SBIRT Intervention for Alcohol Misuse in PrEP Users
This study is testing an intervention called Screening, Brief Intervention, Referral to Treatment (SBIRT) to see if it can help people who use PrEP (Pre-exposure prophylaxis, a medication to prevent HIV) reduce their hazardous alcohol use. Researchers want to understand how alcohol use affects PrEP adherence and how SBIRT impacts alcohol use and changes in gut health (dysbiosis). You might be able to join if you are between 18 and 85, use PrEP, are HIV-negative, and can speak English or Spanish. The study will measure hazardous alcohol use using tests like the AUDIT and TLFB over 12 months to see if SBIRT is successful. The current recruitment status is unclear.
- Study design
- This is a randomized controlled trial planning to enroll 120 participants. It compares the SBIRT intervention to usual care and PrEP users without elevated alcohol use.
- What's involved
- You will attend visits at 3, 6, and 12 months, each lasting 60-90 minutes. These visits may include surveys, interviews, meeting an SBIRT interventionist, and providing blood, urine, stool, saliva, and oral/vaginal samples.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after starting the study.
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Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Shirish Barve, PhD · PRINCIPAL_INVESTIGATOR · University of Louisville
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of Patients with Hazardous Alcohol usebaseline, 3 months, 6 months, 12 months
Hazardous alcohol use in the experimental group (SBIRT) will be compared to the control group (treatment as usual).
- Subjects AUDIT testbaseline, 3 months, 6 months, 12 months
This will be measured by the Alcohol Use Disorders Identification Test (AUDIT), which is an alcohol screening instrument.
- Subjects TLFB reviewbaseline, 3 months, 6 months, 12 months
TLFB / Timeline Followback, which involves asking participants to retrospectively estimate their alcohol use 7 days to 2 years prior to the interview date.
- Subjects TAPS toolbaseline, 3 months, 6 months, 12 months
TAPS Tool / The Tobacco, Alcohol, Prescription medications, and other Substance Tool, which is a screening and assessment tool for alcohol use in the past year.
- Number of Patients with Gut Microbial alpha diversity measured by the Shannon indexbaseline, 3 months, 6 months, 12 months
Another significant primary outcomes for this aim is gut microbial alpha diversity measured by the Shannon index. Among all PrEP users, the comparison will be done between those who drink alcohol with those who do not drink alcohol in terms of the Shannon index. This will be analyzed using stool samples.
- Number of Patients with Gut Microbial alpha diversity measured by abundance of bacteriabaseline, 3 months, 6 months, 12 months
The primary outcome for this aim- Gut microbial alpha diversity measurement using the abundance of bacteria family Lachnospiraceae. This involves transforming the relative abundance (RA) of Lachnospiraceae during logit transformation to expand the RA. This will be analyzed using stool samples.
- Number of Patients reaching PrEP adherence by Tenofovir Urine Testbaseline, 3 months, 6 months, 12 months
PrEP adherence in the experimental group (SBIRT) will be compared to the control group (treatment as usual). This will be measured using a single-item measure using a Tenofovir Urine Test.