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Evaluating Post-test HIV Counseling Videos for Teens (Control)

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ClinicalTrials.gov Identifier: NCT00851539
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : December 10, 2014
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Yvette Calderon,MD, MS, North Bronx Healthcare Network

Brief Summary:
The design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video in educating adolescents about HIV transmission and affecting their intentions to engage in risk-reduction behavior.

Condition or disease Intervention/treatment Phase
HIV HIV Infections Behavioral: Video Not Applicable

Detailed Description:
Adolescents are at risk for HIV because of their engagement in high risk sexual activity. This study seeks to determine effective ways to educate teens about HIV and how to protect themselves by use of multimedia. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial
Study Start Date : June 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Participants received counseling from a live counselor.
Experimental: Video
Behavioral Intervention Video
Behavioral: Video
Behavioral Intervention Video



Primary Outcome Measures :
  1. Intention to use condoms [ Time Frame: 5 months ]
    Participants are asked about their intention to use condoms during sexual activity over the next 5 months


Secondary Outcome Measures :
  1. Consent to rapid HIV testing [ Time Frame: Immediate ]
    All participants are offered an HIV test but do not have to get tested to participate. We will evaluate whether the videos or counselors convince more participants to get tested for HIV.



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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Youth who have had vaginal, anal or oral sex
  2. 15-21 years of age
  3. English speaking

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851539


Locations
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
North Bronx Healthcare Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Yvette Calderon, MD MS Jacobi Medical Center/ Albert Einstein Medical College

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yvette Calderon,MD, MS, Professor of Clinical Emergency Medicine, North Bronx Healthcare Network
ClinicalTrials.gov Identifier: NCT00851539     History of Changes
Other Study ID Numbers: 2006-443
5K23HD054315 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Yvette Calderon,MD, MS, North Bronx Healthcare Network:
HIV
Teenagers
Adolescent
HIV Testing
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases