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

HIV Prevention Clinical Trial

— BPrEP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06094634
• Other study ID #: 23-0256
• Secondary ID: R01AA030479
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: July 2027

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Teerada Sripaipan
• Phone: (919) 966 6236
• Email: teerada[@]email.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 564
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Alcohol Drinking
• HIV Prevention
• Unhealthy Alcohol Use

Intervention

Behavioral:
• The Brief Alcohol Intervention (BAI): Behavioral
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.

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University	Hanoi

Sponsors (6)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Hanoi Medical University, Johns Hopkins University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), University of Washington

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP Persistence	PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.	12 months
Primary	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.	12 months
Primary	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
Primary	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.	3 months
Primary	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
Primary	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
Primary	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	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 anal or vaginal intercourse event.	Up to 12 months
Secondary	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: Persistent oral, event-driven or injectable PrEP,; Clinician-approved PrEP discontinuation.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	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.	Up to 12 months
Secondary	Penetration	Completion of at least one session among those assigned to the intervention arm.	Up to 4 weeks