- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154802
Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology
May 30, 2014 updated by: Ian Aronson, National Development and Research Institutes, Inc.
Because people with undiagnosed HIV will not receive treatment and may unknowingly infect others, the investigators propose a mobile computer-based video intervention to increase HIV test rates in high volume urban hospital emergency departments (EDs).
EDs offer important points of contact for many of those at greatest risk for HIV.
Unfortunately, when ED patients are offered routine HIV testing, most decline.
Our proposed intervention builds upon initial findings from a trial our research team conducted with patients who declined HIV testing.
The intervention, grounded in the Information-Motivation and Behavioral Skills model (IMB), showed an onscreen physician explaining the importance of HIV testing (to build knowledge and motivation) and modeling a rapid HIV test (to increase motivation and behavioral skill).
This brief intervention had a potent effect: a third accepted HIV testing post-intervention.
While this preliminary study is highly encouraging, it revealed a number of other critical research questions.
First, it remains unclear what intervention component most strongly contributed to patients' decisions to test: the video content or the offer of an HIV test by a computer rather than a person.
Second, consistent with the literature, participants indicated a community member disclosing positive HIV status onscreen would increase the proportion of patients who test.
Third, results suggest there is individual variation in the extent to which behavior is more strongly influenced by onscreen community members or experts (e.g.
physicians).
Therefore, the goal of the present study, guided by the IMB model, is to determine how the investigators can refine mobile computer-based interventions to maximize HIV testing rates among patients who initially decline to test in the ED.
At the end of the computerized intervention, onscreen text will ask patients if they would agree to an HIV test.
Those who agree will be tested by ED staff.
The study's endpoint will be post-intervention HIV test rates.
The investigators' study will inform scalable interventions for underserved populations nationwide.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
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 Contact
- Name: Ian D Aronson, Ph.D.
- Phone Number: 212-845-4567
- Email: aronson@ndri.org
Study Contact Backup
- Name: Lisa Bernhard
- Email: bernhard@ndri.org
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- St. Luke's Emergency Department
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or over
- Capable of providing informed consent
- Reads English
- Declined HIV test offered by hospital staf at triage
Exclusion Criteria:
- intoxicated
- a prisoner
- known to be HIV positive
- presenting to the hospital for a psychiatric problem
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
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: video: community member
Participant watches video of a community member
|
|
Experimental: video: physician
Participant watches video of a physician
|
|
Experimental: video: choice of video
Participant can choose to watch video of either the community member of the physician
|
|
No Intervention: no video
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who accept an HIV test after completing the intervention
Time Frame: Day 1
|
The intervention computers will show participants a set of videos and data collection instruments.
When the participant has watched the video and responded to all instruments, the computers will ask patients if they would like an HIV test.
Answers are yes or no.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge change
Time Frame: Baseline, Day 1
|
The intervention computers will display a set of HIV-related knowledge questions before and after a video segment.
This will enable the investigators to examine potential increases in participants' knowledge after watching a video.
|
Baseline, Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
July 1, 2014
Primary Completion (Anticipated)
January 1, 2017
Study Registration Dates
First Submitted
May 29, 2014
First Submitted That Met QC Criteria
May 30, 2014
First Posted (Estimate)
June 3, 2014
Study Record Updates
Last Update Posted (Estimate)
June 3, 2014
Last Update Submitted That Met QC Criteria
May 30, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 1R34DA037129-01A1 (U.S. NIH Grant/Contract)
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.
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