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
Introduction 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...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e056243.full |
| _version_ | 1798003051855872000 |
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| author | Cheryl Johnson Amiran Gamkrelidze Stefano Ongarello Niklas Luhmann Jessica Markby Sonjelle Shilton Ketevan Stvilia Maia Japaridze Nino Tsereteli Dali Usharidze Shota Phevadze Miranda Jghenti Antons Mozalevskis Pamela Nabeta Elena Ivanova Reipold |
| author_facet | Cheryl Johnson Amiran Gamkrelidze Stefano Ongarello Niklas Luhmann Jessica Markby Sonjelle Shilton Ketevan Stvilia Maia Japaridze Nino Tsereteli Dali Usharidze Shota Phevadze Miranda Jghenti Antons Mozalevskis Pamela Nabeta Elena Ivanova Reipold |
| author_sort | Cheryl Johnson |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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).Ethics and dissemination 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.Trial registration number ClinicalTrials.gov Registry (NCT04961723). |
| first_indexed | 2024-04-11T12:01:53Z |
| format | Article |
| id | doaj.art-7b21b48a6e72423699b64f0b60609ca5 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T12:01:53Z |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-7b21b48a6e72423699b64f0b60609ca52022-12-22T04:24:50ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2021-056243Home-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 trialCheryl Johnson0Amiran Gamkrelidze1Stefano Ongarello2Niklas Luhmann3Jessica Markby4Sonjelle Shilton5Ketevan Stvilia6Maia Japaridze7Nino Tsereteli8Dali Usharidze9Shota Phevadze10Miranda Jghenti11Antons Mozalevskis12Pamela Nabeta13Elena Ivanova Reipold14Global HIV, Hepatitis and STI Programmes, WHO Headquarters, Geneva, SwitzerlandNational Centre for Disease Control and Public Health of Georgia, Tbilisi, GeorgiaFIND, Geneva, SwitzerlandGlobal HIV, Hepatitis and STI Programmes, WHO Headquarters, Geneva, SwitzerlandFIND, Geneva, SwitzerlandFIND, Geneva, SwitzerlandNational Centre for Disease Control and Public Health of Georgia, Tbilisi, GeorgiaFIND, Tbilisi, GeorgiaCenter for Information and Counselling on Reproductive Health-Tanadgoma, Tbilisi, GeorgiaNew Way, Tbilisi, GeorgiaEquality Movement, Tbilisi, GeorgiaBatumi Imedi, Batumi, GeorgiaRegional Office for Europe, WHO, Copenhagen, DenmarkFIND, Geneva, SwitzerlandFIND, Geneva, SwitzerlandIntroduction 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.Methods and analysis 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).Ethics and dissemination 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.Trial registration number ClinicalTrials.gov Registry (NCT04961723).https://bmjopen.bmj.com/content/12/9/e056243.full |
| spellingShingle | Cheryl Johnson Amiran Gamkrelidze Stefano Ongarello Niklas Luhmann Jessica Markby Sonjelle Shilton Ketevan Stvilia Maia Japaridze Nino Tsereteli Dali Usharidze Shota Phevadze Miranda Jghenti Antons Mozalevskis Pamela Nabeta Elena Ivanova Reipold 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 BMJ Open |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/9/e056243.full |
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