<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/NCT04413708</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0099</org_study_id>
    <nct_id>NCT04413708</nct_id>
  </id_info>
  <brief_title>mHealth Technologies to Enhance PrEP Adherence Among Thai MSM</brief_title>
  <acronym>P3-T</acronym>
  <official_title>Novel mHealth Technologies to Enhance PrEP Adherence Among Thai MSM: Collaborative Adaptation and Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thai Red Cross AIDS Research Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</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>
      This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app&#xD;
      designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical&#xD;
      care, and PrEP persistence among young men who have sex with men (YMSM) in the United States&#xD;
      for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the&#xD;
      feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This R21 study, titled &quot;Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM:&#xD;
      Collaborative Adaptation and Evaluation&quot;, is: 1) adapting the theory-based smartphone app,&#xD;
      P3, designed to improve PrEP adherence, retention in PrEP clinical care, and PrEP persistence&#xD;
      among YMSM in the United States for YMSM in Thailand, and 2) conducting a pilot RCT to assess&#xD;
      the feasibility and acceptability of the adapted P3-T app and to examine the potential impact&#xD;
      of the app on PrEP adherence.&#xD;
&#xD;
      The study is a partnership between Duke University, Chulalongkorn University, Thai Red Cross&#xD;
      AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and&#xD;
      includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC.&#xD;
&#xD;
      P3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social&#xD;
      networking and game-based mechanics as well as evidenced-based features to improve PrEP&#xD;
      medication adherence. P3 is a product born from the collaborative effort of researchers and&#xD;
      health game developers working closely with members of the target population in the United&#xD;
      States. Built on a successful, evidence-based platform designed by our collaborating&#xD;
      technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for&#xD;
      customization and adaptations for different cultural and linguistic contexts, and responsive&#xD;
      to changes in technology.&#xD;
&#xD;
      The social networking features of P3 are designed to capitalize on social involvement as a&#xD;
      means through which YMSM can receive information and social support, experience social norms&#xD;
      and reflective appraisals, and feel a sense of connectedness to peers. Peers have been&#xD;
      recognized as a highly important source of sexual health and HIV prevention information and&#xD;
      support among Thai YMSM. The gaming features of P3 are goal-oriented and immersive and&#xD;
      provide a challenging and motivating environment for behavior change. As a result, P3 is&#xD;
      ideal for engaging YMSM in behavior change, by maintaining attention, avoiding boredom and&#xD;
      attrition.&#xD;
&#xD;
      The pilot RCT of the adapted P3-T app with be conducted with 60 YMSM newly starting PrEP in&#xD;
      Thailand to: 1) assess app feasibility and acceptability, and 2) explore the potential impact&#xD;
      of the app on PrEP adherence. The study will be 6 months in duration with a 3-month&#xD;
      intervention period and include study visits at baseline, 3-months, and 6-months. At&#xD;
      baseline, participants will complete a baseline web-based computer-assisted self-interviewing&#xD;
      (CASI) survey. Next, participants will be randomized in a 1:1 ratio into the P3-T arm or&#xD;
      standard of care (SOC) study arm. All study participants will complete follow-up CASI surveys&#xD;
      and have their blood drawn via venipuncture at 3 and 6 months for collection of dried blood&#xD;
      spots (DBS).&#xD;
&#xD;
      In-depth interviews will be conducted with 10 P3-T arm participants after the 3-month&#xD;
      intervention period. The interview will ask participants about their experience and&#xD;
      impressions of the app, how they used it, and how it may have impacted their behaviors during&#xD;
      the 3-month intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">August 10, 2021</completion_date>
  <primary_completion_date type="Actual">August 10, 2021</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>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intervention Feasibility: Average proportion of days of any app use</measure>
    <time_frame>3 Months</time_frame>
    <description>The average proportion of days of any app use during the trial across all participants as recorded by backend app metrics. Total possible range: 0-1. Higher proportion indicates higher intervention feasibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Feasibility: Average proportion of days of PrEP medication tracked</measure>
    <time_frame>Month 3</time_frame>
    <description>The average proportion of days participants used the app to track PrEP medication taking. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Acceptability: Mean intervention acceptability, composite score CSQ-8</measure>
    <time_frame>Month 3</time_frame>
    <description>The mean composite score calculated from the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction. Total possible composite score range: 8 (lowest acceptability, worst outcome) to 32 (highest acceptable, best outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in PrEP medication adherence between study arms at Month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>Comparison of the proportion of participants with protective levels of tenofovir-diphosphate (TFV-DP)/emtricitabine triphosphate (FTC-TP) at month 3 between the study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in PrEP medication adherence between study arms at Month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Comparison of the proportion of participants with protective levels of TFV-DP/FTC-TP at month 6 between the study arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Adherence, Patient</condition>
  <condition>Pre-Exposure Prophylaxis</condition>
  <condition>HIV/AIDS</condition>
  <arm_group>
    <arm_group_label>P3-T PrEP adherence app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3 month intervention period.&#xD;
Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>P3-T PrEP Adherence App</intervention_name>
    <description>P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a &quot;bank account&quot; that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.</description>
    <arm_group_label>P3-T PrEP adherence app</arm_group_label>
    <other_name>P3-T</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Male sex at birth&#xD;
&#xD;
          -  Gender identity is male&#xD;
&#xD;
          -  Identify as a man who has sex with men&#xD;
&#xD;
          -  Ages 16-24&#xD;
&#xD;
          -  Plan to start PrEP in next 14 days&#xD;
&#xD;
          -  Able to speak and read Thai&#xD;
&#xD;
          -  Own an Android or iOS smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating in another experimental PrEP adherence intervention&#xD;
&#xD;
          -  Plan to move out of Bangkok in the next 6 months&#xD;
&#xD;
          -  Unable to be consented due to an active substance use or psychological condition&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identify as male</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara LeGrand, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PrEP adherence</keyword>
  <keyword>HIV</keyword>
  <keyword>Young men who have sex with men</keyword>
  <keyword>YMSM</keyword>
  <keyword>Thailand</keyword>
  <keyword>Mobile app</keyword>
  <keyword>mHealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 11, 2023</submitted>
  </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/NCT04413708
org study id: 2020-0099
nct id: NCT04413708
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to: 1) adapt the theory-based P3 (Prepared, Protected, emPowered) app
      designed to improve pre-exposure prophylaxis (PrEP) adherence, retention in PrEP clinical
      care, and PrEP persistence among young men who have sex with men (YMSM) in the United States
      for YMSM in Thailand, and 2) conduct a pilot randomized controlled trial (RCT) to assess the
      feasibility, acceptability, and potential impact of the adapted P3-Thailand (P3-T) app.
This R21 study, titled "Novel mHealth Technologies to Enhance PrEP Adherence among Thai MSM:
      Collaborative Adaptation and Evaluation", is: 1) adapting the theory-based smartphone app,
      P3, designed to improve PrEP adherence, retention in PrEP clinical care, and PrEP persistence
      among YMSM in the United States for YMSM in Thailand, and 2) conducting a pilot RCT to assess
      the feasibility and acceptability of the adapted P3-T app and to examine the potential impact
      of the app on PrEP adherence.

      The study is a partnership between Duke University, Chulalongkorn University, Thai Red Cross
      AIDS Research Centre (TRC-ARC), and the University of North Carolina-Chapel Hill, and
      includes a robust plan to increase mHealth capacity at Chulalongkorn University and TRC-ARC.

      P3 is a theory-based, comprehensive smartphone app platform for YMSM that utilizes social
      networking and game-based mechanics as well as evidenced-based features to improve PrEP
      medication adherence. P3 is a product born from the collaborative effort of researchers and
      health game developers working closely with members of the target population in the United
      States. Built on a successful, evidence-based platform designed by our collaborating
      technology partner, Ayogo, and tested by our study team, P3 is flexible, allowing for
      customization and adaptations for different cultural and linguistic contexts, and responsive
      to changes in technology.

      The social networking features of P3 are designed to capitalize on social involvement as a
      means through which YMSM can receive information and social support, experience social norms
      and reflective appraisals, and feel a sense of connectedness to peers. Peers have been
      recognized as a highly important source of sexual health and HIV prevention information and
      support among Thai YMSM. The gaming features of P3 are goal-oriented and immersive and
      provide a challenging and motivating environment for behavior change. As a result, P3 is
      ideal for engaging YMSM in behavior change, by maintaining attention, avoiding boredom and
      attrition.

      The pilot RCT of the adapted P3-T app with be conducted with 60 YMSM newly starting PrEP in
      Thailand to: 1) assess app feasibility and acceptability, and 2) explore the potential impact
      of the app on PrEP adherence. The study will be 6 months in duration with a 3-month
      intervention period and include study visits at baseline, 3-months, and 6-months. At
      baseline, participants will complete a baseline web-based computer-assisted self-interviewing
      (CASI) survey. Next, participants will be randomized in a 1:1 ratio into the P3-T arm or
      standard of care (SOC) study arm. All study participants will complete follow-up CASI surveys
      and have their blood drawn via venipuncture at 3 and 6 months for collection of dried blood
      spots (DBS).

      In-depth interviews will be conducted with 10 P3-T arm participants after the 3-month
      intervention period. The interview will ask participants about their experience and
      impressions of the app, how they used it, and how it may have impacted their behaviors during
      the 3-month intervention period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Intervention Feasibility: Average proportion of days of any app use
time frame: 3 Months
description: The average proportion of days of any app use during the trial across all participants as recorded by backend app metrics. Total possible range: 0-1. Higher proportion indicates higher intervention feasibility.
measure: Intervention Feasibility: Average proportion of days of PrEP medication tracked
time frame: Month 3
description: The average proportion of days participants used the app to track PrEP medication taking. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility.
measure: Intervention Acceptability: Mean intervention acceptability, composite score CSQ-8
time frame: Month 3
description: The mean composite score calculated from the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction. Total possible composite score range: 8 (lowest acceptability, worst outcome) to 32 (highest acceptable, best outcome).
measure: Difference in PrEP medication adherence between study arms at Month 3
time frame: Month 3
description: Comparison of the proportion of participants with protective levels of tenofovir-diphosphate (TFV-DP)/emtricitabine triphosphate (FTC-TP) at month 3 between the study arms.
measure: Difference in PrEP medication adherence between study arms at Month 6
time frame: Month 6
description: Comparison of the proportion of participants with protective levels of TFV-DP/FTC-TP at month 6 between the study arms.
arm group label: P3-T PrEP adherence app
arm group type: Experimental
description: Intended app use includes, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3 month intervention period.
Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.
arm group label: Standard of Care
arm group type: No Intervention
description: Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit.
intervention type: Behavioral
intervention name: P3-T PrEP Adherence App
description: P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar.
arm group label: P3-T PrEP adherence app
other name: P3-T
criteria: 
gender: Male
gender based: Yes
gender description: Self-identify as male
minimum age: 16 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sara LeGrand, Ph.D.
role: Principal Investigator
affiliation: Duke University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No
submitted: April 11, 2023