by Dr. Karin Hatzold, STAR Initative Project Director, PSI
This era of global health is ripe for disruption. It will take the right innovations to maintain the gains we’ve made. But technology alone isn’t enough. Larger systems must be established for the technology to reach consumers in the developing world.
Kenneth Xhimba always recognized the benefit of knowing his HIV status, but he was put off by the lack of privacy and time required for testing, which could translate to a potential loss of income. The 47-year-old father of seven often relied on “proxy testing”—using his partner’s HIV status to determine his own by virtue of them being involved. “If my wife is negative, then I am too.”
Today, only an estimated 70% of all people living with HIV are aware they have the virus. By 2030, the global health community intends to have 95% of people living with HIV worldwide know their status, 95% of those who test positive to access treatment, and 95% of those on treatment to be virally suppressed.
With a USD 72 million investment from Unitaid, a PSI-led consortium launched the HIV Self-Testing Africa (STAR) Initiative in 2015 to catalyze and shape the global marketfor HIV self-testing (HIVST). The aim: reach the first “95” by improving the uptake and frequency of testing among those who are reluctant or have limited access to conventional testing, including men, adolescents and key populations.
Kenneth is one of over 5,000 residents of Madala Hostel, a government-run complex built to house migrant workers in Alexandra Township in Johannesburg, South Africa. In this male-dominated hostel, far from home for most, unprotected sex and AIDS are not an openly discussed topics, nor is anyone’s HIV status. Most will only visit the local clinic when they’re extremely ill.
“The men here left their villages in hope of finding work in the big city,” explains Kenneth who survives on odds jobs. “They fear an HIV-positive result, so they’re even less likely to go test.”
HIVST allows individuals to collect their own specimen (blood or saliva) and perform the test by themselves, getting the results within minutes. There is no need to wait in the queue at the local clinic or risk being seen by a neighbor—making being in control of their own HIV testing process particularly appealing.
After 30 years at Madala, Kenneth is well aware of the temptations of hostel life and encourages his son who recently joined him to also take up self-testing. “When you test yourself and know your status, you at least know where you stand and can be more serious about protecting yourself.”
Kenneth and his son are part of an unprecedented effort to not only generate demand for HIVST, but also accelerate suppliers’ market entry at affordable and sustainable prices, as well as develop an evidence base to inform global normative guidelines, and make HIVST an integral component of national HIV responses.
As with any successful disruption, there are learnings for how to evolve the market quickly from early product development to product introduction and inclusion into national programs to accelerated scale-up.
Two years in, we take a look at the different players that have helped shape a dynamic and rapidly growing market for this disruptive technology.
MAKING THE INVESTMENT CASE FOR SELF-TESTING
by Lelio Marmora, Executive Director, Unitaid
At Unitaid, we are supporting innovative ways to close the gap in HIV diagnosis. To do so, we must overcome the most common barriers to HIV testing: stigma, discrimination, and lack of accessible services.
HIVST has been highlighted as a discreet and convenient approach for reaching the remaining 30% of people who do not know their HIV status. Evidence shows that self-testing increases access to HIV testing in populations with low coverage and higher risk, including men (68%), young people (95%), and other key populations.
HIVST helps reach those who would not normally visit healthcare centers—in particular key populations and first-time testers— and empowers consumers to decide when and where they test. Moreover, self-testing can link more people living with HIV to treatment, and link those who test negative to prevention services.
Unitaid’s investment has stimulated the HIVST market and demonstrates HIVST’s public health and economic benefits. Our PSI-led HIV Self-Testing Africa (STAR) Initiative is distributing 4.2 million test kits in six African countries. We are also supporting the MTV Staying Alive Foundation in a unique demand-generation campaign and moving toward investments to stimulate the HIVST market in West Africa.
Watch to learn how Unitaid, PSI and partners are revolutionizing HIV testing in Southern Africa.
ADDRESSING SUPPLY SIDE BARRIERS
by Brigette Bard, Founder & CEO, Biosure (UK) LTD., and Cindy MacCullough, Vice President, Marketing, Orasure Technologies
Entering new markets with innovative solutions is a challenge for suppliers as it is difficult to assess the size of the opportunity and to define the investment required to maximize the overall health impact. HIVSTmanufacturers have had to tread an untrodden path and quickly learn how to overcome numerous hurdles.
Among the challenges: navigating the regulatory framework, addressing country-specific policies, and developing affordable solutions with scalable manufacturing capacity. Each is vital to ensuring reliable and sustainable solutions for large scale programs.
The key to adoption is the test platform usability and performance. Without adequate (or any) policing mechanisms, there remain numerous unregulated tests on many markets, posing a serious risk of end-users being unable to tell if they have performed their test correctly and gaining false negative results—the worst possible outcome from both a public and a personal health perspective. Suppliers must develop test platforms that are easy to use from collection, to result, to disposal. Elements such as optimized user instructions that are translated with useful illustrations have a notable impact on usability and performance. ‘
Most importantly, suppliers must continue to learn and evolve through engagements with customers, partners, regulators, funders, and collaborators. The ability for us all to now engage, educate, and catalyze the public at large is key to delivering on critical testing programs.
Sustainability really has to be the main consideration for all stakeholders; to build confidence and grow a sustainable market where end-users participate, and companies are happy to commit marketing spending. It is also essential for funders to support manufacturers with realistic pricing to allow continued investment in product development and regulatory approvals.
CREATING AN ENABLING ENVIRONMENT
by Getrude Ncube, National HIV Prevention Coordinator, Zimbabwe Ministry of Health Child Care
While WHO recommends HIVST as an additional testing approach, the formation of national policy, regulations, and moving to implementation and scale-up is new to many countries. In November 2016, while 23 countries had policies, only three reported implementation. By April 2018, 43 countries—including Zimbabwe—reported having HIVST policies.
To guide the process, Zimbabwe put in place a technical working group tasked with improving the coordination and consolidation of efforts of all stakeholders, resulting in HIVST being included in the national guidelines endorsed by the Minister of Health and Child Care.
With support from WHO and the STAR Initiative, Zimbabwe’s Ministry of Health and Child Care and other relevant bodies are working to fill key regulation and policy gaps to scale-up HIVST interventions.
Going forward, the regulatory system will need continuous improvement, enforcing legal instruments to ensure that substandard and falsified products do not find their way onto the market.
TESTING OUT NEW TECHNOLOGY
by Bright Phiri, STAR Initiative Knowledge Management Advisor, PSI
From the beginning, the STAR Initiative aimed to generate crucial information about how to deliver HIVST products effectively, ethically, and efficiently. In all, seven distribution models—varying in the level of support provided to self-testers and point of access—are being investigated for cost, client preferences, and linkage to care and prevention.
Across all six countries, community-based distribution plays a crucial role in the introduction and awareness-building around self-testing, particularly in remote areas. Often organized in collaboration with local leaders, this helps to reduce stigma around HIV and AIDS in these communities.
Going from house to house, distributors discuss the benefits of getting to know one’s HIV status and demonstrate how to use the test kit.
“I talk about the privacy and confidentiality, the ease and convenience of using the test kit, and how it could help save people’s time and money,” explains a community-based distributor in Machinga, Zimbabwe. “Most people go ahead and test on their own, and some ask that I assist them, especially older people. If people test HIV-positive, they often disclose their status to me and I direct them to the healthcare facility where treatment is available.”
Generally, people are interested in this new technology and are eager to try the test. Many who choose to test had never tested before, either because of fear of a positive result or because they did not have the opportunity to go to the clinic for testing.
“This helps people living with HIV know their status and get on treatment, and for those who test negative, it motivates them to stay negative and to test on a regular basis.”
BUILDING AN HIV SELF-TESTING ENVIRONMENT
by Peter Godfrey-Faussett, Senior Science Adviser, UNAIDS and Professor of International Health, London School of Hygiene and Tropical Medicine
The era of AIDS has witnessed remarkable progress led by social movements that have changed the way that public health science responds to new infectious epidemics. Community engagement, activism, and the greater involvement of people living with HIV have been central to building global solidarity and political momentum, but also to accelerating scientific developments and regulatory approvals.
But to maintain this progress, everybody living with HIV—or at risk of HIV—needs to know their status in order to benefit from the effective treatment and prevention options that are now widely available. Sadly, many people are being left behind.
HIVST is a new approach that has been shown to appeal to the very people who are being left behind, including younger people, men, key populations, and partners of those living with HIV. Self-testing offers people the opportunity to screen themselves in privacy or with their partners or friends. When linked to accessible prevention and treatment services, HIVST can be a key element in the push towards ending AIDS. Their use is limited only by our imagination. We need to reinvigorate the social movements that set HIV on the road to success and ensure that we reach the end of that road.