Computer-based Alcohol Reduction Intervention for alcohol-using HIV/HCV+ Russian women in Clinical Care

临床护理中对使用酒精的 HIV/HCV 俄罗斯女性进行基于计算机的酒精减少干预

• 批准号: 9767536
• 负责人: Jennifer L Brown
• 金额: $ 14.84万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9767536
• 关键词: Acquired Immunodeficiency Syndrome; Address; Age-Years; Alcohol consumption; Alcohols; Algorithms; Biological Assay; Biological Markers; Blood; Caring; Chronic Hepatitis C; Computer Assisted; Computers; Counseling; Data Analyses; Disease Marker; Disease Progression; Eligibility Determination; Epidemic; Equation; Evaluation; Frequencies; Funding; Gender; HIV; HIV/HCV; Health; Hepatitis C Transmission; Hepatitis C co-infection; Hepatitis C virus; High Prevalence; Intervention; Interview; Laboratories; Linguistics; Logistics; Methodology; Modeling; Morbidity - disease rate; National Institute on Alcohol Abuse and Alcoholism; Observational Study; Outcome; Phase; Procedures; Process; Randomized; Regimen; Reporting; Research; Research Personnel; Risk; Russia; Serum; Serum Markers; Specimen; Spottings; Techniques; Testing; Treatment Efficacy; Viral Load result; Vulnerable Populations; Woman; Women' s Health; alcohol and other drug; alcohol intervention; alcohol measurement; base; care seeking; clinical care; clinical practice; computer generated; cost effective; design; evidence base; experience; follow up assessment; follow-up; improved; innovation; intervention effect; mortality; multidisciplinary; novel; novel marker; phosphatidylethanol; randomized trial; recruit; reduced alcohol use; sample collection; standard of care; therapy design; trial design

Women co-infected with HIV and HCV are at elevated risk for adverse health outcomes associated with alcohol use. Evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, the proposed study is an exciting opportunity to extend and deepen a longstanding partnership between Russian and U.S. investigators. We propose to harness the multidisciplinary expertise and experience of our collaborative Russian-U.S. research team to adapt an effective computer-based intervention, called CBT4CBT, to enhance its appropriateness for HIV/HCV co-infected women and evaluate its efficacy. The proposed study will be conducted in three sequential stages: (1) Adaptation, (2) Implementation, and (3) Evaluation. In Stage 1, Adaptation, we will use our ADAPT-ITT framework to systematically guide the adaptation process enhancing the linguistic-, gender- and HIV/HCV-appropriateness of the intervention. In Stage 2, Implementation, we will evaluate the efficacy of intervention in a Phase III randomized trial with 250 alcohol-using HIV/HCV co-infected women, 18-40 years of age, in clinical care. Women will be screened to assess eligibility and those willing to participate and identified as having laboratory- confirmed recent alcohol use, as assessed by a novel biomarker, phosphatidylethanol (PEth), will be eligible to participate. Eligible women will be asked to return to the AIDS Centre to complete a baseline assessment consisting of an audio-computer-assisted self-interview (ACASI) and specimen collection for PEth assay, and HIV (VL, CD4) and HCV (Fibroscan, serum markers) biomarkers. Following baseline assessment, women will be randomized, using a computer-generated algorithm and concealment of allocation techniques designed to minimize assignment bias, to one of two conditions: (1) adapted computer-based alcohol reduction intervention, or (2) standard-of-care control condition. Women complete the first session of the intervention immediately following assignment to the that condition and return to the AIDS Centre on consecutive weeks to complete two additional sessions (one session each week). All women will complete follow-up assessments consisting of an identical ACASI and specimen collection at 3-, 6- and 9-months post-baseline. In Stage 3, Evaluation, 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 PEth over the follow-up period. Other analyses will evaluate intervention effects on reducing viral load, HCV markers of disease progression, and improving CD4 levels. The proposed trial design and analysis provides an appropriate conceptual and methodological framework to assess the efficacy of the adapted computer-based intervention. The intervention, if effective, may be an efficient and cost- effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated in clinical care at other AIDS Centres in Russia to enhance women’s health and reduce HIV/HCV transmission risk.

