Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology

HIV Testing Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02154802
• Other study ID #: 1R34DA037129-01A1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 29, 2014
• Last updated: May 30, 2014
• Start date: July 2014

Study information

• Verified date: May 2014
• Source: National Development and Research Institutes, Inc.
• Contact: Ian D Aronson, Ph.D.
• Phone: 212-845-4567
• Email: aronson[@]ndri.org
• Is FDA regulated: No
• Health authority: United States: National Institutes of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Testing

Intervention

Behavioral:
• video: community member

• video: physician

• video: choice of video

Locations

Country	Name	City	State
United States	St. Luke's Emergency Department	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Development and Research Institutes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who accept an HIV test after completing the intervention	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	No
Secondary	Knowledge change	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	No