Improving Health Outcomes in Young Men (mLab App)

Status:Not yet recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Age Range:18 - 29
Start Date:May 2019
End Date:May 2023
Contact:Riva Grimball

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mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care

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 500 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 the intervention (mLab
App) and control 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.

Inclusion Criteria:

- Birth sex male of any current gender identification;

- Understand and read English or Spanish

- Substantial risk for acquiring HIV infection per CDC guidance (e.g.,Sexual partner
with HIV and/or recent bacterial sexually transmitted disease (STD) and/or high number
of sex partners and/or history of inconsistent or no condom use and/or commercial sex

- Smartphone ownership

- Self-report being HIV-negative or unknown status

Exclusion Criteria:

- Persons who have a known diagnosis of HIV

- Persons for whom the investigators determine that participation may be detrimental to
the participant or to the study (e.g., severe cognitive deficit).
We found this trial at
Chicago, Illinois 60611
Chicago, IL
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617 West 168th Street
New York, New York 10032
New York, NY
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