Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by National Development and Research Institutes, Inc.
Sponsor:
Information provided by (Responsible Party):
Ian Aronson, National Development and Research Institutes, Inc.
ClinicalTrials.gov Identifier:
NCT02154802
First received: May 29, 2014
Last updated: May 30, 2014
Last verified: May 2014
  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: Open Label

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

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

No publications provided

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
Study First Received: May 29, 2014
Last Updated: May 30, 2014
Health Authority: United States: National Institutes of Health

ClinicalTrials.gov processed this record on September 16, 2014