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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00851539
First received: February 25, 2009
Last updated: December 9, 2014
Last verified: December 2014
History of Changes
  Purpose

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 Intervention
HIV
HIV Infections
 Behavioral: Video

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: HIV/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 ]
    Participants are asked about their intention to use condoms during sexual activity over the next 5 months


Secondary Outcome Measures:
  • Consent to rapid HIV testing [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    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.
Enrollment: 200
Study Start Date: June 2008
Study Completion Date: April 2011
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Participants received counseling from a live counselor.
Experimental: Video
Behavioral Intervention Video
 Behavioral: Video
Behavioral Intervention Video

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.

  Eligibility
Ages Eligible for Study:   15 Years to 21 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by North Bronx Healthcare Network

Additional 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
Study First Received: February 25, 2009
Last Updated: December 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Bronx Healthcare Network:
HIV
Teenagers
Adolescent
HIV Testing
HIV Seronegativity

ClinicalTrials.gov processed this record on February 27, 2015