NCT05097430

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

Enhancing HIV Pre-Exposure Prophylaxis (PrEP) by Targeting Hazardous Alcohol Use and Concurrent Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hazardous Alcohol Use

Interventions

Type	Name	Description
BEHAVIORAL	Alcohol-focused brief intervention	The primary intervention component is the Check Your Drinking (CYD) intervention - an electronically-delivered brief intervention designed to assess and provide personalized feedback regarding the quantity, frequency, and severity of one's alcohol consumption. Additionally, intervention condition participants who are identified as having a concurrent substance use concern or who may be experiencing depression will receive information about local resources that can assist with such concerns.

Timeline

• Start date: 2021-09-28
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-10-28
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

3 sites across 1 country: Canada