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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435783
• Other study ID #: 1411001155
• Status: Completed
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: March 3, 2018

Study information

• Verified date: April 2019
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 3, 2018
• Est. primary completion date: March 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• HIV Infections

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.
• Attention-Matched Control
Participants will view a video clip on general health promotion that is a similar length as the intervention arm.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of New Sex Partners, Past 30 Days	Assessed via self-report using Timeline Follow Back (TLFB)	Past 30 days
Primary	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.	Past 30 days
Primary	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	Past 30 days
Primary	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.	Past 30 days
Primary	Average Number of Drinks Per Drinking Day	Assessed using Timeline Follow Back (TLFB)	Past 30 days