The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among PrEP initiators and re-initiators.
This is a two-arm effectiveness randomized controlled trial (RCT) to compare the brief alcohol intervention (BAI) to the standard of care (SOC) among PrEP initiators and re-initiators with unhealthy alcohol use who are initiating or reinitiating oral, event-driven, or injectable PrEP. The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and includes 2 in-person sessions and 2 telephone sessions. Eligible participants (n=564) will be randomized 1:1 to each arm (282 per arm). Additional assessments among a subset of participants in the BAI arm will assess acceptability of the intervention (n=48). Study activities will span 5 years. Individual PrEP initiators and re-initiators will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
562
The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and comprises 2 in-person face-to-face sessions and 2 booster telephone sessions by a trained counselor.
Hanoi Medical University
Hanoi, Vietnam
PrEP Persistence
PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.
Time frame: 12 months
Heavy Drinking Days (Binge drinking)
The number of days with ≥6 standard drinks of alcohol per occasion among the previous 30 days as assessed on the Timeline Followback.
Time frame: 12 months
Incremental Cost-Effectiveness Ratio (ICER)
The incremental cost-effectiveness ratio (ICER) is expressed as the incremental cost of the Brief Alcohol Intervention (BAI) per quality adjusted life-year (QALY) gained. ICER is defined as \[Ci - Ca\]/\[Ei - Ea\] with Ci and Ca being the respective costs of the BAI \[i\] and assessment only \[a\], and Ei and Ea the corresponding effectiveness.
Time frame: 12 months
Acceptability of the brief alcohol intervention, as measured with mHIST
Acceptability is an implementation-focused outcome and will be assessed using the Mental Health Implementation Science Tools (mhIST) Acceptability Scale for consumers, which consists of 15 items containing responses on a 4-point Likert scale. The mhIST score is calculated as the mean score of all responses ranging from 0-3. Higher mhIST scores indicate higher acceptability.
Time frame: 3 months
Feasibility - proportion completed 4 sessions (intervention arm)
Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The first metric will be the proportion of participants who completed all 4 sessions among those who were assigned to the intervention arm, measured from the date of randomization.
Time frame: 17 weeks
Feasibility - proportion completed 2 sessions (intervention arm)
Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The second metric will be the proportion of participants who completed at least 2 sessions among those who were assigned to the intervention arm, measured from the date of randomization.
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Time frame: 17 weeks
Feasibility - proportion completed 4 sessions (among initiators)
Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The third metric will be the proportion of participants who completed at least 4 sessions among those who initiated at least one session, measured from the date of the first in-person session.
Time frame: 10 weeks
PrEP Adherence
PrEP adherence is a measure of pill-taking behavior and will be assessed by self-report and pharmacy records. Adherence will be assessed per person based on the type of PrEP prescribed but will be compared as a single measure. Oral and event-driven PrEP adherence will be assessed as self-reported number of doses taken. Oral PrEP adherence is defined with two thresholds: ≥ 4 days/week, a threshold consistent with standard prevention definitions, and 7 days/week, indicating perfect adherence. Event-driven PrEP adherence will be defined as completion of the 2+1+1 regimen for every reported intercourse event.
Time frame: Up to 12 months
Risk-aligned PrEP use
Risk-aligned PrEP use is a measure of whether PrEP use is consistent with concurrent risk behavior. It is defined as persistent oral/injectable PrEP, event-driven PrEP (2+1+1), or clinician-supervised PrEP discontinuation. More specifically, risk-aligned PrEP is defined as: 1. Persistent oral, event-driven or injectable PrEP, 2. Clinician-approved PrEP discontinuation.
Time frame: Up to 12 months
Number of Drinking Days
Number of drinking days is defined as the number of days with any alcohol use, among the previous 30 days as assessed on the Timeline Followback. The timeline followback will be administered at enrollment, 3 months and 12 months.
Time frame: Up to 12 months
Number of Drinks Per Drinking Day
Drinks per drinking day is defined as the number of standard drinks of alcohol consumed on a drinking day, among the past 30 days as assessed on the Timeline Followback. The timeline followback will be administered at enrollment, 3 months and 12 months.
Time frame: Up to 12 months
Penetration
Completion of at least one session among those assigned to the intervention arm, measured from the date of randomization.
Time frame: Up to 7 weeks