Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care
1 other identifier
interventional
210
1 country
2
Brief Summary
The purpose of the present study is to conduct a fully-crossed 2 X 2 X 2 factorial randomized controlled trial with a diverse sample of 224 MSM recruited from 2 urban HIV primary care clinics (one in the Northeast and one in the South). The first study factor will compare brief advice (BA) vs. a motivational intervention (MI) that contains detailed personalized normative and HIV-specific feedback. The second factor compares an interactive text messaging (ITM) intervention vs. no text messaging. The final factor compares intervention of low intensity and duration (two sessions over 1 month) to extended intervention (EI) entailing 5 sessions over 9 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedResults Posted
Study results publicly available
August 22, 2024
CompletedAugust 22, 2024
April 1, 2024
4.8 years
March 11, 2016
April 2, 2024
April 2, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Average Number of Drinks Per Week at 6 Months
Average number of alcoholic drinks consumed per week assessed at 6 months. Covers the period of 30 days prior to the assessment.
Past 30 days
Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months
Average number of alcoholic drinks consumed per week assessed at 12 months. Covers the period of 30 days prior to the assessment.
Past 30 days
Number of Heavy Drinking Days at 6 Months
Number of heavy drinking days (5 or more alcoholic drinks in a single day) assessed at 6 months
Past 30 days
Number of Heavy Drinking Days at 12 Months
Number of days drinking 5 or more alcoholic drinks
Past 30 days
Study Arms (8)
MI
ACTIVE COMPARATORMotivational interviewing focused on reducing alcohol use, delivered by videoconferencing.
BA
ACTIVE COMPARATORBrief Advice to reduce drinking delivered by videoconferencing
MI + ITM
ACTIVE COMPARATORMotivational intervention to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use
BA + ITM
ACTIVE COMPARATORBrief Advice to reduce drinking, delivered by videoconferencing, plus Interactive text messaging around alcohol use
MI + ITM + EI
ACTIVE COMPARATORParticipants in this arm receive MI delivered by videoconferencing and ITM over 9 months rather than 1
BA + ITM + EI
ACTIVE COMPARATORParticipants in this arm receive BA delivered by videoconferencing and ITM over 9 months rather than 1
BA + EI
ACTIVE COMPARATORParticipants in this arm receive BA delivered by videoconferencing over 9 months rather than 1
MI + EI
ACTIVE COMPARATORParticipants in this arm receive MI delivered by videoconferencing over 9 months rather than 1
Interventions
Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.
Involves 5-10 minutes of brief counseling to reduce drinking
Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals.
Eligibility Criteria
You may qualify if:
- be at least 18 years of age
- drink heavily at least once per month on average (≥5 drinks) or drink have drunk more than 14 drinks per week over the past 3 months
- have a confirmed diagnosis of HIV
- be a biological male who identifies as male
- report having had sex (oral or anal) with a male partner in the past 12 months and/or, identify as gay or bisexual.
- For those on ART, they must be stabilized on their current regimen for at least 3 months prior to study enrollment.
You may not qualify if:
- report past 3 month intravenous drug use
- are currently psychotic, suicidal, or manic
- being treated or have been treated in the past 3 months for an HIV-related opportunistic infection
- currently receiving treatment for an alcohol or drug problem.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
Study Sites (2)
Fenway Health
Boston, Massachusetts, United States
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, 02912, United States
Related Publications (1)
Kahler CW, Surace A, Liu T, Pantalone DW, Mastroleo NR, Yan Y, Wray TB, Mayer KH, Monti PM. Efficacy of Behavioral Intervention, Text Messaging, and Extended Intervention to Address Alcohol Misuse in Sexual Minority Men with HIV: A Factorial Randomized Clinical Trial. AIDS Behav. 2024 Dec;28(12):3970-3983. doi: 10.1007/s10461-024-04493-x. Epub 2024 Sep 13.
PMID: 39266891DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Kahler
- Organization
- Brown University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 16, 2016
Study Start
August 1, 2016
Primary Completion
May 1, 2021
Study Completion
January 20, 2022
Last Updated
August 22, 2024
Results First Posted
August 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share