同时感染HIV和HCV的女性出现不良健康结果的风险增加， 饮酒针对这一弱势群体的循证酒精减少干预措施有限。到 解决这一差距，拟议的研究是一个令人兴奋的机会，以扩大和深化一个长期的 俄罗斯和美国调查人员之间的合作。我们建议利用多学科的专业知识 我们的合作俄美研究团队的经验，以适应有效的计算机为基础的 干预，称为CBT 4CBT，以提高其对艾滋病毒/丙型肝炎病毒合并感染的妇女的适当性，并评估 其功效。拟议的研究将分三个连续阶段进行：（1）适应，（2） （3）评价;（4）评价。在第一阶段，适应，我们将使用我们的ADAPT-ITT框架， 系统地指导适应过程，提高语言、性别和艾滋病毒/丙肝病毒的适当性 的干预。在第二阶段（推行），我们会评估第三阶段的干预措施的成效， 一项随机试验，250名年龄在18-40岁之间的饮酒的HIV/HCV合并感染妇女接受临床护理。 将对妇女进行筛选，以评估合格性和那些愿意参加并被确定为具有实验室- 通过一种新的生物标志物磷脂酰乙醇（PEth）评估，确认近期饮酒，将有资格 参加符合条件的妇女将被要求返回艾滋病中心完成基线评估 包括音频计算机辅助自我访问（ACASI）和用于PEth测定的标本采集，以及 HIV（VL，CD 4）和HCV（Fibroscan，血清标志物）生物标志物。在基线评估后，妇女将 使用计算机生成的算法和隐藏分配技术进行随机化， 最大限度地减少分配偏差，以两个条件之一：（1）适应计算机为基础的酒精减少 干预，或（2）护理标准控制条件。妇女完成第一次干预 并连续几周返回艾滋病中心， 完成两个额外的会议（每周一次会议）。所有妇女将完成后续评估 包括基线后3个月、6个月和9个月的相同ACASI和标本采集。在第三阶段， 评估时，我们将使用意向治疗分析和逻辑和线性广义估计方程， 评价干预措施相对于护理标准在提高患有以下疾病的妇女比例方面的效果： 随访期间实验室确认的阴性PEth。其他分析将评估干预效果 降低病毒载量、疾病进展的HCV标志物和改善CD 4水平。拟定试验 设计和分析提供了一个适当的概念和方法框架， 基于计算机的适应性干预。干预如果有效，可能是一个有效和成本- 有效的酒精减少策略是可扩展的，可以很容易地传播和整合在临床 俄罗斯其他艾滋病中心的护理，以增强妇女的健康并降低艾滋病毒/丙型肝炎病毒传播风险。

项目成果

Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial.

• DOI: 10.1186/s13063-021-05079-x
• 发表时间: 2021-02-17
• 期刊: Trials
• 影响因子: 2.5
• 作者: DiClemente RJ;Brown JL;Capasso A;Revzina N;Sales JM;Boeva E;Gutova LV;Khalezova NB;Belyakov N;Rassokhin V
• 通讯作者: Rassokhin V

Situational and motivational factors associated with unhealthy alcohol use among Russian women with HIV and hepatitis C Virus co-infection.

与艾滋病毒和丙型肝炎病毒双重感染的俄罗斯女性不健康饮酒相关的情境和动机因素。

• DOI: 10.1016/j.dadr.2022.100053
• 发表时间: 2022
• 期刊: Drug and alcohol dependence reports
• 作者: Khalezova,NB;Capasso,A;Boeva,EV;Gutova,LV;Rassokhin,VV;Neznanov,NG;Belyakov,NA;Brown,JL;DiClemente,RJ
• 通讯作者: DiClemente,RJ

Development and Cultural Adaptation of a Computer-Delivered and Multi-Component Alcohol Reduction Intervention for Russian Women Living with HIV and HCV.

• DOI: 10.1177/23259582211044920
• 发表时间: 2021-01
• 期刊: Journal of the International Association of Providers of AIDS Care
• 作者: Brown JL;Anastasakis I;Revzina N;Capasso A;Boeva E;Rassokhin V;Crusey A;Sales JM;Hitch A;Renfro T;DiClemente RJ
• 通讯作者: DiClemente RJ