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Alcohol Use DisorderSEALNCT06005298

Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention

A study testing Screening, Brief Intervention, Referral to Treatment (SBIRT) in people with Alcohol Use Disorder and Risk Behavior, Health, run by Shirish S Barve at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
Screening, Brief Intervention, Referral to Treatment (SBIRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 24 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Reyes Vega, MD, MSc contact

502852884

a0reye02@louisville.edu

Vania Remenik, MD contact

5028528884

vania.remenik@louisville.edu

United States1 site, 1 recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Andrea M Reyes Vega, MD,MSc, 502-852-8884, a0reye02@louisville.edu

    Vania Remenik, MD, vania.remenik@louisville.edu

    Recruiting

Other trials in United States

About this study

Official title: Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)

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.
Read the 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.

Being tested
Screening, Brief Intervention, Referral to Treatment (SBIRT)
Keywords
PrEP, Alcohol, SBIRT
Medical subject headings
Alcoholism, Health Risk Behaviors, Dysbiosis, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Screening, Brief Intervention, Referral to Treatment (SBIRT)Behavioural

    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.
Study groups in NCT06005298
Study groupRoleWhat they receive
AUDIT <8No interventionParticipants 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.
AUDIT >8 + SBIRTExperimentalThis 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.
Receives: Behavioral: Screening, Brief Intervention, Referral to Treatment (SBIRT)
AUDIT > 8 NO SBIRTNo interventionThis is NOT an experimental arm, despite an AUDIT score > 8.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline, 3 months, 6 months, 12 months

  2. Subjects AUDIT test

    This will be measured by the Alcohol Use Disorders Identification Test (AUDIT), which is an alcohol screening instrument.

    Measured: baseline, 3 months, 6 months, 12 months

  3. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  4. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  5. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  6. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  7. 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.

    Measured: baseline, 3 months, 6 months, 12 months

Secondary outcomes (9)

  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.

    Measured: baseline, 3 months, 6 months, 12 months

  2. 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).

    Measured: baseline, 3 months, 6 months, 12 months

  3. 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).

    Measured: baseline, 3 months, 6 months, 12 months

  4. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  5. 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).

    Measured: baseline, 3 months, 6 months, 12 months

  6. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  7. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  8. 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.

    Measured: baseline, 3 months, 6 months, 12 months

  9. 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.

    Measured: baseline, 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start1 Aug 2023
  3. Primary completion24 Oct 2027 (estimated)
  4. Study completion24 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06005298
Sponsor's protocol ID
22.0606
Other IDs
1R01AA030485-01
Acronym
SEAL
Status last verified
Jul 2024
First submitted
28 Oct 2022
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Blumenthal J, Pasipanodya EC, Jain S, Sun S, Ellorin E, Morris S, Moore DJ. Comparing Self-Report Pre-Exposure Prophylaxis Adherence Questions to Pharmacologic Measures of Recent and Cumulative Pre-Exposure Prophylaxis Exposure. Front Pharmacol. 2019 Jul 5;10:721. doi: 10.3389/fphar.2019.00721. eCollection 2019.

    PubMed 31333454

  • Higgins-Biddle JC, Babor TF. A review of the Alcohol Use Disorders Identification Test (AUDIT), AUDIT-C, and USAUDIT for screening in the United States: Past issues and future directions. Am J Drug Alcohol Abuse. 2018;44(6):578-586. doi: 10.1080/00952990.2018.1456545. Epub 2018 May 3.

    PubMed 29723083

  • Conigrave KM, Hall WD, Saunders JB. The AUDIT questionnaire: choosing a cut-off score. Alcohol Use Disorder Identification Test. Addiction. 1995 Oct;90(10):1349-56. doi: 10.1046/j.1360-0443.1995.901013496.x.

    PubMed 8616463

  • Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. doi: 10.1111/j.1360-0443.1993.tb02093.x.

    PubMed 8329970

  • Humeniuk R, Henry-Edwards S, Ali R, Poznyak V, Monteiro MGea. The Alcohol, Smoking and Substance involvement Screening Test (ASSIST): manual for use in primary care. Geneva, Swizterland World Health Organization;2010.

  • Zhang W, O'Brien N, Forrest JI, Salters KA, Patterson TL, Montaner JS, Hogg RS, Lima VD. Validating a shortened depression scale (10 item CES-D) among HIV-positive people in British Columbia, Canada. PLoS One. 2012;7(7):e40793. doi: 10.1371/journal.pone.0040793. Epub 2012 Jul 19.

    PubMed 22829885

  • Ghare S, Singhal R, Bryant V, Gautam S, Tirumala CC, Srisailam PK, Reyes-Vega A, Ghooray D, McClain CJ, Hoffman K, Petrosino J, Bryant K, Govind V, Cohen R, Cook RL, Barve S. Age-Associated Gut Dysbiosis, Marked by Loss of Butyrogenic Potential, Correlates With Altered Plasma Tryptophan Metabolites in Older People Living With HIV. J Acquir Immune Defic Syndr. 2022 Feb 1;89(Suppl 1):S56-S64. doi: 10.1097/QAI.0000000000002866.

    PubMed 35015746

  • Fulcher JA, Li F, Cook RR, Zabih S, Louie A, Okochi H, Tobin NH, Gandhi M, Shoptaw S, Gorbach PM, Aldrovandi GM. Rectal Microbiome Alterations Associated With Oral Human Immunodeficiency Virus Pre-Exposure Prophylaxis. Open Forum Infect Dis. 2019 Oct 29;6(11):ofz463. doi: 10.1093/ofid/ofz463. eCollection 2019 Nov.

    PubMed 32258202

  • Dube MP, Park SY, Ross H, Love TMT, Morris SR, Lee HY. Daily HIV pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine reduced Streptococcus and increased Erysipelotrichaceae in rectal microbiota. Sci Rep. 2018 Oct 12;8(1):15212. doi: 10.1038/s41598-018-33524-6.

    PubMed 30315206

  • Perler BK, Reinhart EM, Montgomery M, Maynard M, Shapiro JM, Belenky P, Chan PA. Evaluation of the Microbiome in Men Taking Pre-exposure Prophylaxis for HIV Prevention. AIDS Behav. 2021 Jul;25(7):2005-2013. doi: 10.1007/s10461-020-03130-7. Epub 2021 Jan 4.

    PubMed 33394167

Questions about this trial

What is this clinical trial studying?

A study testing Screening, Brief Intervention, Referral to Treatment (SBIRT) in people with Alcohol Use Disorder and Risk Behavior, Health, run by Shirish S Barve at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Reyes Vega, MD, MSc (502852884, a0reye02@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients with Hazardous Alcohol use (time frame: baseline, 3 months, 6 months, 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06005298, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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