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IGHID 12219 - A Brief Alcohol Intervention for PrEP Use Among MSM in Vietnam: A Randomized Controlled Trial (BPrEP) (BPrEP)

Primary Purpose

HIV Prevention, Unhealthy Alcohol Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
The Brief Alcohol Intervention (BAI): Behavioral
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Prevention focused on measuring Preexposure Prophylaxis (PrEP), Alcohol Intervention, HIV/AIDS, Motivational Interviewing, Cognitive Behavioral Therapy, Motivational Enhancement Therapy, Vietnam, Cost Analysis, Economic Evaluation, Men who have sex with men

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hanoi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Assessment-only control

The Brief Alcohol Intervention (BAI)

Arm Description

Participants receive study assessment visits and standard of care from providers at the PrEP clinic.

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.

Outcomes

Primary Outcome Measures

PrEP Persistence
PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Hanoi Medical University, Ohio State University, Johns Hopkins University, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT06094634
Brief Title
IGHID 12219 - A Brief Alcohol Intervention for PrEP Use Among MSM in Vietnam: A Randomized Controlled Trial (BPrEP)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Hanoi Medical University, Ohio State University, Johns Hopkins University, University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Prevention, Unhealthy Alcohol Use
Keywords
Preexposure Prophylaxis (PrEP), Alcohol Intervention, HIV/AIDS, Motivational Interviewing, Cognitive Behavioral Therapy, Motivational Enhancement Therapy, Vietnam, Cost Analysis, Economic Evaluation, Men who have sex with men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assessment-only control
Arm Type
No Intervention
Arm Description
Participants receive study assessment visits and standard of care from providers at the PrEP clinic.
Arm Title
The Brief Alcohol Intervention (BAI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Brief Alcohol Intervention (BAI): Behavioral
Intervention Description
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.
Primary Outcome Measure Information:
Title
PrEP Persistence
Description
PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.
Time Frame
12 months
Title
Binge Drinking
Description
The number of days with ≥5 standard drinks of alcohol per occasion among the previous 30 days as assessed on the Timeline Followback.
Time Frame
12 months
Title
Incremental Cost-Effectiveness Ratio (ICER)
Description
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
Title
Acceptability of the brief alcohol intervention, as measured with mHIST
Description
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.
Time Frame
3 months
Title
Feasibility - proportion completed 4 sessions (intervention arm)
Description
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.
Time Frame
7 weeks
Title
Feasibility - proportion completed 2 sessions (intervention arm)
Description
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.
Time Frame
7 weeks
Title
Feasibility - proportion completed 4 sessions (among initiators)
Description
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.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
PrEP Adherence
Description
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.
Time Frame
Up to 12 months
Title
Risk-aligned PrEP use
Description
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).
Time Frame
Up to 12 months
Title
Number of Drinking Days
Description
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.
Time Frame
Up to 12 months
Title
Number of Drinks Per Drinking Day
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teerada Sripaipan
Phone
(919) 966 6236
Email
teerada@email.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian F Go, MD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William C Miller, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Le Minh Giang, PhD
Organizational Affiliation
Hanoi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanoi Medical University
City
Hanoi
Country
Vietnam
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le Minh Giang, PhD
Email
leminhgiang@hmu.edu.vn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
beginning 9 and continuing for 36 months following publication
IPD Sharing Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Learn more about this trial

IGHID 12219 - A Brief Alcohol Intervention for PrEP Use Among MSM in Vietnam: A Randomized Controlled Trial (BPrEP)

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