<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/NCT04417946</url>
  </required_header>
  <id_info>
    <org_study_id>2000022728</org_study_id>
    <secondary_id>1H79TI080736</secondary_id>
    <nct_id>NCT04417946</nct_id>
  </id_info>
  <brief_title>Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)</brief_title>
  <official_title>Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Substance Abuse and Mental Health Services Administration (SAMHSA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale 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>
      The aim of this study is to examine the effect of social media intervention on the use of&#xD;
      pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New&#xD;
      Haven area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are three specific aims of this study. In the first specific aim, two focus group&#xD;
      discussions (FGDs) of YMSM will be conducted to assess the feasibility and acceptability of&#xD;
      social media intervention. In the second specific aim of the study, a quasi-pre-post&#xD;
      experimental study will be conducted to examine the effect of social media intervention on&#xD;
      PrEP uptake (primary outcome) and PrEP use intention, HIV testing, PrEP knowledge,&#xD;
      self-efficacy and social support (secondary outcome). In the third specific aim of the study,&#xD;
      the most important topics around PrEP will be assessed on the Facebook page of the&#xD;
      intervention group by conducting a content analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PrEP uptake</measure>
    <time_frame>PrEP uptake at baseline</time_frame>
    <description>Actual PrEP uptake: participants self report if they use prep (Yes/No)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP uptake</measure>
    <time_frame>PrEP uptake (Yes/No) at 24-weeks</time_frame>
    <description>Actual PrEP uptake: participants self report if they use prep (Yes/No)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV testing</measure>
    <time_frame>baseline</time_frame>
    <description>Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV testing</measure>
    <time_frame>24-weeks</time_frame>
    <description>Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP use intention</measure>
    <time_frame>PrEP use intention at baseline</time_frame>
    <description>Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP use intention</measure>
    <time_frame>PrEP use intention at 24-weeks</time_frame>
    <description>Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP knowledge</measure>
    <time_frame>PrEP knowledge at baseline</time_frame>
    <description>Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP knowledge</measure>
    <time_frame>PrEP knowledge at 24-weeks</time_frame>
    <description>Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self efficacy to use PrEP</measure>
    <time_frame>self efficacy to use PrEP at baseline</time_frame>
    <description>Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self efficacy to use PrEP</measure>
    <time_frame>self efficacy to use PrEP at 24-weeks</time_frame>
    <description>Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motivation to use PrEP</measure>
    <time_frame>motivation to use PrEP at baseline</time_frame>
    <description>How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motivation to use PrEP</measure>
    <time_frame>motivation to use PrEP at 24-weeks</time_frame>
    <description>How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP stigma</measure>
    <time_frame>PrEP stigma at baseline</time_frame>
    <description>Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PrEP stigma</measure>
    <time_frame>PrEP stigma at 24-weeks</time_frame>
    <description>Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social support for PrEP use</measure>
    <time_frame>Social support for PrEP use at baseline</time_frame>
    <description>Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social support for PrEP use</measure>
    <time_frame>Social support for PrEP use at 24-weeks</time_frame>
    <description>Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">325</enrollment>
  <condition>Pre-Exposure Prophylaxis</condition>
  <condition>Hiv</condition>
  <condition>Men</condition>
  <arm_group>
    <arm_group_label>PrEP Messages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The peer leaders and the study staff will post PrEP related health messages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health messages</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The peer leaders and study staff will post general health messages that are not related to sexual health.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PrEP messages</intervention_name>
    <description>The peer leaders and the study staff will post PrEP related health messages</description>
    <arm_group_label>PrEP Messages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Heath messages</intervention_name>
    <description>The peer leaders and study staff will post general health messages that are not related to sexual health</description>
    <arm_group_label>Health messages</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biologically male or transgender man&#xD;
&#xD;
          -  Self-identification as gay or bi-sexual&#xD;
&#xD;
          -  Resident of greater New Haven area&#xD;
&#xD;
          -  Willing and able to use Facebook during the span of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Women will not be included in the study&#xD;
&#xD;
               -  Under the age of 18 and over the age of 29&#xD;
&#xD;
               -  Unable to provide informed consent&#xD;
&#xD;
               -  Verbally or physically threatening to research staff&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Biologically male or transgender man</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederick Altice, M.D., M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xin Zhou, Ph.D.</last_name>
    <phone>(203)-764-9958</phone>
    <email>xin.zhou19@yale.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natalie Kil, MPH</last_name>
    <phone>(203)-764-9958</phone>
    <email>natalie.kil@yale.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>APNH: A Place to Nourish your Health (APNH)</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melanie DeFilippo, B.A.</last_name>
      <email>melanie.defilippo@apnh.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Zhou, Ph.D.</last_name>
      <email>xin.zhou19@yale.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pre-exposure prophylaxis (PrEP)</keyword>
  <keyword>social media intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data will be kept confidential.</ipd_description>
  </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/NCT04417946
org study id: 2000022728
secondary id: 1H79TI080736
nct id: NCT04417946
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to examine the effect of social media intervention on the use of
      pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New
      Haven area.
