---
title: "HIV self-testing (HIVST) and the diagnostic gap: a decade of missed scale-up"
id: "plos-medicine-0-hiv-self-testing-and-the-global-diagnostic-gap-addressing-a-decade-of-missed"
canonical_url: "https://medichelpline.com/clinical-feed/plos-medicine-0-hiv-self-testing-and-the-global-diagnostic-gap-addressing-a-decade-of-missed"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "PLOS Medicine"
source_url: "https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241"
published_at: "2026-09-16T14:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# HIV self-testing (HIVST) and the diagnostic gap: a decade of missed scale-up
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/plos-medicine-0-hiv-self-testing-and-the-global-diagnostic-gap-addressing-a-decade-of-missed
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** PLOS Medicine
- **Source URL:** [Original Journal Publication](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241)
- **Published At:** 2026-09-16T14:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- Diagnosis is the gateway to antiretroviral therapy (ART), prevention, and viral suppression; early evidence established treatment as prevention and underpins the U = U concept. - In 2015 pooled surveys in 16 sub-Saharan African countries estimated ~46% of people living with HIV were undiagnosed (≈11 million in the region), making diagnosis the primary bottleneck in the cascade. - **HIV self-testing (HIVST)**—an individual-performed oral fluid or blood rapid test—was endorsed by WHO in 2016 and offers private, clinic-free access that can reach people reluctant to use facility-based services. - Despite rapid accumulation of evidence and policy endorsements, HIVST deployment remained negligible for roughly a decade; confirmed procurement reached only 21 million kits from 2020–2025 against an estimated need of 177–192 million per year. - Four structural failures explain the missed opportunity: (1) research capture via demonstration projects that substituted for population-scale deployment; (2) supervised delivery requirements that reintroduced clinic barriers; (3) conservative procurement that stifled market development; and (4) accountability and surveillance gaps with no public Africa-level volume series. - By 2025 the diagnostic gap narrowed largely through conventional testing, but an estimated 2.6 million people in sub-Saharan Africa and 4.9 million globally still did not know their HIV status. The decade of delay likely produced avoidable illnesses, deaths and onward transmissions, though those impacts were not formally modelled in the source. - Proposed actions to expand access include mandatory public reporting of HIVST commodity volumes, an Africa-specific distribution target of at least 50 million kits per year within the UNAIDS 95-95-95 framework, prioritizing community-based distribution as the default model, and explicit HIVST volume commitments in GHSD 2026–2030 agreements. - The report emphasizes preserving the evidence-based promise of self-testing by removing provider- and procurement-led barriers, improving market signals, and introducing accountability mechanisms to track volumes and impact.
## Clinical Analysis & Structured Key Points
[ Skip to main content ](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#main-content) Advertisement * [plos.org](https://plos.org/) * [Create account](https://community.plos.org/registration/new) * [Sign in](https://journals.plos.org/user/secure/login?page=%2Fplosmedicine%2Farticle%3Fid%3D10.1371%2Fjournal.pmed.1005241) * * About * Browse * Publish * [](https://journals.plos.org/plosmedicine/ "PLOS Medicine") * Search [advanced search](https://journals.plos.org/plosmedicine/search) * 0 [Save](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#savedHeader) [Total Mendeley and Citeulike bookmarks.](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#savedHeader) * 0 [Citation](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#citedHeader) [Paper's citation count computed by Dimensions.](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#citedHeader) * 0 [View](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#viewedHeader) [PLOS views and downloads.](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#viewedHeader) * 0 [Share](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#discussedHeader) [Sum of Facebook, Twitter, Reddit and Wikipedia activity.](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241#discussedHeader) Open Access Policy Forum Policy Forum articles provide a platform for health policy makers from around the world to discuss the challenges and opportunities in improving health care to their constituencies. [See all article types » ](https://journals.plos.org/plosmedicine/s/other-article-types) # HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity * Reuben Granich, Roles Conceptualization, Formal analysis, Writing – original draft, Writing – review & editing Affiliation Independent Global Health Consultant, Geneva, Switzerland [ ![ORCID logo](https://journals.plos.org/resource/img/orcid_16x16.png) https://orcid.org/0000-0002-7715-3940 ](https://orcid.org/0000-0002-7715-3940 "ORCID Registry") ⨯ * Somya Gupta, Roles Conceptualization, Formal analysis, Writing – original draft, Writing – review & editing Affiliation Independent Global Health Consultant, New Delhi, India [ ![ORCID logo](https://journals.plos.org/resource/img/orcid_16x16.png) https://orcid.org/0000-0001-9739-455X ](https://orcid.org/0000-0001-9739-455X "ORCID Registry") ⨯ * Isabelle Munyangaju , Roles Conceptualization, Formal analysis, Writing – original draft, Writing – review & editing * E-mail: imunyangaju@gmail.com Affiliations Tinpswalo Research Association to Fight AIDS and TB, Chokwe, Mozambique, Nucleo de Pesquisa Pediatria, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique [ ![ORCID logo](https://journals.plos.org/resource/img/orcid_16x16.png) https://orcid.org/0000-0002-7190-6016 ](https://orcid.org/0000-0002-7190-6016 "ORCID Registry") ⨯ * Mike Ruffner Roles Conceptualization, Formal analysis, Writing – original draft, Writing – review & editing Affiliation Independent Global Health Consultant, Washington, DC, United