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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

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

Clinicaltrials.gov identifier NCT03939455

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted August 22, 2019

Study Description

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:HIV Testing
  • Intervention/Treatment: Other: Mobile Augmented Screening tool
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: August 2020
Arms and interventions
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
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 13 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.

Contacts and Locations
Contacts

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

Locations

United States, New York
Columbia University Medical Center
New York

Sponsors and Collaborators

New York University

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