{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T03:33:35Z","timestamp":1765596815953,"version":"3.48.0"},"reference-count":15,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2022,9,8]],"date-time":"2022-09-08T00:00:00Z","timestamp":1662595200000},"content-version":"unspecified","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Government of the Netherlands","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,8,11]]},"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Globally, it is estimated that more than three-quarters of people with chronic hepatitis C virus (HCV) are unaware of their HCV status. HCV self-testing (HCVST) may improve access and uptake of HCV testing particularly among key populations such as people who inject drugs (PWID) and men who have sex with men (MSM) where HCV prevalence and incidence are high and barriers to accessing health services due to stigma and discrimination are common.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This randomised controlled trial compares an online programme offering oral fluid-based HCVST delivered to the home with referral to standard-of-care HCV testing at HCV testing sites. Eligible participants are adults self-identifying as either MSM or PWID who live in Tbilisi or Batumi, Georgia, and whose current HCV status is unknown. Participants will be recruited through an online platform and randomised to one of three arms for MSM (courier delivery, peer delivery and standard-of-care HCV testing (control)) and two for PWID (peer delivery and standard-of-care HCV testing (control)). Participants in the postal delivery group will receive an HCVST kit delivered by an anonymised courier. Participants in the peer delivery groups will schedule delivery of the HCVST by a peer. Control groups will receive information on how to access standard-of-care testing at a testing site. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, and attitudes around HCV testing and cost will also be evaluated. The target sample size is 1250 participants (250 per arm).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been obtained from the National Centers for Disease Control and Public Health Georgia Institutional Review Board (IRB) (IRB# 2021-049). Study results will be disseminated by presentations at conferences and via peer-reviewed journals. Protocol version 1.1; 14 July 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Registry (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04961723\">NCT04961723<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-056243","type":"journal-article","created":{"date-parts":[[2022,9,8]],"date-time":"2022-09-08T11:36:20Z","timestamp":1662636980000},"page":"e056243","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Home-based hepatitis C self-testing in people who inject drugs and men who have sex with men in Georgia: a protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04961723","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1569-8758","authenticated-orcid":false,"given":"Sonjelle","family":"Shilton","sequence":"first","affiliation":[{"name":"FIND, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ketevan","family":"Stvilia","sequence":"additional","affiliation":[{"name":"National Centre for Disease Control and Public Health of Georgia, Tbilisi, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maia","family":"Japaridze","sequence":"additional","affiliation":[{"name":"FIND, Tbilisi, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nino","family":"Tsereteli","sequence":"additional","affiliation":[{"name":"Center for Information and Counselling on Reproductive Health-Tanadgoma, Tbilisi, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dali","family":"Usharidze","sequence":"additional","affiliation":[{"name":"New Way, Tbilisi, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shota","family":"Phevadze","sequence":"additional","affiliation":[{"name":"Equality Movement, Tbilisi, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miranda","family":"Jghenti","sequence":"additional","affiliation":[{"name":"Batumi Imedi, Batumi, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antons","family":"Mozalevskis","sequence":"additional","affiliation":[{"name":"Regional Office for Europe, WHO, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Markby","sequence":"additional","affiliation":[{"name":"FIND, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niklas","family":"Luhmann","sequence":"additional","affiliation":[{"name":"Global HIV, Hepatitis and STI Programmes, WHO Headquarters, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl","family":"Johnson","sequence":"additional","affiliation":[{"name":"Global HIV, Hepatitis and STI Programmes, WHO Headquarters, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pamela","family":"Nabeta","sequence":"additional","affiliation":[{"name":"FIND, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefano","family":"Ongarello","sequence":"additional","affiliation":[{"name":"FIND, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena Ivanova","family":"Reipold","sequence":"additional","affiliation":[{"name":"FIND, Geneva, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amiran","family":"Gamkrelidze","sequence":"additional","affiliation":[{"name":"National Centre for Disease Control and Public Health of Georgia, Tbilisi, Georgia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,9,8]]},"reference":[{"key":"2025121219314382000_12.9.e056243.1","unstructured":"World Health Organization (WHO) . Recommendations and guidance on hepatitis C virus self-testing, 2021. Available: https:\/\/www.who.int\/publications\/i\/item\/9789240031128 [Accessed 20 Jul 2021]."},{"key":"2025121219314382000_12.9.e056243.2","doi-asserted-by":"crossref","DOI":"10.1186\/s12879-018-3185-7","article-title":"A qualitative assessment of the acceptability of hepatitis C remote self-testing and self-sampling amongst people who use drugs in London, UK","volume":"18","author":"Guise","year":"2018","journal-title":"BMC Infect Dis"},{"key":"2025121219314382000_12.9.e056243.3","doi-asserted-by":"crossref","first-page":"463","DOI":"10.3390\/diagnostics11030463","article-title":"A lay-user assessment of hepatitis C virus self-testing device usability and interpretation in Johannesburg, South Africa","volume":"11","author":"Majam","year":"2021","journal-title":"Diagnostics"},{"key":"2025121219314382000_12.9.e056243.4","doi-asserted-by":"crossref","DOI":"10.1186\/s12879-021-06332-z","article-title":"Values and preferences for hepatitis C self-testing among people who inject drugs in Kyrgyzstan","volume":"21","author":"Mart\u00ednez-P\u00e9rez","year":"2021","journal-title":"BMC Infect Dis"},{"key":"2025121219314382000_12.9.e056243.5","doi-asserted-by":"crossref","first-page":"377","DOI":"10.3390\/diagnostics11020377","article-title":"Acceptability and usability of HCV self-testing in high risk populations in Vietnam","volume":"11","author":"Nguyen","year":"2021","journal-title":"Diagnostics"},{"key":"2025121219314382000_12.9.e056243.6","doi-asserted-by":"crossref","DOI":"10.1186\/s12889-021-11169-x","article-title":"Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile delta region of Egypt","volume":"21","author":"Reipold","year":"2021","journal-title":"BMC Public Health"},{"key":"2025121219314382000_12.9.e056243.7","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6541a2"},{"key":"2025121219314382000_12.9.e056243.8","doi-asserted-by":"crossref","first-page":"753","DOI":"10.15585\/mmwr.mm6428a2","article-title":"Launch of a nationwide hepatitis C elimination program \u2014 Georgia, April 2015","volume":"64","author":"Mitruka","year":"2015","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"2025121219314382000_12.9.e056243.9","unstructured":"Chikovani I , Shengelia N , Sulaberidze L . HIV risk and prevention behaviors among people who inject drugs in seven cities of Georgia, 2017. Available: http:\/\/curatiofoundation.org\/wp-content\/uploads\/2018\/02\/PWID-IBBS-Report-2017-ENG.pdf [Accessed 20 Jul 2021]."},{"key":"2025121219314382000_12.9.e056243.10","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1007\/s11524-006-9032-y","article-title":"Prevalence of hepatitis C, HIV, and risk behaviors for blood-borne infections: a population-based survey of the adult population of T'bilisi, Republic of Georgia","volume":"83","author":"Stvilia","year":"2006","journal-title":"J Urban Health"},{"key":"2025121219314382000_12.9.e056243.11","first-page":"51","article-title":"Prevailing HCV genotypes and subtypes among HIV infected patients in Georgia","volume":"177","author":"Karchava","year":"2009","journal-title":"Georgian Med News"},{"key":"2025121219314382000_12.9.e056243.12","doi-asserted-by":"crossref","first-page":"871","DOI":"10.1016\/j.drugpo.2014.01.007","article-title":"Hepatitis C among people who inject drugs in Tbilisi, Georgia: an urgent need for prevention and treatment","volume":"25","author":"Bouscaillou","year":"2014","journal-title":"Int J Drug Policy"},{"key":"2025121219314382000_12.9.e056243.13","unstructured":"Dershem L , Tabatadze M , Sirbiladze T . Characteristics, high-risk behaviors and knowledge of STI\/HIV\/AIDS and prevalence of HIV, syphilis and hepatitis among injecting drug users in Kutaisi, Georgia: 2007-2009 USAID Report; 2009 [Accessed 20 Jul 2021]."},{"key":"2025121219314382000_12.9.e056243.14","unstructured":"Georgia Country Coordinating Mechanism, Global Fund . Georgia HIV\/AIDS national strategic plan. Available: http:\/\/www.georgia-ccm.ge\/wp-content\/uploads\/Georgia-HIV-AIDS-National-Strategic-Plan-2019-20222.pdf [Accessed 20 Jul 2021]."},{"key":"2025121219314382000_12.9.e056243.15","doi-asserted-by":"crossref","first-page":"340","DOI":"10.1016\/S2468-1253(21)00060-1","article-title":"Investment cases for hepatitis C: never more important","volume":"6","author":"Wingrove","year":"2021","journal-title":"Lancet Gastroenterol Hepatol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-056243","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T03:31:50Z","timestamp":1765596710000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-056243"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9]]},"references-count":15,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2022,9,8]]},"published-print":{"date-parts":[[2022,9]]}},"alternative-id":["10.1136\/bmjopen-2021-056243"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-056243","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2022,9]]}}}