<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/NCT03752840</url>
  </required_header>
  <id_info>
    <org_study_id>17-22776-2</org_study_id>
    <nct_id>NCT03752840</nct_id>
  </id_info>
  <brief_title>Village-Integrated Eye Worker Trial II</brief_title>
  <acronym>VIEW II</acronym>
  <official_title>Village-Integrated Eye Worker Trial II (VIEW II):A Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening in Nepal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seva Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bharatpur Eye Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lumbini Eye Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates&#xD;
      that 80% of cases of visual impairment could be prevented or reversed with early diagnosis&#xD;
      and treatment. The leading causes of visual impairment are cataract and refractive error,&#xD;
      followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR).&#xD;
      Loss of vision from these conditions is not inevitable; however, identifying at-risk cases&#xD;
      and linking cases with appropriate care remain significant challenges.&#xD;
&#xD;
      To address the global burden of avoidable blindness, eye care systems must determine optimal&#xD;
      strategies for identifying people with or at risk for visual impairment beyond opportunistic&#xD;
      screening. Outreach programs can prevent blindness both by screening for asymptomatic disease&#xD;
      like age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma and case&#xD;
      detection of symptomatic disease like cataract and refractive error. Eye care systems have&#xD;
      developed numerous community-based approaches to these identification methods, including&#xD;
      screening using telemedicine and case detection via cataract camps or community health worker&#xD;
      models, but no studies have been conducted on the comparative effectiveness or cost&#xD;
      effectiveness of these various approaches.&#xD;
&#xD;
      Technology promises to greatly improve access to sophisticated eye care. AMD, DR, and&#xD;
      glaucoma can result in irreversible vision loss, and early diagnosis and effective treatment&#xD;
      can prevent progression.Thus, community screening programs may prevent progression and&#xD;
      improve the vision of a population.However, mass screening for eye disease is currently not&#xD;
      recommended. Although self-evident that early detection can prevent blindness for an&#xD;
      individual, no randomized controlled trial has been able to demonstrate that screening&#xD;
      improves visual acuity at the community level. However, recent technological advances promise&#xD;
      to dramatically change the equation by allowing non-medical personnel to use&#xD;
      mobile,easy-to-use retinal imaging devices to diagnose screenable eye diseases such as AMD,&#xD;
      DR, and glaucoma. Mobile technology could also transform the way clinics communicate with&#xD;
      their patients, improving linkage to and retention in care.&#xD;
&#xD;
      Optical coherence tomography (OCT) is an ideal test for community-based screening. OCT can be&#xD;
      performed through an undilated pupil and is less subject to optical aberrations due to&#xD;
      cataract than is fundus photography. OCT machines have pre-installed algorithms to screen for&#xD;
      glaucoma, and major anatomical abnormalities can easily be detected even by novice&#xD;
      technicians. The infrared image allows detection of referable diabetic retinopathy, and newer&#xD;
      OCT angiography machines offer even more discrimination of early diabetic retinopathy. OCT&#xD;
      machines are ever more portable, and could be feasibly used in community-based screening&#xD;
      programs.&#xD;
&#xD;
      The investigators propose a large cluster-randomized trial in Nepal to compare two&#xD;
      community-based blindness prevention programs: (1) a state-of-the-art screening program&#xD;
      employing OCT and intraocular pressure testing to screen for glaucoma, DR, and AMD followed&#xD;
      by enhanced linkage-to-care to the local eye hospital, and (2) a screening program involving&#xD;
      only visual acuity assessment. An initial door-to-door census will assess baseline visual&#xD;
      acuity in both study arms. The investigators will compare visual acuity between the two arms&#xD;
      through a second door-to-door census 4 years later (primary outcome). The investigators&#xD;
      maximize their chances of finding an effect by conducting the study in Nepal, where the&#xD;
      burden of undiagnosed eye diseases is high. If successful in Nepal, future studies could&#xD;
      assess the generalizability of such a program to other settings, such as rural communities in&#xD;
      the industrialized world.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research will consist of a large cluster-randomized trial in Nepal in which all&#xD;
      communities receive visual acuity screening during a baseline census, and then half&#xD;
      subsequently receive screening with OCT and intraocular pressure testing with an iCare&#xD;
      tonometer. Participants with abnormal results will be referred to the local eye hospital for&#xD;
      examination and treatment. Repeat visual acuity assessment will be performed 4 years later.&#xD;
      Those with incident visual impairment at the time of the final census, defined as visual&#xD;
      acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48),&#xD;
      will receive a comprehensive eye exam to determine the cause of visual impairment.&#xD;
&#xD;
      Specific Aim 1 - Visual Acuity: To determine whether an intensive screening program results&#xD;
      in better visual acuity at 4 years than screening with visual acuity testing alone. The&#xD;
      investigators hypothesize that individuals from clusters randomized to the intensive&#xD;
      screening program will have better visual acuity compared to those receiving visual acuity&#xD;
      testing alone.&#xD;
&#xD;
      Specific Aim 2 - Eye Disease: To determine whether an intensive screening program reduces the&#xD;
      incidence of visual impairment due to AMD, DR, or glaucoma. The investigators hypothesize&#xD;
      that incident visual impairment due to AMD, DR, or glaucoma will be less common in clusters&#xD;
      randomized to the intensive screening program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 21, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pinhole visual acuity (logMAR) in people aged 60 years and older</measure>
    <time_frame>4 years</time_frame>
    <description>Visual acuity will be assessed using the Peek Acuity mobile application during the final census.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of visual impairment due to AMD, DR, or glaucoma</measure>
    <time_frame>4 years</time_frame>
    <description>Participants with incident visual impairment, defined as Snellen worse than 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48), at the time of the final census will receive a comprehensive eye exam to determine the cause of visual impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilateral blindness in people aged 60 years and older, defined as pinhole visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye</measure>
    <time_frame>4 years</time_frame>
    <description>Visual acuity will be assessed using the Peek Acuity mobile application during the final census.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presenting visual acuity (logMAR) in people aged 60 years and older</measure>
    <time_frame>4 years</time_frame>
    <description>Visual acuity will be assessed using the Peek Acuity mobile application during the final census.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of the screening intervention</measure>
    <time_frame>4 years</time_frame>
    <description>Costs associated with the screening intervention will be actively recorded during the study period and number of cases of AMD, DR, and glaucoma diagnosed and visual acuity as assessed with Peek Acuity during the final census will be used to evaluate effectiveness.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Bilateral visual impairment in people aged 60 years and older, defined as pinhole visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye</measure>
    <time_frame>4 years</time_frame>
    <description>Visual acuity will be assessed using the Peek Acuity mobile application during the final census.</description>
  </other_outcome>
  <other_outcome>
    <measure>Bilateral presenting visual impairment in people aged 60 years and older, defined as presenting visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye</measure>
    <time_frame>4 years</time_frame>
    <description>Visual acuity will be assessed using the Peek Acuity mobile application during the final census.</description>
  </other_outcome>
  <other_outcome>
    <measure>Bilateral presenting blindness in people aged 60 years and older, defined as presenting visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye</measure>
    <time_frame>4 years</time_frame>
    <description>Visual acuity will be assessed using the Peek Acuity mobile application during the final census.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60000</enrollment>
  <condition>Age-related Macular Degeneration</condition>
  <condition>Diabetic Retinopathy</condition>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Case detection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Visual acuity (presenting and pinhole)</intervention_name>
    <description>Presenting and pinhole visual acuity will be assessed using the Peek Acuity mobile application. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.</description>
    <arm_group_label>Case detection</arm_group_label>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optical coherence tomography (OCT)</intervention_name>
    <description>OCT will be used to image the anterior segment, the macula, and the retinal nerve fiber layer. The images will be assessed for abnormalities and participants meeting referral criteria will be referred to the local eye hospital.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intraocular pressure</intervention_name>
    <description>Intraocular pressure will be measured using an iCare tonometer. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active linkage to care</intervention_name>
    <description>Referred participants will be followed closely by study staff to ensure completion of follow-up visits.</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Community level&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute&#xD;
&#xD;
          -  Accessible by non-4WD vehicle&#xD;
&#xD;
          -  Urban or peri-urban&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Local leaders unwilling to participate&#xD;
&#xD;
        Person level&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  60 years and older&#xD;
&#xD;
