2023-09-28 14:46:10 +00:00
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abstract: 'IntroductionHIV self-testing (HIVST) was first proposed as an additional
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option to standard HIV testing services in the 1980s. By 2015, two years
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after the first HIVST kit was approved for the American market and the
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year in which Unitaid invested in the HIV Self-Testing AfRica (STAR)
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Initiative, HIVST remained unexplored with negligible access in low- and
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middle-income countries (LMIC). However, rapid progress had been made.
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This commentary outlines the interlinked market, regulatory and policy
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barriers that had inhibited product development and kept HIVST out of
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LMIC policy. We detail the components of STAR that enabled rapid HIVST
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scale-up, including critical investments in implementation, research,
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market forecasting, and engagement with manufacturers and regulators.
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DiscussionThe STAR Initiative has generated crucial information about
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how to distribute HIVST products effectively, ethically and efficiently.
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Service delivery models range from clinic-based distribution to
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workplace and partner-delivered approaches to reach first-time male
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testers, to community outreach to sex workers and general population
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hotspots. These data directly informed supportive policy, notably the
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2016 WHO guidelines strongly recommending HIVST as an additional testing
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approach, and regulatory change through support for WHO prequalification
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of the first HIVST kit in 2017. In July 2015, only two countries had
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national HIVST policies and were implementing HIVST. Three years later,
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59 countries have policies, actively implemented in 28, with an
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additional 53 countries reporting policies under development. By
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end-November 2018 several quality-assured HIVST products had been
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registered, including two WHO prequalified tests. STAR Initiative
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countries have drafted regulations governing invitro diagnostics,
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including HIVST products. With enabling policies, pre-qualification and
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regulations in place, donor procurement of kits has increased rapidly,
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to a forecasted estimate of 16million HIVST kits procured by 2020.
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ConclusionsThe STAR Initiative provided a strong foundation to introduce
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HIVST in LMICs and allow for rapid scale-up based on the wealth of
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multi-country evidence gathered. Together with sustained coordination
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and acceleration of market development work, HIVST can help address the
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testing gap and provide a focused and cost-effective means to expand
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access to treatment and prevention services.'
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affiliation: 'Ingold, H (Corresponding Author), Unitaid, Global Hlth Campus,Chemin
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Pommier 40,5th Floor, CH-1218 Geneva, Switzerland.
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Ingold, Heather; Mwerinde, Ombeni; Ross, Anna Laura; Leach, Ross, Unitaid, Global
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Hlth Campus,Chemin Pommier 40,5th Floor, CH-1218 Geneva, Switzerland.
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Corbett, Elizabeth L., Malawi Liverpool Wellcome Trust Clin Res Programm, Blantyre,
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Malawi.
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Corbett, Elizabeth L., London Sch Hyg \& Trop Med, Fac Infect \& Trop Dis, London,
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England.
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Hatzold, Karin, Populat Serv Int, Washington, DC USA.
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Johnson, Cheryl C.; Baggaley, Rachel C., WHO, Dept HIV AIDS, Geneva, Switzerland.
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Johnson, Cheryl C., London Sch Hyg \& Trop Med, Dept Infect \& Trop Dis, London,
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England.
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Ncube, Getrude, Zimbabwe Minist Hlth, Harare, Zimbabwe.
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Nyirenda, Rose, Malawi Minist Hlth, Lilongwe, Malawi.'
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article-number: e25249
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author: Ingold, Heather and Mwerinde, Ombeni and Ross, Anna Laura and Leach, Ross
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and Corbett, Elizabeth L. and Hatzold, Karin and Johnson, Cheryl C. and Ncube, Getrude
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and Nyirenda, Rose and Baggaley, Rachel C.
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author-email: ingoldh@who.int
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author_list:
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- family: Ingold
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given: Heather
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- family: Mwerinde
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given: Ombeni
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- family: Ross
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given: Anna Laura
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- family: Leach
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given: Ross
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- family: Corbett
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given: Elizabeth L.
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- family: Hatzold
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given: Karin
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- family: Johnson
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given: Cheryl C.
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- family: Ncube
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given: Getrude
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- family: Nyirenda
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given: Rose
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- family: Baggaley
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given: Rachel C.
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da: '2023-09-28'
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doi: 10.1002/jia2.25249
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eissn: 1758-2652
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files: []
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journal: JOURNAL OF THE INTERNATIONAL AIDS SOCIETY
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keywords: 'HIV testing; HIV self-testing; market shaping; scale-up; prevention;
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linkage to care; cost effectiveness'
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keywords-plus: RURAL MALAWI; ACCEPTABILITY; POLICY
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language: English
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month: MAR
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number: 1, SI
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number-of-cited-references: '36'
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orcid-numbers: 'Ingold, Heather/0000-0002-8714-8889
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Corbett, Elizabeth/0000-0002-3552-3181
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Hatzold, Karin/0000-0002-5117-3732
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Johnson, Cheryl/0000-0001-5499-5523'
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papis_id: 7de42c9021a7a3d3b178ee9f9a4249c7
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ref: Ingold2019selftestingafrica
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times-cited: '36'
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title: 'The Self-Testing AfRica (STAR) Initiative: accelerating global access and
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scale-up of HIV self-testing'
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2023-10-01 08:15:07 +00:00
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type: article
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2023-09-28 14:46:10 +00:00
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unique-id: WOS:000462359300008
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usage-count-last-180-days: '0'
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usage-count-since-2013: '5'
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volume: '22'
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web-of-science-categories: Immunology; Infectious Diseases
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year: '2019'
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