<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/NCT03771638</url>
  </required_header>
  <id_info>
    <org_study_id>18-25821</org_study_id>
    <secondary_id>1R01MH109320-01</secondary_id>
    <nct_id>NCT03771638</nct_id>
  </id_info>
  <brief_title>DOT Diary Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men</brief_title>
  <official_title>DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Public Health Foundation Enterprises, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Francisco Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AiCure</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Public Health Foundation Enterprises, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers are working with a technology company, AiCure, to develop a smartphone app,&#xD;
      DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is&#xD;
      time to take their medication, and uses motion-sensing technology to visually and&#xD;
      automatically confirm the pill was swallowed. The goal of this study is to assess the impact&#xD;
      of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the DOT Diary research project, the AiCure automated directly observed therapy (aDOT)&#xD;
      smartphone app has been adapted for use in monitoring and supporting HIV pre-exposure&#xD;
      prophylaxis (PrEP) use among young men who have sex with men (YMSM). The aDOT app uses&#xD;
      automated directly observed therapy (DOT) that use the smartphone camera and artificial&#xD;
      intelligence software to confirm that the right person is taking the right medication at the&#xD;
      right time. A sexual diary has been integrated into the aDOT app to assist YMSM in&#xD;
      understanding whether they are receiving protection from PrEP for individual sexual episodes,&#xD;
      and when it is particularly important to take PrEP (e.g. after a sexual episode).&#xD;
      Specifically, the sexual diary allows participants to track sexual encounters, sexual&#xD;
      behaviors that occurred in each encounter, and rating characteristics of partners. The app&#xD;
      provides a calendar displaying all days in which PrEP medication was taken, and all days in&#xD;
      which sexual activity occurred, allowing participants to see coverage of sexual encounters&#xD;
      with PrEP. Based on pharmacokinetic and pharmacodynamic data from prior PrEP trials, the app&#xD;
      will also indicate the estimated level of protection achieved from PrEP (e.g. low, medium,&#xD;
      high), and also provide personalized messages on the additional numbers of doses needed to&#xD;
      maximize protection.&#xD;
&#xD;
      In the next stage of app development and assessment, the researchers will conduct the DOT&#xD;
      Diary Longitudinal Pilot to assess the impact of the app on PrEP adherence as measured by&#xD;
      pharmacokinetic measures of PrEP use (tenofovir diphosphate [TFV-DP] and emtricitabine&#xD;
      triphosphate [FTC-TP] levels in dried blood spots [DBS]). The researchers will also assess&#xD;
      the concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary, and the&#xD;
      acceptability and ease of use of the app over a longer (24-week) period. This pilot study&#xD;
      will allow evaluation and further refinement of the app in preparation for testing in a&#xD;
      larger efficacy trial among YMSM at risk for HIV acquisition. The researchers will conduct&#xD;
      this pilot protocol among YMSM in Atlanta and San Francisco Bay Area, two metropolitan&#xD;
      regions heavily impacted by HIV, yet differing in sociodemographics, as well as in the&#xD;
      availability and uptake of HIV prevention services, including PrEP. These diverse research&#xD;
      locations will allow collection of data to inform app development among a broad group of&#xD;
      YMSM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">April 21, 2020</completion_date>
  <primary_completion_date type="Actual">April 21, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Randomized, controlled study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of DOT Diary app on PrEP adherence</measure>
    <time_frame>24 weeks</time_frame>
    <description>Measurement of PrEP Adherence as measured by TFV-DP in DBS among young MSM initiating PrEP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary app</measure>
    <time_frame>24 weeks</time_frame>
    <description>Validation of DOT will focus on concordance between aDOT-based assessments of PrEP adherence by the DOT Diary app with DBS measurements</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DOT Diary mobile app acceptability</measure>
    <time_frame>24 weeks</time_frame>
    <description>Combined descriptive analysis of key attributes of acceptability of DOT Diary over 24 weeks by YMSM on PrEP, in order to identify potential improvements to the app to maximize acceptability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DOT Diary mobile app ease of use</measure>
    <time_frame>24 weeks</time_frame>
    <description>Combined descriptive analysis of key attributes of ease of use of DOT Diary over 24 weeks by YMSM on PrEP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PrEP coverage of sexual acts (prevention-effectiveness adherence) as measured by DOT Diary</measure>
    <time_frame>24 weeks</time_frame>
    <description>Combined analysis of the probability of coverage of condomless receptive sexual acts in each period with sexual acts treated as trials, and coverage as success.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of daily use of aDOT components of DOT Diary app</measure>
    <time_frame>24 weeks</time_frame>
    <description>Estimation of the average use of aDOT components, as proportion of days on study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of use of diary components of DOT Diary app</measure>
    <time_frame>24 weeks</time_frame>
    <description>Estimation of the average use of diary component of DOT Diary app as proportions of weeks on study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Adherence, Medication</condition>
  <condition>Risk Behavior</condition>
  <condition>Pre-Exposure Prophylaxis</condition>
  <condition>HIV Prevention</condition>
  <arm_group>
    <arm_group_label>DOT Diary Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DOT Diary Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Emtricitabine / Tenofovir Disoproxil Oral Tablet</intervention_name>
    <description>Open label daily emtricitabine/tenofovir disoproxil oral tablet</description>
    <arm_group_label>DOT Diary Control</arm_group_label>
    <arm_group_label>DOT Diary Intervention</arm_group_label>
    <other_name>Truvada</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DOT Diary mobile app</intervention_name>
    <description>DOT Diary mobile application for tracking medication adherence and sexual activities.</description>
    <arm_group_label>DOT Diary Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identifies as a man&#xD;
&#xD;
          -  Age 18-35 at enrollment&#xD;
&#xD;
          -  Reports having insertive or receptive anal sex with a man or trans woman in the past&#xD;
             12 months and one or more of the following criteria in the last 12 months:&#xD;
&#xD;
               -  Any condomless anal sex outside of a mutually monogamous relationship with an&#xD;
                  HIV-negative partner&#xD;
&#xD;
               -  Two or more anal sex partners&#xD;
&#xD;
               -  Self-reported sexually transmitted infection (STI; gonorrhea, chlamydia,&#xD;
                  syphilis)&#xD;
&#xD;
               -  Having a known HIV-positive sexual partner&#xD;
&#xD;
          -  HIV-negative as determined by a negative 4th generation HIV test at screening and&#xD;
             negative rapid 4th generation test at enrollment&#xD;
&#xD;
          -  Willing to initiate PrEP&#xD;
&#xD;
          -  Eligible to take PrEP&#xD;
&#xD;
               -  Creatinine clearance ≥60 ml/min as estimated by Cockcroft-Gault equation at&#xD;
                  screening&#xD;
&#xD;
               -  Hepatitis B surface antigen (HBsAg) negative&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Smartphone ownership compatible with DOT Diary app&#xD;
&#xD;
          -  Meets local locator requirements&#xD;
&#xD;
          -  Lives, works or plays in Atlanta Metropolitan Area, San Francisco, Alameda, Marin,&#xD;
             Contra Costa, Santa Clara, or San Mateo Counties&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PrEP use within the past 4 months (PrEP naive participants will be prioritized)&#xD;
&#xD;
          -  Any reactive HIV test at screening or enrollment&#xD;
&#xD;
          -  Signs or symptoms of acute HIV infection at screening or enrollment&#xD;
&#xD;
          -  History of pathological bone fracture not related to trauma&#xD;
&#xD;
          -  Taking nephrotoxic medications&#xD;
&#xD;
          -  History of participation in the active arm of an HIV vaccine trial&#xD;
&#xD;
          -  In a mutually monogamous sexual relationship with an HIV-negative partner for the past&#xD;
             12 months&#xD;
&#xD;
          -  Unable to commit to study participation for 24 weeks&#xD;
&#xD;
          -  Any medical, psychiatric, or social condition or other responsibilities that, in the&#xD;
             judgment of the investigator, would make participation in the study unsafe, complicate&#xD;
             interpretation of study outcome data, or otherwise interfere with achieving the study&#xD;
             objectives.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identify as a man</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Buchbinder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bridge HIV, San Francisco Department of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bridge HIV, San Francisco Department of Public Health</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University, School of Public Health</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Public Health Foundation Enterprises, Inc.</investigator_affiliation>
    <investigator_full_name>Susan Buchbinder</investigator_full_name>
    <investigator_title>Director, Bridge HIV</investigator_title>
  </responsible_party>
  <keyword>Adherence</keyword>
  <keyword>PrEP</keyword>
  <keyword>HIV Prevention</keyword>
  <keyword>Truvada</keyword>
  <keyword>HIV Risk Reduction</keyword>
  <keyword>Mobile App</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 14, 2021</submitted>
    <returned>October 11, 2021</returned>
    <submitted>October 12, 2021</submitted>
    <returned>November 8, 2021</returned>
    <submitted>July 22, 2022</submitted>
    <returned>August 16, 2022</returned>
    <submitted>September 16, 2022</submitted>
    <returned>September 29, 2022</returned>
  </pending_results>
  <!-- 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/NCT03771638
org study id: 18-25821
secondary id: 1R01MH109320-01
nct id: NCT03771638
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The researchers are working with a technology company, AiCure, to develop a smartphone app,
      DOT Diary, which combines two drug adherence strategies. DOT Diary reminds people when it is
      time to take their medication, and uses motion-sensing technology to visually and
      automatically confirm the pill was swallowed. The goal of this study is to assess the impact
      of the app on adherence to HIV pre-exposure prophylaxis (PrEP) for the prevention of HIV.
In the DOT Diary research project, the AiCure automated directly observed therapy (aDOT)
      smartphone app has been adapted for use in monitoring and supporting HIV pre-exposure
      prophylaxis (PrEP) use among young men who have sex with men (YMSM). The aDOT app uses
      automated directly observed therapy (DOT) that use the smartphone camera and artificial
      intelligence software to confirm that the right person is taking the right medication at the
      right time. A sexual diary has been integrated into the aDOT app to assist YMSM in
      understanding whether they are receiving protection from PrEP for individual sexual episodes,
      and when it is particularly important to take PrEP (e.g. after a sexual episode).
      Specifically, the sexual diary allows participants to track sexual encounters, sexual
      behaviors that occurred in each encounter, and rating characteristics of partners. The app
      provides a calendar displaying all days in which PrEP medication was taken, and all days in
      which sexual activity occurred, allowing participants to see coverage of sexual encounters
      with PrEP. Based on pharmacokinetic and pharmacodynamic data from prior PrEP trials, the app
      will also indicate the estimated level of protection achieved from PrEP (e.g. low, medium,
      high), and also provide personalized messages on the additional numbers of doses needed to
      maximize protection.

      In the next stage of app development and assessment, the researchers will conduct the DOT
      Diary Longitudinal Pilot to assess the impact of the app on PrEP adherence as measured by
      pharmacokinetic measures of PrEP use (tenofovir diphosphate [TFV-DP] and emtricitabine
      triphosphate [FTC-TP] levels in dried blood spots [DBS]). The researchers will also assess
      the concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary, and the
      acceptability and ease of use of the app over a longer (24-week) period. This pilot study
      will allow evaluation and further refinement of the app in preparation for testing in a
      larger efficacy trial among YMSM at risk for HIV acquisition. The researchers will conduct
      this pilot protocol among YMSM in Atlanta and San Francisco Bay Area, two metropolitan
      regions heavily impacted by HIV, yet differing in sociodemographics, as well as in the
      availability and uptake of HIV prevention services, including PrEP. These diverse research
      locations will allow collection of data to inform app development among a broad group of
      YMSM.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled study
primary purpose: Other
masking: None (Open Label)
measure: Effect of DOT Diary app on PrEP adherence
time frame: 24 weeks
description: Measurement of PrEP Adherence as measured by TFV-DP in DBS among young MSM initiating PrEP
measure: Concordance of TFV-DP and FTC-TP in DBS with adherence measured by DOT Diary app
time frame: 24 weeks
description: Validation of DOT will focus on concordance between aDOT-based assessments of PrEP adherence by the DOT Diary app with DBS measurements
measure: DOT Diary mobile app acceptability
time frame: 24 weeks
description: Combined descriptive analysis of key attributes of acceptability of DOT Diary over 24 weeks by YMSM on PrEP, in order to identify potential improvements to the app to maximize acceptability
measure: DOT Diary mobile app ease of use
time frame: 24 weeks
description: Combined descriptive analysis of key attributes of ease of use of DOT Diary over 24 weeks by YMSM on PrEP
measure: PrEP coverage of sexual acts (prevention-effectiveness adherence) as measured by DOT Diary
time frame: 24 weeks
description: Combined analysis of the probability of coverage of condomless receptive sexual acts in each period with sexual acts treated as trials, and coverage as success.
measure: Evaluation of daily use of aDOT components of DOT Diary app
time frame: 24 weeks
description: Estimation of the average use of aDOT components, as proportion of days on study
measure: Evaluation of use of diary components of DOT Diary app
time frame: 24 weeks
description: Estimation of the average use of diary component of DOT Diary app as proportions of weeks on study.
arm group label: DOT Diary Intervention
arm group type: Experimental
description: DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
arm group label: DOT Diary Control
arm group type: Other
description: Standard of care for Emtricitabine / Tenofovir Disoproxil Oral Tablet (once daily)
intervention type: Drug
intervention name: Emtricitabine / Tenofovir Disoproxil Oral Tablet
description: Open label daily emtricitabine/tenofovir disoproxil oral tablet
arm group label: DOT Diary Control
arm group label: DOT Diary Intervention
other name: Truvada
intervention type: Other
intervention name: DOT Diary mobile app
description: DOT Diary mobile application for tracking medication adherence and sexual activities.
arm group label: DOT Diary Intervention
criteria: 
gender: All
gender based: Yes
gender description: Self-identify as a man
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Buchbinder, MD
role: Principal Investigator
affiliation: Bridge HIV, San Francisco Department of Public Health
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Public Health Foundation Enterprises, Inc.
investigator full name: Susan Buchbinder
investigator title: Director, Bridge HIV
mesh term: Tenofovir
mesh term: Emtricitabine
sharing ipd: No
submitted: September 14, 2021
returned: October 11, 2021
submitted: October 12, 2021
returned: November 8, 2021
submitted: July 22, 2022
returned: August 16, 2022
submitted: September 16, 2022
returned: September 29, 2022