Prevention in Focus

Spring 2014 

Views from the front lines: Home-based HIV testing

We spoke to three people about their thoughts on home-based HIV testing in Canada:

  • Carol Major, Ontario HIV Treatment Network, Consultant
  • Dr. Nitika Pant Pai, Assistant Professor, Faculty of Medicine, Division of Clinical Epidemiology, Royal Victoria Hospital, Montreal, Québec
  • Julie Dingwell, Executive Director, AIDS Saint John, Saint John, New Brunswick

Carol Major

What do you think are the potential benefits and/or drawbacks of home-based testing in Canada?

Any test that will increase the numbers of at-risk people knowing their HIV status should be of net benefit. The OraQuick oral fluid test is easy to do, non-invasive (i.e., it doesn’t require a finger stick or needles), and is readily accepted. On the surface, it sounds great. However, there are a number of drawbacks that must be taken into account.

The relatively poor sensitivity is my first concern. The HIV home-based testing article points out that up to 10% of people with HIV infection will test negative using the OraQuick test. What it doesn’t explicitly state is that those who are in the “window period” and most likely to have a false negative, have early HIV infection, when their viral load is highest and they are most infectious. So, if the test is being used by those at risk to assess whether or not they should use protection, and they happen to be in the “window period” there is the potential for some very disastrous outcomes.

My background is HIV laboratory testing and I have experience with all the detailed technical issues that need attention to guarantee the reliability and accuracy of results. I should point out that the window period for oral fluid is from several days to weeks longer than it is for a blood test. Most standard lab blood tests now detect both antigen and antibody. The licensed HIV point-of-care (POC) test in Canada (bioLytical INSTITM HIV), detects antibodies in a drop of blood, up to several weeks earlier than the oral fluid test will detect antibodies. AND, if a person testing through an Ontario HIV POC testing site is in the window period and has a negative POC test, a standard blood test will be recommended and done through the program (in order to look for p24 antigen).

My second concern is the lack of what lab folks call “Quality Assurance.” All lab tests must be monitored to ensure they are performing properly. Once these kits are released onto the market, there is no provision to ensure they are performing as expected. Products can be affected by storage conditions, user variation, or could be subject to early deterioration due to contamination or subtle variations in any of the reagents in the product. Even though the Ontario POC testing program is not lab-based, it ensures kit performance with controls run at regular intervals, participation in an external quality assessment program (that is, blind samples sent to sites by a lab quality assurance agency, that must be tested and results sent back for assessment) and regular lab-based testing of a proportion of clients tested by the POC test. With all of these processes (and more), we are able to ensure consistent specificity and sensitivity (performance) of the INSTI test – the test used at Ontario’s POC sites.

The issue of counselling, support and referral is paramount. How can we ensure appropriate follow-up for those who are reactive (indicating a potential positive result), and those who are negative but potentially in the window period? Although the specificity of the oral fluid test is good, there will still be false reactive results. It is imperative that people with reactive home tests have a standard lab test to confirm the result.

Another concern I have is that home-based testing opens the door to coercive testing (i.e., partners testing partners, pre-employment, school admission, etc.). We have worked hard to ensure that HIV testing is voluntary and if desired, anonymous. Putting this test into an uncontrolled market place, puts that in question.

I don’t really think the Home Access type of test where the client has to prepare a dried blood spot from a finger stick is really in the running. It has not done well in the U.S. and is not an attractive alternative for people who wish to have an HIV test. It is invasive and you have to wait up to two weeks to get the results. On the other hand, as the test is actually done in a lab, many of the quality issues are not of concern. Collecting a dried blood spot for oneself is not easy though, and many users may not get a result as the sample they collected and sent in will be inadequate.

Do you think home-based testing has a role to play in Canada? Please tell us why.

Clearly, I have some very serious reservations about the use of an oral fluid home test in Canada. Having said that, we still have a significant number of people living with HIV infection who have not been diagnosed, and whatever would facilitate those people learning about their HIV infection would be welcome.

We will need to be strategic in the use of these tests, so that they could facilitate those least likely to come forward for any type of professional service to be tested. Perhaps they would be useful under some type of supervision in outreach settings with vulnerable populations? Where people could do the test themselves, but have support close by to ensure appropriate counselling and follow-up.

The kits are, however, very expensive and so there would need to be a compelling cost benefit to use these tests in addition to the currently licensed POC tests.

Making this test available over the counter, is likely to increase testing for affluent, worried well and potentially some people who may have been or are at risk for HIV, but are unwilling to approach a care provider for fear of disclosing personal details. That could be a good thing, but again the concern is how to ensure the continuity of care for those who do test reactive? As we expand our focus on access to care, treatment adherence and viral suppression, otherwise referred to as the “treatment cascade,” there is the need for more interaction with the healthcare system, at least initially after testing positive, not less. The concern with self-testing is that these opportunities to engage HIV-positive individuals with the healthcare system may be delayed or lost. And, of course, we would need to address the issue of ensuring the ongoing quality of the results.

Do you think self-testing has a role to play in settings such as emergency rooms or community-based agencies?

The bioLytical INSTI HIV test is licensed in Canada for POC HIV testing. Its sensitivity and specificity are better than the OraQuick kit, so there is no advantage for emergency rooms to move to a more expensive product with poorer performance.

Community-based agencies can also use the current POC test as long as there are trained staff available to provide the service. There might be an additional role for an innovative outreach program with a self-test to encourage vulnerable populations to learn about their HIV status. We would need to ensure that appropriate counselling, support and referral was in place in these settings, in order to ensure the continuum of care.

What are the conversations that would need to happen in Canada to prepare us for the possibility of home-based testing? Who should be part of that conversation?

Canada needs to establish its own acceptable performance specifications (sensitivity, specificity). We need to consider whether we are prepared to give up sensitivity for wider test coverage; as well as the potential fall-out from the sensitivity issues and increased HIV transmission versus the increased diagnosis of those who were unaware of their HIV infection

We need to determine if the test needs any safeguards (i.e., distributed by specific professionals – medical, social, etc.) or some type of quality assurance to ensure kit performance over time.

We need to consider follow-up if the test is made widely available and outside a structured counselling setting/healthcare interaction. How can we support those who test positive and ensure they receive appropriate counselling and referral?

We need to consider the financial costs. Is it all user pay, or is there some benefit to using these in a prevention program setting?

Parties with an interest in this discussion would include: federal and provincial laboratory experts, Health Canada Therapeutic Products Regulators, HIV community leaders and legal experts, community agencies, healthcare funders, provincial HIV organizations and social justice groups.

This is a complicated issue. We want people living with HIV to learn about their infection so they can get care and reduce further transmission. Any advance in technology that would assist us with that is welcome. But, we do need to ensure that the new technology will be a net benefit and not ultimately cause more problems than it solves.

Dr. Nitika Pant Pai

What do you think are the potential benefits and/or drawbacks of home-based testing in Canada?

The benefits of home-based testing include expanded and timely access to confidential and private HIV testing. It could also lead to earlier engagement with testing in marginalized populations, and the process of testing becoming de-stigmatized. Because conventional tests will always be needed to confirm a positive or negative test result, self-testing will always be an adjunct to conventional testing and will only serve to expand the reach of conventional tests. If introduced carefully, economically and judiciously, it could help bring the 25% of Canadians who are lost to follow up after conventional testing into care and support.  It will also help introduce early treatment to the percentage of people that show up in hospitals with advanced HIV infection.

Canada is only starting to open up to the possibility of introducing point-of-care testing in a big way. Self-tests are a special subset of point-of-care tests intended for over-the-counter use. With this paradigm shift in testing that is to happen, the lessons learned in introducing self-tests for HIV will have implications down the road for many other point-of-care tests that will become self-tests in the future.

