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

RecruitingNAAges 18 Years - 85 YearsAllShirish S Barve
NCT06005298 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Screening, Brief Intervention, Referral to Treatment (SBIRT)
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Where

1 site
University of Louisville
Louisville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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