xml: <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/NCT05968755</url>
    </required_header>
    <id_info>
      <org_study_id>2000035242</org_study_id>
      <nct_id>NCT05968755</nct_id>
    </id_info>
    <brief_title>Leveraging Chatbot to Improve PrEP in the Southern United States</brief_title>
    <official_title>Leveraging Chatbot Technology to Improve PrEP Awareness and Uptake Among Black MSM in the Southern United States</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gilead Sciences</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Yale University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and&#xD;
        uptake among Black men who have sex with men (MSM) in the Southern United States.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the United States (US), the epicenter of the HIV epidemic is in the South. The HIV-related&#xD;
        death rate in the US South is high, but engagement with quality HIV prevention services and&#xD;
        care is low. Although only 38% of the US population lives in the South, the region accounts&#xD;
        for 51% of new HIV infections. Gay, bisexual, and other men who have sex with men (MSM)&#xD;
        account for 60% of new infections among African Americans in the South. Black MSM are one of&#xD;
        the most vulnerable groups to HIV transmission in the US. HIV testing and PrEP uptake in&#xD;
        Black MSM, however, remain low (10%) due to multiple factors including stigma,&#xD;
        sexual-orientation based discrimination and low PrEP awareness among Black MSM. Innovative&#xD;
        strategies that motivate and provide guidance for PrEP among Black MSM in the US South are&#xD;
        therefore urgently needed. Chatbot technology should be tested and implemented to help&#xD;
        improve PrEP awareness and uptake in the US South. In this project, the investigators aim to&#xD;
        develop and pilot test to assess the acceptability and feasibility of a chatbot for PrEP&#xD;
        awareness and uptake relative to treatment as usual (control).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</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, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline PrEP awareness in 90 days</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>PrEP awareness will be measured as the proportion of participants who are aware of PrEP. Specifically, the investigators will collect PrEP awareness by asking participants standardized questions through a Qualtrics survey.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline PrEP uptake in 90 days</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>PrEP uptake will be measured as the mean of the frequency of taking PrEP medication. Specifically, the investigators will collect PrEP uptake by asking participants through a Qualtrics survey if they have been taken PrEP at baseline and every 30 days. If participants respond that they have taken PrEP, the investigators will ask them the date and frequency of taking it and ask them to upload a photo of their PrEP for verification to reduce social desirability bias in responses.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Usability score</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>The usability score will be measured by the System Usability Scale, which is 5-point Likert scale consisted of 10 questions. Participants' scores range from 0 to 100. A score of 68 is average, below 68 is poor, above 68 is good, and above 80.3 is excellent.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Recommendation score</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>The recommendation score will be calculated by a Net Promote Score, which measures MSM's likelihood to recommend the chatbot to other MSM friends. The score ranges from 0 to 10. The higher the score, the better the recommendation score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Acceptability score</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>Acceptability, defined as the extent to which the chatbot is suitable and satisfactory to MSM, will be measured using the standardized Customer Satisfaction Scale &quot;How would you rate your overall satisfaction with the chatbot?&quot; and a 5-point Likert question &quot;How would you rate the likelihood of continuing to use the chatbot?&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Practicality score</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>Practicality defined as the extent to which the chatbot provides real-time Self-Determination theory inputs, will be measured using a 5-point Likert question &quot;How would you rate the overall quality of the chatbot?&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Demand score</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>Demand, defined as the level of integration to which the chatbot fits into the MSM-preferred online platform, will be measured by the number of actual use documented on developer's platform.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Adaptation score</measure>
      <time_frame>At baseline, 30 days, 60 days, and 90 days</time_frame>
      <description>Adaptation, defined as the extent to which the chatbot can be integrated into other social-networking apps, will be measured by asking &quot;How likely would you use the chatbot if embedded on other apps?&quot;</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">145</enrollment>
    <condition>HIV Prevention</condition>
    <condition>PrEP Awareness</condition>
    <condition>PrEP Uptake</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>A chatbot designed to promote PrEP awareness and uptake for Black MSM</intervention_name>
      <description>Participants in the intervention group will have access to a theory-informed (Self-Determination Theory) chatbot and receive an automated personalized question message (root-node message) from the chatbot. The root-node messages are questions written into the chatbot algorithms to initiate interactive communication with participants. In each round of the interactive communication, the chatbot will provide automated personalized PrEP-related information, autonomous motivation, and psychological needs based on Self-Determination Theory constructs.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>General educational messages</intervention_name>
      <description>Participants in the control group will received general education messages from a research assistant including healthy diet, exercise, and COVID-19 prevention. The frequency of contact will be pre-specified by participants in interviews prior to the RCT.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being cisgender Black male&#xD;
  &#xD;
            -  Being aged ≥ 18 years&#xD;
  &#xD;
            -  Having Internet access&#xD;
  &#xD;
            -  Speaking English&#xD;
  &#xD;
            -  Self-reporting condomless sex with another man in the past 6 months&#xD;
  &#xD;
            -  HIV negative or untested.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having lived in the US South less than 3 months&#xD;
  &#xD;
            -  Having received antiretroviral therapy (ART) treatment.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <reference>
      <citation>Centers for Disease Control and Prevention. HIV and African American Gay and Bisexual Men. [cited 2022 August 4]; Available from: https://www.cdc.gov/hiv/group/msm/bmsm.html.</citation>
    </reference>
    <reference>
      <citation>Adeagbo O, Harrison S, Qiao S, Li X. Pre-Exposure Prophylaxis (PrEP) Uptake among Black Men Who Have Sex with Men (BMSM) in the Southern U.S. Int J Environ Res Public Health. 2021 Sep 15;18(18):9715. doi: 10.3390/ijerph18189715.</citation>
      <PMID>34574652</PMID>
    </reference>
    <reference>
      <citation>Watson RJ, Eaton LA, Maksut JL, Rucinski KB, Earnshaw VA. Links Between Sexual Orientation and Disclosure Among Black MSM: Sexual Orientation and Disclosure Matter for PrEP Awareness. AIDS Behav. 2020 Jan;24(1):39-44. doi: 10.1007/s10461-019-02696-1.</citation>
      <PMID>31606770</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968755
  org study id: 2000035242
  nct id: NCT05968755
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and
        uptake among Black men who have sex with men (MSM) in the Southern United States.
  In the United States (US), the epicenter of the HIV epidemic is in the South. The HIV-related
        death rate in the US South is high, but engagement with quality HIV prevention services and
        care is low. Although only 38% of the US population lives in the South, the region accounts
        for 51% of new HIV infections. Gay, bisexual, and other men who have sex with men (MSM)
        account for 60% of new infections among African Americans in the South. Black MSM are one of
        the most vulnerable groups to HIV transmission in the US. HIV testing and PrEP uptake in
        Black MSM, however, remain low (10%) due to multiple factors including stigma,
        sexual-orientation based discrimination and low PrEP awareness among Black MSM. Innovative
        strategies that motivate and provide guidance for PrEP among Black MSM in the US South are
        therefore urgently needed. Chatbot technology should be tested and implemented to help
        improve PrEP awareness and uptake in the US South. In this project, the investigators aim to
        develop and pilot test to assess the acceptability and feasibility of a chatbot for PrEP
        awareness and uptake relative to treatment as usual (control).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Change from baseline PrEP awareness in 90 days
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: PrEP awareness will be measured as the proportion of participants who are aware of PrEP. Specifically, the investigators will collect PrEP awareness by asking participants standardized questions through a Qualtrics survey.
  measure: Change from baseline PrEP uptake in 90 days
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: PrEP uptake will be measured as the mean of the frequency of taking PrEP medication. Specifically, the investigators will collect PrEP uptake by asking participants through a Qualtrics survey if they have been taken PrEP at baseline and every 30 days. If participants respond that they have taken PrEP, the investigators will ask them the date and frequency of taking it and ask them to upload a photo of their PrEP for verification to reduce social desirability bias in responses.
  measure: Change in Usability score
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: The usability score will be measured by the System Usability Scale, which is 5-point Likert scale consisted of 10 questions. Participants' scores range from 0 to 100. A score of 68 is average, below 68 is poor, above 68 is good, and above 80.3 is excellent.
  measure: Change in Recommendation score
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: The recommendation score will be calculated by a Net Promote Score, which measures MSM's likelihood to recommend the chatbot to other MSM friends. The score ranges from 0 to 10. The higher the score, the better the recommendation score.
  measure: Change in Acceptability score
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: Acceptability, defined as the extent to which the chatbot is suitable and satisfactory to MSM, will be measured using the standardized Customer Satisfaction Scale "How would you rate your overall satisfaction with the chatbot?" and a 5-point Likert question "How would you rate the likelihood of continuing to use the chatbot?"
  measure: Change in Practicality score
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: Practicality defined as the extent to which the chatbot provides real-time Self-Determination theory inputs, will be measured using a 5-point Likert question "How would you rate the overall quality of the chatbot?"
  measure: Change in Demand score
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: Demand, defined as the level of integration to which the chatbot fits into the MSM-preferred online platform, will be measured by the number of actual use documented on developer's platform.
  measure: Change in Adaptation score
  time frame: At baseline, 30 days, 60 days, and 90 days
  description: Adaptation, defined as the extent to which the chatbot can be integrated into other social-networking apps, will be measured by asking "How likely would you use the chatbot if embedded on other apps?"
  arm group label: Intervention group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Placebo Comparator
  intervention type: Device
  intervention name: A chatbot designed to promote PrEP awareness and uptake for Black MSM
  description: Participants in the intervention group will have access to a theory-informed (Self-Determination Theory) chatbot and receive an automated personalized question message (root-node message) from the chatbot. The root-node messages are questions written into the chatbot algorithms to initiate interactive communication with participants. In each round of the interactive communication, the chatbot will provide automated personalized PrEP-related information, autonomous motivation, and psychological needs based on Self-Determination Theory constructs.
  arm group label: Intervention group
  intervention type: Other
  intervention name: General educational messages
  description: Participants in the control group will received general education messages from a research assistant including healthy diet, exercise, and COVID-19 prevention. The frequency of contact will be pre-specified by participants in interviews prior to the RCT.
  arm group label: Control group
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  citation: Centers for Disease Control and Prevention. HIV and African American Gay and Bisexual Men. [cited 2022 August 4]; Available from: https://www.cdc.gov/hiv/group/msm/bmsm.html.
  citation: Adeagbo O, Harrison S, Qiao S, Li X. Pre-Exposure Prophylaxis (PrEP) Uptake among Black Men Who Have Sex with Men (BMSM) in the Southern U.S. Int J Environ Res Public Health. 2021 Sep 15;18(18):9715. doi: 10.3390/ijerph18189715.
  PMID: 34574652
  citation: Watson RJ, Eaton LA, Maksut JL, Rucinski KB, Earnshaw VA. Links Between Sexual Orientation and Disclosure Among Black MSM: Sexual Orientation and Disclosure Matter for PrEP Awareness. AIDS Behav. 2020 Jan;24(1):39-44. doi: 10.1007/s10461-019-02696-1.
  PMID: 31606770
  responsible party type: Sponsor
  sharing ipd: No