Evaluating a Post-Test HIV Counseling Video for Teens

This study is not yet open for participant recruitment.

Verified by North Bronx Healthcare Network, February 2009

First Received: February 25, 2009 Last Updated: March 9, 2009 History of Changes

Sponsor:	North Bronx Healthcare Network
Information provided by:	North Bronx Healthcare Network
ClinicalTrials.gov Identifier:	NCT00851539

Purpose

The design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video. All eligible participants who agree to enroll in this trial will be randomized into two arms: the behavioral intervention video (intervention group) or meeting with an in-person counselor (control group) as they wait for their rapid HIV results. The goals of the RCT involve establishing the feasibility of using touch-screen technology for teenagers in the ED; establishing the receptivity of teens to HIV rapid testing in the ED; providing data on rates, and obtaining preliminary data on the effectiveness of the video in changing condom efficacy, condom outcome expectancies and condom use intention. Consenting to rapid HIV testing is a secondary outcome.

Condition	Intervention
HIV HIV Infections	Behavioral: Video

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Efficacy Study
Official Title:	An RCT to Evaluate the Effectiveness of a HIV Post-Test Behavioral Intervention Video for Teens

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by North Bronx Healthcare Network:

Primary Outcome Measures:

intention to use condoms [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

consent to rapid HIV testing [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	135
Study Start Date:	May 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: No Intervention Participants received counseling from a live counselor.
Video: Experimental Behavioral Intervention Video	Behavioral: Video Behavioral Intervention Video

Eligibility

Ages Eligible for Study:	15 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Youth who have had vaginal, anal or oral sex
15-21 years of age
English speaking

Exclusion Criteria:

Clinically unstable secondary to pain or unstable vitals signs
Unable to understand the consent process for the study
Known HIV status or recent HIV test
Language other than English

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00851539

Contacts

Contact: Yvette Calderon, MD	(718) 918-5845	ycal333@yahoo.com
Contact: Nery Munoz	(718) 918-5819	nery.munoz@nbhn.net

Locations

United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461

Sponsors and Collaborators

North Bronx Healthcare Network

Investigators

Principal Investigator:

Yvette Calderon, MD MS

Jacobi Medical Center/ Albert Einstein Medical College

More Information

No publications provided

Responsible Party:	Albert Einstein College of Medicine ( Yvette Calderon/ Principal Investigator )
Study ID Numbers:	2006-443
Study First Received:	February 25, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00851539 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Bronx Healthcare Network:

HIV
Teenagers
Adolescent
HIV Testing
HIV Seronegativity

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010