Clinical trial NCT06005298: Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention
Official title: Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Risk Behavior, Health
Dysbiosis
HIV Infections
Keywords: PrEP
Alcohol
SBIRT
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Patients with Hazardous Alcohol use
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Subjects AUDIT test
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Subjects TLFB review
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Subjects TAPS tool
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients with Gut Microbial alpha diversity measured by the Shannon index
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients with Gut Microbial alpha diversity measured by abundance of bacteria
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients reaching PrEP adherence by Tenofovir Urine Test
timeFrame: baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Number of Patients reporting self-efficacy related to PrEP or confidence in one's ability to carry out behaviors important to PrEP adherence
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients reporting PrEP stigma by PrEP Stigma Likert Scale
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients reporting self-efficacy related to abstaining from alcohol by AASE / Alcohol Abstinence Self-Efficacy Scale.
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients reporting use of other illicit drugs by the ASSIST (version 2.0) / Alcohol, Smoking and Substance Involvement Screening Test
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients reporting Sense of hope as evidenced by improved sense of goal directed energy and/or planning to accomplish goals m
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients reporting Symptoms of depression
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients reporting Symptoms of anxiety
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients with Gut microbiome/bacterial composition at the genera level, and functional characteristics of genes for bacterial populations
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Number of Patients with Immune Activation, Inflammation and liver injury related outcomes
timeFrame: baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Shirish Barve, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.