Clinical trial NCT05097430: PrEP and Alcohol - Enhancing HIV Pre-Exposure Prophylaxis (PrEP)
Official title: Enhancing HIV Pre-Exposure Prophylaxis (PrEP) by Targeting Hazardous Alcohol Use and Concurrent Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hazardous Alcohol Use
Keywords: PrEP
Alcohol
Substance use
Depression
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Maple Leaf Research
First posted: 2021-10-28
Enrollment: 122
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the intervention condition or treatment as usual (TAU) based on a 2:1 intervention:TAU ratio.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Intervention Feasibility: Intervention Uptake
timeFrame: At study baseline
measure: Intervention Feasibility: Intervention Completion
timeFrame: At study baseline
measure: Intervention Acceptability
timeFrame: At 6-months post-baseline
measure: Alcohol Consumption: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
measure: Alcohol Consumption: Drinks Consumed in a Typical Week
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
measure: Alcohol Consumption: Maximum Drinks on One Day in the Last 3 Months
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
measure: Alcohol Consumption: Phosphatidylethanol (PEth)
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
Secondary outcomes:
measure: PrEP Adherence: 7-day ACTG-based Measure
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
measure: PrEP Adherence: Past Month Visual Analog Scale (VAS)
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
measure: PrEP Adherence: Tenofovir-diphosphate (TFV-DP) and Emtricitabine-triphosphate Concentrations
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
measure: Retention in PrEP Care: PrEP Appointment Attendance
timeFrame: Six-month follow-up period
measure: Condomless Sex
timeFrame: Six months (i.e., baseline, 3-months post-baseline, 6-months post-baseline)
measure: Sexually Transmitted Infection (STI) Incidence
timeFrame: Six-month follow-up period
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Maple Leaf Medical Clinic
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Senior Scientist and Section Head
name: Paul A. Shuper, PhD
role: PRINCIPAL_INVESTIGATOR
References: