abstract: 'IntroductionHIV self-testing (HIVST) was first proposed as an additional

  option to standard HIV testing services in the 1980s. By 2015, two years

  after the first HIVST kit was approved for the American market and the

  year in which Unitaid invested in the HIV Self-Testing AfRica (STAR)

  Initiative, HIVST remained unexplored with negligible access in low- and

  middle-income countries (LMIC). However, rapid progress had been made.

  This commentary outlines the interlinked market, regulatory and policy

  barriers that had inhibited product development and kept HIVST out of

  LMIC policy. We detail the components of STAR that enabled rapid HIVST

  scale-up, including critical investments in implementation, research,

  market forecasting, and engagement with manufacturers and regulators.

  DiscussionThe STAR Initiative has generated crucial information about

  how to distribute HIVST products effectively, ethically and efficiently.

  Service delivery models range from clinic-based distribution to

  workplace and partner-delivered approaches to reach first-time male

  testers, to community outreach to sex workers and general population

  hotspots. These data directly informed supportive policy, notably the

  2016 WHO guidelines strongly recommending HIVST as an additional testing

  approach, and regulatory change through support for WHO prequalification

  of the first HIVST kit in 2017. In July 2015, only two countries had

  national HIVST policies and were implementing HIVST. Three years later,

  59 countries have policies, actively implemented in 28, with an

  additional 53 countries reporting policies under development. By

  end-November 2018 several quality-assured HIVST products had been

  registered, including two WHO prequalified tests. STAR Initiative

  countries have drafted regulations governing invitro diagnostics,

  including HIVST products. With enabling policies, pre-qualification and

  regulations in place, donor procurement of kits has increased rapidly,

  to a forecasted estimate of 16million HIVST kits procured by 2020.

  ConclusionsThe STAR Initiative provided a strong foundation to introduce

  HIVST in LMICs and allow for rapid scale-up based on the wealth of

  multi-country evidence gathered. Together with sustained coordination

  and acceleration of market development work, HIVST can help address the

  testing gap and provide a focused and cost-effective means to expand

  access to treatment and prevention services.'
affiliation: 'Ingold, H (Corresponding Author), Unitaid, Global Hlth Campus,Chemin
  Pommier 40,5th Floor, CH-1218 Geneva, Switzerland.

  Ingold, Heather; Mwerinde, Ombeni; Ross, Anna Laura; Leach, Ross, Unitaid, Global
  Hlth Campus,Chemin Pommier 40,5th Floor, CH-1218 Geneva, Switzerland.

  Corbett, Elizabeth L., Malawi Liverpool Wellcome Trust Clin Res Programm, Blantyre,
  Malawi.

  Corbett, Elizabeth L., London Sch Hyg \& Trop Med, Fac Infect \& Trop Dis, London,
  England.

  Hatzold, Karin, Populat Serv Int, Washington, DC USA.

  Johnson, Cheryl C.; Baggaley, Rachel C., WHO, Dept HIV AIDS, Geneva, Switzerland.

  Johnson, Cheryl C., London Sch Hyg \& Trop Med, Dept Infect \& Trop Dis, London,
  England.

  Ncube, Getrude, Zimbabwe Minist Hlth, Harare, Zimbabwe.

  Nyirenda, Rose, Malawi Minist Hlth, Lilongwe, Malawi.'
article-number: e25249
author: Ingold, Heather and Mwerinde, Ombeni and Ross, Anna Laura and Leach, Ross
  and Corbett, Elizabeth L. and Hatzold, Karin and Johnson, Cheryl C. and Ncube, Getrude
  and Nyirenda, Rose and Baggaley, Rachel C.
author-email: ingoldh@who.int
author_list:
- family: Ingold
  given: Heather
- family: Mwerinde
  given: Ombeni
- family: Ross
  given: Anna Laura
- family: Leach
  given: Ross
- family: Corbett
  given: Elizabeth L.
- family: Hatzold
  given: Karin
- family: Johnson
  given: Cheryl C.
- family: Ncube
  given: Getrude
- family: Nyirenda
  given: Rose
- family: Baggaley
  given: Rachel C.
da: '2023-09-28'
doi: 10.1002/jia2.25249
eissn: 1758-2652
files: []
journal: JOURNAL OF THE INTERNATIONAL AIDS SOCIETY
keywords: 'HIV testing; HIV self-testing; market shaping; scale-up; prevention;

  linkage to care; cost effectiveness'
keywords-plus: RURAL MALAWI; ACCEPTABILITY; POLICY
language: English
month: MAR
number: 1, SI
number-of-cited-references: '36'
orcid-numbers: 'Ingold, Heather/0000-0002-8714-8889

  Corbett, Elizabeth/0000-0002-3552-3181

  Hatzold, Karin/0000-0002-5117-3732

  Johnson, Cheryl/0000-0001-5499-5523'
papis_id: 7de42c9021a7a3d3b178ee9f9a4249c7
ref: Ingold2019selftestingafrica
times-cited: '36'
title: 'The Self-Testing AfRica (STAR) Initiative: accelerating global access and
  scale-up of HIV self-testing'
type: Article
unique-id: WOS:000462359300008
usage-count-last-180-days: '0'
usage-count-since-2013: '5'
volume: '22'
web-of-science-categories: Immunology; Infectious Diseases
year: '2019'