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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803683
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rebecca Schnall, RN, MPH, PhD, Columbia University

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.

Condition or disease Intervention/treatment Phase
HIV Infections Device: mLab App Behavioral: HIV Prevention Information Device: HIV Home Tests Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.
Device: 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.

Behavioral: 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.

Device: HIV Home Tests
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.
Behavioral: 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.

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.
Behavioral: 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.

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




Primary Outcome Measures :
  1. Total number of youth tested for HIV [ Time Frame: 6 months ]
    Total number of youth tested for HIV at 6 months

  2. Total number of youth tested for HIV [ Time Frame: 12 months ]
    Total number of youth tested for HIV at 12 months


Secondary Outcome Measures :
  1. Total number of HIV negative/ positive results [ Time Frame: 6 months ]
    Total number of HIV negative/ positive results at 6 months

  2. Total number of HIV negative/ positive results [ Time Frame: 12 months ]
    Total number of HIV negative/ positive results at 12 months

  3. 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

  4. 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

  5. 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. 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

  7. Number of condomless anal sex acts [ Time Frame: 6 months ]
    Number of condomless anal sex acts at 6 months

  8. Number of condomless anal sex acts [ Time Frame: 12 months ]
    Number of condomless anal sex acts at 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803683


Contacts
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Contact: Brady Bushover 212-342-6989 bb2976@cumc.columbia.edu

Locations
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United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert Garofalo, MD, MPH    773-303-6058    RGarofalo@luriechildrens.org   
Contact: Nathanael Nash    312-227-7749    nnash@luriechildrens.org   
Principal Investigator: Robert Garofalo, MD, MPH         
Sub-Investigator: Lisa Kuhns, PhD         
United States, New York
Columbia University School of Nursing Recruiting
New York, New York, United States, 10032
Contact: Rebecca Schnall, PhD    212-342-6886    rb897@cumc.columbia.edu   
Contact: Brady Bushover    212-342-6989    bb2976@cumc.columbia.edu   
Sponsors and Collaborators
Rebecca Schnall, RN, MPH, PhD
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Rebecca Schnall, PhD, RN Columbia University
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Responsible Party: Rebecca Schnall, RN, MPH, PhD, Mary Dickey Lindsay Associate Professor of Disease Prevention and Health Promotion, Columbia University
ClinicalTrials.gov Identifier: NCT03803683    
Other Study ID Numbers: AAAR8760
R01MH118151 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Rebecca Schnall, RN, MPH, PhD, Columbia University:
mLab
HIV prevention
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases