<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/NCT03763942</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00102006</org_study_id>
    <secondary_id>R01DA045612</secondary_id>
    <nct_id>NCT03763942</nct_id>
  </id_info>
  <brief_title>HealthMindr App to Increase Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex With Men (MSM)</brief_title>
  <official_title>Theoretically Based Mobile App to Increase PrEP Uptake Among MSM</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory 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 is a randomized controlled clinical trial of a theoretically based mobile app,&#xD;
      HealthMindr, to increase pre-exposure prophylaxis (PrEP) uptake among men who have sex with&#xD;
      men (MSM) to prevent human immunodeficiency virus (HIV). Participants in the intervention arm&#xD;
      will receive access to the HealthMindr app, with information about PrEP and other HIV&#xD;
      prevention methods in addition to provider locators. Participants randomized to the control&#xD;
      arm will receive standard of care. The primary aim for this study is to assess PrEP uptake in&#xD;
      the intervention arm compared to the control arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MSM are disproportionately impacted in terms of HIV prevalence and incidence. Electronically&#xD;
      delivered or supported prevention services are effective, are acceptable to MSM, and will&#xD;
      likely reach heavily impacted men. The study is based on the premise that providing, through&#xD;
      a mobile phone app, self-directed PrEP information; periodic behavioral screenings to&#xD;
      identify HIV risk and PrEP indication objectively; referral to PrEP providers with&#xD;
      directions; and related prevention services will increase the uptake of PrEP among at risk,&#xD;
      HIV negative MSM to a greater extent than standard of care referrals to existing resources.&#xD;
&#xD;
      The study will examine the effectiveness of the HealthMindr app to increase uptake of PrEP&#xD;
      among MSM. The study will enroll 657 men across the three sites - the metropolitan&#xD;
      statistical areas (MSA) of Atlanta, Georgia (GA), Jackson, Mississippi (MS), and Washington,&#xD;
      D.C. - into a randomized controlled trial. Participants in the intervention arm will receive&#xD;
      access to the HealthMindr app and men in the control arm will receive standard of care HIV&#xD;
      prevention information. PrEP uptake will be assessed during follow-up by self-report at&#xD;
      months 3, 6, 9, and 12. Self-report will be confirmed by laboratory testing for the presence&#xD;
      of tenofovir diphosphate (TFV-DP) and/or photograph of PrEP prescription or bottle.&#xD;
&#xD;
      At the beginning of the study, all participants will download a study mobile app. After&#xD;
      completing a baseline survey, participants will be randomized to the intervention or control&#xD;
      arm. For participants assigned to the intervention arm, additional app content will become&#xD;
      available. This content will include information about basic prevention services (HIV test&#xD;
      planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test&#xD;
      kit, and at-home sexually transmitted infection (STI) specimen collection kit distribution)&#xD;
      plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about&#xD;
      PrEP, and referrals to local PrEP navigators. The app also provides links to health insurance&#xD;
      exchanges, where men can seek health insurance or assistance to help cover PrEP costs. The&#xD;
      control arm will be referred to existing online PrEP and HIV prevention information.&#xD;
      Participants in the control arm will access the control version of the app that contains&#xD;
      elements pertinent to their participation in the research study.&#xD;
&#xD;
      Additional follow-up surveys will be conducted at 3, 6, 9, and 12 months and participants&#xD;
      will also complete monthly assessments. The monthly assessments will assess indications for&#xD;
      PrEP and PrEP uptake (intervention arm) and other health-related behaviors (control arm).&#xD;
      Participants reporting PrEP initiation will be asked to submit a dried blood spot&#xD;
      self-collection kit to allow for measurement of tenofovir diphosphate (TFV-DP) levels and/or&#xD;
      upload a photo of their PrEP prescription bottle to verify PrEP uptake.&#xD;
&#xD;
      Participants will primarily be recruited online from the main study sites in Atlanta,&#xD;
      Georgia, Jackson, Mississippi, and Washington, District of Columbia (DC). Online recruitment&#xD;
      will expand to other areas of the United States, as needed to meet recruitment targets.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2020</start_date>
  <completion_date type="Actual">March 17, 2023</completion_date>
  <primary_completion_date type="Actual">March 17, 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>
