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

NCT06005298 | Recruiting DMC

• 2 other identifiers: 22.06061R01AA030485-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 1.How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence.
2. 2.Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users.
3. 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.

Conditions

Alcohol Use Disorder; Risk Behavior, Health; Dysbiosis; HIV Infections

Keywords

PrEP; Alcohol; SBIRT

Outcome Measures

Primary Outcomes (7)

• 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).

  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.

  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.

  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.

  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.

  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.

  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.

  baseline, 3 months, 6 months, 12 months

Secondary Outcomes (9)

• 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

• Number of Patients reporting PrEP stigma by PrEP Stigma Likert Scale

  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.

  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

  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

  baseline, 3 months, 6 months, 12 months

Study Arms (3)

AUDIT <8

NO INTERVENTION

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.

AUDIT >8 + SBIRT

EXPERIMENTAL

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)

AUDIT > 8 NO SBIRT

NO INTERVENTION

This is NOT an experimental arm, despite an AUDIT score \> 8.

Interventions

Screening, Brief Intervention, Referral to Treatment (SBIRT) BEHAVIORAL

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.

AUDIT >8 + SBIRT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirish S Barve: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 31333454 BACKGROUND

• 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.

  PMID: 29723083 RESULT

• 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.

  PMID: 8616463 RESULT

• 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.

  PMID: 8329970 RESULT

• 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.

  RESULT

• 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.

  PMID: 22829885 RESULT

• 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.

  PMID: 35015746 RESULT

• 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.

  PMID: 32258202 RESULT

• 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.

  PMID: 30315206 RESULT

• 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.

  PMID: 33394167 RESULT

MeSH Terms

Conditions

Alcoholism; Health Risk Behaviors; Dysbiosis; HIV Infections

Interventions

Mass Screening; Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shirish Barve, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Reyes Vega, MD, MSc

CONTACT

502852884; a0reye02@louisville.edu

Vania Remenik, MD

CONTACT

5028528884; vania.remenik@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: August 22, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): October 24, 2027
• Study Completion (Estimated): October 24, 2027
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)