Case Study: Market Shaping and Health Systems Strengthening

Since 2015, PSI through the catalytic investment from Unitaid, began working to bring HIV self-testing (HIVST) to high-burden countries by combining a multi-faceted research agenda; global policy and guideline development; community engagement, active market creation and market shaping facilitated by donor commitments; and a rapid implementation timeline.

The initiative has already demonstrated laudable successes.

Through this work, over 6 million HIVST kits have been distributed in 16 markets across Africa and Asia through the private and public sector, 6 HIVST kits, both oral fluid and blood based products, have WHO prequalification contributing to a competitive market, with major market initiatives released under PSI STAR leading to a reduction of ex-works pricing to under $2 USD, fast tracking product introduction and registration at the local level, procurement and supply management (PSM) cost benchmarking driving volumes and cost savings in STAR countries and beyond.  Donor investment outside of Unitaid/STAR contribute to an estimated pipeline of confirmed HIVST volumes of 32 million HIVST kits between 2021 and 2024, up from 22 million HIVST kits between 2020 and 2023. Today 98 countries globally have policies on HIV self-testing, offering alternative entry points for accessing healthcare and contributing to accelerated healthcare simplification and transformation for communities and health providers, providing an opportunity to transform infrastructure, delivery models, community engagement and demand in the context of COVID-19 and other diseases.

“People are more comfortable having an HIVST because they know they can do it at home and only need to come to the clinic in case of a reactive self-test to confirm the result,” says Tumiseng Morapedi a Faculty Manager at the Yeoville Clinic in Johannesburg. “We are testing the right people right now – those who need to come to the clinic for confirmative testing and start antiretroviral therapy , versus a thousand people coming on a daily basis, many of whom just want to find out if they have maintained their negative status.

PSI’s work with HIVST is informing how PSI replicates this approach supporting the introduction of Hepatitis C and COVID-19 self-testing. PSI is conducting research to identify areas and populations where Hepatitis C and COVID-19 self-testing could increase testing uptake. PSI is also evaluating acceptability, feasibility, costs and usability of Hepatitis C and COVID-19 self-test kits, along with the management of results and linkages to community and clinical care and prevention, including vaccination services for COVID-19 and harm reduction interventions for Hepatitis and HIV prevention. This demonstrates the use of digital tools in capturing end-to-end data to support reporting tools for rapid outbreak monitoring and linkage data, among other activities. These activities further recognize the importance of both the public and private sectors in bringing to scale new diagnostic technologies, something that cannot be done without necessary research, systems thinking and advocacy. 

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