FIND, Geneva, Switzerland
National Centre for Disease Control and Public Health of Georgia, Tbilisi, Georgia.
BMJ Open. 2022 Sep 8;12(9):e056243. doi: 10.1136/bmjopen-2021-056243.
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.
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).
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.
ClinicalTrials.gov Registry (NCT04961723).
据估计，在全球范围内，超过四分之三的慢性丙型肝炎病毒（HCV）感染者不知道自己的 HCV 状况。HCV 自我检测（HCVST）可能会改善 HCV 检测的可及性和接受度，特别是在那些 HCV 患病率和发病率高且由于污名化和歧视而难以获得卫生服务的关键人群中，如注射毒品者（PWID）和男男性行为者（MSM）。
这项随机对照试验比较了一种提供家庭用口腔液基 HCVST 的在线方案与在 HCV 检测点进行标准护理 HCV 检测的方案。符合条件的参与者是自认为是 MSM 或 PWID 的成年人，他们居住在格鲁吉亚的第比利斯或巴统，且目前的 HCV 状况未知。参与者将通过在线平台招募，并随机分配到 MSM 的三个组（快递组、同伴组和标准护理 HCV 检测（对照组））和 PWID 的两个组（同伴组和标准护理 HCV 检测（对照组））。快递组的参与者将收到由匿名快递员送达的 HCVST 试剂盒。同伴组的参与者将安排由同伴送达 HCVST。对照组将收到有关如何在检测点获得标准护理检测的信息。主要结局是报告完成检测的参与者人数和比例。次要结局包括以下方面的人数和比例：（a）收到阳性结果并了解其状况的参与者，（b）被转介并完成 HCV RNA 确认检测的参与者，以及（c）开始治疗的参与者。还将评估 HCV 检测的可接受性、可行性和态度以及成本。目标样本量为 1250 名参与者（每组 250 名）。
国家疾病控制和公共卫生中心格鲁吉亚机构审查委员会（IRB）已批准本研究（IRB#2021-049）。研究结果将通过会议演讲和同行评议期刊发表。协议版本 1.1；2021 年 7 月 14 日。
ClinicalTrials.gov 注册（NCT04961723）。
