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

Not Applicable

Recruiting

• Conditions: HIV Prevention; Unhealthy Alcohol Use

• Registration Number: NCT06094634
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Status Verified: 2024-02
• Study Start: 2024-04-03
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 564

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

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Exclusion Criteria

• Psychological disturbance, cognitive impairment, or threatening behavior
• Unwilling to provide locator information
• Current participation in alcohol programs or studies
• Current participation in other research studies (including HIV and PrEP studies)
• Ever enrolled in an HIV vaccine study
• Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) ≥ 10, indicating risk for alcohol withdrawal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heavy Drinking Days (Binge drinking)	12 months	The number of days with ≥6 standard drinks of alcohol per occasion among the previous 30 days as assessed on the Timeline Followback.
Feasibility - proportion completed 4 sessions (among initiators)	7 weeks	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.
PrEP Persistence	12 months	PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.
Incremental Cost-Effectiveness Ratio (ICER)	12 months	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.
Acceptability of the brief alcohol intervention, as measured with mHIST	3 months	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.
Feasibility - proportion completed 4 sessions (intervention arm)	7 weeks	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.
Feasibility - proportion completed 2 sessions (intervention arm)	7 weeks	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.

Secondary Outcome Measures

Name	Time	Method
PrEP Adherence	Up to 12 months	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 anal or vaginal intercourse event.
Risk-aligned PrEP use	Up to 12 months	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.
Number of Drinking Days	Up to 12 months	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.
Penetration	Up to 4 weeks	Completion of at least one session among those assigned to the intervention arm.
Number of Drinks Per Drinking Day	Up to 12 months	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.

Trial Locations

Locations (1)

Hanoi Medical University; 🇻🇳 Hanoi, Vietnam