NCT00851539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

February 25, 2009

Last Update Submit

December 9, 2014

Conditions

Keywords

HIVTeenagersAdolescentHIV TestingHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Intention to use condoms

    Participants are asked about their intention to use condoms during sexual activity over the next 5 months

    5 months

Secondary Outcomes (1)

  • Consent to rapid HIV testing

    Immediate

Study Arms (2)

Control

NO INTERVENTION

Participants received counseling from a live counselor.

Video

EXPERIMENTAL

Behavioral Intervention Video

Behavioral: Video

Interventions

VideoBEHAVIORAL

Behavioral Intervention Video

Video

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youth who have had vaginal, anal or oral sex
  • years of age
  • English speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HIV Infections

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Yvette Calderon, MD MS

    Jacobi Medical Center/ Albert Einstein Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Emergency Medicine

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

April 1, 2011

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations