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Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)
Who can join
Ages 18 to 85 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Age: 18-85 years * Confirmation of seronegative HIV, Hep B, and Hep C status * PrEP users * English-speaking or Spanish speaking * Cognitively competent to provide consent * Attend a participating healthcare facility Exclusion Criteria: * Inability to consent * Existing diagnosis of major psychiatric illness * Unstable medical conditions (e.g., cancer) * Taking immunosuppressants or Chemotherapy * Taking daily antibiotics or probiotics * Severe gastrointestinal/liver disease * Autoimmune disease
About the 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.
What is being tested
- Screening, Brief Intervention, Referral to Treatment (SBIRT) (behavioral)
Sponsor: Shirish S Barve · Participants: 120 · Started: Aug 1, 2023
Contact the study team
- Andrea Reyes Vega, MD, MSc · Phone: 502852884
- Vania Remenik, MD · Phone: 5028528884
Official record on ClinicalTrials.gov — NCT06005298
Locations in the U.S.
| Kentucky | University of Louisville, Louisville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.