Clinical trial NCT03803683: Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)
Official title: mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: mLab
HIV prevention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-01-14
Enrollment: 525
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Birth sex male of any current gender identification;
* Understand and read English
* Substantial risk for acquiring HIV infection per CDC guidance (e.g.,YMSM or YTGW and recent anal sex with men)
* Smartphone ownership
* Self-report being HIV-negative or unknown status
* Understand the limitations of the OraQuick test and the mLab App
* Not having been tested for HIV in the past 6 months (e.g., therefore being somewhat outside of the current CDC testing recommendations for high-risk populations)
* Not currently taking PrEP
* Receive a non-reactive result on the rapid HIV test at the Baseline visit

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).

Primary outcomes:
measure: Total Number of Youth Tested for HIV
timeFrame: 6 months
measure: Total Number of Youth Tested for HIV
timeFrame: 12 months
Secondary outcomes:
measure: Total Number of HIV Negative/ Positive Results
timeFrame: 6 months
measure: Total Number of HIV Negative/ Positive Results
timeFrame: 12 months
measure: Total Number of Youth Who Link to HIV Care Services
timeFrame: 6 months
measure: Total Number of Youth Who Link to HIV Care Services
timeFrame: 12 months
measure: Number of Sexual Partners in the Past 3 Months
timeFrame: 6 months
measure: Number of Sexual Partners in the Past 3 Months
timeFrame: 12 months
measure: Number of Condomless Anal Sex Acts
timeFrame: 6 months
measure: Number of Condomless Anal Sex Acts
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: New York
country: United States
facility: Columbia University School of Nursing
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood OR, Garofalo R, Kuhns LM, Scherr TF, Zetina APM, Rodriguez RG, Nash N, Cervantes M, Schnall R. A randomized controlled trial of an mHealth intervention for increasing access to HIV testing and care among young cisgender men and transgender women: the mLab App study protocol. BMC Public Health. 2021 Oct 29;21(1):1959. doi: 10.1186/s12889-021-12015-w.