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

NCT ID: NCT03939455

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2020-06-01

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.

Conditions

HIV Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile Augmented Screening tool

Intervention Type: OTHER

Tablet-based intervention

Treatment as usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile Augmented Screening tool

Tablet-based intervention

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form: Child Assent

View Document

Document Type: Informed Consent Form: Adult Consent

View Document

Other Identifiers

Moile Augmented Screening

Identifier Type: -

Identifier Source: org_study_id