Study on Reducing Alcohol Use and Gut Microbiome Changes in PrEP Users Using SBIRT Intervention

What this Trial Is About

Researchers are conducting a randomized control trial to study the effects of Screening, Brief Intervention, and Referral to Treatment SBIRT on reducing alcohol use among people who use pre-exposure prophylaxis PrEP. The study aims to understand how alcohol affects PrEP adherence, the effectiveness of SBIRT in preventing hazardous drinking, and its impact on gut microbiome changes, intestinal balance, inflammation, and liver disease markers in this population. Participants are assigned to different groups based on their Alcohol Use Disorders Identification Test AUDIT scores, with one group receiving the SBIRT behavioral intervention if their score indicates hazardous drinking. The study compares these participants to those with non-hazardous alcohol use and those with hazardous use not receiving the intervention. Visits occur at 3, 6, and 12 months, during which participants may complete surveys, interviews, and provide various biological samples including blood, urine, stool, saliva, and oral and vaginal samples if applicable. Throughout the study, participants will be monitored for changes in alcohol use, gut microbial diversity, PrEP adherence measured by urine tests, and self-reported factors such as confidence in PrEP use, stigma, substance use, mood symptoms, and hopefulness. The study involves repeated assessments at baseline, 3, 6, and 12 months, including several standardized tools and biological markers. The total duration of participation is about one year with visits lasting 60 to 90 minutes each.

Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention