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Mobile Augmented Screening Tool to Increase Adolescent HIV Testing and Linkage to Care (MAS)

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ClinicalTrials.gov Identifier: NCT03939455
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
New York University

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.

Condition or disease Intervention/treatment Phase
HIV Testing Other: Mobile Augmented Screening tool Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Other: Mobile Augmented Screening tool
Tablet-based intervention

No Intervention: Treatment as usual
Participants will be offered an HIV test by hospital staff, and will respond face-to-face.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Emergency Department patients aged 13 - 24 years will be eligible for the study if they are:

  • awake
  • able to provide consent as determined by ED staff
  • understand written and spoken English
  • not intoxicated
  • not known to be HIV positive
  • not a prisoner
  • have not already agreed to test for HIV during their current ED visit (this will include patients who decline HIV testing offered by hospital staff and patients who are not yet offered HIV testing; potential differences in test rates among participants who decline vs. those who have not previously been offered an HIV test will be explored as a secondary outcome)

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939455


Contacts
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Contact: Ian D Aronson, Ph.D. tel 212-998-9014 ia14@nyu.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Research Administrator    212-305-4687    rs3823@cumc.columbia.edu   
Sponsors and Collaborators
New York University

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Responsible Party: New York University
ClinicalTrials.gov Identifier: NCT03939455     History of Changes
Other Study ID Numbers: Moile Augmented Screening
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No