NIH-funded research R01 grant

Helping people on PrEP reduce alcohol harms and protect gut health

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

Funded at University of Louisville · NIH-11143913 · Data updated 2026-11-12

This project offers a brief alcohol help program (SBIRT) to people taking PrEP to reduce heavy drinking, protect gut bacteria, and help them keep using their HIV prevention medication.

More PrEP research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Louisville
NIH-funded
Lab location1 site (Louisville, United States)
Project startSeptember 10, 2022
Project endJuly 31, 2027
Funding year2025
Award (this year)$659,430
NIH project number5R01AA030485-04
Project IDNIH-11143913 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are HIV-negative adults who are currently taking or planning to take PrEP and who drink alcohol, especially those reporting hazardous or heavy use.

Less likely to help

People who do not drink alcohol, who are HIV-positive, or who are not using PrEP would not be eligible and are unlikely to benefit from this work.

What this research studies

If you're HIV-negative and on or thinking about PrEP, researchers will ask about your alcohol use and PrEP experiences and do interviews to learn how drinking affects your choices. Some participants will get SBIRT, a short counseling and referral approach to reduce hazardous alcohol use, and everyone will be followed over time. The study will collect stool samples and clinical data to see how alcohol and PrEP affect the gut microbiome and side effects. The team will monitor PrEP adherence and health outcomes to see whether lowering alcohol use helps people stay on PrEP.

Why it matters

Potential benefit: If successful, this could help people on PrEP drink less, reduce gastrointestinal and gut-related side effects, and remain on their prevention medication longer.

How similar studies have gone: Brief SBIRT programs have reduced hazardous drinking in other settings, but using SBIRT specifically to protect the gut microbiome and improve PrEP adherence is a newer approach with limited prior data.

Where this research is happening

  • University of Louisville
    Louisville, United States
    Active

Researchers

  • Principal investigator: Barve, Shirish S — University of Louisville
  • Study coordinator: Barve, Shirish S

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.