HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity
by Reuben Granich, Somya Gupta, Isabelle Munyangaju, Mike Ruffner Summary points In 2015, a survey-based analysis across 16 sub-Saharan African countries estimated that nearly half of people living with HIV were undiagnosed, implying ~11 million people in the region were outside the treatment cascade. However, HIV self-testing (HIVST), a technology effectively positioned to close this gap, was…
In 2016, the World Health Organization recommended HIV self-testing (HIVST) as a means to address the global diagnostic gap and identify millions of undiagnosed HIV-positive individuals. However, despite this recommendation, HIVST was only deployed at minimal scale for a decade, hindering its potential to close the treatment cascade.
By 2025, it was estimated that 2.6 million people in sub-Saharan Africa and 4.9 million people globally remained unaware of their HIV status. The delay in adopting HIVST has likely resulted in a substantial burden of illnesses, deaths, and onward transmissions, although this has not been formally calculated.
In 2020, the estimated need for HIVST in low- and middle-income countries was 177 million self-tests, which is projected to rise to 192 million by 2025. Despite this demand, only 21 million HIVST kits were procured over the same period, averaging 5.3 million kits per year – only 3% of the estimated annual need.
Four structural failures have contributed to this missed opportunity. Firstly, research capture through demonstration projects has often prioritized demonstration projects over population-scale deployment. Secondly, the early supervised self-testing paradox, where provider-assisted delivery reinstates clinic barriers that HIVST aimed to overcome, has hindered widespread adoption.
Thirdly, procurement conservatism has suppressed market development, making it difficult to scale up production. Lastly, an accountability failure has resulted in the lack of publicly accessible Africa-level volume series, making it impossible to measure the scale of the missed opportunity from published data alone.
To improve access to HIVST, four actions are proposed. Firstly, mandatory public reporting of HIVST commodity volumes is necessary to track progress and hold stakeholders accountable. Secondly, a dedicated Africa-specific distribution target of at least 50 million kits per year should be included within the UNAIDS 95-95-95 framework, which aims to ensure that 95% of people living with HIV know their status, 95% of diagnosed individuals receive sustained antiretroviral therapy, and 95% of those on treatment have undetectable viral loads.
Thirdly, community-based distribution should be the default model for the general population, as it bypasses the clinic barriers that HIVST was designed to address. Lastly, explicit HIVST volume commitments should be included in the GHSD's (Global Health Supply Chain Programme) 2026–2030 memoranda of understanding and work plans, ensuring that HIVST is prioritized and integrated into global health strategies.
Written by urgent.news from PLOS Medicine's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
