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

Centre for Addiction and Mental Health122 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

122

Conditions

Hazardous Alcohol Use

Interventions

Alcohol-focused brief interventionBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Maple Leaf Medical Clinic

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Intervention Feasibility: Intervention Uptake

Intervention uptake will be employed as an indicator of intervention feasibility. Intervention uptake will entail the proportion of eligible, hazardous drinking, PrEP-prescribed MSM who express a willingness to take part in the intervention trial.

Time frame: At study baseline

Intervention Feasibility: Intervention Completion

Intervention completion will be employed as an indicator of intervention feasibility. This outcome will entail the proportion of participants assigned to the intervention condition who complete the intervention module.

Time frame: At study baseline

Intervention Acceptability

Intervention acceptability will be assessed using a 13-item self-report measure that is comprised of two published scales (references shown below) and three items created by the investigators. Bauermeister JA, Pingel ES, Jadwin-Cakmak L, et al. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav 2015 Oct;19(10):1860-74. NDA-NIH. NIMH Data Archive (NDA). 2020. Acceptability of Intervention, Intervention Appropriateness, and Feasibility of Intervention Measure. https://nda.nih.gov/data\_structure.html?short\_name=aimiamfim01

Time frame: At 6-months post-baseline

Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)

Self-report-based Alcohol Use Disorders Identification Test (AUDIT) scores will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, World Health Organization. Dept. of Mental Health and Substance Dependence. The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Care. 2nd ed. Geneva: World Health Organization; 2001. A cut-off based on AUDIT-C (i.e., AUDIT-consumption) criteria categorizes the presence (i.e., AUDIT-C scores ≥4) or absence (i.e., AUDIT-C scores \<4) of hazardous drinking. Minimum and maximum scores of the AUDIT-C are 0 and 12, respectively.