SBIRT for Alcoholism in PrEP Users (SEAL Trial)

N/A

Recruiting

Led By Shirish Barve, PhD

Research Sponsored by Shirish S Barve

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how alcohol use impacts PrEP users and whether early intervention can reduce risk and improve health outcomes.

Who is the study for?

This trial is for adults aged 18-85 who use PrEP to prevent HIV, can speak English or Spanish, and are able to give consent. They must be free of severe illnesses like cancer, major psychiatric conditions, autoimmune diseases, and not on immunosuppressants or daily antibiotics/probiotics.

What is being tested?

The study tests the SBIRT approach (Screening, Brief Intervention, Referral to Treatment) in reducing alcohol misuse among PrEP users. It examines how early intervention affects alcohol consumption patterns and adherence to PrEP medication.

What are the potential side effects?

Since SBIRT is a behavioral intervention involving screening and counseling rather than medication, it typically does not have physical side effects. However, discussing sensitive issues like alcohol use may cause discomfort or emotional responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients reaching PrEP adherence by Tenofovir Urine Test

Number of Patients with Gut Microbial alpha diversity measured by abundance of bacteria

Number of Patients with Gut Microbial alpha diversity measured by the Shannon index

+4 more

Secondary study objectives

Number of Patients reporting PrEP stigma by PrEP Stigma Likert Scale

Number of Patients reporting Sense of hope as evidenced by improved sense of goal directed energy and/or planning to accomplish goals m

Number of Patients reporting Symptoms of anxiety

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: AUDIT >8 + SBIRTExperimental Treatment1 Intervention

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.

Group II: AUDIT <8Active Control1 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.

Group III: AUDIT > 8 NO SBIRTActive Control1 Intervention

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

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