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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.