评估干预措施以减少男男性行为者中与 HCV 再感染相关行为：一项非盲、2 期、随机试验的研究方案。

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial.

机构信息

Department of Infectious Diseases, Public Health Service of Amsterdam, Amsterdam, the Netherlands.

Amsterdam UMC location University of Amsterdam, Infectious Diseases, Meibergdreef 9, Amsterdam, the Netherlands.

出版信息

Trials. 2023 Mar 15;24(1):193. doi: 10.1186/s13063-023-07161-y.

DOI:10.1186/s13063-023-07161-y

PMID:36922871

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10015546/

Abstract

BACKGROUND

As highly effective therapy against hepatitis C virus (HCV) infection is available with rapid uptake, there is newfound optimism for HCV elimination. Nevertheless, certain key populations have a high risk of HCV reinfection, in particular men who have sex with men (MSM) in Western European countries. Modelling data indicate that HCV elimination will not be feasible without reduction in risk behaviour, thus supporting the need for effective interventions aimed at reducing risk behaviour and preventing reinfections in MSM.

METHODS

The ICECREAM study is an international, multi-centred, phase 2, 3-arm randomised trial comparing run-in and intervention periods enrolling MSM with a history of a cured or spontaneously cleared HCV infection. Individuals are followed in routine care for 6 months (i.e. run-in period) and then randomly allocated (1:1:1) to one of the following: a tailored, interactive online risk-reduction behavioural intervention, a validated home-based HCV-RNA self-sampling test service using dried blood spots, or a combination of both. After randomisation, individuals are followed every 6 months until 18 months (i.e. intervention period). Interventions are delivered in addition to standard of care. Online questionnaire measuring risk behaviour over the past 6 months is administered at every visit. The primary outcome is the proportion at risk of HCV infection during run-in versus intervention periods assessed by using the HCV-MOSAIC risk score. The risk score consists of six self-reported HCV-related risk behaviours. Secondary outcomes include incidence of HCV reinfection, changes in the individual risk behaviour items and changes in sexual well-being since changes in sexual behaviour may have an impact on sexual experience. Two hundred forty-six MSM aged 18 years or older will be invited to participate.

DISCUSSION

The ICECREAM study is a trial aimed at establishing interventions that could effectively decrease the incidence of HCV re-infection in MSM with a previous HCV infection. By offering an online behavioural risk-reduction intervention and HCV-RNA self-sampling, both of which are aimed to influence risk behaviour, we are able to provide products to at-risk MSM that could further reduce population-level HCV incidence and ultimately help reach HCV micro-elimination.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04156945. Registered on November 8, 2019.

摘要

背景

由于针对丙型肝炎病毒 (HCV) 感染的高效治疗方法已经得到迅速普及，因此人们对 HCV 的消除重新充满了希望。然而，某些特定人群感染 HCV 的风险仍然很高，特别是在西欧国家的男男性行为者 (MSM)。建模数据表明，如果不减少风险行为，HCV 的消除是不可能的，因此需要采取有效的干预措施，减少 MSM 的风险行为并防止再次感染。

方法

ICECREAM 研究是一项国际性、多中心、2 期 3 臂随机试验，比较了入组时有治愈或自发性清除 HCV 感染史的 MSM 的入组和干预期。参与者在常规护理中随访 6 个月（即入组期），然后随机分配（1:1:1）至以下三种干预措施之一：量身定制的、互动式在线降低风险行为干预、基于家庭的经干血斑检测 HCV-RNA 自我采样服务，或两者结合。随机分组后，参与者每 6 个月随访一次，直至 18 个月（即干预期）。干预措施在标准治疗的基础上进行。每次就诊时都通过在线问卷评估过去 6 个月的风险行为。主要结局是使用 HCV-MOSAIC 风险评分评估入组和干预期间 HCV 感染风险的比例。风险评分由 6 项自我报告的 HCV 相关风险行为组成。次要结局包括 HCV 再感染的发生率、个体风险行为项目的变化以及性行为变化后性健康的变化，因为性行为的变化可能会对性体验产生影响。将邀请 246 名年龄在 18 岁及以上的 MSM 参与。

讨论

ICECREAM 研究旨在确定有效的干预措施，以降低有既往 HCV 感染的 MSM 的 HCV 再感染发生率。通过提供在线行为风险降低干预和 HCV-RNA 自我采样，这两种方法都旨在影响风险行为，我们能够为高危 MSM 提供产品，进一步降低人群 HCV 发病率，并最终有助于实现 HCV 的微消除。