PRIMARY CARE
(Photo credit: Eric Gauss/Unitaid)
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. M AKING THE INVESTMENT CASE FOR SELF-TESTING 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 selftesting 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 22
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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. LELIO MARMORA
EXECUTIVE DIRECTOR, UNITAID @LeiloMarmora
ADDRESSING SUPPLY SIDE BARRIERS 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. HIVST manufacturers 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. BRIGETTE BARD
FOUNDER & CEO, BIOSURE (UK) LTD. @Brig_Bard
CINDY MACCULLOUGH
VICE PRESIDENT, MARKETING, ORASURE TECHNOLOGIES
628,705 HIVST KITS distributed between May 2015 and June 2017