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HIV TestingNCT02154802

Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology

A study testing video: community member, video: physician and video: choice of video in people with HIV Testing, run by National Development and Research Institutes, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Testing
What is being tested?
video: community member, video: physician and video: choice of video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Jul 2014to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ian D Aronson, Ph.D. contact

212-845-4567

aronson@ndri.org

Lisa Bernhard contact

bernhard@ndri.org

United States1 site
  • St. Luke's Emergency Department

    New York, New York, 10025

Other trials in United States

About this study

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.

Conditions
HIV Testing
Being tested
video: community member, video: physician, video: choice of video

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video: community memberBehavioural

  • video: physicianBehavioural

  • video: choice of videoBehavioural

Study groups in NCT02154802
Study groupRoleWhat they receive
video: community memberExperimentalParticipant watches video of a community member
Receives: Behavioral: video: community member
video: physicianExperimentalParticipant watches video of a physician
Receives: Behavioral: video: physician
video: choice of videoExperimentalParticipant can choose to watch video of either the community member of the physician
Receives: Behavioral: video: choice of video
no videoNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1

Secondary outcomes (1)
  1. 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.

    Measured: Baseline, Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJan 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02154802
Sponsor's protocol ID
1R34DA037129-01A1
Status last verified
May 2014
First submitted
29 May 2014
Last updated
3 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing video: community member, video: physician and video: choice of video in people with HIV Testing, run by National Development and Research Institutes, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ian D Aronson, Ph.D. (212-845-4567, aronson@ndri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who accept an HIV test after completing the intervention (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.

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