<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/NCT03823209</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00029359</org_study_id>
    <nct_id>NCT03823209</nct_id>
  </id_info>
  <brief_title>Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities</brief_title>
  <acronym>SNAP</acronym>
  <official_title>Increasing PrEP Use in High-Risk Social Networks of African-American MSM in Underserved Low-Risk Cities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</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 evaluates the use of a social-network approach to encourage African-American men&#xD;
      who have sex with men (AAMSM) to adopt pre-exposure prophylaxis (PrEP) to prevent HIV&#xD;
      infection. Thirty-six networks of AAMSM will be recruited in Milwaukee, WI, and Cleveland,&#xD;
      OH. Half of these networks will have their leaders trained to endorse PrEP to their social&#xD;
      network members, and the other half will be given brief HIV prevention counseling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-exposure prophylaxis (PrEP) regimens greatly reduce the likelihood that high-risk&#xD;
      uninfected men who have sex with men (MSM) will contract HIV infection. Although this&#xD;
      protective benefit has been unequivocally established in clinical trials, the number of&#xD;
      high-risk men on PrEP remains far below the threshold needed to substantially reduce HIV&#xD;
      incidence. This is especially true outside of the country's largest cities. Novel approaches&#xD;
      are needed to increase PrEP use among high-risk racial minority MSM in these neglected&#xD;
      cities.&#xD;
&#xD;
      This study will recruit 36 sociocentric social networks of high-risk young racial minority&#xD;
      MSM, 18 networks per city (total n=36 networks x 14 anticipated recruited members per network&#xD;
      = 504 participants). Participants will complete measures assessing baseline PrEP use;&#xD;
      knowledge, attitudes, perceived norms, intentions, and stage of readiness for PrEP; sexual&#xD;
      risk practices and substance use; and prior or current ART use. Participants will also&#xD;
      complete measures used to identify each network's leaders.&#xD;
&#xD;
      Networks will be randomized in equal numbers in each city to comparison or intervention&#xD;
      conditions. All study participants will receive individual baseline counseling about risk&#xD;
      reduction and PrEP, with referral offered to clinics prescribing PrEP. Members of the 18&#xD;
      experimental condition networks will also receive the social network PrEP intervention being&#xD;
      tested in the study. In it, cadres of leaders in each network-selected based on their&#xD;
      leadership position within the network and their own openness to PrEP-will attend a 5-session&#xD;
      intervention that trains, engages, and supports network leaders in communicating to friends&#xD;
      accurate information about PrEP and its availability; corrects PrEP misconceptions and&#xD;
      negative stereotypes; endorses PrEP use and its benefits; and strengthens friends' attitudes,&#xD;
      intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV&#xD;
      protective strategy. Two additional booster sessions spaced monthly will support maintenance&#xD;
      of leaders' efforts in talking with friends in their network about the benefits of PrEP, as&#xD;
      well as where and how to access it.&#xD;
&#xD;
      At 6- and 15-month followup points, all study participants will complete the same behavioral&#xD;
      measures that were administered at baseline, as well as measures of intervention exposure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 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>Self-report of pre-exposure prophylaxis (PrEP) use</measure>
    <time_frame>6 and 15 months</time_frame>
    <description>Change in self-reported PrEP use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-Exposure Prophylaxis (PrEP) Knowledge</measure>
    <time_frame>6 and 15 months</time_frame>
    <description>PrEP Knowledge: 13 items in scale, items are added to determine score, with higher scores indicating greater knowledge&#xD;
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-Exposure Prophylaxis Attitudes</measure>
    <time_frame>6 and 15 months</time_frame>
    <description>PrEP Attitudes: 5 items in scale, items are averaged to determine score, with higher scores indicating more positive attitudes&#xD;
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-Exposure Prophylaxis Norm Perceptions</measure>
    <time_frame>6 and 15 months</time_frame>
    <description>PrEP Norm Perceptions: 6 items in scale, items are averaged to determine score, with higher scores indicating more favorable norms&#xD;
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-Exposure Prophylaxis Intentions</measure>
    <time_frame>6 and 15 months</time_frame>
    <description>PrEP Intentions: 3 items in scale, items are averaged to determine score, with higher scores indicating greater intentions to use PrEP&#xD;
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-Exposure Prophylaxis Self-Efficacy</measure>
    <time_frame>6 and 15 months</time_frame>
    <description>PrEP Self-Efficacy: 8 items in scale, items are averaged to determine score, with higher scores indicating greater self-efficacy for PrEP use.&#xD;
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Human Immunodeficiency Virus</condition>
  <arm_group>
    <arm_group_label>Social Network Approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive brief HIV counseling at baseline visit.&#xD;
Leaders of social networks will be determined using data from participants. These leaders will then be invited to attend a 5-session small-group training that will teach them how to communicate the benefits of PrEP to their social network members.&#xD;
All social network members will be asked about intervention exposure at 6- and 15-month followups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive brief HIV counseling at baseline visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Network</intervention_name>
    <description>Leaders of social networks will be statistically determined. Over 5 small-group training sessions, these leaders will be trained to communicate to their social network members accurate information about PrEP and its availability; correct PrEP misconceptions and negative stereotypes; endorse PrEP use and its benefits; and strengthen friends' attitudes, intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV protective strategy.</description>
    <arm_group_label>Social Network Approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief HIV Prevention Counseling</intervention_name>
    <description>Participants will receive brief (15-minute) counseling on how to prevent HIV infection.</description>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_label>Social Network Approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        INDIVIDUALS:&#xD;
&#xD;
          1. Age 16 or older&#xD;
&#xD;
          2. For the seed only, self-report of HIV-negative serostatus or unknown serostatus&#xD;
&#xD;
          3. Except for the seed, being named as a friend by an already-enrolled participant&#xD;
&#xD;
          4. Male at birth&#xD;
&#xD;
          5. Sex with at least one male partner in the past 12 months&#xD;
&#xD;
        NETWORKS&#xD;
&#xD;
          1. More than 49% of the seed's eligible friends agree to participate&#xD;
&#xD;
          2. More than 49% of all network members self-report they are HIV-negative at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        INDIVIDUALS:&#xD;
&#xD;
          1. Age 15 or younger&#xD;
&#xD;
          2. For the seed only, self-report of HIV-positive serostatus&#xD;
&#xD;
          3. Except for the seed, not being named as a friend by an already-enrolled participant&#xD;
&#xD;
          4. Not male at birth&#xD;
&#xD;
          5. No report of sex with at least one male partner in the past 12 months&#xD;
&#xD;
        NETWORKS&#xD;
&#xD;
          1. Less than 50% of the seed's eligible friends agree to participate&#xD;
&#xD;
          2. Less than 50% of all network members self-report they are HIV-negative at baseline&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey A. Kelly, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yuri A. Amirkhanian, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AIDS TaskForce of Greater Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kelly JA. Ten Things We Need to Do to Achieve the Goals of the End the HIV Epidemic Plan for America. J Acquir Immune Defic Syndr. 2019 Dec 1;82 Suppl 2(2):S94-S98. doi: 10.1097/QAI.0000000000002166.</citation>
    <PMID>31658194</PMID>
  </results_reference>
  <results_reference>
    <citation>Quinn KG, Christenson E, Spector A, Amirkhanian Y, Kelly JA. The Influence of Peers on PrEP Perceptions and Use Among Young Black Gay, Bisexual, and Other Men Who Have Sex with Men: A Qualitative Examination. Arch Sex Behav. 2020 Aug;49(6):2129-2143. doi: 10.1007/s10508-019-01593-x. Epub 2020 Feb 3.</citation>
    <PMID>32016815</PMID>
  </results_reference>
  <results_reference>
    <citation>Kelly JA, Amirkhanian YA, Walsh JL, Brown KD, Quinn KG, Petroll AE, Pearson BM, Rosado AN, Ertl T. Social network intervention to increase pre-exposure prophylaxis (PrEP) awareness, interest, and use among African American men who have sex with men. AIDS Care. 2020 May;32(sup2):40-46. doi: 10.1080/09540121.2020.1739207. Epub 2020 Mar 13.</citation>
    <PMID>32167374</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Jeffrey Kelly</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pre-exposure prophylaxis (PrEP)</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>
  <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>April 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03823209/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/NCT03823209
org study id: PRO00029359
nct id: NCT03823209
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the use of a social-network approach to encourage African-American men
      who have sex with men (AAMSM) to adopt pre-exposure prophylaxis (PrEP) to prevent HIV
      infection. Thirty-six networks of AAMSM will be recruited in Milwaukee, WI, and Cleveland,
      OH. Half of these networks will have their leaders trained to endorse PrEP to their social
      network members, and the other half will be given brief HIV prevention counseling.
Pre-exposure prophylaxis (PrEP) regimens greatly reduce the likelihood that high-risk
      uninfected men who have sex with men (MSM) will contract HIV infection. Although this
      protective benefit has been unequivocally established in clinical trials, the number of
      high-risk men on PrEP remains far below the threshold needed to substantially reduce HIV
      incidence. This is especially true outside of the country's largest cities. Novel approaches
      are needed to increase PrEP use among high-risk racial minority MSM in these neglected
      cities.

      This study will recruit 36 sociocentric social networks of high-risk young racial minority
      MSM, 18 networks per city (total n=36 networks x 14 anticipated recruited members per network
      = 504 participants). Participants will complete measures assessing baseline PrEP use;
      knowledge, attitudes, perceived norms, intentions, and stage of readiness for PrEP; sexual
      risk practices and substance use; and prior or current ART use. Participants will also
      complete measures used to identify each network's leaders.

