Status:

RECRUITING

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

Lead Sponsor:

Shirish S Barve

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions:

Alcohol Use Disorder

Risk Behavior, Health

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

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 reducin...

Detailed Description

The study pursues a randomized control trial (RCT) with persons who use pre-exposure prophylaxis (PrEP) to determine the efficacy of SBIRT (Screening, Brief Intervention, \& Referral to Treatment) in ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 24 2027

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06005298

Start Date

August 1 2023

End Date

October 24 2027

Last Update

July 22 2024

Active Locations (1)

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1

University of Louisville

Louisville, Kentucky, United States, 40202