Back to resultsEvaluating Post-test HIV Counseling Videos for Teens (Control)
Primary Purpose
HIV, HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
Sponsored by
About this trial
This is an interventional prevention trial for HIV focused on measuring HIV, Teenagers, Adolescent, HIV Testing, HIV Seronegativity
Eligibility 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
Sites / Locations
- Jacobi Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Video
Arm Description
Participants received counseling from a live counselor.
Behavioral Intervention Video
Outcomes
Primary Outcome Measures
Intention to use condoms
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
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.
Full Information
NCT ID
NCT00851539
First Posted
February 25, 2009
Last Updated
December 9, 2014
Sponsor
North Bronx Healthcare Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00851539
Brief Title
Evaluating Post-test HIV Counseling Videos for Teens
Acronym
Control
Official Title
Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Bronx Healthcare Network
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HIV, Teenagers, Adolescent, HIV Testing, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants received counseling from a live counselor.
Arm Title
Video
Arm Type
Experimental
Arm Description
Behavioral Intervention Video
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
Behavioral Intervention Video
Primary Outcome Measure Information:
Title
Intention to use condoms
Description
Participants are asked about their intention to use condoms during sexual activity over the next 5 months
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Consent to rapid HIV testing
Description
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.
Time Frame
Immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette Calderon, MD MS
Organizational Affiliation
Jacobi Medical Center/ Albert Einstein Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23582525
Citation
Calderon Y, Cowan E, Leu CS, Brusalis C, Rhee JY, Nickerson J, Leider J, Bauman LJ. A human immunodeficiency virus posttest video to increase condom use among adolescent emergency department patients. J Adolesc Health. 2013 Jul;53(1):79-84. doi: 10.1016/j.jadohealth.2013.01.028. Epub 2013 Apr 9.
Results Reference
derived
Learn more about this trial
Evaluating Post-test HIV Counseling Videos for Teens
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