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RecruitingNot ApplicableNCT06005298

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

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

Sponsor

Shirish S Barve

Enrollment

120 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

HIV InfectionsDysbiosisAlcohol Use DisorderRisk Behavior, Health

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brief counseling intervention called SBIRT (Screening, Brief Intervention, and Referral to Treatment) to help PrEP users who drink alcohol reduce risky drinking — and to study how alcohol affects the gut microbiome and HIV prevention adherence. **You may be eligible if:** - You are between 18 and 85 years old - You are HIV-negative, Hepatitis B-negative, and Hepatitis C-negative - You are currently using PrEP (HIV prevention medication) - You speak English or Spanish - You attend one of the participating healthcare facilities **You may NOT be eligible if:** - You have a major psychiatric illness - You have cancer or another unstable medical condition - You take immunosuppressants or chemotherapy - You take daily antibiotics or probiotics - You have severe gastrointestinal or liver disease - You have an autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALScreening, Brief Intervention, Referral to Treatment (SBIRT)

SBIRT has been defined by SAMHSA as a comprehensive, integrated, public health approach to the delivery of early intervention for individuals with risky alcohol and drug use and the timely referral to more intensive substance abuse treatment for those who have substance abuse disorders. There is consensus that a comprehensive SBIRT model includes screening, brief intervention/brief treatment, and referral to treatment. In addition there are following characteristics: * It is brief (e.g., typically about 5-10 minutes for brief interventions; about 5 to 12 sessions for brief treatments) * The screening is universal. * One or more specific behaviors related to risky alcohol and drug use are targeted. * The services occur in a public health non-substance abuse treatment setting. * It is comprehensive (comprised of screening, brief intervention/treatment, and referral to treatment). * Strong research or experiential evidence supports the model's effectiveness.

Locations(1)

University of Louisville

Louisville, Kentucky, United States

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NCT06005298

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