N/A
N=188
Behavioral Interventions to Reduce Heavy Drinking Among MSM in HIV Primary Care
Alcohol Drinking · HIV
Bottom Line
View on ClinicalTrials.gov: NCT02709759 ↗Enrolled (actual)
188
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Average Number of Drinks Per Week at 6 Months — 13.3; 14.9; 7.5; 5.0 number of drinks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motivational intervention (Behavioral); Brief Advice (Behavioral); Interactive text messaging (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Brown University
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Drinks Per Week at 6 Months |
13.3; 14.9; 7.5; 5.0; 9.6; 7.6 | — |
| PRIMARY Average Number of Alcoholic Drinks Consumed Per Week Assessed at 12 Months |
8.3; 16.5; 4.6; 3.7; 5.4; 8.1 | — |
| PRIMARY Number of Heavy Drinking Days at 6 Months |
4.3; 5.2; 1.8; 1.4; 3.1; 3.5 | — |
| PRIMARY Number of Heavy Drinking Days at 12 Months |
2.2; 5.6; 1.8; 1.2; 2.6; 2.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02709759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.