An interventional study of Screening, Brief Intervention, Referral to Treatment (SBIRT) in Alcohol Use Disorder, Risk Behavior, Health and Dysbiosis, sponsored by Shirish S Barve. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Shirish S Barve · Not applicable, Interventional, and Prevention
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:
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.
1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 120 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →This is the only study on the registry with Shirish S Barve as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants whose audit score is less than eight are assigned to this arm. AUDIT is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, dependence, and experience of alcohol-related harm. AUDIT \<8 is non-hazardous.
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.
Behavioral: Screening, Brief Intervention, Referral to Treatment (SBIRT)
This is NOT an experimental arm, despite an AUDIT score \> 8.
SBIRT has been defined by SAMHSA as a comprehensive, integrated, public health approach to the delivery of early intervention for individuals with risky alcohol and drug use and the timely referral to more intensive substance abuse treatment for those who have substance abuse disorders. There is consensus that a comprehensive SBIRT model includes screening, brief intervention/brief treatment, and referral to treatment. In addition there are following characteristics: * It is brief (e.g., typically about 5-10 minutes for brief interventions; about 5 to 12 sessions for brief treatments) * The screening is universal. * One or more specific behaviors related to risky alcohol and drug use are targeted. * The services occur in a public health non-substance abuse treatment setting. * It is comprehensive (comprised of screening, brief intervention/treatment, and referral to treatment). * Strong research or experiential evidence supports the model's effectiveness.
Number of Patients with Hazardous Alcohol use
Hazardous alcohol use in the experimental group (SBIRT) will be compared to the control group (treatment as usual).
Time frame: baseline, 3 months, 6 months, 12 months
Subjects AUDIT test
This will be measured by the Alcohol Use Disorders Identification Test (AUDIT), which is an alcohol screening instrument.
Time frame: baseline, 3 months, 6 months, 12 months
Subjects TLFB review
TLFB / Timeline Followback, which involves asking participants to retrospectively estimate their alcohol use 7 days to 2 years prior to the interview date.
Time frame: baseline, 3 months, 6 months, 12 months
Subjects TAPS tool
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.
Time frame: baseline, 3 months, 6 months, 12 months
Number of Patients with Gut Microbial alpha diversity measured by the Shannon index
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.
Time frame: baseline, 3 months, 6 months, 12 months
Number of Patients with Gut Microbial alpha diversity measured by abundance of bacteria
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.
Time frame: baseline, 3 months, 6 months, 12 months
Number of Patients reaching PrEP adherence by Tenofovir Urine Test
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.
Time frame: 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
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.
Time frame: baseline, 3 months, 6 months, 12 months
Number of Patients reporting PrEP stigma by PrEP Stigma Likert Scale
PrEP stigma in the experimental group (SBIRT) will be compared to the control group (treatment as usual).
Time frame: 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.
Self-efficacy related to abstaining from alcohol will increase in the experimental group (SBIRT) compared to the control group (treatment as usual).
Time frame: 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
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.
Time frame: 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
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).
Time frame: baseline, 3 months, 6 months, 12 months
Number of Patients reporting Symptoms of depression
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.
Time frame: baseline, 3 months, 6 months, 12 months
Number of Patients reporting Symptoms of anxiety
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.
Time frame: 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
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.
Time frame: baseline, 3 months, 6 months, 12 months
Number of Patients with Immune Activation, Inflammation and liver injury related outcomes
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.
Time frame: baseline, 3 months, 6 months, 12 months
Plan to share: No
Started Aug 2023 (actual). Primary completion is estimated for Oct 2027, 50 months after the start.
Of 459 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 50 months is above that.
Counting every sponsor, half of 482 studies reached it within 34 months; a quarter within 17 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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