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Brief Intervention for Alcohol Use in HIV Prevention

N/A
Waitlist Available
Led By Paul A. Shuper, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be aged 18 years or older
Participants must have been prescribed PrEP for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six-month follow-up period
Awards & highlights

Study Summary

This trial will explore if a brief intervention on reducing alcohol use & substance use can help people on HIV PrEP treatment.

Who is the study for?
This trial is for men aged 18 or older who identify as gay, bisexual, or have sex with other men and are patients at TGH or MLMC. They must be on PrEP for HIV prevention for at least 3 months and drink alcohol at levels considered hazardous.Check my eligibility
What is being tested?
The study tests if a brief intervention focused on reducing alcohol use can be practical, well-received, and effective among individuals using HIV pre-exposure prophylaxis (PrEP) treatment.See study design
What are the potential side effects?
Since the intervention involves counseling rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort discussing personal habits like drinking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been on PrEP for at least 3 months.
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I am a man who identifies as gay, bisexual, or has sex with other men.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol consumption: Alcohol Use Disorders Identification Test (AUDIT)
Alcohol consumption: Greatest number of drinks on one day in the last 3 months
Alcohol consumption: Number of drinks consumed in a typical week
+4 more
Secondary outcome measures
Condomless sex
PrEP adherence: 7-day ACTG-based measure
PrEP adherence: Past month visual analog scale (VAS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Alcohol-focused brief interventionExperimental Treatment1 Intervention
Intervention arm participants will be provided with an electronically-delivered, personalized drinking feedback report that compares their drinking with other Canadian males of the same age. This report also includes other relevant feedback, including an assessment of severity of alcohol use, and it provides recommendations for safe levels of alcohol consumption.
Group II: Treatment as usualActive Control1 Intervention
Treatment as usual (TAU) participants will not receive the intervention.

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
354 Previous Clinical Trials
80,998 Total Patients Enrolled
1 Trials studying Alcohol Abuse
33 Patients Enrolled for Alcohol Abuse
University Health Network, TorontoOTHER
1,468 Previous Clinical Trials
484,397 Total Patients Enrolled
Maple Leaf ResearchOTHER
3 Previous Clinical Trials
129 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)
Paul Shuper 2021. "PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05097430.
~11 spots leftby Aug 2024
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