Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

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.
    

Detailed description: 
      The number of youth living with human immunodeficiency virus (HIV) continues to rise, and
      they are disproportionately represented at each stage of the care continuum. Most relevant to
      this study, it is estimated that less than half of HIV-infected youth in the United States
      (US) have been diagnosed with HIV, and acquired immunodeficiency syndrome (AIDS)-related
      deaths among youth have increased over the past decade despite decreased death rates among
      all other age groups, pointing to the urgent need for increased testing among youth.

      Black and Latino youth are at increased risk of poor HIV-related outcomes and have disparate
      testing rates as compared to White youth. Mobile Health (mHealth) technology is a powerful
      and relevant tool which represents a promising approach for improving outcomes among youth
      living with HIV. Youth are avid adopters and heavy users of smartphones and digital
      technologies, and these technologies offer opportunities to tailor interventions to
      developmental stages and personal needs. Importantly, these technologies are capable of
      delivering interventions in real-time and in ecologic settings. This creates an opportunity
      to remotely reach youth through mobile and connected health approaches to strengthen their
      HIV care continuum engagement and treatment outcomes. In response, the investigators have
      developed the mLab App, an innovative mobile and connected technology that combines HIV
      prevention information with push notifications/reminders to complete HIV testing and an
      automated image processing feature to provide accessible, objective, secure, and real-time
      feedback on home-based OraQuick (lateral flow assay) HIV test results. The mLab App also
      contains an innovative automated data collection and a results reporting feature. Findings
      from the investigators' preliminary work in New York City indicate that youth perceive the
      mLab App as useful, easy to use, and effective at improving health outcomes and intend to use
      the technology. Furthermore, preliminary work in Africa support the sensitivity and
      specificity of the imaging algorithm for interpreting lateral flow assay results.

      The investigators will conduct a careful, iterative process of technology refinement based on
      input from end users, experts, and the youth advisory board. The investigators will then
      enroll 525 high-risk youth (age 18-29 years) in a 12-month randomized controlled trial (RCT)
      to assess differences in HIV testing rates and linkage to care between three arms the
      intervention arm, the standard of care-HIV information control arm, and the HIV home test
      arm. Finally, the investigators will analyze paradata, defined as auxiliary data that capture
      details about the process of interaction with the technology, to understand the effect of
      user engagement of the mLab App on improving HIV testing rates and linkage to care.
      Interventions delivered through mHealth technology represent a promising approach for
      improving outcomes among youth.
    

Intervention name(s): mLab App; HIV Prevention Information; HIV Home Tests
Intervention type(s): Device; Behavioral; Device
Intervention description(s): The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.; 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.; Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: mLab; HIV prevention