Please can you give a brief introduction to HIV home tests?
30 years into the HIV epidemic, there is no vaccine in sight. Yet, even though there are fantastic and effective cheap and universally available drugs, and a treatment as prevention strategy is known to work, people do not wish to get tested for HIV! If everyone got tested, and treated, we could have brought the infection under control a long time ago!
We have as a society made great progress with biomedical tools, drugs and strategies, but we haven’t conquered HIV related stigma and perceived discrimination. Social embarrassment, shame, judgemental attitudes of providers, fear of visibility and fear of lack of confidentiality prevents people in rich and poor endemic settings to come forward and seek an HIV test.
To quote UN Secretary General Ban Ki Moon on HIV related stigma: "Stigma remains the single most important barrier to public action. It is a main reason why too many people are afraid to see a doctor to determine whether they have the disease, or to seek treatment if so. It helps make AIDS the silent killer, because people fear the social disgrace of speaking about it, or taking easily available precautions. Stigma is a chief reason why the AIDS epidemic continues to devastate societies around the world."
Is it any surprise that as much as 50-60% of people living with HIV worldwide do not know their HIV status? Why is that important? For once, science has many tools and biomedical strategies that are known to work, yet their uptake seems to be limited by a societal problem: HIV stigma.
To offset stigma, we need a de-stigmatized, de-mystified, personalized, preferred, confidential option; and that option is HIV self-testing!
I firmly believe that access to an HIV self-test will help improve access to screening, reduce the scare and visibility, judgement and perceived attitudes and misperceptions around HIV testing and truly engage individuals.
Think of a pregnancy test. Many of us women have used one in our lives. It is an example of a urine based self-test, which provides a preliminary result that requires confirmation at a laboratory or clinic.
HIV home tests work similarly except that they are performed in oral samples, and if positive, definitely require confirmation at a clinic (which can be arranged in various ways), and can provide results in 20 minutes. They are non-invasive, convenient, do not involve a finger stick or blood from your arm for a preliminary screen. They are also robust and work at a wide range of temperatures.
How do these tests work?
In 2012, the US FDA approved an oral antibody based rapid point–of-care test. It requires an individual considering to test, to buy the test kit and then, follow instructions that are available in the booklet to use the test kit.
The self-tester swabs around the insides of his/her mouth (gum lining in particular), ONE TIME AROUND for the oral sample, using the kit’s flat pad. Once that is done, he/she sticks the flat pad containing the sample into a vial containing a solution that allows the fluid to react and give a test result. From then on, one needs to wait for 20 minutes to obtain a test result.
After 20 minutes, the self-tester reads his/her result. A single line in the test window means that the HIV test is negative. Double lines in the test window mean that the test is positive. A faint double line will also imply that the test is positive.
To interpret the self test result themselves, some may find it helpful to call a confidential 1-800 number provided with the kit. Counselling provides re-assurance to a lay individual. Our research in Canada and South Africa and several other research studies in US and other settings, show that those that obtain a positive result always wish to call and seek counselling.
Counsellors can connect you to a laboratory for confirmatory testing confidentially, and also offer advice and support if one is anxious or stressed. Counsellors will also help with arranging referrals to a community or hospital clinic of choice and eventually help you start your treatment quickly.
Those that obtain a negative test result should ideally also call the counsellor. This call will reassure them of their result and also encourage them to re-test in 3 to 6 months, if they practice risky behaviours, or have not seroconverted, and desire to repeat self-testing in future.
It is important to note that these self-tests offer preliminary results: they always require a confirmatory laboratory testing for a positive.
How do these tests differ from traditional HIV tests?
Traditional HIV tests are performed in facilities – they involve scheduling, long lines to get tested, visibility, and wait time to get a result. These conventional laboratory based HIV tests are not rapid tests; they are performed in blood or serum samples at a reference laboratory, with specimens that are pooled in batches, therefore they take time. Time taken to deliver results ranges from one week to 3 weeks depending on the site, setting, country (or, in sum, context).
Oral HIV self-tests used at home require only an oral sample and offer preliminary results in about 20 minutes, in total confidentiality and privacy.
What are the benefits of HIV home tests?
Societal perspective: game changers
Community perspective: tools for community engagement and expanded access to screening
Individual perspective: proactive tools for fast, rapid, accurate, convenient, preferred, non-invasive, confidential, pain free, time saving preliminary screening!! (aka the pregnancy test equivalent for infectious diseases)
Health systems perspective: Time savers, resource savers, allow for targeting screening of individuals that need the resources the most.…Allow the focus to be shifted to the positives to get them into care. The negatives could re-test themselves and come in for care if needed. Allow for expanded reach of counsellors.
However, the costs of these self-tests must be kept reasonable. A “Walmart” approach to selling these tests must be adopted, i.e. big volume of sales brings down the cost per test kit. And even though the price of each test could be reduced, the huge number of kits sold globally will ensure profit for companies.
Reducing costs of these tests will allow for expanded access and agencies could negotiate prices for countries.
Countries must offer them linked to counselling and referral systems. Counsellors are available in countries; the challenge is setting up or linking these systems, strategically and thoughtfully
Why is it important for HIV to be diagnosed early?
An early HIV diagnosis saves money and costs to the individual, and the health care system.
Statistics in North America show that many individuals (40%) show up late for care often with advanced late stage HIV or AIDS increasing hospitalization costs. And of those tested in facilities (25%) are lost to follow up.
Early HIV diagnosis in a pregnant woman allows for early and timely initiation of HAART that significantly reduces chances of transmission (less than 2%) of HIV to her infant. Timely and early treatment also reduces the chances of passing the infection to the partner (about 96%).
How frequently should you be tested for HIV?
If you share needles, have a history of frequent episodes of STDs, have multiple sexual partners then, the CDC & P Atlanta, recommends that one should seek frequent HIV testing. By frequent, I mean every 3-6 months depending on the personal risk level for HIV—it takes about 3 months to seroconvert (to develop antibodies to the virus, so that it can be detected). Otherwise, we should get tested once every year.
Are HIV home tests as accurate as traditional HIV tests?
We reviewed evidence on the same oral tests that were evaluated in research settings, and found that their pooled accuracy was as high as 98% in oral samples and 99.5% in blood samples. If the same tests are being used as home tests, then their accuracy (sensitivity) will be high. The specificity of these tests is close to 99.99%. Citation (Pant Pai et al, Lancet ID, 2012).
Are there any limitations of HIV home tests?
These tests are antibody based in that they cannot pick up new infection (before seroconversion). So, if we had an unprotected exposure last week and would like to know our status today, then we must wait for 90 days for the tests to be accurate.
We must read instructions to self test and follow instructions carefully. Care has to be emphasized in reading the test result and communicating these results confidentially with a counsellor on the phone will also help a self tester engage with further testing if needed.
How much do HIV home tests cost?
Home tests are currently priced at 40$. A reasonable price range for a developed setting could be 10-20$. For developing settings, 7-10$ should be a good target price.
I think with a global market ready to absorb them, a high price of these tests will be a deterrent in their widespread uptake.
To this you cannot discount the dreaded potential introduction of cheap, fake and poor quality tests in developing countries with weak regulatory oversight.
How can HIV home tests be accessed?
Only a few countries (US, Singapore, Kenya) have approved HIV home tests for sale over-the-counter, such as in pharmacies – that’s not the case yet for Canada, UK, France. In general, they could be made available in pharmacies and clinics, or could be prescribed.
How popular have HIV home tests been so far?
In the US, their approval in July 2012, was met with widespread optimism. It remains to be seen as to how well they have performed in bringing people to care. Post marketing surveillance data will reveal these results.
Anecdotal reports suggest that online sales of these tests are on the rise. Anecdotal reports suggest that Canadians travel across the border to access these self tests. So the time is ripe to consider their introduction in Canada.
Globally, the Gates foundation, Grand Challenges, PATH and Wellcome Trust are involved in funding feasibility studies to generate proof of concept feasibility data on self testing. We need to integrate and link counselling and referral systems with these self tests, simply offering them over the counter wont be useful in many health systems.
But the good news is that today there is a huge global momentum in favour of self-testing strategies.
If HIV self-testing strategies prove to be a success, then, self-testing options may be exercised for other co-infections like Hepatitis C (that has a highly accurate non invasive oral test as well), and a few other STDs that depend on non invasive vaginal swabs or urine samples (i.e., Human Papilloma Virus, Chlamydiae and Gonorhea) These infections are highly prevalent in global settings and will prevent pre term birth, still births, prevent sequelae of infections and cancer.
With personalized medicine knocking on our doors, the possibilities of the home test concept expanding into infectious diseases are endless. It is good to try out those possibilities with a stigmatized infection like HIV that will help pave the way for others to follow suit.
What can be done to encourage people to use HIV home tests?
Awareness and education needs to be spread through social media, television and internet.
Political figures or key opinion leaders in every country could talk openly about getting tested using private options. This approach will help bring more individuals that need services into care. A one size fits all strategy will not work. Every country will have to figure out the best way to reach its people. Social media can help engage people in conversations about testing. And gentle introductions regarding these tests will help demystify HIV.
Talking about it is the first step in overcoming stigma and perceived discrimination.
People in Africa, are not aware about HIV oral rapid tests. And if they are, they sometimes doubt their accuracy. These myths need to be dispelled first. The only way to do so is through effective health communication messages.
Do you think HIV home tests will help to slow the transmission of HIV?
I do think that HIV home tests will prove to be useful tools to improve access to confidential, private, patient preferred, convenient, time saving HIV testing. If those that find themselves positive seek confirmatory testing and get linked to care within a reasonable time window, then, by putting themselves on treatment they will reduce the chance of passing infections to their partner, their children and eventually their communities. This will eventually benefit health systems of countries, and economies, with individuals living longer with HIV and the infection under control in countries!
What do you think the future holds for HIV self-testing?
Having spent a decade on developing innovative strategies to bring people to care using point-of-care tests, I think that the time has come for us professionals to take a proactive approach to HIV testing.
This out of the box self-testing strategy will however be “the middle path”—it will seek to supplement facility based testing. It may not cure all that is not right about HIV testing process and its service delivery and integration issues, but it will certainly help create and offer more testing options to people globally, especially if they’re not comfortable and are not exercising current testing options.
All stakeholders in the testing and counselling space have a calling to bring people to care and this could well be a strategy waiting to be tried…And, as a public health physician, and professional, that is my public health wish!
It has recently been reported that a baby girl born with HIV was cured after very early treatment. Do you think this treatment will work for others?
This report talks of a functional cure, the virus has been reduced to very low levels and the body can control it without the need for drugs.
Early and timely and aggressive treatment given to infants can prevent the virus from replicating and hiding in reservoirs of the body. This phenomena is similar to that seen in elite controllers that can also suppress the virus to undetectable levels without treatment.
This report is fantastic news of providing early aggressive treatment to newborns that can help live without the need for taking medicines. But for that to happen, in resource limited settings, intensive monitoring will be required and women will need to deliver at a facility!
For now, it is safer to ask pregnant women to get tested early on and get on to treatment if positive.
Where can readers find more information?
There are so many but these are the top sites:
My website is www.nitikapantpai.com
About Dr Nitika Pant Pai
Nitika Pant Pai is an Assistant Professor in the Department of Medicine (Divisions of Clinical Epidemiology and Infectious Diseases), at McGill University and McGill University Health Center, Montreal, Canada.
Her Global research program in vulnerable populations is focused on evaluation of innovative screening strategies with “Point-of-care (POC) tests” for HIV and related co-infections.
She is a recipient of CIHR New Investigator Award recipient, Grand Challenges Canada’s Rising Star in Global Health Award 2011 and Chanchlani Global Health Research Award from McMaster University 2012.
She is currently focused on developing innovative synergistic self-testing strategies for HIV for three countries (i.e., South Africa, India and Canada). She has also evaluated simultaneous screening strategies with point-of-care tests and multiplexed tests in Mumbai, India and (Montreal, Canada. Her research work is supported by grants from CIHR, Grand Challenges Canada, and the Bill and Melinda Gates Foundation.
Her team has recently developed an HIV self -screening smartphone application (Android and Iphone), an internet self testing program and paper based instructional self testing packages, with funding from Grand Challenges Canada. The team is also evaluating barriers to implementation of point of care technologies for HIV and related co-infections including barriers to self testing – a project that is funded by the Gates Foundation.
Her work has been featured on the CTV, CBC, Reuters, Huffington Post, The Toronto Star, The Vancouver Sun, The Montreal Gazette, Radio Canada, Times of India, The Hindu, La Metro, CBC, The Scientist, Daily Mail UK.
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