Around one in ten of the over seven million people living with HIV in South Africa are not aware that they have the virus in their bodies. One way to ensure more people are diagnosed quicker is to make HIV self-tests more widely available - particularly to people who may not otherwise opt to have an HIV test.
The World Health Organization (WHO) defines HIV self-testing (HIV ST) as the process whereby an individual collects their own specimen (blood or oral fluid), performs HIV testing using an HIV rapid diagnostic test (RDT) and interprets the result themselves either assisted or unassisted.
According to Director of Ezintsha Professor Francois Venter, who is also the Deputy Executive Director of the Wits Reproductive Health and HIV Institute, each test is packaged with a set of easy-to-use instructions that dictates the step-by-step process that needs to be followed to obtain an accurate result.
He 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 swap in the mouth), applying it to the device, adding in the buffer and waiting the run time is standard (about 20 minutes).
“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 the test did not work. For HIV ST, additional materials both paper-based and digital are available to assist testers along the process,” he says.
CEO of the Desmond Tutu HIV Foundation Professor Linda-Gail Bekker says self-testing is quick, easy and discreet. “I think these tests need to be made more widely available. They should certainly accompany PrEP services,” she says. (PrEP stands for pre-exposure prophylaxis and involves taking antiretroviral medicines to prevent HIV infection.)
To demonstrate how easy it is to get the self-test and how one can do the test, Bekker ordered her HIV Self-Test 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 HIV Self-Test and how to safely dispose of it thereafter. (You can order an HIV Self Testing kit here.)
Policy in SA
Director of HIV Prevention Programmes at the National Department of Health (NDoH), Dr Thato Chidarikire says HIV ST often happens in the comfort of your own space and not always in a health facility. 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 ST since 2016 (HTS Policy, 2016) in alignment with WHO recommendations. Chidarikire says although data is still being collected and collated, it is currently estimated that around 775 000 people in South Africa have used HIV self-tests.
The target population includes the test averse and under-tested such as men, adolescent girls and young women, key populations including sex workers, men who have sex with men (MSM) and mobile populations including farmworkers and mine workers.
South African guidelines for HIV Self Screening published in 2018 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 HIV Self-Test. Through Department of Health and donor funding, the Orasure, Insti and Mylan tests are available for use in the public sector.
The Department of Health is procuring HIV self-test kits through the national tender for HIV rapid tests. The Global Fund and PEPFAR (the United States President’s Emergency Plan for AIDS Relief) are also procuring the 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.
Prices in the private sector range from around R100 to R300 per test kit. If you are considering buying a test kit, it is safest to buy one that has been prequalified by the WHO (see list above).
Pricing of the test kits has been a barrier especially for middle-to-low-income countries but a recent deal has resulted in reduced pricing that 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 a list of all registered HIV Self-Test kits in the country from the South African Health Products Regulatory Authority (Sahpra). Sahpra spokesperson Yuven Gounden says that a product registration call-out has not yet been done. Until such a call-out is done SAHPRA HIV self-tests are not subject to SAHPRA registration.
Apart from price, Gray says another hurdle in the past was that all HIV testing be preceded by pre-test counselling, and followed by professional counselling and interpretation of the result. The South African Pharmacy Council (SAPC) included a prohibition on the sale of HIV self-tests in the Good Pharmacy Practice standards.
“As self-tests were being sold in other outlets, we ended 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 their attention to the anomaly.
"We also published a paper in SAMJ (2010) and SA J HIV Med (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 all tests that are approved by the WHO need to meet very stringent requirements around accuracy. “Tests that are used in SA’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 (WHO prequalified) are considered to be 99% accurate,” he says adding that it is important to remember HIV ST (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 i.e., HIV self-testing kits 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, doctor or NGO using the full approved national testing algorithm, after which they will be referred to treatment if positive.
‘Liberating for one taking the test’
Gray says HIV ST has a very important role in reaching some hard-to-reach population groups, especially men who are reluctant to visit health facilities. However, the 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 that and adds that HIV is a stigma-associated topic for many regardless of whether you fall within the key population group or not and HIV ST gives everyone the option to know their status, at a time that is convenient, and, in a place, they would consider safe and confidential.
“It is, for this reason, I would say HIV ST 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 (within 15 minutes) test results,” he says.
“HIV ST 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 ST 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.
"The information, education and communication (IEC) materials are available in all official languages and include a range of contact details including additional mHealth solutions to ensure swift response and support where needed,” says Dr Thembisile Xulu, CEO of the South African National AIDS Council.
She further states that “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 ST 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 tests are free at clinics and price of HIV ST in pharmacy caters only for the employed,” says Venter. “There is a lack of awareness: a more committed, targeted, and aggressive marketing strategy for this concept would not hurt.
There is a lack of accessibility, if getting an HIV ST was as easy as going to work/a garage/tertiary institute and using the vending machine, the probability of HIV ST 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 ST awareness and acceptability, making this the ‘new norm’,” he says.
Immediate past president of the Pharmaceutical Society of South Africa Tshif Rabali says there is indeed uptake for the self-testing kits. “When it was first introduced, I was one of those that were sceptical.
At first, I was worried because I work in a previously disadvantaged community and I wondered how they will be able to use that. I was asking myself how is this 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.
Just before taking your call, I just ordered more kits, the ones I ordered last week are finished. Indeed, there is a good opportunity to use these kits,” he says.
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 that 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.