KwaZulu Natal and Malawi have also showed reduced risk of HIV transmission even with limited treatment coverage. Further back in time, the 2008 Swiss Statement had already indicated that within specific circumstances, HIV infected individual could be considered as not infectious.

As always, it takes time for scientific results to diffuse from the scientific community to the public, and when it does, one can be sure it will trigger all kind of debates and arguments more than often entrenched in beliefs and prejudices than facts.

One of the key facts in the PARTNER study is that being on treatment is not good enough to prevent HIV transmission. Viral load of the HIV infected must be below 200 copies/ml, and the statistical analysis leading to the much publicised conclusion actually specifically excluded people with a viral load above 200 copies/ml, as were couples in which HIV-negative partners took PEP or PrEP or couples in which people did not attend follow-up visits. It also showed that infections could happen and often be attributable to sexual encounters outside an established relationship.

Nevertheless, taken together, existing study results support a conclusion that the Swiss Statement suggested 5 years ago. So what to make of it?

Whilst most of the community welcomed the news for its potential to affect the course of the epidemic, other have adopted a more prudent and critical approach. Kristian Johns, writing for GMFA is one of those for whom being on treatment for HIV is not a licence to bareback (He is not alone and his column for FS is only used here as a case in point).

“Lads, lads, lads. Let’s just rein in our penises and hold fire on the condom-burning for a cotton-picking second. No transmissions doesn’t mean there’s a zero risk of transmitting HIV, it just means there were no transmissions. Granted, it’s encouraging, but only as encouraging as playing Russian Roulette with a loaded gun and getting away with your head intact after multiple tries. There’s still a bullet in the gun, my friends. ” write Johns in the issue 141 of FS magazine.

Kristian raised here the very valid point that no observed transmission does not mean no transmission at all and later that viral load must be controlled and that some people did become infected by people outside their relationship, finally adding that “until we have a cure for HIV, or at the very least, a vaccine, there is no ‘new negative’.”

There aren’t, but there are HIV positive people who are very closed to be “new negative” and some sexual intercourses much closer to no risk of transmission than anything else abstinence or condom can offer. Data from clinical trials not only prove it but epidemiological records also confirm it.

What optimism and its counter-reaction (much less publicised and Kristian Johns can be praised for voicing his concerns, as should GMFA for printing them) indicate, is that facts and all the facts needs and must be explained because gay men can decide, based on an informed choice (which is something I believe FS stands for) to ditch or not condoms or to no longer feel guilty for not using condoms with some of their partners (and why not, start to enjoy sex again).

The reality is that, as individual, with a minimum of educational intent and effort, we can take control of our sexual life, and relax those clenched cheeks that make us looks like an uptight condom brigade Janissary.

If condoms work for you then carry on with using them, but as fellow writer Gus Cairns wrote “[the PARTNER study] confirms that we gay men have to change our ideas about infectiousness and HIV radically if we are to stand a chance of reducing HIV infection in our community.”

The message of the PARTNER study is not to ditch condoms but to change our understanding and beliefs about our risk of getting infected by HIV. Whilst serosorting, seropositioning and negotiated safety have failed to show real effectiveness, whilst PrEP is not available in the UK, whilst PEP is underused, whilst condom use is on the decline, treatment as/for prevention has shown a string of successes in reducing HIV transmission.

What the PARTNER study should forces us to do is to rethink our relationship with HIV status; it should forces us to question our preferences for sexual partners with an alleged or declared HIV negative status and our discriminatory attitude toward those HIV positive (until we become one of them).

What PARTNER, HPTN 052 and other treatment as/for prevention studies should do is not to lead us to react against the possibility of an HIV-free generation but to revisit our HIV prevention messages and beyond our HIV prevention strategies.

What the PARTNER study should not do is to throw us back into dualist and outdated debates about HIV prevention.

Institutionalised HIV prevention tends to be monolithic, and why bother with it if “Bareback feels good and there’s no amount of health promotion that’s going to convince penis-owners of anything else”, as wrote Kristian. That statement is in need of qualification. True, most people, whether they are gay or not, whether it is about HIV or not, will remain impervious to prevention messages of all sorts as long as they do not feel they are at risk. Look at 48-year-old Rachel Dilley, who recalls finding out she was HIV positive and never thought she could be at risk because she believed HIV only affected Black people in Africa.

For organisations involved in messaging prevention it is also a strong signal that they should get up to date with  the science, that they should be wary of engaging in partisan debate, that they should built on evidence, engage with the research at much earlier stage of development and work hard(er) to make complex information intelligible facts.

There is no doubt that HIV transmission could occur from those on treatment with a perfect, undetectable viral load, even if we have not seen it yet. But an upfront dismissal of is neither justified nor justifiable. It only shows an inability to move along with clinical developments. It deprives men, particularly those who do not use condoms, of a prevention choice that could protect them from becoming infected, as long as they understand the limitations of treatment as/for prevention. It stigmatises HIV positive gay men who do not need to be reminded that they still have HIV as the pill(s) they take everyday does that for them.

Treatment for prevention is not a magic bullet. Until there is a HIV vaccine, there is no magic bullet, not even in that gun that some use to play “Russian Roulette” with; but there are guns that jam and TasP is the first prevention intervention to actually jam that gun.

~rjt

Edit 30/03: clarifications and (some) typos.

This content is published under the Attribution-Noncommercial-No Derivative Works 3.0 Unported license.

 

HIV Home Testing: Opening Pandora’s Box?

HIV home testing may appeal to some people unaware of their HIV status and not prepared to visit a GUM clinic. However, home testing could lead to an increased attrition in the HIV cascade of care and treatment, as well as threaten sexual health and its management. Is the legalisation of HIV home testing opening Pandora’s Box? Is the UK health care system prepared to mitigate the risks?

Two recent reports are adding more information in the debate about HIV home testing and its potential outcomes when legally available from April 2014 in the UK.

The first is a study by Christopher Pilcher published in PLOS One which investigated the performance of a number of HIV point of care tests (Summary from AIDSmap).  The second is a modelling study by David Katz estimating the effect of replacing clinic-based testing with home-based tests on HIV prevalence among men who have sex with men (AIDSmap report here). Both studies were conducted in the US in geographically limited areas.

The first study showed that different HIV testing kits performed with substantial differences (unsurprisingly). Remarkably, the FDA-approved and market leader OraQuick Advance was unable to identify acute HIV infections which are suspected to play a key role in the ongoing epidemic amongst gay men and gave a correct HIV positive results in only 86.6% of all the case (saliva test). The second study, Katz’s study, concluded that replacing clinic-based testing by home testing could lead to more infections amongst MSM. The two approaches to testings are not mutually exclusive but one may well come to replace the other.

Taken together, the use  of  poorly performing  HIV testing kits at home could have a detrimental impact on the effort to reduce HIV incidence, leading to increased risk of transmission, increased prevalence and contributing to increased attrition in the HIV cascade of care/treatment.

The impact of a poorly managed HIV home testing strategy can be better understood looking at how and where it could impact the HIV cascade of care and treatment in the UK.

HIV Cascade of Care 2011

What HIV home testing could do is

  1. Increase the number of people who are aware of their status (positive and negative) and therefore lead to a higher number of people knowing they are infected. This is a good thing as it is estimated that a very large majority of HIV transmission can be attributed to HIV-infected people who do not know they are infected.
  2. However, there is no guarantee that such increase could translate in knowledgeable numbers. Indeed, current figures are known because diagnostic is performed in a clinical context. The knowledge will remain hidden to the health practitioners if after testing positive people do not visit a clinic to confirm their self diagnosis (positive and, why not, negative). At this point false negative could have a negative feedback effect, increasing the number of new infections if people wrongly identify as HIV negative and then engage in unsafe sex (with regular partners of casual ones).
  3. If users do not report to a clinic after testing positive for various reasons (one being stigma, that same stigma that prevented them to visit a clinic in the first place), attrition will increase between the number diagnosed and the number entering care, leading to fewer people entering or retained in care (for an article on attrition in the cascade of care see this AIDSmap report).
  4. This will trigger a domino effect oie whole cascade leading to …
  5. More people with uncontrolled or detectable viral load. And since viral load is correlated to infection rate, an increased risk for transmission.

But this is not all. It is important to look beyond HIV testing alone to understand the true extent and impact HIV home testing could have on the sexual health of the nation and its management.

An added-value of clinic-based HIV testing is that people are also tested for a whole range of other sexually transmitted infections. Testing is often tailored to people based on their sexual activity and practice. Hepatitis B and C, Syphilis, Gonorrhea, and Chlamydia infections are on the increase in the UK.

By testing in “the comfort of their home” users may actually contribute unwillingly to an increase in the number of STIs other than HIV. Taking into account that the presence of a pre-existing STI has been correlated with increased risk of both transmission and acquisition of HIV, are we sleepwalking into a disaster?

Testing in clinic is also an opportunity to address other health concerns (especially mental health). GUM clinics offer psychological support beside sexual health advice. Not attending a clinic will lead to less opportunity to offer people and those most vulnerable to infection with the help they may seek or need.

This may indeed sound like a disaster scenario, but the real disaster is that in a few months, a tool that could contribute to improve the health of the nation may indeed led to the exact opposite because none of the above has been thoroughly considered of thought through. Though inevitable, the decision to legalise HIV home testing has been based on limited and inadequate research and despite research predicting low uptake and weak contribution to improving diagnosis (at the same time, research investigating HIV home sampling in the UK has shown much more promising outcomes).

Plans to mitigate the risks arising from the legalisation of HIV home testing are found wanting. National prevention organisations and public health organisations are still not engaging seriously with the issue. Community preparedness, mechanisms to ensure linkage to care, and psychological support remain elusive.

Pandora’s box is open.

~rjt

Note: There is much more to say about the quality and performance of HIV testing kits and the regulations affecting their sale. With the EU devolving the decision to lift the ban on sale to member states, EU countries will have to set up their own mechanisms. In the UK kits should comply with MHRA regulations. More accurate 4th generation tests will be available but at a cost. They will improve sensitivity and specificity but won’t address other issues.

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World AIDS day at 25

After 25 World AIDS Day days, how are we doing? And do we still need a WAD?

It is the time of the year when activists and NGOs are going through the final preparation for the 1st of December, World AIDS Day  (though many will have started working on this year’s event as soon as last year’s WAD ended) the day to raise awareness about HIV and AIDS on a global scale.

WAD is nearly as old as the HIV/AIDS epidemic. It was conceived in 1987 by two WHO information officers, James W. Bunn and Thomas Netter with the approval of Jonathan Mann, then Director of the Global Programme on AIDS which later became UNAIDS. Starting in 1988 with “Communication” as its theme, the events as since adopted a new theme every now and then.

Since 2011 and until 2015 WAD’s theme has been Getting to Zero, that is “reducing new HIV infections, discrimination and AIDS related deaths to zero through increased advances and equal access to HIV prevention, testing, treatment and care.

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UK Workshop: Where are we in the search for an HIV vaccine?

Search for an HIV VaccineThere is not a month without an announcement that we are one step closer to an HIV vaccine or HIV cure or of any other revolutionary approaches that will once and for all put an end to an epidemic that has claimed more than 30 million lives. One day it is the great promise of an HIV vaccine developed in Canada, the other it is the great promise of eradication from a trial conducted in monkeys. But more than 30 years into the epidemic and despite announcements made soon after the discovery of the virus that a vaccine would only take a few years to develop, there is still no such thing as an efficient preventive or therapeutic HIV vaccine.

And there is a good reason for this: It is not as easy or simple as overhyped media announcements make it looks like.

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