There are also two major drawbacks to home-based testing. If the cost of home-based testing kits is high, it may impede the uptake of testing by the marginalized people who need it the most. Companies need to think big and to think of providing quality products at affordable prices. A $20 price point is much more reasonable than a $40 price point. We need many more companies in the business of self-tests, to help bring prices to affordable levels. As with pregnancy tests, for example, we need to offer a choice of HIV self-tests.

Most importantly, we need mechanisms in place to ensure timely linkages to care for people who test positive through home-based testing. If such pro-active counselling and linkages to care and support are not offered efficiently, self-tests won’t be able to make a huge impact in getting more HIV-positive people into care.

Oftentimes, stakeholders need to work to introduce a policy that will work best for the populations they care the most about. Those policies should facilitate access to testing and treatment. If regulations are tightened, and policies make it hard for confirmatory tests to be made available in time, then the whole process can backfire. The Centers for Disease Control and Prevention (CDC) in the U.S. is a great example of the successful introduction of many point-of-care tests. Besides, several different models of implementation of self-tests and point-of-care tests are being thought through globally and we in Canada need to look at those examples and learn from them.

Do you think home-based testing has a role to play in Canada? Please tell us why.

Of course home-based testing has a role to play in Canada. Home-based testing could be a preliminary screening/triage strategy that will only expand the reach of conventional testing and, if successfully initiated, make antiretroviral therapy (ART)-based prevention strategy a successful reality. Timely ART initiation will also improve the health of people living with HIV, besides controlling associated co-infections. One thing can benefit another. However, linkage to care and treatment are crucial.

Home-based testing has niche populations. On the one hand, it is intended to cater to populations that are hard to reach – especially those that are isolated – while, on the other hand, it also offers a private, convenient, rapid and desirable option to test for those who have the ability to pay. Aboriginal populations, immigrant women and commercial sex workers that are hard to engage in testing initiatives will also stand to benefit. Men who have sex with men are the population most likely to be open to accepting new technologies, are the hardest hit by HIV, and are willing to pay and may demand self-tests in clinics.

HIV today is a manageable disease but some communities are still living in fear of a getting a diagnosis. Some people are afraid to take a test – the prejudice and discrimination experienced by some on the basis of a test result also adds to that fear. Prejudice and discrimination need to be addressed and stigma needs to be talked about. Policies (and laws) need to be amended in parallel. We cannot live in the past. We need to make the most of the present – with the tools that we have – in the most patient-sensitive manner. Self-testing offers some hope…and it is just one potential solution.

Several different options to offer self-testing are possible – creative solutions and innovations are also needed in clinics.

Do you think self-testing has a role to play in settings such as emergency rooms or community-based agencies?

Emergency rooms will stand to benefit from a choice of HIV point-of-care tests, which may include self-tests.

Community-based agencies can serve a role in engaging populations in the process of testing and perhaps could offer self-testing initiatives.

What are the conversations that would need to happen in Canada to prepare us for the possibility of home-based testing? Who should be part of that conversation?

In 2012, we organized a point-of-care workshop at the Canadian Association for HIV Research (CAHR) conference in Montreal, where we talked about self-testing and we were surprised at the level of interest and demand. Many community organizations raised the issue of making self-tests available in Canada.

Some of the conversations that need to begin are:

