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Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)

NCT03803683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2024-11-26

Study results available
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Summary

The mLab App combines HIV prevention information with push notifications/reminders to complete HIV testing and an automated image processing feature to provide real-time feedback on home-based HIV test results. Theoretically-guided by the Health Information Technology Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the pervasiveness, low cost, and convenience of mobile technology, the investigators hope that the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing the number of persons living with HIV who know their serostatus, decreasing HIV-related disparities, and ultimately reducing the risk of HIV transmission and acquisition.

Conditions

  • HIV Infections

Interventions

DEVICE

mLab App

The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.

BEHAVIORAL

HIV Prevention Information

Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.

DEVICE

HIV Home Tests

Youth randomized into this arm will receive OraQuick® In-Home HIV Test.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Rebecca Schnall, RN, MPH, PhD

    lead OTHER

Principal Investigators

  • Rebecca Schnall, PhD, RN · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
29 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-21
Primary Completion
2023-10-02
Completion
2023-10-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03803683 on ClinicalTrials.gov