NCT03939455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

April 30, 2019

Last Update Submit

May 11, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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

Treatment as usual

NO INTERVENTION

Participants will be offered an HIV test by hospital staff, and will respond face-to-face.

Interventions

Tablet-based intervention

Experimental

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 6, 2019

Study Start

July 22, 2019

Primary Completion

March 5, 2020

Study Completion

June 1, 2020

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations