About one in 10 of the more than 7 million people living with HIV in South Africa are not aware that they have the virus. One way to ensure that more people are diagnosed quicker is to make HIV self-testing kits more widely available – particularly to people who may not otherwise opt to have an HIV test done at a facility.
The World Health Organisation (WHO) defines HIV self-testing as the process whereby an individual collects their own specimen (blood or oral fluid), performs HIV testing using an HIV rapid diagnostic test and interprets the result themselves, either assisted or unassisted.
According to professor Francois Venter, deputy executive director of the Wits Reproductive Health and HIV Institute, and director of Ezintsha – a group of South African academics and health professionals – each test is packaged with a set of easy-to-use instructions which dictate the step-by-step process that needs to be followed to obtain an accurate result.
Venter says the details of each step will differ from kit to kit, but the overall principle of obtaining a sample (this can be a prick on the finger or a swab of the mouth), applying it to the device, adding in the buffer and waiting for the run time to complete (about 20 minutes) remains the same.
“Interpretation is standardised too, where two lines indicate a positive result, one line means you are HIV-negative and no lines or a missing control line indicates that the test did not work. For HIV self-testing, additional materials, both paper-based and digital, are available to assist testers along the process,” he says.
Professor Linda-Gail Bekker, chief executive of the Desmond Tutu HIV Foundation, says self-testing is quick, easy and discreet.
“I think these tests need to be made more widely available. They should certainly accompany PrEP [pre-exposure prophylaxis] services,” she says.
PrEP involves taking antiretroviral medicines to prevent HIV infection.
To demonstrate how easy it is to get the self-test and perform it yourself, Bekker ordered an HIV self-test kit and did it at her home. It was quick and easy; after 20 minutes she had her results. Her package had all the instructions on how to use the kit and how to safely dispose of it afterwards.
Policy and quality assurance
Dr Thato Chidarikire, director of HIV prevention programmes at the national health department, says HIV self-testing often happens in the comfort of your own space. There is an option, however, where an individual may need support and they can get this from a trained provider. This is called assisted HIV self-testing.
The South African government has supported HIV self-testing since 2016 –through the HTS Policy – in alignment with WHO recommendations.
Chidarikire says although data is still being collected and collated, it is estimated that about 775 000 people in South Africa have used HIV self-tests to date.
The target population includes the test-averse and undertested, such as men, adolescent girls and young women; vulnerable populations including sex workers and men who have sex with men; and mobile populations including farmworkers and mineworkers.
South African guidelines for HIV self-screening clearly stipulate which type of tests should and can be used in both the public and private sector.
For the public sector, only tests that are WHO pre-qualified can be used. Currently, there are four pre-qualified tests available – OraQuick (Orasure Technologies), Insti (Biolytical Laboratories), SureCheck (Chembio) and Mylan.
The department is procuring self-test kits through the national tender for HIV rapid tests. The Global Fund and Pepfar (the US President’s Emergency Plan for Aids Relief) are also procuring test kits for use in communities in South Africa.
For the private sector, the minimum requirement is for a test to have Conformitè Europëenne (CE) or Food and Drug Administration approval, with being WHO pre-qualified an added bonus.
There are several tests available on the private market, some of which are not approved and should not be sold.
Barriers to access
Prices in the private sector range from about R100 to R300 per test kit. If you are considering buying one, it is safest to buy a test kit that has been prequalified by the WHO.
Pricing of the test kits has been a barrier, especially for middle- and low-income countries, but a recent deal has resulted in reduced pricing, which should increase access.
Andy Gray, pharmacist and senior lecturer at the University of KwaZulu-Natal, says there are a limited number of quality-assured manufacturers in this space, so the prices demanded remain higher than desired.
However, he says, the recent Unitaid-negotiated intervention has the potential to reduce prices in a large number of countries.
Spotlight requested from the SA Health Products Regulatory Authority (Sahpra) a list of all registered HIV self-test kits in the country. Sahpra spokesperson Yuven Gounden says that a product registration call-out has not yet been done. Until such a call-out is done, HIV self-tests are not subject to Sahpra registration.
Apart from price, Gray says another hurdle in the past was that all HIV testing had to be preceded by pre-test counselling and followed by professional counselling and interpretation of the result.
The SA Pharmacy Council (SAPC) also included a prohibition on the sale of HIV self-tests in its Good Pharmacy Practice (GPP) standards.
“As self-tests were being sold in other outlets, we ended up with the ridiculous situation where one could buy them in a supermarket but not a pharmacy. A group of us – Marlise Richter, Francois Venter and I – wrote to the SAPC and drew its attention to the anomaly. We also published a paper in the SA Medical Journal (2010) and the Southern African Journal of HIV Medicine (2012) to highlight the issue. The SAPC eventually accepted our proposal, and then published an amendment to the GPP standards (2017), removing the prohibition and updating the advice to pharmacists,” he says.
How accurate are self-tests?
Venter says that all testing kits that are approved by the WHO need must meet stringent requirements around accuracy.
“Tests that are used in South Africa’s public sector need to be validated and verified by the National Institute of Communicable Diseases prior to lot release. Bearing in mind that these tests are screening tests and positive results need to be confirmed by a healthcare worker if the results turn out to be positive or invalid, the tests that have been approved by WHO are considered to be 99% accurate,” he says, adding that it is important to remember that HIV self-testing, regardless of blood or oral-based sample types, are antibody tests and will only be able to pick up infection after 12 weeks of exposure to virus. The test cannot pick up virus if a person is in the window period.
Chidarikire says if the test is positive, one should get their status confirmed at a healthcare facility using the approved national testing algorithm, after which they will be referred to treatment if positive.
‘Liberating for one taking the test’
Gray says HIV self-testing has an important role in accessing some hard-to-reach population groups, especially men who are reluctant to visit health facilities. However, systems need to be in place to assist people who do test positive and to ensure that those who test negative know how to interpret the result.
Venter echoes this and adds that HIV is a stigma-associated topic for many regardless of whether you fall within the key population group or not, and that HIV self-testing gives everyone the option to know their status at a time that is convenient and in a place they consider safe and confidential.
“It is, for this reason, I would say HIV self-testing is liberating for the one taking the test as they are able to take personal control of their health. In addition, the tests are easy to use, accurate in relation to clinic-based tests and they provide quick test results [within 15 minutes],” he says.
Says Dr Thembisile Xulu, chief executive of the SA National Aids Council: “HIV self-testing kits have largely been paid for and distributed by donor-funded organisations. South Africa is one of the only countries in the world that procures HIV self-testing kits through their testing budget to increase accessibility. There have been some initiatives to promote the kits, but we certainly need to do much more. Information, education and communication materials are available in all official languages and include a range of contact details including additional mobile health solutions to ensure swift response and support where needed.”
“There should be adequate information to empower people so they don’t harm themselves. Promoting a culture of regular testing needs to be scaled up so that people are comfortable with the idea to self-test in the comfort of their homes.”
Bekker says HIV self-testing has the potential to expand and make testing more accessible – like pregnancy testing – and so should be wholeheartedly embraced.
Bekker says information, cost and availability are limiting the uptake of self-testing.
“Price is a challenge, considering that tests are free at clinics and the price of HIV ST in pharmacy caters only for the employed,” says Venter.
“There is a lack of awareness – more committed, targeted and aggressive marketing strategy for this concept would not hurt.”
“There is a lack of accessibility – if getting an HIVST was as easy as going to work/a garage/tertiary institution and using the vending machine, the probability of HIV self-testing as a testing option would be much higher.”
“Promoting the concept at universities, wellness days, places of work, churches and through social media would potentially contribute to broader HIV self-testing awareness and acceptability, making this the new norm,” he says.
Tshif Rabali, immediate past president of the Pharmaceutical Society of SA, says there has been uptake for the self-testing kits.
“When [the kits were] was first introduced, I was one of those who were sceptical. At first I was worried because I work in a previously disadvantaged community and I wondered how they would be able to use them. I was asking myself how this was going to work.
“However, the younger generation seems to be embracing it a lot and using it often. In my pharmacy, the age group between 21 to 45 are really buying these self-testing kits and using them. I just ordered more kits; the ones I ordered last week are finished,” he said.
Xulu admits that self-testing kits may not be for everyone, so it is important that the public is aware of how and where to access information, both at facility and community level.
“As a country, we need to do much more to scale up the accessibility of self-testing kits by tapping into various distribution channels that are easily accessible to people, such as community-based access points, facility-based access points and workplace-based access points,” she says, adding that if used correctly and with adequate information to empower end users, HIV self-testing kits are some of the most important tools at our disposal which could potentially promote a culture of regular testing for HIV.
“Early detection of HIV and initiation on antiretroviral therapy enables infected persons to enjoy a longer, healthier life. The kits could even contribute towards the elimination of HIV-related stigma and discrimination by making HIV testing popular in communities. We certainly need them, alongside suitable education around their use,” says Xulu.
- This article was produced by Spotlight, health journalism in the public interest