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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00250549
Other study ID # 03-190
Secondary ID
Status Completed
Phase N/A
First received November 7, 2005
Last updated December 9, 2014
Start date May 2005
Est. completion date March 2006

Study information

Verified date December 2014
Source North Bronx Healthcare Network
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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%.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date March 2006
Est. primary completion date October 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Jacobi Medical Center Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
North Bronx Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Knowledge Score within both groups. One year No
Secondary Overall condom intention measures and Condom Self efficacy measures One year No
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