RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-08-01
Study Completion:2027-10-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06005298

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.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 18-85 years
  2. * Confirmation of seronegative HIV, Hep B, and Hep C status
  3. * PrEP users
  4. * English-speaking or Spanish speaking
  5. * Cognitively competent to provide consent
  6. * Attend a participating healthcare facility
  1. * Inability to consent
  2. * Existing diagnosis of major psychiatric illness
  3. * Unstable medical conditions (e.g., cancer)
  4. * Taking immunosuppressants or Chemotherapy
  5. * Taking daily antibiotics or probiotics
  6. * Severe gastrointestinal/liver disease
  7. * Autoimmune disease

Contacts and Locations

Study Contact

Andrea Reyes Vega, MD, MSc
CONTACT
502852884
a0reye02@louisville.edu
Vania Remenik, MD
CONTACT
5028528884
vania.remenik@louisville.edu

Principal Investigator

Shirish Barve, PhD
PRINCIPAL_INVESTIGATOR
University of Louisville

Study Locations (Sites)

University of Louisville
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: Shirish S Barve

  • Shirish Barve, PhD, PRINCIPAL_INVESTIGATOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01
Study Completion Date2027-10-24

Study Record Updates

Study Start Date2023-08-01
Study Completion Date2027-10-24

Terms related to this study

Keywords Provided by Researchers

  • PrEP
  • Alcohol
  • SBIRT

Additional Relevant MeSH Terms

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