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Completed

NCT Number: NCT05097430

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

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.

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Key information

Conditions

Hazardous Alcohol Use Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Intervention Feasibility: Intervention Uptake

    Time frame: At study baseline

    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.

  2. Intervention Feasibility: Intervention Completion

    Time frame: At study baseline

    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.

  3. Intervention Acceptability

    Time frame: At 6-months post-baseline

    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

  4. Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)

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

    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.

  5. Alcohol Consumption: Drinks Consumed in a Typical Week

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

    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.

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

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

    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.

  7. Alcohol Consumption: Phosphatidylethanol (PEth)

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

    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.

Secondary outcomes

  1. PrEP Adherence: 7-day ACTG-based Measure

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

    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.

  2. PrEP Adherence: Past Month Visual Analog Scale (VAS)

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

    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.

  3. 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)

    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.

  4. Retention in PrEP Care: PrEP Appointment Attendance

    Time frame: Six-month follow-up period

    Missed PrEP appointments across the six-month follow-up period will be identified through clinic chart extraction.

  5. Condomless Sex

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

    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.

  6. Sexually Transmitted Infection (STI) Incidence

    Time frame: Six-month follow-up period

    Incident sexually transmitted infections (STIs) during the 6-month follow-up period will be identified through clinic chart extraction.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Maple Leaf Research
  • University Health Network, Toronto

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2021
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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