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

NCT05097430 | Completed Results

• 1 other identifier: 4UH3AA026212-03
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hazardous Alcohol Use

Keywords

PrEP; Alcohol; Substance use; Depression

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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

  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.

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

• Alcohol Consumption: Drinks Consumed in a Typical Week

  A single self-report question will ask "How many drinks containing alcohol do you have on a typical week when you are drinking?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

• Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months

  A single self-report question will ask "What is the greatest number of drinks you've had on one day in the last 3 months?" Responses will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

• Alcohol Consumption: Phosphatidylethanol (PEth)

  PEth levels will be measured from dried blood spot (DBS) samples using liquid chromatography-tandem mass spectrometry to identify hazardous drinking. PEth will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

Secondary Outcomes (6)

• PrEP Adherence: 7-day ACTG-based Measure

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

• PrEP Adherence: Past Month Visual Analog Scale (VAS)

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

• PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

• Retention in PrEP Care: PrEP Appointment Attendance

  Six-month follow-up period

• Condomless Sex

  Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)

Study Arms (2)

Alcohol-focused brief intervention

EXPERIMENTAL

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.

Behavioral: Alcohol-focused brief intervention

Treatment as usual

NO INTERVENTION

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

Interventions

Alcohol-focused brief intervention BEHAVIORAL

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.

Alcohol-focused brief intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study only includes men who have sex with men. This criterion is based on the fact that in Canada and the United States, men who have sex with men (MSM) remain the risk group most affected by HIV, comprising roughly two-thirds of all new infections.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University Health Network, Toronto: collaborator
• Maple Leaf Research: collaborator

Study Sites (3)

Maple Leaf Medical Clinic

Toronto, Ontario, M5G 1K2, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Substance-Related Disorders; Depression

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

This was a pilot trial and was therefore not statistically powered to test the effect of the intervention.

Results Point of Contact

• Title: Dr. Paul Shuper
• Organization: Centre for Addiction and Mental Health (CAMH)

paul.shuper@camh.ca

416-535-8501

Study Officials

• Paul A. Shuper, PhD

  Senior Scientist and Section Head

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This is not a double-blind study. Participants in the intervention arm will be aware that they are receiving the intervention but the investigators will not know as the randomization will take place within the software program.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist and Section Head

Model Details: Participants will be randomly assigned to either the intervention condition or treatment as usual (TAU) based on a 2:1 intervention:TAU ratio.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 28, 2021
• Study Start: September 28, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)