NCT02154802

Brief 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.

Trial Health

55
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Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 29, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

2.5 years

First QC Date

May 29, 2014

Last Update Submit

May 30, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Knowledge change

    Baseline, Day 1

Study Arms (4)

video: community member

EXPERIMENTAL

Participant watches video of a community member

Behavioral: video: community member

video: physician

EXPERIMENTAL

Participant watches video of a physician

Behavioral: video: physician

video: choice of video

EXPERIMENTAL

Participant can choose to watch video of either the community member of the physician

Behavioral: video: choice of video

no video

NO INTERVENTION

Interventions

video: community member
video: physician
video: choice of video

Eligibility Criteria

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

You may qualify if:

  • Age 18 or over
  • Capable of providing informed consent
  • Reads English
  • Declined HIV test offered by hospital staf at triage

You may not qualify if:

  • intoxicated
  • a prisoner
  • known to be HIV positive
  • presenting to the hospital for a psychiatric problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Emergency Department

New York, New York, 10025, United States

Location

Central Study Contacts

Ian D Aronson, Ph.D.

CONTACT

Lisa Bernhard

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 3, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2017

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations