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ArticleTrials2024

A Brief Alcohol Intervention (BAI) to reduce alcohol use and improve PrEP outcomes among men who have sex with men in Vietnam: study protocol for a randomized controlled trial.

Hao T M Bui, Le Minh Giang, Jane S Chen, Teerada Sripaipan, Ha T T Nong, Ngan T K Nguyen, Sophia M Bartels, Sarah L Rossi, Heidi Hutton, Geetanjali Chander and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06094634 (IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06094634 naactive not recruitingnot on this map

IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes: A Randomized Controlled Trial

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2024 to 2027Enrolled562ConditionsUnhealthy Alcohol UseArmsThe Brief Alcohol Intervention (BAI): Behavioral
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Hao T M BuiCenter for Training and Research on Substance Abuse -HIV (CREATA-H), Hanoi Medical University, Hanoi, Vietnam.
Le Minh GiangCenter for Training and Research on Substance Abuse -HIV (CREATA-H), Hanoi Medical University, Hanoi, Vietnam.
Jane S ChenDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Teerada SripaipanDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Ha T T NongUniversity of North Carolina Project Vietnam, Van Phuc Diplomatic Compound, Apartment 407-408, A2 Building298 Kim Ma Street, Ba Dinh District, Hanoi, Vietnam.
Ngan T K NguyenUniversity of North Carolina Project Vietnam, Van Phuc Diplomatic Compound, Apartment 407-408, A2 Building298 Kim Ma Street, Ba Dinh District, Hanoi, Vietnam.
Sophia M BartelsDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Sarah L RossiDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Heidi HuttonDepartment of Psychiatry, School of Medicine, Johns Hopkins University, Baltimore, USA.
Geetanjali ChanderDivision of General Internal Medicine, School of Medicine, University of Washington, Seatle, USA.
Hojoon SohnDepartment of Preventive Medicine, College of Medicine, Seoul National University, Seoul, Republic of Korea.
Olivia FergusonDepartment of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Ha V TranUniversity of North Carolina Project Vietnam, Van Phuc Diplomatic Compound, Apartment 407-408, A2 Building298 Kim Ma Street, Ba Dinh District, Hanoi, Vietnam.
Minh X NguyenDepartment of Epidemiology, School of Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam.
Khanh D NguyenCenter for Training and Research on Substance Abuse -HIV (CREATA-H), Hanoi Medical University, Hanoi, Vietnam.
Sarah E RutsteinDivision of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Sara LevintowDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Irving F HoffmanDivision of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Byron J PowellGeorge Warren Brown School of Social Work, Washington University, St. Louis, MO, USA.
Brian W PenceDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
Vivian F Go *Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA.
William C Miller *Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, USA. bill_miller@unc.edu.ORCID http://orcid.org/0000-0002-1934-7827

Funding

A brief alcohol intervention to reduce alcohol use and improve PrEP outcomes: A randomized controlled trial.R01AA030479 · NIAAA · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VIVIAN F. GO, Giang M Le · 2022 to 2026
$3.0M
Vietnam Implementation Science Advancement: A Training Program to Improve HIV Prevention and CareD43TW011548 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI VIVIAN F. GO, Huong Thi Le · 2021 to 2026
$1.7M
FIC NIH HHS D43 TW011548NIAAA NIH HHS R01 AA030479NIAAA NIH HHS R01AA030479
6 · The paper itself

Abstract

backgroundIn Vietnam and other global settings, men who have sex with men (MSM) have become the population at greatest risk of HIV infection. Although HIV pre-exposure prophylaxis (PrEP) has been implemented as a prevention strategy, PrEP outcomes may be affected by low persistence and adherence among MSM with unhealthy alcohol use. MSM have a high prevalence of unhealthy alcohol use in Vietnam, which may affect PrEP outcomes.

methodsDesign: We will conduct a two-arm hybrid type 1 effectiveness-implementation randomized controlled trial of a brief alcohol intervention (BAI) compared to the standard of care (SOC) at the Sexual Health Promotion (SHP) clinic Hanoi, Vietnam.

participantsSexually active MSM (n=564) who are newly initiating PrEP or re-initiating PrEP and have unhealthy alcohol use will be recruited and randomized 1:1 to the SOC or BAI arm. A subgroup of participants (n=20) in each arm will be selected for longitudinal qualitative interviews; an additional subset (n=48) in the BAI arm will complete brief quantitative and qualitative interviews after completion of the BAI to assess the acceptability of the intervention. Additional implementation outcomes will be assessed through interviews with clinic staff and stakeholders (n=35).

interventionStudy participants in both arms will receive standard care for PrEP clients. In the BAI arm, each participant will receive two face-to-face intervention sessions and two brief booster phone sessions, based on cognitive behavioral therapy and delivered in motivational interviewing informed style, to address their unhealthy alcohol use. OUTCOMES: Effectiveness (PrEP and alcohol use) and cost-effectiveness outcomes will be compared between the two arms. Intervention implementation outcomes (acceptability, feasibility, adoption) will be assessed among MSM participants, clinic staff, and stakeholders. DISCUSSION: This proposed trial will assess an alcohol intervention for MSM with unhealthy alcohol use who initiate or re-initiate PrEP, while simultaneously preparing for subsequent implementation. The study will measure the effectiveness of the BAI for increasing PrEP persistence through reducing unhealthy alcohol use in a setting where excessive alcohol consumption is a normative behavior. If effective, implementation-focused results will inform future scale-up of the BAI in similar settings.

trial registrationNCT06094634 on clinicaltrials.gov. Registered 16 October 2023.

Indexed as

Alcohol DrinkingHIV InfectionsHomosexuality, MalePre-Exposure ProphylaxisRandomized Controlled Trials as TopicAdultHumansMaleTreatment OutcomeVietnamYoung AdultBrief alcohol intervention (BAI)HIV pre-exposure prophylaxis (PrEP)Men who have sex with men (MSM)Motivational interview (MI)

Identifiers

PMID39164770
PMCPMC11337901

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.