          -  Residing in the community during the time of the census&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Unwilling to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy Keenan</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Krisianne M Aromin, BS</last_name>
    <phone>4154761442</phone>
    <email>krisianne.aromin@ucsf.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bharatpur Eye Hospital</name>
      <address>
        <city>Bharatpur</city>
        <state>Chitwan</state>
        <country>Nepal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raghunandan Byanju</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lumbini Eye Institute</name>
      <address>
        <city>Bhairahawa</city>
        <country>Nepal</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Salma Rai</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be shared with other investigators upon request after the conclusion of the study. A request form will be available on Open Science Framework (https://osf.io/fgvrt/); all requests will be approved by the executive committee of the trial before sharing data. GPS data will not be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>De-identified data will be shared after publication of the major findings of the study, which we anticipate will occur around 6 months after the study conclusion.</ipd_time_frame>
    <ipd_access_criteria>De-identified data will be available upon request.</ipd_access_criteria>
    <ipd_url>https://osf.io/fgvrt/</ipd_url>
  </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/NCT03752840
org study id: 17-22776-2
nct id: NCT03752840
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates
      that 80% of cases of visual impairment could be prevented or reversed with early diagnosis
      and treatment. The leading causes of visual impairment are cataract and refractive error,
      followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR).
      Loss of vision from these conditions is not inevitable; however, identifying at-risk cases
      and linking cases with appropriate care remain significant challenges.

      To address the global burden of avoidable blindness, eye care systems must determine optimal
      strategies for identifying people with or at risk for visual impairment beyond opportunistic
      screening. Outreach programs can prevent blindness both by screening for asymptomatic disease
      like age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma and case
      detection of symptomatic disease like cataract and refractive error. Eye care systems have
      developed numerous community-based approaches to these identification methods, including
      screening using telemedicine and case detection via cataract camps or community health worker
      models, but no studies have been conducted on the comparative effectiveness or cost
      effectiveness of these various approaches.

      Technology promises to greatly improve access to sophisticated eye care. AMD, DR, and
      glaucoma can result in irreversible vision loss, and early diagnosis and effective treatment
      can prevent progression.Thus, community screening programs may prevent progression and
      improve the vision of a population.However, mass screening for eye disease is currently not
      recommended. Although self-evident that early detection can prevent blindness for an
      individual, no randomized controlled trial has been able to demonstrate that screening
      improves visual acuity at the community level. However, recent technological advances promise
      to dramatically change the equation by allowing non-medical personnel to use
      mobile,easy-to-use retinal imaging devices to diagnose screenable eye diseases such as AMD,
      DR, and glaucoma. Mobile technology could also transform the way clinics communicate with
      their patients, improving linkage to and retention in care.

      Optical coherence tomography (OCT) is an ideal test for community-based screening. OCT can be
      performed through an undilated pupil and is less subject to optical aberrations due to
      cataract than is fundus photography. OCT machines have pre-installed algorithms to screen for
      glaucoma, and major anatomical abnormalities can easily be detected even by novice
      technicians. The infrared image allows detection of referable diabetic retinopathy, and newer
      OCT angiography machines offer even more discrimination of early diabetic retinopathy. OCT
      machines are ever more portable, and could be feasibly used in community-based screening
      programs.

      The investigators propose a large cluster-randomized trial in Nepal to compare two
      community-based blindness prevention programs: (1) a state-of-the-art screening program
      employing OCT and intraocular pressure testing to screen for glaucoma, DR, and AMD followed
      by enhanced linkage-to-care to the local eye hospital, and (2) a screening program involving
      only visual acuity assessment. An initial door-to-door census will assess baseline visual
      acuity in both study arms. The investigators will compare visual acuity between the two arms
      through a second door-to-door census 4 years later (primary outcome). The investigators
      maximize their chances of finding an effect by conducting the study in Nepal, where the
      burden of undiagnosed eye diseases is high. If successful in Nepal, future studies could
      assess the generalizability of such a program to other settings, such as rural communities in
      the industrialized world.
