Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing

April 18, 2019 updated by: Tyler Wray, Brown University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02901
        • Brown University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Biologically male
  2. Aged 18 or older
  3. Fluent English speaker
  4. Unprotected anal sex with a casual male partner at least once in the past 3 months
  5. Heavy alcohol use during the past 2-weeks (>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion)
  6. Breath alcohol concentration (BrAC) of .000 at the time of enrollment
  7. No history of complex alcohol withdrawal
  8. HIV-negative

Exclusion Criteria:

  1. Individuals who are HIV-positive
  2. Individuals who participated in other phases of the research
  3. Individuals who report being coerced to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Brief Electronic Intervention
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.
Active Comparator: Attention-matched control
Behavioral: Attention-Matched Control
Participants will view a video clip on general health promotion that is a similar length as the intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of New Sex Partners, Past 30 Days
Time Frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB)
Past 30 days
Number of Condomless Anal Sex Events, Past 30 Days
Time Frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.
Past 30 days
Number of Drinking Days, Past 30 Days
Time Frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30
Past 30 days
Number of Heavy Drinking Days (5 or More), Past 30 Days
Time Frame: Past 30 days
Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.
Past 30 days
Average Number of Drinks Per Drinking Day
Time Frame: Past 30 days
Assessed using Timeline Follow Back (TLFB)
Past 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2017

Primary Completion (Actual)

March 3, 2018

Study Completion (Actual)

March 3, 2018

Study Registration Dates

First Submitted

August 2, 2017

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1411001155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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