HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity
4 affiliations
- 1Independent Global Health Consultant, Geneva, Switzerland
- 2Independent Global Health Consultant, New Delhi, India
- 3Tinpswalo Research Association to Fight AIDS and TB, Chokwe, Mozambique
- 4Nucleo de Pesquisa Pediatria, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique
Abstract
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 deployed at negligible scale for a decade following WHO recommendation in 2016. The gap has narrowed, but through conventional testing rather than HIVST, and 2.6 million people in sub-Saharan Africa and 4.9 million globally still did not know their HIV status in 2025. The decade of delay carries a likely avoidable burden of millions of illnesses, deaths and onward transmissions, though this has not been formally modelled. The need for HIVST in low- and middle-income countries was estimated at 177 million self-tests in 2020, rising to 192 million by 2025. Confirmed procurement over the same period reached only 21 million kits in total, an average of 5.3 million per year, or 3% of estimated annual need. Four interlocking structural failures explain this missed opportunity: 1) research capture through demonstration projects that substituted for population-scale deployment; 2) the early supervised self-testing paradox in which provider-assisted delivery reconstituted the clinic barriers HIVST was designed to bypass; 3) procurement conservatism that suppressed market development; and 4) an accountability failure with no publicly accessible Africa-level volume series, making the scale of the missed opportunity impossible to measure from published data. Four actions could improve access: 1) mandatory public reporting of HIVST commodity volumes; 2) a dedicated Africa-specific distribution target of at least 50 million kits per year within the UNAIDS 95-95-95 framework; 3) community-based distribution as the default model for the general population; and 4) explicit HIVST volume commitments in the GHSD’s 2026–2030 memoranda of understanding and work plans. In this Policy Forum article, Isabelle Munyangaju and colleagues discuss why the roll-out and scale-up of HIV self-testing over the last decade has been inadequate, and highlight what is needed—learning from past failures around governance, distribution and financing—to close the diagnostic gap.
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BibTeX
@article{granich2026selftesting,
title = {{HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity}},
author = {Reuben Granich and Somya Gupta and Isabelle Munyangaju and Mike Ruffner},
journal = {PLOS Medicine},
year = {2026},
month = sep,
doi = {10.1371/journal.pmed.1005241},
url = {https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity
AU - Reuben Granich
AU - Somya Gupta
AU - Isabelle Munyangaju
AU - Mike Ruffner
PY - 2026
DA - 2026/09/16
JO - PLOS Medicine
DO - 10.1371/journal.pmed.1005241
UR - https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241
AB - 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 deployed at negligible scale for a decade following WHO recommendation in 2016. The gap has narrowed, but through conventional testing rather than HIVST, and 2.6 million people in sub-Saharan Africa and 4.9 million globally still did not know their HIV status in 2025. The decade of delay carries a likely avoidable burden of millions of illnesses, deaths and onward transmissions, though this has not been formally modelled. The need for HIVST in low- and middle-income countries was estimated at 177 million self-tests in 2020, rising to 192 million by 2025. Confirmed procurement over the same period reached only 21 million kits in total, an average of 5.3 million per year, or 3% of estimated annual need. Four interlocking structural failures explain this missed opportunity: 1) research capture through demonstration projects that substituted for population-scale deployment; 2) the early supervised self-testing paradox in which provider-assisted delivery reconstituted the clinic barriers HIVST was designed to bypass; 3) procurement conservatism that suppressed market development; and 4) an accountability failure with no publicly accessible Africa-level volume series, making the scale of the missed opportunity impossible to measure from published data. Four actions could improve access: 1) mandatory public reporting of HIVST commodity volumes; 2) a dedicated Africa-specific distribution target of at least 50 million kits per year within the UNAIDS 95-95-95 framework; 3) community-based distribution as the default model for the general population; and 4) explicit HIVST volume commitments in the GHSD’s 2026–2030 memoranda of understanding and work plans. In this Policy Forum article, Isabelle Munyangaju and colleagues discuss why the roll-out and scale-up of HIV self-testing over the last decade has been inadequate, and highlight what is needed—learning from past failures around governance, distribution and financing—to close the diagnostic gap.
SN - 1549-1676
ER -