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Video-based Counseling & Rapid HIV Testing for Teens

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
in-person HIV pre-test counseling
Sponsored by
North Bronx Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, HIV knowledge measure, Teen HIV testing, HIV Seronegativity

Eligibility Criteria

15 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 15-21 year old
  • sexually active
  • English-Speaking

Exclusion Criteria:

  • medically unstable

Sites / Locations

  • Jacobi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Video

Arm Description

The participants spoke with a live counselor prior to answering the knowledge measure

Outcomes

Primary Outcome Measures

Knowledge of HIV

Secondary Outcome Measures

Consent to HIV testing

Full Information

First Posted
February 3, 2009
Last Updated
September 18, 2009
Sponsor
North Bronx Healthcare Network
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00836550
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
North Bronx Healthcare Network
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HIV, HIV knowledge measure, Teen 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
Active Comparator
Arm Description
The participants spoke with a live counselor prior to answering the knowledge measure
Arm Title
Video
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
The participants saw a 6 minute video
Intervention Type
Behavioral
Intervention Name(s)
in-person HIV pre-test counseling
Primary Outcome Measure Information:
Title
Knowledge of HIV
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Consent to HIV testing
Time Frame
2 months

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: 15-21 year old sexually active English-Speaking Exclusion Criteria: medically unstable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette Calderon, MD MS
Organizational Affiliation
Jacobi Medical Center/ Albert Einstein College of Medicine
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

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Video-based Counseling & Rapid HIV Testing for Teens

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