About this trial
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.
Eligibility criteria
Qualifiers
Age: 18-85 years
Confirmation of seronegative HIV, Hep B, and Hep C status
PrEP users
English-speaking or Spanish speaking
Disqualifiers
Inability to consent
Existing diagnosis of major psychiatric illness
Unstable medical conditions (e.g., cancer)
Taking immunosuppressants or Chemotherapy
Trial design
Treatments tested in this trial
- Screening, Brief Intervention, Referral to Treatment (SBIRT)
Treatment groups
Sponsors and collaborators
Shirish S Barve
Lead sponsor
University of Louisville
Sponsor institution
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator