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

合并感染艾滋病毒和丙型肝炎病毒的妇女与以下疾病相关的不良健康后果的风险增加 酗酒。针对这一弱势群体的循证减少酒精干预措施有限。至 为了解决这一差距，拟议的研究是一个令人兴奋的机会，可以扩大和深化长期的 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 和我们的俄美合作研究团队的经验，以适应有效的基于计算机的 被称为CBT4CBT的干预措施，以增强其对艾滋病毒/丙型肝炎合并感染妇女的适宜性，并评估 它的功效。拟议的研究将分三个顺序进行：(1)适应，(2) 实施；(3)评估。在第一阶段，适应，我们将使用我们的适应-ITT框架来 系统地指导适应进程，提高语言、性别和艾滋病毒/丙型肝炎病毒的适当性 干预的结果。在第二阶段，即实施阶段，我们将评估第三阶段干预的效果 在临床护理中，对250名18-40岁、酗酒的艾滋病毒/丙型肝炎病毒混合感染妇女进行随机试验。 将对妇女进行筛查，以评估资格和那些愿意参加并被确认为具有实验室- 通过一种新的生物标记物磷脂酰乙醇(PEH)评估，确认最近饮酒将有资格 参与进来。将要求符合条件的妇女返回艾滋病中心完成基线评估 包括音频计算机辅助自访(ACASI)和采集样本以进行佩斯测试，以及 艾滋病毒(VL、CD4)和丙型肝炎(纤维扫描、血清标志物)生物标记物。在基线评估之后，妇女将 随机化，使用计算机生成的算法和隐藏分配技术，旨在 最大限度地减少分配偏差，达到以下两个条件之一：(1)适应基于计算机的酒精减少 干预，或(2)标准护理控制条件。妇女完成干预的第一阶段 在被分配到这种情况后立即返回艾滋病中心，连续几周 完成两次额外的课程(每周一次)。所有女性都将完成后续评估 包括相同的ACASI和基线后3个月、6个月和9个月的标本采集。在第三阶段， 评估，我们将使用意向治疗分析和Logistic和线性广义估计方程 评估与护理标准相关的干预效果，以提高患有艾滋病妇女比例 在随访期内，实验室确认为阴性。其他分析将评估干预效果 关于减少病毒载量、疾病进展的丙型肝炎标志物和改善CD4水平。拟议中的审判 设计和分析为评估疗效提供了适当的概念和方法框架 经过调整的基于计算机的干预。如果干预有效，可能是一种高效且成本低廉的- 有效的减酒策略，可扩展并易于在临床上传播和集成 在俄罗斯的其他艾滋病中心提供护理，以增进妇女健康，降低艾滋病毒/丙型肝炎病毒传播风险。

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.