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是否有效?——一项针对中国美沙酮维持治疗点吸毒者的 HCV 和 HIV 相关教育效果的随机对照试验。

DOES IT WORK? -a randomized controlled trial to test the efficacy of HCV and HIV-related education on drug users in MMT, China.

机构信息

Collaborative Innovation Center for Brain Science, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wanping Road, Shanghai, 200030, China.

Mental Health Center of Jiading District in Shanghai, Shanghai, China.

出版信息

BMC Infect Dis. 2019 Sep 5;19(1):774. doi: 10.1186/s12879-019-4421-5.

DOI:10.1186/s12879-019-4421-5
PMID:31488064
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6727322/
Abstract

BACKGROUND

HCV (Hepatitis C virus) is a prevalent chronic disease with potentially deadly consequences, especially for drug users. However, there are no special HCV or HIV (human immunodeficiency virus)-related intervention programs that are tailored for drug users in China; to fill this gap, the purpose of this study was to explore HCV and HIV-related knowledge among drug users in MMT (methadone maintenance treatment) sites of China and to investigate the effectiveness of HCV and HIV-related education for improving the knowledge of IDUs (injection drug users) and their awareness of infection.

METHODS

The study was a randomized cluster controlled trial that compared a usual care group to a usual care plus HCV/HIV-REP (HCV/HIV-Reduction Education Program) group with a 24-week follow-up. The self-designed questionnaires, the HCV- and HIV-related knowledge questionnaire and the HIV/HCV infection awareness questionnaire, were used to collect the data. Four MMT clinics were selected for this project; two MMT clinics were randomly assigned to the research group, with subjects receiving their usual care plus HCV/HIV-REP, and the remaining two MMT clinics were the control group, with subjects receiving their usual care over 12 weeks. Sixty patients were recruited from each MMT clinic. A total of 240 patients were recruited. Follow-up studies were conducted at the end of the 12th week and the 24th week after the intervention.

RESULTS

At baseline, the mean score (out of 20 possible correct answers) for HCV knowledge among the patients in the group receiving the intervention was 6.51 (SD = 3.5), and it was 20.57 (SD = 6.54) for HIV knowledge (out of 45 correct answers) and 8.35 (SD = 2.8) for HIV/HCV infection awareness (out of 20 correct answers). At the 12-week and 24-week follow-up assessments, the research group showed a greater increase in HCV-/HIV-related knowledge (group × time effect, F = 37.444/11.281, P < 0.05) but no difference in their HIV/HCV infection awareness (group × time effect, F = 2.056, P > 0.05).

CONCLUSION

An MMT-based HCV/HIV intervention program could be used to improve patient knowledge of HCV and HIV prevention, but more effort should be devoted to HIV/HCV infection awareness.

TRIAL REGISTRATION

Protocols for this study were approved by institution review board (IRB) of Shanghai Mental Health Center (IRB:2009036), and registered in U.S national institutes of health (http://www.clinicaltrials.gov, NCT01647191 ). Registered 23 July 2012.

摘要

背景

丙型肝炎(HCV,Hepatitis C virus)是一种常见的慢性疾病,可能导致致命后果,尤其是对吸毒者而言。然而,中国并没有针对吸毒者的特殊 HCV 或 HIV(人类免疫缺陷病毒)相关干预计划;为填补这一空白,本研究旨在探讨中国美沙酮维持治疗(MMT)点吸毒者的 HCV 和 HIV 相关知识,并调查 HCV 和 HIV 相关教育对提高 IDUs(注射吸毒者)的知识和感染意识的效果。

方法

本研究采用随机对照群集试验,将常规护理组与常规护理加 HCV/HIV-REP(HCV/HIV 减少教育计划)组进行比较,随访 24 周。使用自行设计的问卷,即 HCV 和 HIV 相关知识问卷和 HIV/HCV 感染意识问卷,收集数据。该项目选择了 4 个 MMT 诊所;其中 2 个 MMT 诊所被随机分配到研究组,接受常规护理加 HCV/HIV-REP,其余 2 个 MMT 诊所为对照组,接受 12 周的常规护理。每个 MMT 诊所招募 60 名患者。共招募 240 名患者。干预后 12 周和 24 周进行随访研究。

结果

在基线时,接受干预组的患者 HCV 知识平均得分为 6.51(SD=3.5),HIV 知识得分为 20.57(SD=6.54)(45 个正确答案),HIV/HCV 感染意识得分为 8.35(SD=2.8)(20 个正确答案)。在 12 周和 24 周的随访评估中,研究组 HCV-/HIV 相关知识的增加更为明显(组间×时间效应,F=37.444/11.281,P<0.05),但 HIV/HCV 感染意识无差异(组间×时间效应,F=2.056,P>0.05)。

结论

基于 MMT 的 HCV/HIV 干预计划可用于提高患者对 HCV 和 HIV 预防的认识,但应更加关注 HIV/HCV 感染意识。

试验注册

本研究方案经上海精神卫生中心机构审查委员会(IRB)批准(IRB:2009036),并在美国国立卫生研究院注册(http://www.clinicaltrials.gov,NCT01647191)。于 2012 年 7 月 23 日注册。

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