    <intervention_model_description>This trial will include 657 participants with 2:1 allocation for the intervention (438) and control (219) conditions. Recruitment strategies will be formulated to increase enrollment of MSM who identify as members of racial/ethnic minority groups.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PrEP Uptake</measure>
    <time_frame>3, 6, 9, and 12 months post-randomization</time_frame>
    <description>PrEP uptake will be assessed at each follow-up timepoint (3, 6, 9, and 12 months) in the intervention and control groups. The primary measure of PrEP uptake will be self-report. Validation will occur through submission of a dried blood spot self-collection kit to detect tenofovir diphosphate (TFV-DP) and/or upload of a photo of a PrEP prescription bottle.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">658</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>HealthMindr App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control App</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control arm will be directed to download a study app that allows study staff to interact with them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HealthMindr App</intervention_name>
    <description>Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.</description>
    <arm_group_label>HealthMindr App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control App</intervention_name>
    <description>Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.</description>
    <arm_group_label>Control App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cisgender male&#xD;
&#xD;
          -  18-34 years of age (inclusive)&#xD;
&#xD;
          -  Resides in one of the study MSAs&#xD;
&#xD;
          -  Intends to remain in study area for duration of the trial&#xD;
&#xD;
          -  Owns an Android or Apple operating system (iOS) smartphone and willing to download&#xD;
             study app&#xD;
&#xD;
          -  Able to read and understand English without assistance&#xD;
&#xD;
          -  Reports having anal sex with a man in the past 6 months&#xD;
&#xD;
          -  Reports being HIV negative or never tested for HIV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cisgender female, transgender male, transgender female, gender non-conforming&#xD;
&#xD;
          -  Currently on PrEP&#xD;
&#xD;
          -  &lt; 18 or &gt;34 years of age&#xD;
&#xD;
          -  Reports being HIV positive&#xD;
&#xD;
          -  Resides outside of the MSAs or plans to move outside study MSA within 12 months&#xD;
&#xD;
          -  Current participant in another HIV prevention study&#xD;
&#xD;
          -  Unable to download study app&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>34 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Sullivan, DVM PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeb Jones, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jones J, Dominguez K, Stephenson R, Stekler JD, Castel AD, Mena LA, Jenness SM, Siegler AJ, Sullivan PS. A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 21;9(2):e16231. doi: 10.2196/16231.</citation>
    <PMID>32130178</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Patrick S Sullivan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus (HIV)</keyword>
  <keyword>Men who have sex with men (MSM)</keyword>
  <keyword>Pre-Exposure Prophylaxis (PrEP)</keyword>
  <keyword>HealthMindr</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 31, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03763942/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03763942
org study id: IRB00102006
secondary id: R01DA045612
nct id: NCT03763942
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a randomized controlled clinical trial of a theoretically based mobile app,
      HealthMindr, to increase pre-exposure prophylaxis (PrEP) uptake among men who have sex with
      men (MSM) to prevent human immunodeficiency virus (HIV). Participants in the intervention arm
      will receive access to the HealthMindr app, with information about PrEP and other HIV
      prevention methods in addition to provider locators. Participants randomized to the control
      arm will receive standard of care. The primary aim for this study is to assess PrEP uptake in
      the intervention arm compared to the control arm.
MSM are disproportionately impacted in terms of HIV prevalence and incidence. Electronically
      delivered or supported prevention services are effective, are acceptable to MSM, and will
      likely reach heavily impacted men. The study is based on the premise that providing, through
      a mobile phone app, self-directed PrEP information; periodic behavioral screenings to
      identify HIV risk and PrEP indication objectively; referral to PrEP providers with
      directions; and related prevention services will increase the uptake of PrEP among at risk,
      HIV negative MSM to a greater extent than standard of care referrals to existing resources.

