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

Shirish S Barve · with National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NCT06005298

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
120
US sites recruiting
1
Study start
August 1, 2023
Record last updated
July 22, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence.
  • Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users.
  • 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.

Being studied: Screening, Brief Intervention, Referral to Treatment (SBIRT)

Conditions: Alcohol Use Disorder; Risk Behavior, Health; Dysbiosis; HIV Infections

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Louisville

    Louisville, KY 40202

    Site contact: Andrea M Reyes Vega, MD,MSc · 502-852-8884 · a0reye02@louisville.edu

Study contacts (from the official record)

  • Andrea Reyes Vega, MD, MSc · 502852884 · a0reye02@louisville.edu
  • Vania Remenik, MD · 5028528884 · vania.remenik@louisville.edu
All healthy volunteers studies in Kentucky →
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum:… (NCT06005298) | Bored Studies