Evaluating Post-test HIV Counseling Videos for Teens (Control)
This study has been completed.
Sponsor:
North Bronx Healthcare Network
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
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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:
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 (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
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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
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
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 |
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 |
ClinicalTrials.gov processed this record on September 27, 2016