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

Recruiting now · Not applicable

Conditions studied: Alcohol Use Disorder, Risk Behavior, Health, Dysbiosis, HIV Infections

In brief

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.

Key facts

Study ID

NCT06005298

Run by

Shirish S Barve

People needed

120

Starts

2023-08-01

Expected to finish

2027-10-24

Last updated by the study team

2024-07-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Louisville — Louisville, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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