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Search / Trial NCT06005298

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

Pr Ep Alcohol Sbirt

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.

Locations

Louisville, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Shirish Barve, PhD

Principal Investigator

University of Louisville

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported