Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
- Conditions
- Alcohol Use DisorderHIV InfectionsRisk Behavior, HealthDysbiosis
- Interventions
- Behavioral: Screening, Brief Intervention, Referral to Treatment (SBIRT)
- Registration Number
- NCT06005298
- Lead Sponsor
- Shirish S Barve
- 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:
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AUDIT >8 + SBIRT Screening, Brief Intervention, Referral to Treatment (SBIRT) This is an experimental arm, and AUDIT \>8 is hazardous. The goal is to make connections on the impact of the SBIRT intervention on PrEP engagement and alcohol use among the participants to create a full picture of the impact of the intervention on groups exhibiting different types of alcohol use.
- Primary Outcome Measures
Name Time Method Subjects TLFB review 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 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 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 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 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 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 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 Outcome Measures
Name Time Method Number of Patients with Immune Activation, Inflammation and liver injury related outcomes baseline, 3 months, 6 months, 12 months Secondary outcomes from plasma/blood samples will be i) Intestinal fatty acid binding protein (IFABP) and lipopolysaccharide (LPS) for gut permeability and microbial translocation; ii) sCD14 and inflammatory cytokines including TNFα, IL-1β, MCP-1, IL-8, IL-6 for immune activation and inflammation and iii)AST, ALT and CK18 for liver injury.
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 Use of other illicit drugs will decrease in the experimental group (SBIRT) compared to the control group (treatment as usual). This will be measured by the ASSIST (version 2.0) / Alcohol, Smoking and Substance Involvement Screening Test which is a screening instrument for Cannabis, Cocaine, Prescription Stimulants, Methamphetamine, Inhalants, Sedatives, Hallucinogens, Street Opioids, Prescription Opioids, other drugs, the TLFB / Timeline Followback, which involves asking participants to retrospectively estimate their illicit drug use 7 days to 2 years prior to the interview date, and the TAPS Tool / The Tobacco, Alcohol, Prescription medications, and other Substance Tool, which is a screening and assessment tool for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the past year.
Number of Patients reporting Symptoms of anxiety baseline, 3 months, 6 months, 12 months Symptoms of anxiety will decrease in the experimental group (SBIRT) compared to the control group (treatment as usual). This will be measured by the CESA / Center for Epidemiologic Studies Anxiety Scale.
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 Self-efficacy related to PrEP or confidence in one's ability to carry out behaviors important to PrEP adherence in the experimental group (SBIRT) will be compared to the control group (treatment as usual). This will be measured by the PrEP self-efficacy scale.
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 Sense of hope will increase in the experimental group (SBIRT) compared to the control group (treatment as usual). This will be measured by the Adult Hope Scale (AHS).
Number of Patients reporting Symptoms of depression baseline, 3 months, 6 months, 12 months Symptoms of depression will decrease in the experimental group (SBIRT) compared to the control group (treatment as usual). This will be measured by the CES-D / Center for Epidemiologic Studies Depression Scale.
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 Secondary outcomes from gut microbiome evaluation will be bacterial composition at the genera level, and functional characteristics of genes for bacterial populations. This will be analyzed using stool samples.
Number of Patients reporting PrEP stigma by PrEP Stigma Likert Scale baseline, 3 months, 6 months, 12 months PrEP stigma in the experimental group (SBIRT) will be compared to the control group (treatment as usual).
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 Self-efficacy related to abstaining from alcohol will increase in the experimental group (SBIRT) compared to the control group (treatment as usual).
Trial Locations
- Locations (1)
University of Louisville
🇺🇸Louisville, Kentucky, United States