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

Description

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.

Conditions

Alcohol Use Disorder, Risk Behavior, Health, Dysbiosis, HIV Infections

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Shirish S Barve,

Shirish Barve, PhD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

2027-10-24