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Study identifier: NCT06005298 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Alcohol Use Disorder · Risk Behavior, Health · Dysbiosis  ·  Sponsor: Shirish S Barve

PhaseNA
Planned participants120
Who can joinAll sexes, 18 Years to 85 Years
Healthy volunteersYes

About this study

This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are: 1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence. 2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. 3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.

This description comes directly from the study's public registry record.

Talk to the study team

Andrea Reyes Vega, MD, MSc  ·  502852884  ·  a0reye02@louisville.edu

Vania Remenik, MD  ·  5028528884  ·  vania.remenik@louisville.edu

Always discuss trial participation with your own doctor first.

Locations (1)

University of LouisvilleLouisville, Kentucky, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06005298