NCT00836550

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

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 Aug 2008

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

February 3, 2009

Last Update Submit

September 18, 2009

Conditions

Keywords

HIVHIV knowledge measureTeen HIV testingHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Knowledge of HIV

    2 months

Secondary Outcomes (1)

  • Consent to HIV testing

    2 months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Behavioral: in-person HIV pre-test counseling

Video

EXPERIMENTAL
Behavioral: Video

Interventions

VideoBEHAVIORAL

The participants saw a 6 minute video

Video

Eligibility Criteria

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

You may qualify if:

  • year old
  • sexually active
  • English-Speaking

You may not qualify if:

  • medically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

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 College of Medicine

    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

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations