NCT Number: NCT06005298
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Louisville, Kentucky, 40202, United States
Location status: Recruiting
Andrea M Reyes Vega, MD,MSc
CONTACT
Andrea Reyes Vega, MD, MSc
SUB_INVESTIGATOR
Jelani Kerr, PhD
SUB_INVESTIGATOR
Lesley Harris, PhD
SUB_INVESTIGATOR
Shirish Barve, PhD
PRINCIPAL_INVESTIGATOR
Smita Ghare, PhD
SUB_INVESTIGATOR
Vania Remenik, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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).
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.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: baseline, 3 months, 6 months, 12 months
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
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
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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Andrea Reyes Vega, MD, MSc
CONTACT
Vania Remenik, MD
CONTACT
Shirish S Barve
Other
Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)
Acronym: SEAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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