METHODS AND ANALYSIS CORE

方法与分析核心

• 批准号: 10685460
• 负责人: Samuel Bosomprah
• 金额: $ 25.45万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-10 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10685460
• 关键词: Abstinence; Achievement; Address; Adoption; Africa; Africa South of the Sahara; Alabama; Alcohol consumption; Alcohols; Assessment tool; Benchmarking; Biological Markers; Biomedical Research; Caring; Characteristics; Clinic; Clinical; Clinical Trials; Cognitive Therapy; Competence; Data; Data Collection; Databases; Diagnostic; Disparity population; Effectiveness; Elements; Ensure; Epidemic; Epidemiologist; Evaluation; Funding; Gender; HIV; Head; Human Resources; Infectious Diseases Research; Information Technology; Institution; International; Intervention; Interview; Laboratories; Measurement; Measures; Mediating; Mediation; Mediator; Mental Health; Methods; Modality; Modeling; Outcome; Outcome Measure; Participant; Patient Outcomes Assessments; Patient Self-Report; Persons; Policies; Practical Robust Implementation and Sustainability Model; Procedures; Professional counselor; Program Research Project Grants; Provider; Randomized; Research Methodology; Research Personnel; Resources; Role; Rural; Site; Social Desirability; Symptoms; Telemedicine; Testing; Therapeutic Intervention; Treatment outcome; United States; Universities; Vulnerable Populations; Zambia; alcohol abstinence; alcohol abuse therapy; alcohol comorbidity; alcohol epidemiology; alcohol intervention; alcohol misuse; behavior change; brief alcohol intervention; comorbidity; contextual factors; cost; cost effectiveness; cost-effectiveness ratio; data harmonization; data management; effectiveness evaluation; effectiveness testing; experience; global health; implementation determinants; implementation facilitators; implementation outcomes; implementation/effectiveness; improved; incremental cost-effectiveness; intervention effect; multidisciplinary; phosphatidylethanol; primary outcome; programs; psychiatric comorbidity; scale up; secondary outcome; substance use; synergism; tool; treatment effect; underserved area

Project Summary/Abstract Unhealthy alcohol use is a major unaddressed barrier to control of the HIV epidemic in sub-Saharan Africa and the United States. The Zambia Alabama HIV Alcohol Comorbidities (ZAMBAMA) program aims to address this barrier through the following overarching aims: (a) test the effectiveness of a transdiagnostic model (Common Elements Treatment Approach [CETA]) to reduce unhealthy alcohol use and improve HIV clinical outcomes; (b) evaluate the mechanisms through which CETA impacts HIV outcomes; (c) investigate whether the treatment effect of CETA varies by clinical (e.g., presence of mental health comorbidities), demographic (e.g., gender) and contextual (e.g., Zambia, Alabama) factors; and (d) examine implementation factors, including cost, related to integrated delivery of alcohol reduction interventions to disadvantaged people with HIV and unhealthy alcohol use at front-line HIV clinics. The Methods and Analysis Core (MAC) will support ZAMBAMA’s two clinical trials and promote integration and synergy within the program. The specific aims of MAC are (1) implement the scientific approach of both trials (e.g., overseeing randomization procedures, measurement tools, and data management); (2) conduct primary and secondary outcomes analyses evaluating CETA’s effectiveness (including moderator analyses); (3) conduct mediator/mechanisms analysis investigating the degree to which CETA’s impact on HIV outcomes are mediated by reductions in alcohol use, substance use, and mental health problems; (4) analyze and interpret alcohol biomarker (phosphatidylethanol) data used to confirm self-reported alcohol abstinence data; and (5) analyze implementation and cost effectiveness data to inform the scale-up and sustainability potential of CETA. MAC will be staffed by investigators with international and multidisciplinary expertise in research methods, including in substance use, HIV, clinical trials, and global health. MAC will leverage a wealth of information technology, statistical, and laboratory resources at participating institutions, including Centre for Infectious Disease Research in Zambia, Columbia University, and the University of Alabama at Birmingham. Harmonized patient reported outcome measures and a centralized team to oversee the intervention (i.e., CETA core) for both trials will create unique opportunities to understand the interplay between unhealthy alcohol use and psychiatric comorbidities, whether and how comorbidities influence alcohol treatment outcomes, and how differences in delivery modality and contextual factors impact CETA’s effectiveness.

项目摘要/摘要 不健康的饮酒是控制撒哈拉以南非洲和 美国。赞比亚阿拉巴马州艾滋病毒合并症（Zambama）计划旨在解决这个问题 通过以下总体目的进行障碍：（a）测试转诊模型的有效性（常见 元素治疗方法[CETA]）减少不健康的饮酒并改善HIV临床结果； （b） 评估CETA影响HIV结果的机制； （c）调查治疗是否 临床（例如，心理健康合并症的存在），人口统计学（例如性别）和 上下文（例如赞比亚，阿拉巴马州）因素； （d）审查实施因素，包括成本，与 对艾滋病毒和不健康酒精的灾害人员进行饮酒干预措施的综合交付 在前线HIV诊所使用。方法和分析核心（MAC）将支持Zambama的两个临床试验 并促进该计划中的集成和协同作用。 Mac的具体目的是（1）实施 这两个试验的科学方法（例如，监督随机化程序，测量工具和数据 管理）; （2）进行评估CETA有效性的主要和次要结果分析 （包括主持人分析）； （3）进行调解员/机制分析，以研究 CETA对HIV结果的影响是通过饮酒，药物使用和心理健康的减少来介导的 问题； （4）分析和解释用于确认自我报告的数据的酒精生物标志物（磷脂酰乙醇）数据 酒精节制数据； （5）分析实施和成本效益数据，以告知扩大规模和 CETA的可持续性潜力。 Mac将由国际和多学科的调查员组成 研究方法的专业知识，包括药物使用，艾滋病毒，临床试验和全球健康。 Mac Will 利用参与机构的大量信息技术，统计和实验室资源， 包括赞比亚，哥伦比亚大学和阿拉巴马大学传染病研究中心 在伯明翰。协调的患者报告了结果指标和集中式团队，以监督 两种试验的干预（即CETA核心）将创造独特的机会来了解 不健康的饮酒和精神病合并症，合并症如何影响酒精治疗 结果，以及交付方式和上下文因素的差异如何影响CETA的有效性。