- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01573065
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department
August 9, 2012 updated by: Lynn E. Fiellin, Yale University
Addressing HIV Risk in Young Unhealthy Alcohol Drinkers in the Emergency Department With Rapid HIV Testing and Brief Intervention
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
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
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Yale New Haven Hospital Emergency Deparmtment
-
-
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 to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single arm
|
Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing.
Telephone booster at 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility
Time Frame: baseline and 2 month follow-up
|
number of patients enrolled and retained at 2 months.
|
baseline and 2 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol consumption
Time Frame: baseline vs. 2 month follow-up
|
As assessed by the Time Line Follow Back, change in alcohol consumption.
|
baseline vs. 2 month follow-up
|
Sexual risk behaviors
Time Frame: baseline vs. 2 month follow-up
|
As assessed by an adapted HIV Risk Behaviors Scale, change in sexual risk behaviors.
|
baseline vs. 2 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2010
Primary Completion (ACTUAL)
May 1, 2010
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
April 4, 2012
First Submitted That Met QC Criteria
April 4, 2012
First Posted (ESTIMATE)
April 6, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 10, 2012
Last Update Submitted That Met QC Criteria
August 9, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0906005270
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.
Clinical Trials on Alcohol Consumption
-
Centre for Addiction and Mental HealthCanadian Institutes of Health Research (CIHR)CompletedAlcohol Consumption | Hazardous Alcohol ConsumptionCanada
-
Centre for Addiction and Mental HealthUniversity of HoustonCompleted
-
Wayne State UniversityCompleted
-
Institut national de prevention et d'education...CompletedHazardous Alcohol Consumption
-
International Agency for Research on CancerUniversidad de Murcia; Federico II University; University of Tromso; Imperial College... and other collaboratorsCompletedNo Condition, Focus: Metabolites of Alcohol Consumption
-
Denver Health and Hospital AuthorityMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.CompletedModerate Alcohol Consumption (1-3 Drinks Per Day)
-
Jordi Gol i Gurina FoundationSocietat Catalana de Medicina Familiar i Comunitària (CAMFIC); Associació Catalana... and other collaboratorsUnknownAlcohol Consumption | Traffic Accident | Risk Perception of Driving After Alcohol ConsumptionSpain
-
Technische Universität DresdenCharite University, Berlin, GermanyCompletedHigh-risk Alcohol Consumption Pattern | Low-risk Alcohol Consumption PatternGermany
-
University of WashingtonNational Institutes of Health (NIH); National Institute on Aging (NIA); Seattle...Active, not recruitingMild to Heavy Alcohol ConsumptionUnited States
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
Clinical Trials on Counseling intervention with rapid HIV testing
-
University of MiamiNational Institute on Drug Abuse (NIDA); University of California, San FranciscoCompleted
-
Harvard School of Public Health (HSPH)University of Heidelberg Medical Center; University of Witwatersrand, South...UnknownHIV Infections | Knowledge, Attitudes, PracticeSouth Africa
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)Enrolling by invitation
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsSouth Africa
-
Susan M. KieneNational Institute of Mental Health (NIMH); Rhode Island Hospital; Makerere UniversityCompletedHIV | Sexual BehaviorUganda
-
San Francisco Department of Public HealthCenters for Disease Control and PreventionCompletedHIV Infections | Episodic Substance UseUnited States
-
Columbia UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHuman Immunodeficiency Virus (HIV) | Acquired Immune Deficiency Syndrome (AIDS)Lesotho
-
Chinese University of Hong KongNot yet recruitingBehaviors, HealthHong Kong
-
Emory UniversityNational Institute of Mental Health (NIMH)Completed
-
Hopital LariboisièreCompleted