COVID-19 demonstrated the power of a potential game-changer: self-tests

More than likely, sitting in a cupboard somewhere in your home or office there is a revolutionary technology that has forever changed health systems around the world – the COVID self-test.

“COVID was a profoundly mind-changing moment for self-testing for many people,” said Pavlo Smyrnov, deputy executive director of the Alliance for Public Health in Ukraine. “The idea that a medical test can happen without a doctor and outside of a lab, that was a shock for the general public.”

After more than two years of routinely swabbing ourselves for COVID in advance of meetings, flights, and family gatherings, self-testing is now normalized and expanding. Today, self-tests are available for COVID, HIV, syphilis, and hepatitis C (though the latter is not yet quality assured), with more in the works.

Exemplars News spoke with health leaders about how health systems in low- and middle-income countries are leveraging the power of self-tests to provide critical medical information and diagnosis in remote and hard-to-reach areas, among populations that don’t readily access the health system, and in conflict areas. At the same time, these experts shared how they are managing the risks of a technology that, by its very private nature, can undermine national data collection efforts and poses challenges to connecting patients with appropriate care.

The World Health Organization (WHO) has recommended HIV self-testing since 2016. Examining the steadily evolving use of HIV self-tests in Ukraine can illuminate the challenges and potential of this technology. The country launched the use of HIV self-tests in 2007, when health leaders recognized that stigma made IV drug users reluctant to visit health clinics or hospitals to request HIV tests. As the first step to expanding the use of rapid tests, Ukraine equipped doctors and nurses with the tests to be administered outside of a clinic.

With this cautious approach, Ukraine was not unusual.

“When HIV self-tests were first developed, there were many doubts and critics saying people will commit suicide if they learn their HIV status without support from a medical professional," said Dr. Olga Denisiuk, a senior manager at FIND, the global alliance for diagnostics. "And there were fears that people would not be able to conduct the test or interpret the results. This concern was especially strong when came to HIV tests for IV drug users. People said, ‘These people are on drugs. How can they perform such a complicated process?’."

Ukraine would soon learn the answer to this question. When the Global Fund, a worldwide partnership to tackle HIV, TB, and malaria, trimmed funding for the HIV testing program in 2013, Ukraine shifted to what was called “assisted self-testing” with outreach workers instead of doctors and nurses conducting the test and providing referrals for treatment. And when Russia invaded Ukraine in 2022, destroying medical clinics and hospitals and straining the health system, the government approved unassisted HIV self-testing.

Those tests are available through health centers, outreach workers, and through vending machines. And Ukraine has seen no related increase in suicides and those taking the test, including drug users, appear to be conducting the test correctly.

The next concern was ensuring those using the test connected with appropriate treatment and counseling. “With self-testing, you only control distribution,” said Smyrnov. “You don’t know what will happen next. But you can make it as easy, convenient, and simple as possible for someone to share their results. That has been powerful in Ukraine.”

Ukraine developed a chatbot that tracks a self-test throughout its lifecycle. When an outreach worker gives out a self-test kit, they scan a unique QR code printed on a sticker on the box, which helps programs record information on where and to which group of clients self-tests are being distributed. At the "usage" stage, the sticker prompts the self-test user to scan the QR code for instructions and prompts them to provide their age and their test result. Upon receiving that information, the chatbot refers those who tested positive to treatment options, locations, and contact information for health workers and tells the tester to bring the package with the QR code so it can be scanned for a third time to close the data loop including the “linkage to care” stage. The chatbot also refers those who tested negative to resources where they can receive counseling and prophylaxis, known as PrEP (pre-exposure prophylaxis of HIV).

Of the 8,300 self-tests distributed from January to June of this year, 4,110 users scanned the QR code sticker. Of those, 94 individuals brought their QR code for scanning when they connected with the health system for treatment or counseling.

“This is the age-old limitation of self-testing,” said Mohammed Majam, director of Medical Technologies at Ezintsha, a division of Wits Health Consortium and a leader in the development, testing, and roll out of HIV self-tests in South Africa. “Managing the linkage to care is hard. But understanding what happens to each self-test is not realistic. In fact, placing too much emphasis on counting the results is counterproductive. Self-testing is about giving people information and getting them to know their status.”

The question is, said Majam, “What is the ultimate purpose of a self-test?” Is the goal to alert the individual of their status or notify the health system?

Majam explained his answer to this thorny question: by leveraging self-testing, Ukraine, South Africa, and other health systems can educate and empower the user first and foremost. Tracking that user and connecting them with the health system is a second-tier goal.

“Self-tests allow us to reach people who have never been tested in their lives and I have no doubt would not be tested ever except by a self-test,” said Majam.

Evidence from randomized trials by Majam and others have found that the proportion of people linked to antiretroviral therapy (ART) following HIV self-tests is comparable to that of facility-based testing.

South Africa finalized its HIV self-testing policies and distribution models just as the pandemic struck and quickly became a leader in self-testing. As South Africans were ordered to shelter in place the government began buying HIV self-tests. Between 2019 and 2022, South Africa’s government procured and distributed more than 600,000 additional HIV self-tests.

Today, HIV self-tests are available in private pharmacies, taxi ranks, online, and free through public health clinics. South Africa has embraced a decentralized testing network to connect hard-to-reach groups with the tests they need to know their status. Ongoing communications campaigns create and sustain access and demand.

South Africa’s self-testing strategy benefited from years of research launched by Unitaid in 2015.

The organization was concerned that countries would not be able to achieve their 90/90/90 goals, which called for 90% of people living with HIV to know their HIV status by 2020, 90% of all people with diagnosed HIV infection to receive sustained ART, and 90% of all people receiving ART to have viral suppression by 2020. The goals have since been updated to 95/95/95 by 2030.

Unitaid saw self-testing as a pathway toward meeting those goals. It launched the STAR initiative, led by Population Services International, the London School of Hygiene and Tropical Medicine, ministries of health, and local research partners and implementers, along with support from the WHO, to catalyze the global market for HIV self-testing, generate evidence for decision-making, and create an enabling environment for HIV self-testing to achieve impact at scale.

Over the next eight years, STAR helped 13 countries, including South Africa, develop effective HIV self-testing policies and strategies, and has supported the distribution of more than 4.8 million HIV self-tests.

Majam, funded through the Bill & Melinda Gates Foundation at the time, supported STAR’s usability and performance research that would ultimately help the first four HIV self-tests gain WHO pre-qualification. Majam and his colleagues worked with manufacturers to develop instruction inserts that required little to no formal education to understand.

“A test’s performance is only as good as its usability in the hands of its intended user,” said Majam. Pictorial-based instructions, with minimal text translated into local languages, is key. So is making sure the test is quick and requires as few steps as possible to process.

Majam and his colleagues also tested 13 distribution models, focusing on high-yield populations – such as female sex workers – and high-volume distribution models. Their research identified optimal distribution strategies that were more cost effective than community-based or facility-based testing in South Africa, specifically taxi rank and workplace distribution models.

They built a business case for use in South Africa and conducted pricing negotiations with manufacturers. The program tested digital tools, such as chatbots, patient journey apps, and a variety of incentives to encourage users to report their results to the health system.

Those incentives varied from offering testers 20 Rand (US$1) if they shared a photo of their test result and 100 Rand (US$5) if they took a photo of their ARVs and shared it with health workers – helping the health system track results and connect with testers for post-testing treatment or counseling. Generally, none of the incentive models tested were able to increase the percent of users reporting their results beyond about 20% to 25%.

“That low reporting statistic doesn’t dilute the significance of what the self-test offers,” said Majam. “We are at least getting them to know their status.”

During the pandemic, the STAR initiative adapted and adopted the HIV self-testing learnings to support COVID self-testing and, more recently, to inform strategies for nascent hepatitis C self-testing programs under development in Brazil, Cameroon, India, Nigeria, South Africa, Uganda, and Vietnam.

More recently, FIND has completed randomized trials demonstrating high usability, acceptability, and performance of hepatitis C self-tests in Pakistan, Malaysia, and Georgia.

Self-testing distribution models vary and should reflect the target population and local cultures and economies, explained Dr. Anna Deryabina, who has supported HIV self-testing programs in Central Asia. For example, Kazakhstan, Kyrgyzstan, and Tajikistan have tailored their HIV self-testing campaigns to respond to the needs of their mostly urban and educated target population.

“When we launched our first campaign, we saw on social media all of these young girls taking the test and posting on social media that they were negative,” said Dr. Deryabina. “That was a problem for us, as we can’t afford to provide free tests to everyone. The HIV self-tests are expensive, between $5 to $12 depending on the country. We needed to develop a strategy that reflects our extremely concentrated HIV epidemic. So, we hired online outreach workers who posted targeted messages through WhatsApp groups, Hornet [a queer social media network], and various Telegram channels which are popular among our key population.”

An online order portal was developed by ICAP at Columbia University as part of the Almaty Model for Epidemic Control project to effectively reach high-risk young people using drugs and men who have sex with men in Almaty, Kazakhstan. The service was then expanded using PEPFAR funds to scale up the use of HIV self-testing among key populations in Kyrgyzstan and Tajikistan.

After ordering tests online, users are asked to identify if they are members of any high-risk groups and share what prompted their decision to order an HIV self-test. Clients reporting any high-risk behaviors receive a pop-up notification with HIV prevention information tailored to the user. The packages delivered to clients include comprehensive material, such as information about HIV treatment, counseling, drug treatment, PrEP, and harm reduction services. The packages can be picked up, for free, at local pharmacies or kiosks, NGOs, local health facilities, or delivered to the client’s preferred location by courier service.

The online ordering portal invites users to report their results, to order a test for a partner, and to send a notification to a partner who may have been exposed to HIV. Generally, just under half of those taking an HIV self-test ordered online in these countries report their test results – well above the reporting rates found in many other countries.

“We do not require or force people to report back the result,” said Dr. Deryabina. “But we are trying to be honest and transparent and include messages on the platform, as well as on the materials included in the testing package that 1) we need the results to monitor the progress of our intervention and to ensure it gets funded and 2) reporting results through the system will allow us to provide better support when linking people to HIV services.”

To help achieve that high response rate, they also send two SMS reminders to people asking them to share their test result. The first reminder is sent the day after the test is received by the user. The second reminder is issued the day after the first reminder.

Another surprise, said Dr. Deryabina, is the number of testers who want to provide feedback on the program. Testers in Kazakhstan generally prefer online resources, while users in Tajikistan prefer the paper pamphlets and report that they don’t have good access to online resources. “Users’ needs vary by country,” said Dr. Deryabina. “To succeed, we must accommodate and tailor our efforts to meet their needs.”