      Networks will be randomized in equal numbers in each city to comparison or intervention
      conditions. All study participants will receive individual baseline counseling about risk
      reduction and PrEP, with referral offered to clinics prescribing PrEP. Members of the 18
      experimental condition networks will also receive the social network PrEP intervention being
      tested in the study. In it, cadres of leaders in each network-selected based on their
      leadership position within the network and their own openness to PrEP-will attend a 5-session
      intervention that trains, engages, and supports network leaders in communicating to friends
      accurate information about PrEP and its availability; corrects PrEP misconceptions and
      negative stereotypes; endorses PrEP use and its benefits; and strengthens friends' attitudes,
      intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV
      protective strategy. Two additional booster sessions spaced monthly will support maintenance
      of leaders' efforts in talking with friends in their network about the benefits of PrEP, as
      well as where and how to access it.

      At 6- and 15-month followup points, all study participants will complete the same behavioral
      measures that were administered at baseline, as well as measures of intervention exposure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Self-report of pre-exposure prophylaxis (PrEP) use
time frame: 6 and 15 months
description: Change in self-reported PrEP use
measure: Pre-Exposure Prophylaxis (PrEP) Knowledge
time frame: 6 and 15 months
description: PrEP Knowledge: 13 items in scale, items are added to determine score, with higher scores indicating greater knowledge
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
measure: Pre-Exposure Prophylaxis Attitudes
time frame: 6 and 15 months
description: PrEP Attitudes: 5 items in scale, items are averaged to determine score, with higher scores indicating more positive attitudes
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
measure: Pre-Exposure Prophylaxis Norm Perceptions
time frame: 6 and 15 months
description: PrEP Norm Perceptions: 6 items in scale, items are averaged to determine score, with higher scores indicating more favorable norms
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
measure: Pre-Exposure Prophylaxis Intentions
time frame: 6 and 15 months
description: PrEP Intentions: 3 items in scale, items are averaged to determine score, with higher scores indicating greater intentions to use PrEP
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
measure: Pre-Exposure Prophylaxis Self-Efficacy
time frame: 6 and 15 months
description: PrEP Self-Efficacy: 8 items in scale, items are averaged to determine score, with higher scores indicating greater self-efficacy for PrEP use.
Scale taken from Walsh, J.L. (2018). Applying the Information-Motivation-Behavioral Skills Model to Understand PrEP Intentions and Use Among Men Who Have Sex with Men. AIDS and Behavior.
arm group label: Social Network Approach
arm group type: Experimental
description: Participants will receive brief HIV counseling at baseline visit.
Leaders of social networks will be determined using data from participants. These leaders will then be invited to attend a 5-session small-group training that will teach them how to communicate the benefits of PrEP to their social network members.
All social network members will be asked about intervention exposure at 6- and 15-month followups.
arm group label: Comparison
arm group type: Active Comparator
description: Participants will receive brief HIV counseling at baseline visit.
intervention type: Behavioral
intervention name: Social Network
description: Leaders of social networks will be statistically determined. Over 5 small-group training sessions, these leaders will be trained to communicate to their social network members accurate information about PrEP and its availability; correct PrEP misconceptions and negative stereotypes; endorse PrEP use and its benefits; and strengthen friends' attitudes, intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV protective strategy.
arm group label: Social Network Approach
intervention type: Behavioral
intervention name: Brief HIV Prevention Counseling
description: Participants will receive brief (15-minute) counseling on how to prevent HIV infection.
arm group label: Comparison
arm group label: Social Network Approach
criteria: 
gender: Male
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Jeffrey A. Kelly, PhD
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Yuri A. Amirkhanian, PhD
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
facility: 
country: United States
citation: Kelly JA. Ten Things We Need to Do to Achieve the Goals of the End the HIV Epidemic Plan for America. J Acquir Immune Defic Syndr. 2019 Dec 1;82 Suppl 2(2):S94-S98. doi: 10.1097/QAI.0000000000002166.
PMID: 31658194
citation: Quinn KG, Christenson E, Spector A, Amirkhanian Y, Kelly JA. The Influence of Peers on PrEP Perceptions and Use Among Young Black Gay, Bisexual, and Other Men Who Have Sex with Men: A Qualitative Examination. Arch Sex Behav. 2020 Aug;49(6):2129-2143. doi: 10.1007/s10508-019-01593-x. Epub 2020 Feb 3.
PMID: 32016815
citation: Kelly JA, Amirkhanian YA, Walsh JL, Brown KD, Quinn KG, Petroll AE, Pearson BM, Rosado AN, Ertl T. Social network intervention to increase pre-exposure prophylaxis (PrEP) awareness, interest, and use among African American men who have sex with men. AIDS Care. 2020 May;32(sup2):40-46. doi: 10.1080/09540121.2020.1739207. Epub 2020 Mar 13.
PMID: 32167374
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Jeffrey Kelly
investigator title: Professor
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No
provided document: 