NCT06005298 Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
| NCT ID | NCT06005298 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirish S Barve |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2027-10-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-08-01 with a primary completion date of 2027-10-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 reducing the risk of alcohol use. The main questions it aims to answer are: 1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence. 2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users. 3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.
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
Contact & Investigator
Shirish Barve, PhD
PRINCIPAL INVESTIGATOR
University of Louisville
Frequently Asked Questions
Who can join the NCT06005298 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06005298 currently recruiting?
Yes, NCT06005298 is actively recruiting participants. Contact the research team at a0reye02@louisville.edu for enrollment information.
Where is the NCT06005298 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT06005298 clinical trial?
NCT06005298 is sponsored by Shirish S Barve. The principal investigator is Shirish Barve, PhD at University of Louisville. The trial plans to enroll 120 participants.