RecruitingNot ApplicableNCT06005298

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

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

Sponsor

Shirish S Barve

Enrollment

120 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

HIV Infections Dysbiosis Alcohol Use Disorder Risk Behavior, Health

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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 Criteria7

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

Interventions

BEHAVIORALScreening, Brief Intervention, Referral to Treatment (SBIRT)

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.