Back to resultsBrief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
Primary Purpose
HIV Infections, Alcohol Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Electronic Intervention
Attention-Matched Control
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Biologically male
- Aged 18 or older
- Fluent English speaker
- Unprotected anal sex with a casual male partner at least once in the past 3 months
- Heavy alcohol use during the past 2-weeks (>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)
- Breath alcohol concentration (BrAC) of .000 at the time of enrollment
- No history of complex alcohol withdrawal
- HIV-negative
Exclusion Criteria:
- Individuals who are HIV-positive
- Individuals who participated in other phases of the research
- Individuals who report being coerced to participate
Sites / Locations
- Brown University School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Attention-matched control
Arm Description
Outcomes
Primary Outcome Measures
Number of New Sex Partners, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB)
Number of Condomless Anal Sex Events, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.
Number of Drinking Days, Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30
Number of Heavy Drinking Days (5 or More), Past 30 Days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.
Average Number of Drinks Per Drinking Day
Assessed using Timeline Follow Back (TLFB)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03435783
Brief Title
Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
Official Title
Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
March 3, 2018 (Actual)
Study Completion Date
March 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (MSM) who are seeking free HIV testing. Investigators will be conducting a randomized-controlled pilot test of the intervention among MSM seeking HIV testing in community-based settings to explore its potential impact on alcohol and HIV-related behavioral outcomes. This research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk MSM engage with prevention services.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Alcohol Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized controlled trial where participants are assigned to either a treatment or control group.
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Attention-matched control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Brief Electronic Intervention
Intervention Description
The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so.
Intervention Type
Behavioral
Intervention Name(s)
Attention-Matched Control
Intervention Description
Participants will view a video clip on general health promotion that is a similar length as the intervention arm.
Primary Outcome Measure Information:
Title
Number of New Sex Partners, Past 30 Days
Description
Assessed via self-report using Timeline Follow Back (TLFB)
Time Frame
Past 30 days
Title
Number of Condomless Anal Sex Events, Past 30 Days
Description
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.
Time Frame
Past 30 days
Title
Number of Drinking Days, Past 30 Days
Description
Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30
Time Frame
Past 30 days
Title
Number of Heavy Drinking Days (5 or More), Past 30 Days
Description
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.
Time Frame
Past 30 days
Title
Average Number of Drinks Per Drinking Day
Description
Assessed using Timeline Follow Back (TLFB)
Time Frame
Past 30 days
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Biologically male
Aged 18 or older
Fluent English speaker
Unprotected anal sex with a casual male partner at least once in the past 3 months
Heavy alcohol use during the past 2-weeks (>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)
Breath alcohol concentration (BrAC) of .000 at the time of enrollment
No history of complex alcohol withdrawal
HIV-negative
Exclusion Criteria:
Individuals who are HIV-positive
Individuals who participated in other phases of the research
Individuals who report being coerced to participate
Facility Information:
Facility Name
Brown University School of Public Health
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02901
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
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