States of America [ ![ORCID logo](https://journals.plos.org/resource/img/orcid_16x16.png) https://orcid.org/0000-0002-1970-2403 ](https://orcid.org/0000-0002-1970-2403 "ORCID Registry") ⨯ # HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity * Reuben Granich, * Somya Gupta, * Isabelle Munyangaju, * Mike Ruffner ![PLOS](https://journals.plos.org/resource/img/logo-plos-full-color.svg) x * Published: September 16, 2026 * * [Article](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241) * [Authors](https://journals.plos.org/plosmedicine/article/authors?id=10.1371/journal.pmed.1005241) * [Metrics](https://journals.plos.org/plosmedicine/article/metrics?id=10.1371/journal.pmed.1005241) * [Comments](https://journals.plos.org/plosmedicine/article/comments?id=10.1371/journal.pmed.1005241) * [Media Coverage](http://plos.altmetric.com/details/doi/10.1371/journal.pmed.1005241) * [Summary points](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#abstract0) * [Introduction](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec001) * [The promise of HIV self-testing](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec002) * [Four interlocking failures behind a decade of inadequate scale-up](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec009) * [Power, decision-making, and the geography of implementation](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec014) * [The surveillance failure](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec015) * [Quantifying the cost of delay](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec016) * [Actions to increase access and reduce the HIV diagnosis gap](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec017) * [Conclusions](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#sec022) * [References](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#references) * [Reader Comments](https://journals.plos.org/plosmedicine/article/comments?id=10.1371/journal.pmed.1005241) * [Figures](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241) ## 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. ## Figures ![Table 3](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.t003) ![Fig 2](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.g002) ![Fig 1](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.g001) ![Table 1](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.t001) ![Table 2](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.t002) ![Table 3](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.t003) ![Fig 2](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.g002) ![Fig 1](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.g001) ![Table 1](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.t001) ![Table 2](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.t002) **Citation:** Granich R, Gupta S, Munyangaju I, Ruffner M (2026) HIV self-testing and the global diagnostic gap: Addressing a decade of missed opportunity. PLoS Med 23(9): e1005241. https://doi.org/10.1371/journal.pmed.1005241 **Academic Editor:** Nitika Pant Pai, McGill University Faculty of Medicine and Health Sciences, CANADA **Published:** September 16, 2026 **Copyright:** © 2026 Granich et al. This is an open access article distributed under the terms of the [Creative Commons Attribution License](http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. **Funding:** The authors received no specific funding for this work. **Competing interests:** The authors have declared that no competing interests exist. **Abbreviations:** ART, Antiretroviral therapy; GHSD, Global Health Security and Diplomacy; HIVST, HIV self-testing; LMICs, low- and middle-income countries; PEPFAR, President’s Emergency Plan for AIDS Relief; PLHIV, people living with HIV; PrEP, pre-exposure prophylaxis; STAR, Self-Testing AfRica; UNAIDS, United Nations Programme on HIV/AIDS; WHO, World Health Organization. ## Introduction Antiretroviral therapy (ART) suppresses HIV replication and prevents AIDS and onward transmission while preserving immune function and restoring near-normal life expectancy [[1](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref001)–[3](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref003)]. In 2000, the Rakai cohort in Uganda first suggested this by finding no linked transmissions below 1,500 copies of HIV per millilitre [[4](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref004)]. In 2006, Montaner and colleagues first called publicly for expanded ART access to reduce transmission and curb epidemic growth [[5](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref005)] and subsequent modelling showed that universal voluntary testing with immediate treatment could eliminate HIV in South Africa by driving incidence below one case per 1,000 per year [[6](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref006)]. In 2011, the HPTN 052 trial confirmed a 96% reduction in linked transmission with early ART initiation [[7](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref007)] and the PARTNER, PARTNER 2, and Opposites Attract studies subsequently documented zero genetically linked transmissions where suppression was maintained [[8](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref008)–[10](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref010)]. Undetectable equals untransmittable (U = U) built on those earlier calls for treatment as prevention [[5](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref005)], and by 2019 rested on one of the strongest bodies of evidence in infectious disease epidemiology [[11](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref011)]. Diagnosis is the gateway to treatment, survival and other prevention interventions. In 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) introduced the 90-90-90 target: 90% of people living with HIV diagnosed, 90% of those diagnosed on ART and 90% of those on ART virally suppressed by 2020 [[12](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref012)]. The target linked diagnosis, treatment, and suppression for the first time and made closing the diagnostic gap the rate-limiting step in the prevention cascade [[12](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref012)]. In 