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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Shirish S Barve
Study ID
NCT06005298
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Screening, Brief Intervention, Referral to Treatment (SBIRT) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Jul 2024
Primary completion
Oct 24, 2027
Completion
Oct 24, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: AUDIT <8
    Participants whose audit score is less than eight are assigned to this arm. AUDIT is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, dependence, and experience of alcohol-related harm. AUDIT \<8 is non-hazardous.
  • Experimental: AUDIT >8 + SBIRT
    This is an experimental arm, and AUDIT \>8 is hazardous. The goal is to make connections on the impact of the SBIRT intervention on PrEP engagement and alcohol use among the participants to create a full picture of the impact of the intervention on groups exhibiting different types of alcohol use.
  • No Intervention: AUDIT > 8 NO SBIRT
    This is NOT an experimental arm, despite an AUDIT score \> 8.

Primary Outcome Measure

Number of Patients with Hazardous Alcohol use [ Time Frame: baseline, 3 months, 6 months, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Andrea M Reyes Vega, MD,MSc
[email protected]
502-852-8884
Vania Remenik, MD
[email protected]
Shirish Barve, PhD (PRINCIPAL_INVESTIGATOR)
Smita Ghare, PhD (SUB_INVESTIGATOR)
Jelani Kerr, PhD (SUB_INVESTIGATOR)
Lesley Harris, PhD (SUB_INVESTIGATOR)
Andrea Reyes Vega, MD, MSc (SUB_INVESTIGATOR)

Find similar trials in Louisville, KY

By condition
Substance use disorderHIV
By specialty
Behavioral healthAddiction medicineInfectious disease
By research site
University of Louisville· Louisville, KY

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