      The study will examine the effectiveness of the HealthMindr app to increase uptake of PrEP
      among MSM. The study will enroll 657 men across the three sites - the metropolitan
      statistical areas (MSA) of Atlanta, Georgia (GA), Jackson, Mississippi (MS), and Washington,
      D.C. - into a randomized controlled trial. Participants in the intervention arm will receive
      access to the HealthMindr app and men in the control arm will receive standard of care HIV
      prevention information. PrEP uptake will be assessed during follow-up by self-report at
      months 3, 6, 9, and 12. Self-report will be confirmed by laboratory testing for the presence
      of tenofovir diphosphate (TFV-DP) and/or photograph of PrEP prescription or bottle.

      At the beginning of the study, all participants will download a study mobile app. After
      completing a baseline survey, participants will be randomized to the intervention or control
      arm. For participants assigned to the intervention arm, additional app content will become
      available. This content will include information about basic prevention services (HIV test
      planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test
      kit, and at-home sexually transmitted infection (STI) specimen collection kit distribution)
      plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about
      PrEP, and referrals to local PrEP navigators. The app also provides links to health insurance
      exchanges, where men can seek health insurance or assistance to help cover PrEP costs. The
      control arm will be referred to existing online PrEP and HIV prevention information.
      Participants in the control arm will access the control version of the app that contains
      elements pertinent to their participation in the research study.

      Additional follow-up surveys will be conducted at 3, 6, 9, and 12 months and participants
      will also complete monthly assessments. The monthly assessments will assess indications for
      PrEP and PrEP uptake (intervention arm) and other health-related behaviors (control arm).
      Participants reporting PrEP initiation will be asked to submit a dried blood spot
      self-collection kit to allow for measurement of tenofovir diphosphate (TFV-DP) levels and/or
      upload a photo of their PrEP prescription bottle to verify PrEP uptake.

      Participants will primarily be recruited online from the main study sites in Atlanta,
      Georgia, Jackson, Mississippi, and Washington, District of Columbia (DC). Online recruitment
      will expand to other areas of the United States, as needed to meet recruitment targets.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This trial will include 657 participants with 2:1 allocation for the intervention (438) and control (219) conditions. Recruitment strategies will be formulated to increase enrollment of MSM who identify as members of racial/ethnic minority groups.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in PrEP Uptake
time frame: 3, 6, 9, and 12 months post-randomization
description: PrEP uptake will be assessed at each follow-up timepoint (3, 6, 9, and 12 months) in the intervention and control groups. The primary measure of PrEP uptake will be self-report. Validation will occur through submission of a dried blood spot self-collection kit to detect tenofovir diphosphate (TFV-DP) and/or upload of a photo of a PrEP prescription bottle.
arm group label: HealthMindr App
arm group type: Experimental
description: Participants in the intervention arm will receive access to all HealthMindr app capabilities. The app information will cover the importance of testing, links to HIV prevention resources, resources to locate HIV testing and PrEP services, the Substance Abuse and Mental Health Services Administration (SAMHSA) substance abuse treatment resource locator, and other prevention information specific to their area.
arm group label: Control App
arm group type: Placebo Comparator
description: Participants in the control arm will be directed to download a study app that allows study staff to interact with them.
intervention type: Behavioral
intervention name: HealthMindr App
description: Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.
arm group label: HealthMindr App
intervention type: Behavioral
intervention name: Control App
description: Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.
arm group label: Control App
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 34 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick Sullivan, DVM PhD
role: Principal Investigator
affiliation: Emory University
last name: Jeb Jones, PhD
role: Study Director
affiliation: Emory University
facility: 
facility: 
facility: 
country: United States
citation: Jones J, Dominguez K, Stephenson R, Stekler JD, Castel AD, Mena LA, Jenness SM, Siegler AJ, Sullivan PS. A Theoretically Based Mobile App to Increase Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 21;9(2):e16231. doi: 10.2196/16231.
PMID: 32130178
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Patrick S Sullivan
investigator title: Professor
mesh term: HIV Infections
provided document: 