2015, WHO issued consolidated guidelines on HIV testing services and recommended immediate ART for all people diagnosed with HIV regardless of CD4 count; WHO’s dedicated guidance endorsing HIV self-testing (HIVST) followed in December 2016. However, despite the millions of people undiagnosed, the technology best positioned to close that gap—HIVST—was deployed cautiously, constrained by research protocols, supervised delivery mandates and procurement timidity. [Figure 1](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed-1005241-g001) summarises the sequence from the 2012 approval of the first self-test through successive WHO recommendations to the deployment that did not follow. [![thumbnail](https://journals.plos.org/plosmedicine/article/figure/image?size=inline&id=10.1371/journal.pmed.1005241.g001)](https://journals.plos.org/plosmedicine/article/figure/image?size=medium&id=10.1371/journal.pmed.1005241.g001 "Click for larger image") Download: * [PNG larger image](https://journals.plos.org/plosmedicine/article/figure/image?download&size=large&id=10.1371/journal.pmed.1005241.g001) * [TIFF original image](https://journals.plos.org/plosmedicine/article/figure/image?download&size=original&id=10.1371/journal.pmed.1005241.g001) Fig 1. The missed opportunity to scale HIVST: evidence, policy and deployment, 2012–2025. A two-track timeline of the HIVST response. The left track shows evidence and policy milestones from US Food and Drug Administration approval of the first self-test in 2012 through successive World Health Organization (WHO) recommendations, including the period in which no volume commitments, procurement targets, or accountability mechanisms were set. The right track shows deployment and procurement over the same period. The lower panel compares estimated annual need with confirmed procurement, drawn to scale. The figure illustrates how substantial scientific and policy advances were not matched by population-scale implementation. The 2025 entry reports undiagnosed and viral suppression estimates for that year; ~10.6 million unsuppressed is derived by subtracting the 30.4 million with suppressed viral loads from the 41.0 million people living with HIV [[13](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref013)]. Compiled from US Food and Drug Administration approval records [[14](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref014)]; WHO HIVST guidance and policy documents [[15](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref015)–[17](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref017)]; Unitaid and WHO market and technology landscape reports [[18](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref018),[19](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref019)]; STAR programme implementation data [[20](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref020)]; national programme data from eight African countries [[21](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref021)]; and UNAIDS epidemiological estimates [[13](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref013)]. [ https://doi.org/10.1371/journal.pmed.1005241.g001](https://doi.org/10.1371/journal.pmed.1005241.g001) In 2015, when WHO recommended ART for all people living with HIV (PLHIV) regardless of CD4 count, pooled population-based survey analyses from 16 sub-Saharan African countries estimated that 46% of PLHIV remained undiagnosed [[22](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref022)]. Applied to the 24.1 million PLHIV in the region that year, this implies ~11 million people [[13](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref013)]. Population-based impact assessments confirmed that diagnosis translated reliably into treatment and suppression. In Zambia in 2016, 87% of diagnosed individuals were on ART and 89% of those virally suppressed [[23](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref023)], with similar results in Kenya in 2018 [[24](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref024)]. Diagnosis rather than linkage to care was the operative bottleneck and HIVST was a new technology designed to close it. HIVST provides an important option as an individual collects their own specimen of oral fluid or blood, performs a rapid diagnostic test and interprets the result themselves in private without clinic attendance or interaction with a healthcare worker [[15](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref015)]. The gap has since narrowed. However, by 2025 an estimated 2.6 million PLHIV in sub-Saharan Africa still did not know their status, while 1.5 million in eastern and southern Africa and 1.1 million in western and central Africa (22%) remain undiagnosed [[13](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref013)]. These gains took a decade and came through conventional facility-based testing at considerable cost. An inexpensive self-administered diagnostic was available throughout but was never deployed at a volume capable of accelerating it. The question this Policy Forum addresses is not whether the gap narrowed but how much faster it could have narrowed and at what cost in missed diagnoses, delayed treatment and preventable transmissions. Learning from these missed opportunities, we recommend policy actions to expand access and close the remaining gap. ## The promise of HIV self-testing Conventional facility-based testing requires disclosure of risk behaviours to a provider, navigation of health systems and in many settings disclosure of serostatus to household members. Self-testing removes each of these barriers, since a person who cannot or will not test in a clinic may test at home, at a workplace or through a trusted peer. In July 2012, the US Food and Drug Administration approved the OraQuick In-Home HIV Test, the first over-the-counter HIV self-test [[14](https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005241#pmed.1005241.ref014)]. In 2016, WHO endorsed self-testing as an additional approach, citing its potential to reach people reluctant to present to facilities and to enable testing through community networks, pharmacies, workplaces and peer distr
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