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NCT06005298Recruiting

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)

Source: ClinicalTrials.gov · Last updated 22 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
28 Oct 2022
Start date
1 Aug 2023
Primary completion date
24 Oct 2027
Lead sponsor
Shirish S Barve
Diseases
HIV
NCT number
NCT06005298

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 1 Aug 2023 to the primary completion date, 24 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking immunosuppressants or Chemotherapy

Other illness

  • Existing diagnosis of major psychiatric illness
  • Unstable medical conditions (e.g., cancer)
  • Severe gastrointestinal/liver disease
  • Autoimmune disease

Other

  • Inability to consent
  • Taking daily antibiotics or probiotics

Who the study is looking for

  • 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

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Louisville
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.