Brief Intervention for Alcohol Use in HIV Prevention

Recruiting at 2 trial locations

Overseen By Narges Joharchi, MSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Must be taking: PrEP

Disqualifiers: Not TGH/MLMC patient, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 months

122 Participants Needed

Trial Summary

What is the purpose of this trial?

The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment.

Research Team

Paul A. Shuper, PhD

Principal Investigator

Senior Scientist and Section Head

Eligibility Criteria

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.

Inclusion Criteria

Participants must be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC)

I am a man who identifies as gay, bisexual, or has sex with other men.

Participants must meet the criteria for hazardous drinking (i.e., based on a score of ≥4 on the Alcohol Use Disorders Identification Test-Consumption measures (AUDIT-C))

Exclusion Criteria

Participants will be excluded if they do not meet all of the above-mentioned inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment including biomarker testing and self-report electronic surveys

1 week

1 visit (in-person)

Treatment

Participants receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual

6 months

3 visits (in-person) at baseline, 3-months, and 6-months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PrEP adherence and alcohol consumption

6 months

3 visits (in-person) at baseline, 3-months, and 6-months

Treatment Details

Interventions

• Alcohol-focused brief intervention

Trial Overview 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.

Participant Groups

Group I: Alcohol-focused brief intervention Experimental Treatment 1 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 usual Active Control 1 Intervention

Treatment as usual (TAU) participants will not receive the intervention.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Maple Leaf Research

Collaborator

Trials

5

Recruited

280+