- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05097430
PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)
Enhancing HIV Pre-Exposure Prophylaxis (PrEP) by Targeting Hazardous Alcohol Use and Concurrent Conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul A. Shuper, PhD
- Phone Number: 34097 416-535-8501
- Email: paul.shuper@camh.ca
Study Contact Backup
- Name: Narges Joharchi, MSc
- Phone Number: 36675 416-535-8501
- Email: narges.joharchi@camh.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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Toronto, Ontario, Canada, M5G 1K2
- Maple Leaf Medical Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alcohol-focused brief intervention
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.
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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.
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No Intervention: Treatment as usual
Treatment as usual (TAU) participants will not receive the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention feasibility: Intervention uptake
Time Frame: At study baseline
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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.
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At study baseline
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Intervention feasibility: Intervention completion
Time Frame: At study baseline
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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.
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At study baseline
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Intervention acceptability
Time Frame: At 6-months post-baseline
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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
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Alcohol consumption: Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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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. |
Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Alcohol consumption: Number of drinks consumed in a typical week
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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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.
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Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Alcohol consumption: Greatest number of drinks on one day in the last 3 months
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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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.
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Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Alcohol consumption: Phosphatidylethanol (PEth)
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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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.
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Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PrEP adherence: 7-day ACTG-based measure
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Self-reported adherence to PrEP will be assessed using a 7-day, PrEP-focused, ACTG-based adherence measure (the reference for the original, antiretroviral therapy (ART)-focused ACTG measure is shown below). 7-day adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Chesney MA. Ickovics JR. Chambers DB, et al. Self-reported adherence to antiretroviral medications among participants in HIV clinical trials: Tthe AACTG adherence instruments. Patient Care Committee & Adherence Working Group of the Outcomes Committe of the Adult AIDS Clinical Trials Group (AACTG) AIDS Care. 2000;12:255-266. |
Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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PrEP adherence: Past month visual analog scale (VAS)
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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A self-report-based, PrEP-focused visual analog scale (VAS) will be used to assess PrEP adherence over the past month (the reference for the original, antiretroviral therapy (ART)-focused VAS is shown below). Past month adherence will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. Amico KR. Fisher WA. Cornman DH, et al. Visual analog scale of ART adherence: Association with 3-day self-report and adherence barriers. J Acquir Immune Defic Syndr. 2006;42:455-459. |
Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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PrEP adherence: Tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate concentrations
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Dried blood spots will be assessed for Tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate concentrations using validated liquid chromatography tandem mass spectrometry.
Concentrations will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions.
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Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Retention in PrEP care: PrEP appointment attendance
Time Frame: Six-month follow-up period
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Missed PrEP appointments across the six-month follow-up period will be identified through clinic chart extraction.
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Six-month follow-up period
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Condomless sex
Time Frame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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The engagement in condomless anal sex will be assessed using a self-report measure based on an MSM-focused sexual behavior assessment that has been employed in previous trials (see reference below). Condomless sex will be compared across baseline, 3-months post-baseline, and 6-months post-baseline sessions. The Explore Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet 2004;364:41-50. |
Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
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Sexually transmitted infection (STI) incidence
Time Frame: Six-month follow-up period
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Incident sexually transmitted infections (STIs) during the 6-month follow-up period will be identified through clinic chart extraction.
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Six-month follow-up period
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Collaborators and Investigators
Investigators
- Principal Investigator: Paul A. Shuper, PhD, Senior Scientist and Section Head
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4UH3AA026212-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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