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A Theory Based HIV Prevention Video For Rapid HIV Testing: A Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00250549
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
OraQuick is a safe, rapid test that accurately identifies HIV in as little as 20 minutes. By providing an accurate, quick method for detecting a person's serostatus and access to immediate post-test counseling, rapid testing has a crucial role in identifying HIV status and improving post-test counseling rates in populations who are at high risk of HIV infection and high failure to return rates. This prospective randomized control trial compared the educational effectiveness of a fifteen-minute post-test counseling video with the normal practice of a session with an HIV counselor.

Condition or disease Intervention/treatment
HIV Behavioral: Post test video

Detailed Description:
A convenience sample of stable patients presenting to the walk-in section of the Jacobi Medical Center Adult ED were recruited for rapid HIV testing. After consenting for the rapid HIV test and completing measures on condom intention and condom use self-efficacy, participants were randomized to either a fifteen-minute HIV post-test educational video available in English or to an HIV counselor for post-test counseling. Afterwards, both groups completed a measure of HIV knowledge assessing relevant testing information and level of satisfaction. An equivalence analysis was carried out to assess whether the video was at least as good as counseling, measured by total score on the knowledge questionnaire, with a lower equivalence bound of -5%.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: A Randomized Control Trial Evaluating the Educational Effectiveness of a Rapid HIV Post-Test Counseling Video.
Study Start Date : May 2005
Primary Completion Date : October 2005
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: HIV counselor
Patients who tested for HIV and consent to participate in the study receive a posttest educational session with an HIV counselor. Afterwards, patients complete an assessment tool concerning HIV prevention and transmission.
Experimental: Post test video
Patients who tested for HIV and consent to participate in the study watch a a 15-minute HIV posttest educational video available in English/Spanish. Afterwards, patients complete an assessment tool concerning HIV prevention and transmission.
Behavioral: Post test video
We compared the educational effectiveness of a 15-minute posttest counseling video with the normal practice of a session with an HIV counselor.Patients in the experimental group watched an HIV posttest educational video.


Outcome Measures

Primary Outcome Measures :
  1. Mean Knowledge Score within both groups. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Overall condom intention measures and Condom Self efficacy measures [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adult patients presenting to the Urgent Care Area at Jacobi Medical Center

Exclusion Criteria:

  • Patients that were in to much pain, unable to understand the consent process or spoke another language other than the languages offered via the video or were HIV tested with in 6 months.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250549


Locations
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
North Bronx Healthcare Network
Investigators
Principal Investigator: Yvette Calderon, MD, MS Jacobi Medical Center
More Information

Responsible Party: Yvette Calderon,MD, MS, Professor of Clinical Emergency Medicine, North Bronx Healthcare Network
ClinicalTrials.gov Identifier: NCT00250549     History of Changes
Other Study ID Numbers: 03-190
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

Keywords provided by Yvette Calderon,MD, MS, North Bronx Healthcare Network:
HIV
Prevention
Rapid HIV testing