N/A
N=122
PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)
Hazardous Alcohol Use
Bottom Line
View on ClinicalTrials.gov: NCT05097430 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Intervention Feasibility: Intervention Uptake — 122 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alcohol-focused brief intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Centre for Addiction and Mental Health
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility: Intervention Uptake |
122 | — |
| PRIMARY Intervention Feasibility: Intervention Completion |
81 | — |
| PRIMARY Intervention Acceptability |
5.72; 2.58; 5.27; 5.76; 5.60; 4.78 | — |
| PRIMARY Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT) |
81; 41; 63; 38; 68; 35 | — |
| PRIMARY Alcohol Consumption: Drinks Consumed in a Typical Week |
8.3; 9.7; 8.9; 9.1; 9.3; 9.2 | — |
| PRIMARY Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months |
7.9; 8.2; 7.8; 7.3; 7.4; 7.7 | — |
| PRIMARY Alcohol Consumption: Phosphatidylethanol (PEth) |
41; 23; 37; 18; 50; 27 | — |
| SECONDARY PrEP Adherence: 7-day ACTG-based Measure |
23; 12; 15; 18; 27; 15 | — |
| SECONDARY PrEP Adherence: Past Month Visual Analog Scale (VAS) |
6; 1; 2; 6; 6; 3 | — |
| SECONDARY PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations |
21; 15; 19; 14; 25; 18 | — |
| SECONDARY Retention in PrEP Care: PrEP Appointment Attendance |
6; 3; 1; 1; 2; 2 | — |
| SECONDARY Condomless Sex |
78; 38; 70; 37; 71; 33 | — |
| SECONDARY Sexually Transmitted Infection (STI) Incidence |
23; 5; 12; 3; 15; 6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05097430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.