Reducing alcohol use in PrEP users through SBIRT intervention
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)
This study is testing if a program that helps people cut down on drinking can improve the health of those using PrEP for HIV prevention and help them stick to their medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06005298 on ClinicalTrials.gov |
What this trial studies
This randomized control trial focuses on individuals using pre-exposure prophylaxis (PrEP) to evaluate the effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) in mitigating hazardous alcohol use. The study aims to understand how alcohol consumption affects PrEP adherence and the gut microbiome, as well as to assess the impact of early intervention on these factors. Participants will attend multiple visits over a year, where they will engage in surveys, interviews, and provide biological samples to analyze changes in gut health and inflammation related to alcohol use. The research employs a syndemic approach to enhance HIV prevention strategies among populations affected by alcohol misuse.
Who should consider this trial
Good fit: Ideal candidates for this study are English or Spanish-speaking adults aged 18-85 who are seronegative for HIV, Hep B, and Hep C, and currently using PrEP.
Not a fit: Patients with major psychiatric illnesses, unstable medical conditions, or severe gastrointestinal/liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PrEP adherence and health outcomes for individuals at risk of HIV by reducing alcohol misuse.
How similar studies have performed: Other studies have shown promise in using SBIRT interventions for alcohol misuse, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Shirish Barve, PhD — University of Louisville
- Study coordinator: Andrea Reyes Vega, MD, MSc
- Email: a0reye02@louisville.edu
- Phone: 502852884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.