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

NCT ID: NCT03803683

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2023-10-02

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

mLab App Intervention

Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.

Group Type: EXPERIMENTAL

mLab App

Intervention Type: DEVICE

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

HIV Prevention Information

Intervention Type: BEHAVIORAL

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.

HIV Home Tests

Intervention Type: DEVICE

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

Standard of Care HIV Information Control Arm

Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.

Group Type: ACTIVE_COMPARATOR

HIV Prevention Information

Intervention Type: BEHAVIORAL

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.

HIV Home Tests

Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.

Group Type: ACTIVE_COMPARATOR

HIV Prevention Information

Intervention Type: BEHAVIORAL

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.

HIV Home Tests

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

HIV Home Tests

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rebecca Schnall, RN, MPH, PhD

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Schnall, RN, MPH, PhD

Mary Dickey Lindsay Associate Professor of Disease Prevention and Health Promotion

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rebecca Schnall, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Lurie Children's Hospital

Chicago, Illinois, United States

Columbia University School of Nursing

New York, New York, United States

Countries

United States

References

Schnall R, Scherr TF, Kuhns LM, Janulis P, Jia H, Wood OR, Almodovar M, Garofalo R. Efficacy of the mLab App: a randomized clinical trial for increasing HIV testing uptake using mobile technology. J Am Med Inform Assoc. 2025 Feb 1;32(2):275-284. doi: 10.1093/jamia/ocae261.

Reference Type: DERIVED

PMID: 39560363 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34715833 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH118151

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR8760

Identifier Type: -

Identifier Source: org_study_id