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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treatment as usual | No Intervention | Participants will be offered an HIV test by hospital staff, and will respond face-to-face. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Augmented Screening tool | Other | Tablet-based intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| HIV testing | 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. | Day of study participation. |
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Child Assent | Jul 8, 2019 | Apr 26, 2021 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adult Consent | Jul 8, 2019 | Apr 26, 2021 | ICF_001.pdf |
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