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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShirish S Barve

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

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Shirish S Barve

Lead sponsor

University of Louisville

Sponsor institution

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator