Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Subjects TLFB review
Study Overview
Brief Summary
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.
Detailed Description
The study pursues a randomized control trial (RCT) with persons who use pre-exposure prophylaxis (PrEP) to determine the efficacy of SBIRT (Screening, Brief Intervention, & Referral to Treatment) in reducing the risk of alcohol drinking and associated pathogenic changes in the gut liver axis.
Participants in this study will attend visits at 3 months, 6 months,s and 12 months for about 60 to 90 minutes. These visits may include filling out a survey, participating in an interview, meeting with an SBIRT interventionist, and providing the aforementioned samples: Blood, urine, stool, saliva, oral and vaginal, if applicable.
This study will use a syndemic approach to expand the HIV/AIDS prevention toolkit among populations impacted by alcohol with a range of patterns of episodic and long-term use and associated behavioral and biological risks for HIV acquisition.
Specifically, the team will execute a randomized control trial among Pre-Exposure Prophylaxis (PrEP) users demonstrating heightened alcohol use to test the effectiveness of the Screening, Brief Intervention, & Referral to Treatment (SBIRT) intervention to reduce alcohol use and examine the subsequent impact on the gut microbiome compared to individuals receiving treatment as usual and PrEP users not demonstrating elevated alcohol use. Finally, we will employ qualitative methods (in-depth interviews) and analysis to understand decision-making factors influencing PrEP adherence and alcohol use over time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Subjects TLFB review
Time Frame: baseline, 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 tool
Time Frame: baseline, 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 abundance of bacteria
Time Frame: baseline, 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 with Hazardous Alcohol use
Time Frame: baseline, 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 test
Time Frame: baseline, 3 months, 6 months, 12 months
This will be measured by the Alcohol Use Disorders Identification Test (AUDIT), which is an alcohol screening instrument.
Number of Patients with Gut Microbial alpha diversity measured by the Shannon index
Time Frame: baseline, 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 reaching PrEP adherence by Tenofovir Urine Test
Time Frame: baseline, 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.
Secondary Outcomes
- Number of Patients with Immune Activation, Inflammation and liver injury related outcomes(baseline, 3 months, 6 months, 12 months)
- Number of Patients reporting use of other illicit drugs by the ASSIST (version 2.0) / Alcohol, Smoking and Substance Involvement Screening Test(baseline, 3 months, 6 months, 12 months)
- Number of Patients reporting Symptoms of anxiety(baseline, 3 months, 6 months, 12 months)
- Number of Patients reporting self-efficacy related to PrEP or confidence in one's ability to carry out behaviors important to PrEP adherence(baseline, 3 months, 6 months, 12 months)
- Number of Patients reporting Sense of hope as evidenced by improved sense of goal directed energy and/or planning to accomplish goals m(baseline, 3 months, 6 months, 12 months)
- Number of Patients reporting Symptoms of depression(baseline, 3 months, 6 months, 12 months)
- Number of Patients with Gut microbiome/bacterial composition at the genera level, and functional characteristics of genes for bacterial populations(baseline, 3 months, 6 months, 12 months)
- Number of Patients reporting PrEP stigma by PrEP Stigma Likert Scale(baseline, 3 months, 6 months, 12 months)
- Number of Patients reporting self-efficacy related to abstaining from alcohol by AASE / Alcohol Abstinence Self-Efficacy Scale.(baseline, 3 months, 6 months, 12 months)
Investigators
Shirish S Barve
Professor
University of Louisville