Condition or disease | Intervention/treatment | Phase |
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HIV Testing | Other: Mobile Augmented Screening tool | Not Applicable |
Our randomized trial will evaluate HIV test rates among participants who complete a tablet-based intervention, the Mobile Augmented Screening tool (MAS), compared to participants in a treatment as usual (TAU) condition.
Research staff will approach 350 emergency department (ED) patients aged 13 - 24 years. Participants will be randomized into the intervention or TAU condition. Participants will be randomized in a 1:1 ratio to the intervention or TAU condition, stratified by patient age (13-17 and 18-24). Within each of these age strata, permuted blocks randomization with varying block sizes will be employed to ensure balance and concealment of allocations prior to randomization.
Participants who are randomized into the intervention condition will watch a 5-minute video on a tablet computer, and the tablet will ask intervention participants if they would like an HIV test. Possible responses will be "Yes" or "No". Participants who are randomized into TAU will be offered HIV tests by research staff. All participants in both conditions who agree to HIV testing will be tested by hospital staff in the location where they are receiving treatment. All participants who test will receive their results in person from ED staff before discharge.
The primary trial outcome will be percentages of patients, by treatment group, who test for HIV.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 295 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care |
Actual Study Start Date : | July 22, 2019 |
Actual Primary Completion Date : | March 5, 2020 |
Actual Study Completion Date : | June 1, 2020 |
Arm | Intervention/treatment |
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Experimental: Experimental
Participants will complete a brief tablet-based intervention, which includes watching a 5 minute educational video on the importance of HIV testing, and respond via tablet computer to the offer of an HIV test.
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Other: Mobile Augmented Screening tool
Tablet-based intervention
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No Intervention: Treatment as usual
Participants will be offered an HIV test by hospital staff, and will respond face-to-face.
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Ages Eligible for Study: | 13 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Emergency Department patients aged 13 - 24 years will be eligible for the study if they are:
Exclusion Criteria:
Exclusion criteria include patients who are prisoners, patients who are asleep/unconscious, unable to provide consent as determined by ED staff, do not understand written and spoken English, are intoxicated, are known to be HIV positive, have already agreed to an HIV test during their current ED visit, have been categorized by ED staff as altered mental status or are presenting to the ED for a psychiatric problem. Additionally, the proposed research will exclude patients if medical records indicate hospital staff have categorized the patient as most urgently in need of medical care.
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Tracking Information | |||||
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First Submitted Date ICMJE | April 30, 2019 | ||||
First Posted Date ICMJE | May 6, 2019 | ||||
Last Update Posted Date | May 13, 2021 | ||||
Actual Study Start Date ICMJE | July 22, 2019 | ||||
Actual Primary Completion Date | March 5, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
HIV testing [ Time Frame: Day of study participation. ] The main outcome is participant HIV testing. We will measure whether the participant accepts an HIV test when offered. Possible outcomes are Yes or No.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care | ||||
Official Title ICMJE | Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care | ||||
Brief Summary | Because adolescents and young adults face markedly increased HIV risk yet frequently do not test, we propose to complete the Mobile Augmented Screening (MAS) tool designed to increase HIV testing, and to facilitate linkage to care and ongoing prevention education. This tool will help clinicians address undiagnosed youth HIV, and enable young patients to receive much needed treatment and avoid unknowingly transmitting infection. Our product is designed to help existing program staff reach an increased number of clients; and to improve public health by encouraging reluctant young patients to accept important HIV testing and care they may otherwise decline. | ||||
Detailed Description |
Our randomized trial will evaluate HIV test rates among participants who complete a tablet-based intervention, the Mobile Augmented Screening tool (MAS), compared to participants in a treatment as usual (TAU) condition. Research staff will approach 350 emergency department (ED) patients aged 13 - 24 years. Participants will be randomized into the intervention or TAU condition. Participants will be randomized in a 1:1 ratio to the intervention or TAU condition, stratified by patient age (13-17 and 18-24). Within each of these age strata, permuted blocks randomization with varying block sizes will be employed to ensure balance and concealment of allocations prior to randomization. Participants who are randomized into the intervention condition will watch a 5-minute video on a tablet computer, and the tablet will ask intervention participants if they would like an HIV test. Possible responses will be "Yes" or "No". Participants who are randomized into TAU will be offered HIV tests by research staff. All participants in both conditions who agree to HIV testing will be tested by hospital staff in the location where they are receiving treatment. All participants who test will receive their results in person from ED staff before discharge. The primary trial outcome will be percentages of patients, by treatment group, who test for HIV. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Screening |
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Condition ICMJE | HIV Testing | ||||
Intervention ICMJE | Other: Mobile Augmented Screening tool
Tablet-based intervention
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
295 | ||||
Original Estimated Enrollment ICMJE |
350 | ||||
Actual Study Completion Date ICMJE | June 1, 2020 | ||||
Actual Primary Completion Date | March 5, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Emergency Department patients aged 13 - 24 years will be eligible for the study if they are:
Exclusion Criteria: Exclusion criteria include patients who are prisoners, patients who are asleep/unconscious, unable to provide consent as determined by ED staff, do not understand written and spoken English, are intoxicated, are known to be HIV positive, have already agreed to an HIV test during their current ED visit, have been categorized by ED staff as altered mental status or are presenting to the ED for a psychiatric problem. Additionally, the proposed research will exclude patients if medical records indicate hospital staff have categorized the patient as most urgently in need of medical care. |
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years to 24 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03939455 | ||||
Other Study ID Numbers ICMJE | Moile Augmented Screening | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | New York University | ||||
Study Sponsor ICMJE | New York University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | New York University | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |