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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
525
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.
Lurie Children's Hospital
Chicago, Illinois, United States
Columbia University School of Nursing
New York, New York, United States
Total Number of Youth Tested for HIV
Total number of youth tested for HIV at 6 months
Time frame: 6 months
Total Number of Youth Tested for HIV
Total number of youth tested for HIV at 12 months
Time frame: 12 months
Total Number of HIV Negative/ Positive Results
Total number of HIV negative/ positive results at 6 months
Time frame: 6 months
Total Number of HIV Negative/ Positive Results
Total number of HIV negative/ positive results at 12 months
Time frame: 12 months
Total Number of Youth Who Link to HIV Care Services
Total number of youth who link to HIV care services at 6 months
Time frame: 6 months
Total Number of Youth Who Link to HIV Care Services
Total number of youth who link to HIV care services at 12 months
Time frame: 12 months
Number of Sexual Partners in the Past 3 Months
Number of Sexual Partners in the past 3 months collected at the 6 month mark
Time frame: 6 months
Number of Sexual Partners in the Past 3 Months
Number of Sexual Partners in the past 3 months collected at the 12 month mark
Time frame: 12 months
Number of Condomless Anal Sex Acts
Number of condomless anal sex acts in the past 3 months at 6 months
Time frame: 6 months
Number of Condomless Anal Sex Acts
Number of condomless anal sex acts in the past 3 months at 12 months
Time frame: 12 months
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