There are three specific aims of this study. In the first specific aim, two focus group
      discussions (FGDs) of YMSM will be conducted to assess the feasibility and acceptability of
      social media intervention. In the second specific aim of the study, a quasi-pre-post
      experimental study will be conducted to examine the effect of social media intervention on
      PrEP uptake (primary outcome) and PrEP use intention, HIV testing, PrEP knowledge,
      self-efficacy and social support (secondary outcome). In the third specific aim of the study,
      the most important topics around PrEP will be assessed on the Facebook page of the
      intervention group by conducting a content analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: PrEP uptake
time frame: PrEP uptake at baseline
description: Actual PrEP uptake: participants self report if they use prep (Yes/No)
measure: PrEP uptake
time frame: PrEP uptake (Yes/No) at 24-weeks
description: Actual PrEP uptake: participants self report if they use prep (Yes/No)
measure: HIV testing
time frame: baseline
description: Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days.
measure: HIV testing
time frame: 24-weeks
description: Date of the last HIV test: participants self report the date of their last HIV test as a function of time in days.
measure: PrEP use intention
time frame: PrEP use intention at baseline
description: Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely)
measure: PrEP use intention
time frame: PrEP use intention at 24-weeks
description: Willingness to use/likelihood of using PrEP in the next 6 months : self reported assessment to measure participants' willingness to use prep in the next 6 month s on a single question using Likert scale from 1(very unlikely) to 7 (very likely)
measure: PrEP knowledge
time frame: PrEP knowledge at baseline
description: Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions
measure: PrEP knowledge
time frame: PrEP knowledge at 24-weeks
description: Knowledge of PrEP for HIV prevention: self reported assessment to measure participants' knowledge on PrEP on a set of True or False questions
measure: self efficacy to use PrEP
time frame: self efficacy to use PrEP at baseline
description: Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident)
measure: self efficacy to use PrEP
time frame: self efficacy to use PrEP at 24-weeks
description: Beliefs in his/her ability of using PrEP: participants self report their level of confidence in taking PrEP on a set of items using Likert scales from 1 (Not at all confident) to 5 (completely confident)
measure: motivation to use PrEP
time frame: motivation to use PrEP at baseline
description: How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)
measure: motivation to use PrEP
time frame: motivation to use PrEP at 24-weeks
description: How motivated s/he is to use PrEP and what motivates s/he to use PrEP: self reported assessment to measure participants' different types of motivation to use PrEP on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)
measure: PrEP stigma
time frame: PrEP stigma at baseline
description: Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)
measure: PrEP stigma
time frame: PrEP stigma at 24-weeks
description: Perceived stigma related to PrEP use: self reported assessment to measure perception of stigma related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)
measure: Social support for PrEP use
time frame: Social support for PrEP use at baseline
description: Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)
measure: Social support for PrEP use
time frame: Social support for PrEP use at 24-weeks
description: Help and support that individuals receive that can facilitate PrEP uptake: Perceived stigma related to PrEP use: self reported assessment to measure perception of social support related to PrEP use on a set of items using Likert scales from 1(strongly disagree) to 7 (strongly agree)
arm group label: PrEP Messages
arm group type: Experimental
description: The peer leaders and the study staff will post PrEP related health messages
arm group label: Health messages
arm group type: Active Comparator
description: The peer leaders and study staff will post general health messages that are not related to sexual health.
intervention type: Behavioral
intervention name: PrEP messages
description: The peer leaders and the study staff will post PrEP related health messages
arm group label: PrEP Messages
intervention type: Behavioral
intervention name: Heath messages
description: The peer leaders and study staff will post general health messages that are not related to sexual health
arm group label: Health messages
criteria: 
gender: Male
gender based: Yes
gender description: Biologically male or transgender man
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Frederick Altice, M.D., M.A.
role: Principal Investigator
affiliation: Yale University
last name: Xin Zhou, Ph.D.
phone: (203)-764-9958
email: xin.zhou19@yale.edu
last name: Natalie Kil, MPH
phone: (203)-764-9958
email: natalie.kil@yale.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: All data will be kept confidential.