IGHID 12219 - A Brief Alcohol Intervention for PrEP Use Among MSM in Vietnam

Study Overview
=================
Brief Summary
-----------------
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 men who have sex with men (MSM) with unhealthy alcohol use initiating or re-initiating PrEP in Vietnam.

Detailed Description
-----------------
This is a two-arm effectiveness randomized controlled trial (RCT) to compare the brief alcohol intervention (BAI) to the standard of care (SOC) among MSM with unhealthy alcohol use who are initiating or reinitiating oral, event-driven, or injectable PrEP in Vietnam. 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 MSM participants will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment.

Official Title
-----------------
IGHID 12219 - A Brief Alcohol Reduction Intervention to Reduce Alcohol Use and Improve PrEP Outcomes Among Men Who Have Sex With Men: A Randomized Controlled Trial in Vietnam

Conditions
-----------------
HIV Prevention, Unhealthy Alcohol Use

Intervention / Treatment
-----------------
* Behavioral: The Brief Alcohol Intervention (BAI): Behavioral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly initiating PrEP or re-initiating PrEP after at least 3 months from a missed PrEP appointment, based on Vietnamese PrEP guidelines Assigned male sex at birth Identify as male Receptive or penetrative anal intercourse with a man in the past 6 months AUDIT-C score ≥ 4 (unhealthy alcohol use) 16 years of age or older Intention to receive PrEP care in Hanoi for 12 months Willingness to provide informed consent Exclusion Criteria: Psychological disturbance, cognitive impairment, or threatening behavior Unwilling to provide locator information Current participation in alcohol programs Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) ≥ 10, indicating risk for alcohol withdrawal

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Assessment-only control<br>Participants receive study assessment visits and standard of care from providers at the PrEP clinic. | |
| Experimental: The Brief Alcohol Intervention (BAI)<br>Participants receive the Brief Alcohol Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the PrEP clinic. | Behavioral: The Brief Alcohol Intervention (BAI): Behavioral<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Persistence | PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills. | 12 months | 
| Binge Drinking | The number of days with ≥5 standard drinks of alcohol per occasion among the previous 30 days as assessed on the Timeline Followback. | 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. | 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 1-4. Higher mhIST scores indicate higher acceptability. | 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 MSM. Three metrics will be considered, measured from the date of the first in-person session. The first metric will be the proportion of participants who completed all 4 sessions among those who were assigned to the intervention arm. | 7 weeks | 
| Feasibility - proportion completed 2 sessions (intervention arm) | Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among MSM. Three metrics will be considered, measured from the date of the first in-person session. The second metric will be the proportion of participants who completed at least 2 sessions among those who were assigned to the intervention arm. | 7 weeks | 
| Feasibility - proportion completed 4 sessions (among initiators) | Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among MSM. Three metrics will be considered, measured from the date of the first in-person session. The third metric will be the proportion of participants who completed at least 4 sessions among those who initiated at least one session. | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 HIV prevention among MSM, and 7 days, indicating perfect adherence. Event-driven PrEP adherence will be defined as completion of the 2+1+1 regimen for every reported condomless anal intercourse event. | 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) with adherence, or clinician-supervised PrEP discontinuation for reduced sexual risk More specifically, risk-aligned PrEP is defined as: persistent oral or injectable PrEP, event-driven PrEP (2+1+1) with 100% adherence, or appropriate PrEP discontinuation for reduced sexual risk, using 1 of 2 definitions: clinician-approved PrEP discontinuation for reduced sexual risk, or PrEP self-discontinuation with documented minimal risk by Vietnamese guidelines and no concurrent sexually transmitted infection (STI). | 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, 6 months, 9 months, and 12 months. | 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, 6 months, 9 months, and 12 months. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV/AIDS, Preexposure Prophylaxis (PrEP), Alcohol Intervention, Motivational Interviewing, Cognitive Behavioral Therapy, Motivational Enhancement Therapy, Vietnam, Cost Analysis, Economic Evaluation, Men who have sex with men