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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01573065
Other study ID # 0906005270
Secondary ID
Status Completed
Phase N/A
First received April 4, 2012
Last updated August 9, 2012
Start date March 2010
Est. completion date August 2011

Study information

Verified date August 2012
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date August 2011
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 40 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Counseling intervention with rapid HIV testing
Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks.

Locations

Country Name City State
United States Yale New Haven Hospital Emergency Deparmtment New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility number of patients enrolled and retained at 2 months. baseline and 2 month follow-up No
Secondary Alcohol consumption As assessed by the Time Line Follow Back, change in alcohol consumption. baseline vs. 2 month follow-up No
Secondary Sexual risk behaviors As assessed by an adapted HIV Risk Behaviors Scale, change in sexual risk behaviors. baseline vs. 2 month follow-up No
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