Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)
mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care
2 other identifiers
interventional
525
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Jan 2020
Typical duration for not_applicable hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2018
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedStudy Start
First participant enrolled
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2023
CompletedResults Posted
Study results publicly available
November 26, 2024
CompletedNovember 26, 2024
November 1, 2024
3.7 years
September 2, 2018
October 2, 2024
November 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total Number of Youth Tested for HIV
Total number of youth tested for HIV at 6 months
6 months
Total Number of Youth Tested for HIV
Total number of youth tested for HIV at 12 months
12 months
Secondary Outcomes (8)
Total Number of HIV Negative/ Positive Results
6 months
Total Number of HIV Negative/ Positive Results
12 months
Total Number of Youth Who Link to HIV Care Services
6 months
Total Number of Youth Who Link to HIV Care Services
12 months
Number of Sexual Partners in the Past 3 Months
6 months
- +3 more secondary outcomes
Study Arms (3)
mLab App Intervention
EXPERIMENTALYouth 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.
Standard of Care HIV Information Control Arm
ACTIVE COMPARATORYouth 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.
HIV Home Tests
ACTIVE COMPARATORYouth 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Columbia University School of Nursing
New York, New York, 10032, United States
Related Publications (2)
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.
PMID: 39560363DERIVEDWood 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.
PMID: 34715833DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Schnall, PhD, RN
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Mary Dickey Lindsay Associate Professor of Disease Prevention and Health Promotion
Study Record Dates
First Submitted
September 2, 2018
First Posted
January 14, 2019
Study Start
January 21, 2020
Primary Completion
October 2, 2023
Study Completion
October 2, 2023
Last Updated
November 26, 2024
Results First Posted
November 26, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share