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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: t
View:

• 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

Locations
United States
Kentucky
University of Louisville
RECRUITING
Louisville
Contact Information
Primary
Andrea Reyes Vega, MD, MSc
a0reye02@louisville.edu
502852884
Backup
Vania Remenik, MD
vania.remenik@louisville.edu
5028528884
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-10-24
Participants
Target number of participants: 120
Treatments
No_intervention: AUDIT <8
Participants whose audit score is less than eight are assigned to this arm. AUDIT is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, dependence, and experience of alcohol-related harm. AUDIT \<8 is non-hazardous.
Experimental: AUDIT >8 + SBIRT
This is an experimental arm, and AUDIT \>8 is hazardous. The goal is to make connections on the impact of the SBIRT intervention on PrEP engagement and alcohol use among the participants to create a full picture of the impact of the intervention on groups exhibiting different types of alcohol use.
No_intervention: AUDIT > 8 NO SBIRT
This is NOT an experimental arm, despite an AUDIT score \> 8.
Related Therapeutic Areas
Sponsors
Leads: Shirish S Barve
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This content was sourced from clinicaltrials.gov