PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)

Center for Addiction and Mental Health (CAMH)

Status: Completed

Conditions: Hazardous Alcohol Use

Treatments: Behavioral: Alcohol-focused brief intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05097430

4UH3AA026212-03

Details and patient eligibility

About

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.

Full description

Although HIV pre-exposure prophylaxis (PrEP) is an effective tool that can help prevent the acquisition of HIV, its degree of effectiveness has been shown to be linked to a number of key behaviors, including treatment adherence, attendance in follow-up care, and the concurrent use of condoms. Hazardous alcohol consumption has the potential to contribute to suboptimal PrEP adherence, poor retention in PrEP care, and condomless sex/sexually transmitted infections (STIs); and its impact on these PrEP-related behaviors may also become exacerbated in the presence of concurrent issues such as substance use and depression, thus reflecting a potential syndemic effect. The present investigation entails a pilot randomized controlled trial in which 120 hazardous drinking, PrEP-prescribed men who have sex with men (MSM) will be randomly assigned to receive either a tablet-based, alcohol-reduction brief intervention or treatment-as-usual. Participants assigned to the former condition for whom substance use- and/or depression-related concerns are identified will additionally be provided with links to relevant supportive resources. Feasibility and acceptability of the intervention will be examined. Furthermore, biomarker testing and self-report electronic surveys at baseline, 3-months, and 6-months will be employed to assess the preliminary impact of the intervention on alcohol use, PrEP adherence, retention in PrEP care, and the engagement in condomless sex/STI acquisition.

Enrollment: 122 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Participants must be:

• aged 18 years or older,
• be a patient of Toronto General Hospital (TGH) or Maple Leaf Medical Clinic (MLMC),
• be a man who identifies as gay, bisexual, and/or a man who has sex with other men,
• have been prescribed PrEP for at least 3 months, and
• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Alcohol-focused brief intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Alcohol-focused brief intervention

Treatment as usual

No Intervention group

Description:

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