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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Lisa Bernhard contact
United States1 site
St. Luke's Emergency Department
New York, New York, 10025
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 group | Role | What they receive |
|---|---|---|
| video: community member | Experimental | Participant watches video of a community member Receives: Behavioral: video: community member |
| video: physician | Experimental | Participant watches video of a physician Receives: Behavioral: video: physician |
| video: choice of video | Experimental | Participant can choose to watch video of either the community member of the physician Receives: Behavioral: video: choice of video |
| no video | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted3 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ian Aronson, National Development and Research Institutes, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing HIV Testing in Urban Emergency Departments Via Mobile Technology
- ClinicalTrials.gov ID
- NCT02154802
- Acronym / sponsor ID
- 1R34DA037129-01A1
- Conditions
- HIV Testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2017 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| video: community member | Experimental | Behavioral: video: community memberParticipant watches video of a community member |
| video: physician | Experimental | Behavioral: video: physicianParticipant watches video of a physician |
| video: choice of video | Experimental | Behavioral: video: choice of videoParticipant can choose to watch video of either the community member of the physician |
| no video | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or over
- Capable of providing informed consent
- Reads English
- Declined HIV test offered by hospital staf at triage
Key exclusion criteria (4 listed)
- intoxicated
- a prisoner
- known to be HIV positive
- presenting to the hospital for a psychiatric problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video: community member | Behavioural | video: community member |
| video: physician | Behavioural | video: physician |
| video: choice of video | Behavioural | video: choice of video |
Primary outcome
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.
1 secondary outcome
Knowledge change
Time frame: Baseline, Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Bernhard contact
1 site in 1 country: see every site and its status.
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.