Abstract

Ending HIV transmission in Europe is possible, but requires increased testing efforts and ensured linkage to care pathways across different settings. Evidence supports the implementation and scale-up of the ethical, effective, acceptable, and evidence-based HIV self-testing (HIVST) approach 1, 2. A high acceptability of HIVST and self-sampling has been found among key populations largely because it helps overcome self-identified barriers to HIV testing 3. The HIV in Europe Initiative (HiE), a pan-European initiative to improve early diagnosis and enrolment in care 4, supports increasing the range of voluntary HIV testing options within accessible comprehensive service delivery frameworks, including HIVST, where individuals perform an HIV rapid test themselves and read their own results, and HIV self-sampling, where individuals take the specimen and send a dried blood spot or oral fluid sample to a laboratory and receive the results after analysis. Despite some progress in HIV testing among key populations, rates remain low, particularly in eastern Europe 5, and few countries currently authorize or implement HIVST and/or self-sampling. The Dublin Declaration 2017 monitoring report lists eight countries authorizing self-sampling kits (Bosnia and Herzegovina, France, Georgia, Moldova, the Netherlands, Norway, Spain and the UK) and six authorizing HIVST (Bosnia and Herzegovina, France, Georgia, Moldova, Norway and the UK). 6 However, this is an area in rapid expansion, and HIVST kits went on sale in pharmacies in Belgium in November 2016 (http://www.breach-hiv.be/media/docs/BREACHSympo2017/18HIVPlanBREACH2017.pdf) and in Denmark in November 2017 (https://aidsfondet.dk/Nyheder/Selvtest-for-hiv-kan-nu-k%C3%B8bes-i-Danmark), and most recently HIVST has been approved in Spain in January 2018. Ample room remains for expanding HIV testing modalities across European countries to achieve earlier diagnosis and prevent onwards transmission. For a successful rollout of HIVST and/or self-sampling, a series of challenges need to be addressed (see Table 1), with emphasis on the quality of the testing process, access, information, and support and linkage to care for those with a reactive/positive test 7. Within the framework of the European Union (EU) co-financed Joint Action INTEGRATE (Joint Action on integrating prevention, testing and linkage to care strategies across HIV, viral hepatitis, tuberculosis and sexually transmitted illnesses in Europe: a collaboration between 15 EU countries and Serbia, involving 29 partner organizations, which runs for 3 years from 1 September 2017; see http://www.integrateja.eu), lessons learned from countries already implementing HIVST and self-sampling will be reflected upon and a best practice guide developed to facilitate implementation in other countries. To enhance HIV testing, HIV in Europe encourages European governments to take a proactive role in removing existing legal and regulatory barriers, including those limiting the availability of HIVST, preventing the use of point-of-care technologies by lay providers and restricting access to HIV tests for people < 18 years of age and/or migrants 6. Further, a close collaboration between governments, diagnostic companies and community organizations to identify mechanisms and implementing processes that ensure efficient and timely assessment and approval of safe, high-quality, affordable, consumer-friendly testing technologies to improve testing rates across Europe is essential. Conflicts of interest: The authors of this manuscript have no competing interests to declare. Funding statement: The HIV in Europe initiative has received project grants from Gilead Sciences, Merck, Pfizer, Abbott, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, and ViiV Healthcare. The operational procedures within the initiative include the following, to maintain the autonomy of the initiative: the Steering Committee is the governing body on which sponsors have no representation; data, records, reports, intellectual property rights and know-how generated as result of the initiative shall be deemed vested in and the property of the Steering Committee, represented by the Secretariat CHIP Department of Infectious Diseases, Rigshospitalet. CHIP has received funding from the European Union for the INTEGRATE Joint Action, within the framework of the Third Health Programme, and the Danish National Research Foundation (grant number DNRF126). The funders had no role in the decision to publish or preparation of the manuscript. SF, IS, DR, GMC and CA drafted the manuscript and JL, VD, DR, TP and JC critically revised it and provided technical input. All authors critically revised and finally approved the manuscript for publication. Yusef Azad, Jordi Casabona, Lella Cosmaro, Nikos Dedes, Valerie Delpech, José Gatell, Brian Gazzard, Igor Karpov, Jack Lambert, Jeffrey Lazarus, Jens Lundgren, Liudmyla Maistat, Mojca Maticic, Stefan Mauss, Teymur Noori, Tom Platteau, Stanislas Pol, Jürgen Rockstroh, Daniel Simões, Anders Sönnerborg, Ann Sullivan, Nino Tsereteli, Brian West, Lucas Wiessing, John de Wit, Yazdan Yazdanpanah and Wim Zuilhof.

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