Expired Study
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Bronx, New York 10461


Purpose:

This study evaluated the educational effectiveness of a youth-friendly pre-test video (derived from a previous qualitative study) and compared it with in-person HIV pre-test counseling. A convenience sample of 200 medically stable individuals between the ages of 15 and 21 presenting to an urban ED were recruited to participate in this study and randomized into 2 groups. Individuals were eligible if they were English-speaking, sexually active and able to consent. All participants completed a sexual risk factor and demographic survey. Group 1 completed a validated pre-test knowledge measure, viewed the HIV education video then completed a post-test knowledge measure. Group 2 completed the same knowledge measures, but received pre-test HIV counseling from a trained public health advocate. HIV testing was optional


Criteria:

Inclusion Criteria: - 15-21 year old - sexually active - English-Speaking Exclusion Criteria: - medically unstable


Study is Available At:


Original ID:

2005-456-001


NCT ID:

NCT00836550


Secondary ID:

HD054315-02


Study Acronym:


Brief Title:

Video-based Counseling & Rapid HIV Testing for Teens


Official Title:

An RCT to Evaluate the Effectiveness of an Emergency Department Based Multimedia HIV Testing Model in Adolescents


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

15 Years


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

North Bronx Healthcare Network


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Actual


Overall Contact Information

Official Name:Yvette Calderon, MD MS
Principal Investigator
Jacobi Medical Center/ Albert Einstein College of Medicine

Study Dates

Start Date:August 2008
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:September 2009
Last Changed Date:September 18, 2009
First Received Date:February 3, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Consent to HIV testing
Time Frame:2 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Knowledge of HIV
Time Frame:2 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Video
Description:The participants saw a 6 minute video
Arm Name:Video
Intervention Type:Behavioral
Name:in-person HIV pre-test counseling
Arm Name:Control

Study Arms

Study Arm Type:Experimental
Arm Name:Video
Study Arm Type:Active Comparator
Arm Name:Control
Description:The participants spoke with a live counselor prior to answering the knowledge measure

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:North Bronx Healthcare Network
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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