背景:饮酒和HIV感染都与大脑恶化有关,认知,和老年人的临床结果。然而,大脑和认知功能障碍在减少或停止饮酒后可逆转的程度尚不清楚.
目的:这项为期30天的挑战研究旨在确定减少或停止饮酒是否与认知改善有关。减少全身和脑部炎症,和改善成人重度饮酒的HIV相关结局。
方法:研究设计是机械实验试验,所有参与者都接受了酒精减少干预,然后对行为和临床结局进行反复评估.如果年龄在45岁或以上,则有资格,每周饮酒21杯或以上(男性)或14杯或以上(女性),并且没有戒酒的高风险。在基线评估之后,参与者接受了包括应急管理(非饮酒日的资金)在内的干预措施,持续至少30天,然后进行简短的动机性访谈.在这之后,参与者可以恢复饮酒或不饮酒。研究问卷,神经认知评估,神经影像学,和血,尿液,在基线时收集粪便样本,30天,90天,入学后一年。
结果:我们招募了57名重度饮酒的人,他们发起了应急管理方案(平均年龄56岁,SD4.6年;63%,n=36男性,77%,n=44黑色,58%,n=33名HIV感染者),其中50人完成了30天的随访,43人完成了90天的随访。由于2020-2021年的COVID-19大流行,计划的研究程序被中断和修改。
结论:这是第一项研究,旨在评估非寻求治疗的HIV感染者和非HIV感染者作为对照的酒精干预后大脑(神经影像学)和认知的变化。研究设计优势,局限性,并讨论了未来研究设计的经验教训。计划的分析正在进行中,之后,未识别的研究数据将可用于共享。
背景:ClinicalTrials.govNCT03353701;https://clinicaltrials.gov/study/NCT03353701。
■DERR1-10.2196/53684。
BACKGROUND: Both alcohol consumption and HIV infection are associated with worse brain, cognitive, and clinical outcomes in older adults. However, the extent to which brain and cognitive dysfunction is reversible with reduction or cessation of drinking is unknown.
OBJECTIVE: The 30-Day Challenge
study was designed to determine whether reduction or cessation of drinking would be associated with improvements in cognition, reduction of systemic and brain inflammation, and improvement in HIV-related outcomes in adults with heavy drinking.
METHODS: The
study design was a mechanistic experimental
trial, in which all participants received an alcohol reduction intervention followed by repeated assessments of behavioral and clinical outcomes. Persons were eligible if they were 45 years of age or older, had weekly alcohol consumption of 21 or more drinks (men) or 14 or more drinks (women), and were not at high risk of alcohol withdrawal. After a baseline assessment, participants received an intervention consisting of contingency management (money for nondrinking days) for at least 30 days followed by a brief motivational interview. After this, participants could either resume drinking or not. Study questionnaires, neurocognitive assessments, neuroimaging, and blood, urine, and stool samples were collected at baseline, 30 days, 90 days, and 1 year after enrollment.
RESULTS: We enrolled 57 persons with heavy drinking who initiated the contingency management protocol (mean age 56 years, SD 4.6 years; 63%, n=36 male, 77%, n=44 Black, and 58%, n=33 people with HIV) of whom 50 completed 30-day follow-up and 43 the 90-day follow-up. The planned study procedures were interrupted and modified due to the COVID-19 pandemic of 2020-2021.
CONCLUSIONS: This was the first study seeking to assess changes in brain (neuroimaging) and cognition after alcohol intervention in nontreatment-seeking people with HIV together with people without HIV as controls.
Study design strengths, limitations, and lessons for future
study design considerations are discussed. Planned analyses are in progress, after which deidentified
study data will be available for sharing.
BACKGROUND: ClinicalTrials.gov NCT03353701; https://clinicaltrials.gov/
study/NCT03353701.
UNASSIGNED: DERR1-10.2196/53684.