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Behavioral Intervention

SBIRT for Alcoholism in PrEP Users (SEAL Trial)

Q: What are the eligibility requirements to participate in this clinical trial?

This clinical trial is seeking 120 volunteers aged 18 to 85 that are currently contending with microbial imbalances. Furthermore, prospective participants must also be current <a href="https://www.withpower.com/clinical-trials/prep">Prep</a> users.

Q: Does the protocol for this clinical trial permit individuals aged 35 and younger to take part?

This research necessitates that volunteers be between 18 to 85 years old. Conversely, there are 134 clinical trials specifically designed for minors and 569 studies geared towards patients over 65.

Q: Are there any active recruitment opportunities for this experiment?

The clinical trial's data on clinicaltrials.gov reveals that it is not presently seeking participants. This specific study was first posted on September 1st 2023, and the most recent update was at August 22nd 2023; however, there are 765 other active trials actively recruiting patients right now.

Q: What desired outcomes are investigators hoping to achieve with this research?

The main objective of this medical trial, which will be observed over a baseline, 3 month, 6 month and 12-month period is to evaluate the gut microbial alpha diversity using Shannon's index. Secondary outcomes include gauging <a href="https://www.withpower.com/clinical-trials/prep">Prep</a> stigma with the Likert scale, assessing self-efficacy related to abstaining from alcohol through the Alcohol Abstinence Self Efficacy Scale (AASE), as well as measuring frequency of other illicit drugs usage via ASSIST version 2.0 (Alcohol <a href="https://www.withpower.com/clinical-trials/smoking">Smoking</a> and Substance Involvement Screening Test), Timeline Followback retrospective estimates for 7 days up until two years before interview date, and T

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

SEAL Trial 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.Check my eligibility

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.See study design

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.

SEAL Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients Engaged in the PrEP care continuum

Number of Patients reaching PrEP adherence

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

+2 more

Secondary outcome measures

Number of Patients reporting PrEP stigma

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

SEAL 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 > 8 NO SBIRTActive Control1 Intervention

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

Group III: 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Shirish S BarveLead Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,325 Total Patients Enrolled

Shirish Barve, PhDPrincipal InvestigatorUniversity of Louisville

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility requirements to participate in this clinical trial?

"This clinical trial is seeking 120 volunteers aged 18 to 85 that are currently contending with microbial imbalances. Furthermore, prospective participants must also be current Prep users."

Answered by AI

Does the protocol for this clinical trial permit individuals aged 35 and younger to take part?

"This research necessitates that volunteers be between 18 to 85 years old. Conversely, there are 134 clinical trials specifically designed for minors and 569 studies geared towards patients over 65."

Answered by AI

Are there any active recruitment opportunities for this experiment?

"The clinical trial's data on clinicaltrials.gov reveals that it is not presently seeking participants. This specific study was first posted on September 1st 2023, and the most recent update was at August 22nd 2023; however, there are 765 other active trials actively recruiting patients right now."

Answered by AI

What desired outcomes are investigators hoping to achieve with this research?

"The main objective of this medical trial, which will be observed over a baseline, 3 month, 6 month and 12-month period is to evaluate the gut microbial alpha diversity using Shannon's index. Secondary outcomes include gauging Prep stigma with the Likert scale, assessing self-efficacy related to abstaining from alcohol through the Alcohol Abstinence Self Efficacy Scale (AASE), as well as measuring frequency of other illicit drugs usage via ASSIST version 2.0 (Alcohol Smoking and Substance Involvement Screening Test), Timeline Followback retrospective estimates for 7 days up until two years before interview date, and T"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Shirish S Barve 2023. "Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005298.