Actively Recruiting
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
Led by Shirish S Barve · Updated on 2024-07-22
120
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
Sponsors
S
Shirish S Barve
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Confirmed negative status for HIV, Hepatitis B, and Hepatitis C
- Current user of Pre-Exposure Prophylaxis (PrEP)
- Able to speak English or Spanish
- Cognitively able to provide informed consent
- Receiving care at a participating healthcare facility
You will not qualify if you...
- Unable to provide informed consent
- Diagnosed with a major psychiatric illness
- Having unstable medical conditions such as cancer
- Taking immunosuppressant medications or undergoing chemotherapy
- Using daily antibiotics or probiotics
- Having severe gastrointestinal or liver diseases
- Having autoimmune diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
A
Andrea Reyes Vega, MD, MSc
CONTACT
V
Vania Remenik, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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