A Theory Based HIV Prevention Video For Rapid HIV Testing: A Randomized Trial
December 9, 2014 updated by: Yvette Calderon,MD, MS, North Bronx Healthcare Network
A Randomized Control Trial Evaluating the Educational Effectiveness of a Rapid HIV Post-Test Counseling Video.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Bronx, New York, United States, 10461
- Jacobi Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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|
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean Knowledge Score within both groups.
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall condom intention measures and Condom Self efficacy measures
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yvette Calderon, MD, MS, Jacobi Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
November 7, 2005
First Submitted That Met QC Criteria
November 7, 2005
First Posted (Estimate)
November 8, 2005
Study Record Updates
Last Update Posted (Estimate)
December 10, 2014
Last Update Submitted That Met QC Criteria
December 9, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 03-190
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.