Evaluating Post-test HIV Counseling Videos for Teens

HIV Infections Clinical Trial

— Control  

Official title:

Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851539
• Other study ID #: 2006-443
• Secondary ID: 5K23HD054315
• Status: Completed
• Phase: N/A
• First received: February 25, 2009
• Last updated: December 9, 2014
• Start date: June 2008
• Est. completion date: April 2011

Study information

• Verified date: December 2014
• Source: North Bronx Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2011
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Behavioral:
• Video
Behavioral Intervention Video

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
North Bronx Healthcare Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention to use condoms	Participants are asked about their intention to use condoms during sexual activity over the next 5 months	5 months	No
Secondary	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.	Immediate	No