- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03803683
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Lurie Children's Hospital
-
-
New York
-
New York, New York, United States, 10032
- Columbia University School of Nursing
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of youth tested for HIV
Time Frame: 6 months
|
Total number of youth tested for HIV at 6 months
|
6 months
|
Total number of youth tested for HIV
Time Frame: 12 months
|
Total number of youth tested for HIV at 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total number of HIV negative/ positive results
Time Frame: 6 months
|
Total number of HIV negative/ positive results at 6 months
|
6 months
|
Total number of HIV negative/ positive results
Time Frame: 12 months
|
Total number of HIV negative/ positive results at 12 months
|
12 months
|
Total number of youth who link to HIV care services
Time Frame: 6 months
|
Total number of youth who link to HIV care services at 6 months
|
6 months
|
Total number of youth who link to HIV care services
Time Frame: 12 months
|
Total number of youth who link to HIV care services at 12 months
|
12 months
|
Number of Sexual Partners in the past 6 months
Time Frame: 6 months
|
Number of Sexual Partners in the past 6 months collected at the 6 month mark
|
6 months
|
Number of Sexual Partners in the past 6 months
Time Frame: 12 months
|
Number of Sexual Partners in the past 6 months collected at the 12 month mark
|
12 months
|
Number of condomless anal sex acts
Time Frame: 6 months
|
Number of condomless anal sex acts at 6 months
|
6 months
|
Number of condomless anal sex acts
Time Frame: 12 months
|
Number of condomless anal sex acts at 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca Schnall, PhD, RN, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR8760
- R01MH118151 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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