The research will consist of a large cluster-randomized trial in Nepal in which all
      communities receive visual acuity screening during a baseline census, and then half
      subsequently receive screening with OCT and intraocular pressure testing with an iCare
      tonometer. Participants with abnormal results will be referred to the local eye hospital for
      examination and treatment. Repeat visual acuity assessment will be performed 4 years later.
      Those with incident visual impairment at the time of the final census, defined as visual
      acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48),
      will receive a comprehensive eye exam to determine the cause of visual impairment.

      Specific Aim 1 - Visual Acuity: To determine whether an intensive screening program results
      in better visual acuity at 4 years than screening with visual acuity testing alone. The
      investigators hypothesize that individuals from clusters randomized to the intensive
      screening program will have better visual acuity compared to those receiving visual acuity
      testing alone.

      Specific Aim 2 - Eye Disease: To determine whether an intensive screening program reduces the
      incidence of visual impairment due to AMD, DR, or glaucoma. The investigators hypothesize
      that incident visual impairment due to AMD, DR, or glaucoma will be less common in clusters
      randomized to the intensive screening program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
measure: Pinhole visual acuity (logMAR) in people aged 60 years and older
time frame: 4 years
description: Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
measure: Incidence of visual impairment due to AMD, DR, or glaucoma
time frame: 4 years
description: Participants with incident visual impairment, defined as Snellen worse than 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48), at the time of the final census will receive a comprehensive eye exam to determine the cause of visual impairment
measure: Bilateral blindness in people aged 60 years and older, defined as pinhole visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye
time frame: 4 years
description: Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
measure: Presenting visual acuity (logMAR) in people aged 60 years and older
time frame: 4 years
description: Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
measure: Cost-effectiveness of the screening intervention
time frame: 4 years
description: Costs associated with the screening intervention will be actively recorded during the study period and number of cases of AMD, DR, and glaucoma diagnosed and visual acuity as assessed with Peek Acuity during the final census will be used to evaluate effectiveness.
measure: Bilateral visual impairment in people aged 60 years and older, defined as pinhole visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye
time frame: 4 years
description: Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
measure: Bilateral presenting visual impairment in people aged 60 years and older, defined as presenting visual acuity worse than Snellen 20/60 (Metric Snellen worse than 6/18; logMAR worse than 0.48) in the better-seeing eye
time frame: 4 years
description: Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
measure: Bilateral presenting blindness in people aged 60 years and older, defined as presenting visual acuity worse than Snellen 20/400 (Metric Snellen worse than 6/120; logMAR worse than 1.3) in the better-seeing eye
time frame: 4 years
description: Visual acuity will be assessed using the Peek Acuity mobile application during the final census.
arm group label: Screening
arm group type: Experimental
arm group label: Case detection
arm group type: Active Comparator
intervention type: Other
intervention name: Visual acuity (presenting and pinhole)
description: Presenting and pinhole visual acuity will be assessed using the Peek Acuity mobile application. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.
arm group label: Case detection
arm group label: Screening
intervention type: Other
intervention name: Optical coherence tomography (OCT)
description: OCT will be used to image the anterior segment, the macula, and the retinal nerve fiber layer. The images will be assessed for abnormalities and participants meeting referral criteria will be referred to the local eye hospital.
arm group label: Screening
intervention type: Other
intervention name: Intraocular pressure
description: Intraocular pressure will be measured using an iCare tonometer. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.
arm group label: Screening
intervention type: Other
intervention name: Active linkage to care
description: Referred participants will be followed closely by study staff to ensure completion of follow-up visits.
arm group label: Screening
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeremy Keenan
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Krisianne M Aromin, BS
phone: 4154761442
email: krisianne.aromin@ucsf.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Nepal
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Diabetic Retinopathy
sharing ipd: Yes
ipd description: De-identified data will be shared with other investigators upon request after the conclusion of the study. A request form will be available on Open Science Framework (https://osf.io/fgvrt/); all requests will be approved by the executive committee of the trial before sharing data. GPS data will not be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: De-identified data will be shared after publication of the major findings of the study, which we anticipate will occur around 6 months after the study conclusion.
ipd access criteria: De-identified data will be available upon request.
ipd url: https://osf.io/fgvrt/