NCT00250549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

November 7, 2005

Last Update Submit

December 9, 2014

Conditions

Keywords

HIVPreventionRapid HIV testing

Outcome Measures

Primary Outcomes (1)

  • Mean Knowledge Score within both groups.

    One year

Secondary Outcomes (1)

  • Overall condom intention measures and Condom Self efficacy measures

    One year

Study Arms (2)

HIV counselor

NO INTERVENTION

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.

Post test video

EXPERIMENTAL

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

Interventions

Post test videoBEHAVIORAL

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.

Post test video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Study Officials

  • Yvette Calderon, MD, MS

    Jacobi Medical Center

    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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Emergency Medicine

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2005

Study Completion

March 1, 2006

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations