Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShirish S Barve
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 18-85 years
Confirmation of seronegative HIV, Hep B, and Hep C status
PrEP users
English-speaking or Spanish speaking
Disqualifiers
Inability to consent
Existing diagnosis of major psychiatric illness
Unstable medical conditions (e.g., cancer)
Taking immunosuppressants or Chemotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
Screening, Brief Intervention, Referral to Treatment (SBIRT)
BehavioralSBIRT 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: AUDIT <8No intervention 0 interventions
Group B: AUDIT >8 + SBIRTExperimental treatment 1 intervention
Group C: AUDIT > 8 NO SBIRTNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shirish S Barve
Lead sponsor
University of Louisville
Sponsor institution
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov