JMIR Publications

ABSTRACT

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 age 45+, had weekly alcohol consumption of 21+ drinks (men) or 14+ drinks (women), and were not at high risk of alcohol withdrawal. After a baseline assessment, participants received an intervention consisting of contingency management (CM; money for non-drinking 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. The study was registered at ClinicalTrials.gov (NCT03353701) in November 2017.

Results:

We enrolled 57 persons with heavy drinking who initiated the CM protocol (mean age 56 years, 63% male, 77% black, 58% People with HIV (PWH)) 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 COVID19 epidemic of 2020-2021.

Conclusions:

This was the first study seeking to assess changes in brain (neuroimaging) and cognition after alcohol intervention in non-treatment-seeking PWH 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 de-identified study data will be available for sharing. Clinical Trial: The study was registered at ClinicalTrials.gov (NCT03353701) in November 2017.