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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435783
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Tyler Wray, Brown University

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.

Condition or disease Intervention/treatment Phase
HIV Infections Alcohol Abuse Behavioral: Brief Electronic Intervention Behavioral: Attention-Matched Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized controlled trial where participants are assigned to either a treatment or control group.
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Brief Electronic Intervention for Heavy Drinking and Sex Risk Among MSM Seeking HIV Testing
Actual Study Start Date : October 13, 2017
Actual Primary Completion Date : March 3, 2018
Actual Study Completion Date : March 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Number of New Sex Partners, Past 30 Days [ Time Frame: Past 30 days ]
    Assessed via self-report using Timeline Follow Back (TLFB)

  2. 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.

  3. 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

  4. 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.

  5. Average Number of Drinks Per Drinking Day [ Time Frame: Past 30 days ]
    Assessed using Timeline Follow Back (TLFB)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435783


Locations
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United States, Rhode Island
Brown University School of Public Health
Providence, Rhode Island, United States, 02901
Sponsors and Collaborators
Brown University
  Study Documents (Full-Text)

Documents provided by Tyler Wray, Brown University:
Study Protocol  [PDF] July 21, 2017
Statistical Analysis Plan  [PDF] July 21, 2017

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Responsible Party: Tyler Wray, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT03435783    
Other Study ID Numbers: 1411001155
First Posted: February 19, 2018    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders