Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
Launched by SHIRISH S BARVE · Aug 16, 2023
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how a specific intervention called SBIRT (Screening, Brief Intervention, and Referral to Treatment) can help reduce alcohol misuse among people using PrEP, a medication that helps prevent HIV infections. The researchers want to learn how alcohol use affects adherence to PrEP—meaning how well people stick to taking their medication—and how early support can make a difference. They will also look at how alcohol use impacts gut health and overall inflammation in the body.
To participate in this study, individuals must be between the ages of 18 and 85, be confirmed as HIV-negative, and currently using PrEP. They should be able to understand and communicate in English or Spanish and be mentally capable of giving their consent. Participants will be involved in activities that assess their alcohol use and health, and they can expect support and guidance throughout the process. It's important to know that certain medical conditions or medications might exclude someone from participating. If you're interested or think you might qualify, reaching out to the healthcare facility involved could be a good next step.
Gender
ALL
Eligibility criteria
- 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
About Shirish S Barve
Shirish S. Barve is a dedicated clinical trial sponsor specializing in advancing medical research through innovative trial designs and rigorous methodologies. With a commitment to enhancing patient outcomes, Barve leads initiatives that focus on the development and evaluation of novel therapeutics across various therapeutic areas. His expertise encompasses the entire clinical trial process, from concept to execution, ensuring adherence to regulatory standards and ethical considerations. Through strategic collaborations and a patient-centered approach, Shirish S. Barve aims to contribute significantly to the advancement of healthcare and the discovery of new treatment options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Louisville, Kentucky, United States
Patients applied
Trial Officials
Shirish Barve, PhD
Principal Investigator
University of Louisville
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported