<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03803683</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR8760</org_study_id>
    <secondary_id>R01MH118151</secondary_id>
    <nct_id>NCT03803683</nct_id>
  </id_info>
  <brief_title>Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)</brief_title>
  <official_title>mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rebecca Schnall, RN, MPH, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The mLab App combines HIV prevention information with push notifications/reminders to&#xD;
      complete HIV testing and an automated image processing feature to provide real-time feedback&#xD;
      on home-based HIV test results. Theoretically-guided by the Health Information Technology&#xD;
      Usability Evaluation Model (Health-ITUEM), the proposed project will refine and test a&#xD;
      next-generation diagnostic intervention delivered on a mobile platform to improve HIV testing&#xD;
      and linkage-to-care outcomes among youth living with and at-risk for HIV. Given the&#xD;
      pervasiveness, low cost, and convenience of mobile technology, the investigators hope that&#xD;
      the App can help achieve the goals of the National HIV/AIDS Strategy in the US by increasing&#xD;
      the number of persons living with HIV who know their serostatus, decreasing HIV-related&#xD;
      disparities, and ultimately reducing the risk of HIV transmission and acquisition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of youth living with human immunodeficiency virus (HIV) continues to rise, and&#xD;
      they are disproportionately represented at each stage of the care continuum. Most relevant to&#xD;
      this study, it is estimated that less than half of HIV-infected youth in the United States&#xD;
      (US) have been diagnosed with HIV, and acquired immunodeficiency syndrome (AIDS)-related&#xD;
      deaths among youth have increased over the past decade despite decreased death rates among&#xD;
      all other age groups, pointing to the urgent need for increased testing among youth.&#xD;
&#xD;
      Black and Latino youth are at increased risk of poor HIV-related outcomes and have disparate&#xD;
      testing rates as compared to White youth. Mobile Health (mHealth) technology is a powerful&#xD;
      and relevant tool which represents a promising approach for improving outcomes among youth&#xD;
      living with HIV. Youth are avid adopters and heavy users of smartphones and digital&#xD;
      technologies, and these technologies offer opportunities to tailor interventions to&#xD;
      developmental stages and personal needs. Importantly, these technologies are capable of&#xD;
      delivering interventions in real-time and in ecologic settings. This creates an opportunity&#xD;
      to remotely reach youth through mobile and connected health approaches to strengthen their&#xD;
      HIV care continuum engagement and treatment outcomes. In response, the investigators have&#xD;
      developed the mLab App, an innovative mobile and connected technology that combines HIV&#xD;
      prevention information with push notifications/reminders to complete HIV testing and an&#xD;
      automated image processing feature to provide accessible, objective, secure, and real-time&#xD;
      feedback on home-based OraQuick (lateral flow assay) HIV test results. The mLab App also&#xD;
      contains an innovative automated data collection and a results reporting feature. Findings&#xD;
      from the investigators' preliminary work in New York City indicate that youth perceive the&#xD;
      mLab App as useful, easy to use, and effective at improving health outcomes and intend to use&#xD;
      the technology. Furthermore, preliminary work in Africa support the sensitivity and&#xD;
      specificity of the imaging algorithm for interpreting lateral flow assay results.&#xD;
&#xD;
      The investigators will conduct a careful, iterative process of technology refinement based on&#xD;
      input from end users, experts, and the youth advisory board. The investigators will then&#xD;
      enroll 525 high-risk youth (age 18-29 years) in a 12-month randomized controlled trial (RCT)&#xD;
      to assess differences in HIV testing rates and linkage to care between three arms the&#xD;
      intervention arm, the standard of care-HIV information control arm, and the HIV home test&#xD;
      arm. Finally, the investigators will analyze paradata, defined as auxiliary data that capture&#xD;
      details about the process of interaction with the technology, to understand the effect of&#xD;
      user engagement of the mLab App on improving HIV testing rates and linkage to care.&#xD;
      Interventions delivered through mHealth technology represent a promising approach for&#xD;
      improving outcomes among youth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 21, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total number of youth tested for HIV</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of youth tested for HIV at 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total number of youth tested for HIV</measure>
    <time_frame>12 months</time_frame>
    <description>Total number of youth tested for HIV at 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of HIV negative/ positive results</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of HIV negative/ positive results at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of HIV negative/ positive results</measure>
    <time_frame>12 months</time_frame>
    <description>Total number of HIV negative/ positive results at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of youth who link to HIV care services</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of youth who link to HIV care services at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of youth who link to HIV care services</measure>
    <time_frame>12 months</time_frame>
    <description>Total number of youth who link to HIV care services at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sexual Partners in the past 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Number of Sexual Partners in the past 6 months collected at the 6 month mark</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sexual Partners in the past 6 months</measure>
    <time_frame>12 months</time_frame>
    <description>Number of Sexual Partners in the past 6 months collected at the 12 month mark</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of condomless anal sex acts</measure>
    <time_frame>6 months</time_frame>
    <description>Number of condomless anal sex acts at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of condomless anal sex acts</measure>
    <time_frame>12 months</time_frame>
    <description>Number of condomless anal sex acts at 12 months</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">525</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>mLab App Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care HIV Information Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV Home Tests</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mLab App</intervention_name>
    <description>The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.</description>
    <arm_group_label>mLab App Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HIV Prevention Information</intervention_name>
    <description>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.</description>
    <arm_group_label>HIV Home Tests</arm_group_label>
    <arm_group_label>Standard of Care HIV Information Control Arm</arm_group_label>
    <arm_group_label>mLab App Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HIV Home Tests</intervention_name>
    <description>Youth randomized into this arm will receive OraQuick® In-Home HIV Test.</description>
    <arm_group_label>HIV Home Tests</arm_group_label>
    <arm_group_label>mLab App Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Birth sex male of any current gender identification;&#xD;
&#xD;
          -  Understand and read English&#xD;
&#xD;
          -  Substantial risk for acquiring HIV infection per CDC guidance (e.g.,YMSM or YTGW and&#xD;
             recent anal sex with men)&#xD;
&#xD;
          -  Smartphone ownership&#xD;
&#xD;
          -  Self-report being HIV-negative or unknown status&#xD;
&#xD;
          -  Understand the limitations of the OraQuick test and the mLab App&#xD;
&#xD;
          -  Not having been tested for HIV in the past 6 months (e.g., therefore being somewhat&#xD;
             outside of the current CDC testing recommendations for high-risk populations)&#xD;
&#xD;
          -  Not currently taking PrEP&#xD;
&#xD;
          -  Receive a non-reactive result on the rapid HIV test at the Baseline visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons who have a known diagnosis of HIV&#xD;
&#xD;
          -  Persons for whom the investigators determine that participation may be detrimental to&#xD;
             the participant or to the study (e.g., severe cognitive deficit).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca Schnall, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lurie Children's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University School of Nursing</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 2, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Rebecca Schnall, RN, MPH, PhD</investigator_full_name>
    <investigator_title>Mary Dickey Lindsay Associate Professor of Disease Prevention and Health Promotion</investigator_title>
  </responsible_party>
  <keyword>mLab</keyword>
  <keyword>HIV prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03803683
org study id: AAAR8760
secondary id: R01MH118151
nct id: NCT03803683
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Total number of youth tested for HIV
time frame: 6 months
description: Total number of youth tested for HIV at 6 months
measure: Total number of youth tested for HIV
time frame: 12 months
description: Total number of youth tested for HIV at 12 months
measure: Total number of HIV negative/ positive results
time frame: 6 months
description: Total number of HIV negative/ positive results at 6 months
measure: Total number of HIV negative/ positive results
time frame: 12 months
description: Total number of HIV negative/ positive results at 12 months
measure: Total number of youth who link to HIV care services
time frame: 6 months
description: Total number of youth who link to HIV care services at 6 months
measure: Total number of youth who link to HIV care services
time frame: 12 months
description: Total number of youth who link to HIV care services at 12 months
measure: Number of Sexual Partners in the past 6 months
time frame: 6 months
description: Number of Sexual Partners in the past 6 months collected at the 6 month mark
measure: Number of Sexual Partners in the past 6 months
time frame: 12 months
description: Number of Sexual Partners in the past 6 months collected at the 12 month mark
measure: Number of condomless anal sex acts
time frame: 6 months
description: Number of condomless anal sex acts at 6 months
measure: Number of condomless anal sex acts
time frame: 12 months
description: Number of condomless anal sex acts at 12 months
arm group label: mLab App Intervention
arm group type: Experimental
description: 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.
arm group label: Standard of Care HIV Information Control Arm
arm group type: Active Comparator
description: 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.
arm group label: HIV Home Tests
arm group type: Active Comparator
description: 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.
intervention type: Device
intervention name: mLab App
description: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
arm group label: mLab App Intervention
intervention type: Behavioral
intervention name: HIV Prevention Information
description: 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.
arm group label: HIV Home Tests
arm group label: Standard of Care HIV Information Control Arm
arm group label: mLab App Intervention
intervention type: Device
intervention name: HIV Home Tests
description: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
arm group label: HIV Home Tests
arm group label: mLab App Intervention
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca Schnall, PhD, RN
role: Principal Investigator
affiliation: Columbia University
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Columbia University
investigator full name: Rebecca Schnall, RN, MPH, PhD
investigator title: Mary Dickey Lindsay Associate Professor of Disease Prevention and Health Promotion
mesh term: HIV Infections
sharing ipd: No