Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial.
Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-021-05079-x
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发表时间：
2021-02-17
期刊：
影响因子：
2.5
通讯作者：
Rassokhin V
中科院分区：
文献类型：
--
作者：
DiClemente RJ;Brown JL;Capasso A;Revzina N;Sales JM;Boeva E;Gutova LV;Khalezova NB;Belyakov N;Rassokhin V
俄罗斯的人类免疫缺陷病毒（艾滋病毒）感染率很高。2018年，超过100万人感染艾滋病毒（PLWH）;超过三分之一是女性。感染艾滋病毒的妇女中有很高比例同时感染丙型肝炎病毒（HCV），许多人饮酒，这对艾滋病毒和HCV的治疗和预后产生了不利影响。尽管存在酗酒、艾滋病毒和丙型肝炎病毒三重流行，而且需要采取干预措施减少艾滋病毒/丙型肝炎病毒合并感染妇女的酗酒，但针对这一弱势群体的循证酒精减少干预措施有限。为了解决这一差距，我们开发了一项临床试验，以评估基于计算机的干预措施在临床护理中减少HIV/HCV合并感染妇女饮酒的有效性。在这个双臂平行随机对照试验中，我们建议评估通过计算机为HIV/HCV合并感染的俄罗斯女性提供的文化适应性酒精减少干预的有效性。研究人群由21-45岁的女性组成，这些女性目前正在使用酒精。通过一种新的酒精生物标志物乙基葡萄糖醛酸苷（EtG）以及HIV和HCV疾病进展的生物标志物来评估干预效果。女性以1：1的分配比例随机分配至试验条件，使用计算机生成的算法来开发分配序列和分配技术的隐藏，以最大限度地减少分配偏倚。女性被随机分配到（1）基于计算机的酒精减少干预或（2）标准护理控制条件。我们将使用意向治疗分析和逻辑和线性广义估计方程来评估干预疗效，相对于标准治疗，在9个月随访期间，在每次研究访视时提高实验室确认阴性EtG的女性比例。其他分析将评价干预对HIV（病毒载量和CD 4+水平）和疾病进展的HCV标志物（FibroScan）的影响。拟议的试验设计和分析提供了一个适当的概念和方法框架，以评估基于计算机的干预措施的疗效。我们计划招募200名参与者。干预，如果有效的话，可能是一个有效的和具有成本效益的酒精减少战略，是可扩展的，可以很容易地传播和整合到临床护理在俄罗斯，以减少妇女的酒精消费和提高艾滋病毒/丙型肝炎病毒的预后。ClinicalTrials.gov NCT03362476。2017年12月5日注册
Russia has a high prevalence of human immunodeficiency virus (HIV) infections. In 2018, over one million persons were living with HIV (PLWH); over a third were women. A high proportion of HIV-infected women are co-infected with hepatitis C virus (HCV), and many consume alcohol, which adversely affects HIV and HCV treatment and prognosis. Despite the triple epidemics of alcohol use, HIV and HCV, and the need for interventions to reduce alcohol use among HIV/HCV co-infected women, evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, we developed a clinical trial to evaluate the efficacy of a computer-based intervention to reduce alcohol consumption among HIV/HCV co-infected women in clinical care. In this two-arm parallel randomized controlled trial, we propose to evaluate the efficacy of a culturally adapted alcohol reduction intervention delivered via a computer for HIV/HCV co-infected Russian women. The study population consists of women 21–45 years old with confirmed HIV/HCV co-infection who currently use alcohol. Intervention efficacy is assessed by a novel alcohol biomarker, ethyl glucuronide (EtG), and biomarkers of HIV and HCV disease progression. Women are randomized to trial conditions in a 1:1 allocation ratio, using a computer-generated algorithm to develop the assignment sequence and concealment of allocation techniques to minimize assignment bias. Women are randomized to either (1) the computer-based alcohol reduction intervention or (2) the standard-of-care control condition. We will use an intent-to-treat analysis and logistic and linear generalized estimating equations to evaluate intervention efficacy, relative to the standard of care, in enhancing the proportion of women with a laboratory-confirmed negative EtG at each research study visit over the 9-month follow-up period. Additional analyses will evaluate intervention effects on HIV (viral load and CD4+ levels) and HCV markers of disease progression (FibroScan). The proposed trial design and analysis provides an appropriate conceptual and methodological framework to assess the efficacy of the computer-based intervention. We propose to recruit 200 participants. The intervention, if efficacious, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated into clinical care in Russia to reduce women’s alcohol consumption and enhance HIV/HCV prognosis. ClinicalTrials.gov NCT03362476. Registered on 5 December 2017
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影响因子：
4.6
作者：
Brown, Jennifer L.;DeMartini, Kelly S.;Sales, JessicaM.;Swartzendruber, Andrea L.;DiClemente, Ralph J.
通讯作者：
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通讯作者：
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影响因子：
4.4
作者：
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通讯作者：
Dmitrieva, Alexandra