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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yvette Calderon,MD, MS, North Bronx Healthcare Network

ClinicalTrials.gov Identifier:

NCT00250549

First received: November 7, 2005

Last updated: December 9, 2014

Last verified: December 2014

History of Changes

Purpose

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	Intervention
HIV	Behavioral: Post test video


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention
Official Title:	A Randomized Control Trial Evaluating the Educational Effectiveness of a Rapid HIV Post-Test Counseling Video.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by North Bronx Healthcare Network:

Primary Outcome Measures:

Mean Knowledge Score within both groups. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall condom intention measures and Condom Self efficacy measures [ Time Frame: One year ] [ Designated as safety issue: No ]


Enrollment:	128
Study Start Date:	May 2005
Study Completion Date:	March 2006
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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%.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


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
Study First Received:	November 7, 2005
Last Updated:	December 9, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by North Bronx Healthcare Network:


HIV Prevention Rapid HIV testing

ClinicalTrials.gov processed this record on February 26, 2015

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