Reducing alcohol use in PrEP users through SBIRT intervention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized control trial focuses on individuals using pre-exposure prophylaxis (PrEP) to evaluate the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) in mitigating hazardous alcohol use. The study aims to understand how alcohol consumption affects PrEP adherence and the gut microbiome, as well as to assess the impact of early intervention on these factors. Participants will attend multiple visits over a year, where they will engage in surveys, interviews, and provide biological samples to analyze changes in gut health and inflammation related to alcohol use. The research employs a syndemic approach to enhance HIV prevention strategies among populations affected by alcohol misuse.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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's running

• University of Louisville
  Louisville, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Shirish Barve, PhD — University of Louisville
• Study coordinator: Andrea Reyes Vega, MD, MSc
• Email: a0reye02@louisville.edu
• Phone: 502852884

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.