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

Shirish S Barve

Status: Enrolling

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

Treatments: Behavioral: Screening, Brief Intervention, Referral to Treatment (SBIRT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06005298

1R01AA030485-01 (U.S. NIH Grant/Contract)

22.0606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

AUDIT <8

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Screening, Brief Intervention, Referral to Treatment (SBIRT)

AUDIT > 8 NO SBIRT

No Intervention group

Description:

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