  • Advocacy and debate. We need to organize workshops to talk about self-testing. We need several different representatives who could talk about moving forward not backward. A few steps forward and one step backward won’t get us anywhere.
  • Implementation research. Research on best strategies that will help implement and scale up self-tests is urgently needed. Successful projects from other countries are useful lessons. We recently successfully evaluated an unsupervised self-testing strategy in South Africa. Our lab has been involved in some innovations. We have developed a smartphone app (HIVSmart!) that can help engage and inform any individual who wishes to self-test in the process of testing and also help facilitate linkages to care while providing counselling. We are keen to adapt our HIVSmart! (app and internet) strategy to Canada and conduct some clinical studies to prove its utility in Canadian populations. We have also evaluated an unsupervised self-testing strategy in student populations in Canada with good results.
  • Cohesiveness. Beyond research, we would like the HIV community to come forward and dream of making the control of HIV infection a reality. Cohesiveness is the need of the hour – not doubt.
  • Look to the future and learn lessons from other countries. The U.S. led the way with approval of self-tests by the FDA, and now Britain, France, Amsterdam and Australia are working hard to make self-tests a reality. So why not Canada? We must also be willing to learn from outside the developed country rubric – countries such as Kenya have a policy on self-testing. Other countries, like Malawi and South Africa have generated evidence on their successful implementation. We need to learn, grow, adapt and apply them here and make Canada a better place.

Julie Dingwell

What do you think are the potential benefits and/or drawbacks of home-based testing in Canada?

There are several potential benefits. Home-based testing could provide increased anonymity around testing, thus reducing concerns around privacy. Home-based testing also provides an option that could reduce wait times for testing and reduce the anxiety around waiting for test results. Home-based testing may also be more cost-effective than clinic-based testing. Home-based testing could also improve access to testing, resulting in more people opting to test and encouraging more regular testing. For example, people living in rural areas would be able to order kits through the mail. As we know, increasing the ability to find people living with HIV has two benefits. We know that most people who test positive for HIV reduce their risk of spreading HIV. But equally as important, people who test positive have the option to take care of their health before getting sick.

While there are several potential benefits, there are also some potential drawbacks to this type of testing. Due to the cost of the test, some people who could benefit may lack the resources to purchase the kit. Marginalized populations who test positive may not receive adequate follow-up care and there is the potential for lack of follow-up with partners after a positive test. There is also the risk of violence if a partner is present during testing and there is a potential for self-harm if the results are positive. Finally, there is the potential for false-negative results, which could result in people thinking they are HIV negative when they are in fact HIV positive.

Do you think home-based testing has a role to play in Canada? Please tell us why.

Yes, I think home-based testing may have a role to play in Canada. It is important to allow people choices and control around their health. Home-based testing provides another option for testing and the more options people have, the more likely they will test. Furthermore, the ease and convenience would make it a very attractive option to many. Stigma and discrimination are thought to play a role in why people choose not to get tested and home-based testing could provide an avenue to avoid this. It could also be used in different ways than conventional testing. For example, people could have tests on hand allowing them to test themselves and potential partners before engaging in sex. However, as mentioned above, this could arise in someone receiving a false-negative result because they are in the window period, or could result in someone being forced to test against their will.

Do you think self-testing has a role to play in settings such as emergency rooms or community-based agencies?

Yes, I think self-testing could be used in different settings. Many people at risk for HIV do not have family doctors and often turn to urgent care centres (emergency departments) for meeting basic needs. For example, in New Brunswick, people over the age of 19 years without access to a family doctor are referred to a public health nurse at the Community Health Centre or urgent care for testing for sexually transmitted infections. Furthermore, AIDS service organizations are a natural choice for many people when they think about getting tested. Oral self-testing kits could also be made available in places like bathhouses where fast and accurate testing could help reduce exposure to HIV. It also creates another avenue to provide additional information to people who test, such as on hepatitis C testing.

What are the conversations that would need to happen in Canada to prepare us for the possibility of home-based testing? Who should be part of that conversation?

We need to talk about why we need to step-up the availability of home-based testing and how to provide funding for those who could not afford to purchase the test. Many people need to be part of the conversation including service providers, public health representatives, Health Canada and potential users. These need to be national consultations but not necessarily face-to-face meetings. Such dialogue could include webinars and conference calls – there are many ways to have conversations.

Related article

For more detailed information on home-based testing, see HIV home-based testing: Potential benefits and ongoing concerns.