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Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Ian Aronson, National Development and Research Institutes, Inc..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02154802
First Posted: June 3, 2014
Last Update Posted: June 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ian Aronson, National Development and Research Institutes, Inc.
  Purpose
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.

Condition Intervention
HIV Testing Behavioral: video: community member Behavioral: video: physician Behavioral: video: choice of video

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Ian Aronson, National Development and Research Institutes, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: July 2014
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: video: community member
Participant watches video of a community member
Behavioral: video: community member
Experimental: video: physician
Participant watches video of a physician
Behavioral: video: physician
Experimental: video: choice of video
Participant can choose to watch video of either the community member of the physician
Behavioral: video: choice of video
No Intervention: no video

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154802


Contacts
Contact: Ian D Aronson, Ph.D. 212-845-4567 aronson@ndri.org
Contact: Lisa Bernhard bernhard@ndri.org

Locations
United States, New York
St. Luke's Emergency Department Not yet recruiting
New York, New York, United States, 10025
Sponsors and Collaborators
National Development and Research Institutes, Inc.
  More Information

Responsible Party: Ian Aronson, Principal Investigator, National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier: NCT02154802     History of Changes
Other Study ID Numbers: 1R34DA037129-01A1 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2014
First Posted: June 3, 2014
Last Update Posted: June 3, 2014
Last Verified: May 2014