Back to resultsHIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department
Primary Purpose
Alcohol Consumption, Sexual Risk Behaviors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling intervention with rapid HIV testing
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Consumption focused on measuring alcohol consumption, sexual risk behaviors, young, unhealthy drinkers
Eligibility Criteria
Inclusion Criteria:
- 18-40 years old;
- engaged in at least one sexual risk behavior in past 90 days;
- alcohol consumption greater than NIAAA guidelines for at-risk drinking;
- unknown or negative HIV status and willing to be tested;
- able to provide contact information for follow-up;
- able to provide written informed consent.
Exclusion Criteria:
- known HIV positive status;
- medically or psychiatrically unstable.
Sites / Locations
- Yale New Haven Hospital Emergency Deparmtment
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Feasibility
number of patients enrolled and retained at 2 months.
Secondary Outcome Measures
Alcohol consumption
As assessed by the Time Line Follow Back, change in alcohol consumption.
Sexual risk behaviors
As assessed by an adapted HIV Risk Behaviors Scale, change in sexual risk behaviors.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01573065
Brief Title
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department
Official Title
Addressing HIV Risk in Young Unhealthy Alcohol Drinkers in the Emergency Department With Rapid HIV Testing and Brief Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to determine whether a brief counseling intervention coupled with rapid HIV testing was feasible and effective at decreasing alcohol consumption and sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Sexual Risk Behaviors
Keywords
alcohol consumption, sexual risk behaviors, young, unhealthy drinkers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Counseling intervention with rapid HIV testing
Intervention Description
Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks.
Primary Outcome Measure Information:
Title
Feasibility
Description
number of patients enrolled and retained at 2 months.
Time Frame
baseline and 2 month follow-up
Secondary Outcome Measure Information:
Title
Alcohol consumption
Description
As assessed by the Time Line Follow Back, change in alcohol consumption.
Time Frame
baseline vs. 2 month follow-up
Title
Sexual risk behaviors
Description
As assessed by an adapted HIV Risk Behaviors Scale, change in sexual risk behaviors.
Time Frame
baseline vs. 2 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-40 years old;
engaged in at least one sexual risk behavior in past 90 days;
alcohol consumption greater than NIAAA guidelines for at-risk drinking;
unknown or negative HIV status and willing to be tested;
able to provide contact information for follow-up;
able to provide written informed consent.
Exclusion Criteria:
known HIV positive status;
medically or psychiatrically unstable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn E Fiellin, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital Emergency Deparmtment
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Learn more about this trial
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department
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