<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/NCT03775083</url>
  </required_header>
  <id_info>
    <org_study_id>HFC018001</org_study_id>
    <nct_id>NCT03775083</nct_id>
  </id_info>
  <brief_title>What Happens in Vegas: PEP to PrEP Opportunities</brief_title>
  <official_title>What Happens in Vegas: Identifying Opportunities to Expand an HIV Prevention Network to Improve PEP and PrEP Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huntridge Family Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huntridge Family Clinic</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>
      Observational study looking at barriers to care for individuals seeking care, Post Exposure&#xD;
      Prophylaxis (PEP) after an actual or perceived exposure to HIV. Following PEP treatment&#xD;
      subjects will be asked about there intent to transition to Pre-Exposure Prophylaxis (PrEP)&#xD;
      and surveyed about barriers to care or perceptions of care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to assess the rate of engagement in a PEP to PrEP HIV&#xD;
      provider network for those patients presenting following a non-occupational HIV exposure.&#xD;
&#xD;
      The development of a referral network and intensive clinical follow up of PEP patients will&#xD;
      result in more patients appropriately initiating PEP, being referred to appropriate follow&#xD;
      up, and post exposure transition and maintaining on PrEP (if indicated) at completion of the&#xD;
      PEP medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>rate of engagement</measure>
    <time_frame>from enrollment to day 90</time_frame>
    <description>Assess the rate of engagement in a PEP to PrEP HIV prevention provider network for those patients presenting following a non-occupational HIV exposure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>characteristics</measure>
    <time_frame>from enrollment through end of study for all participants</time_frame>
    <description>Describe the characteristics of patients successfully engaging in HIV prevention via a patient collected survey using a qualtric survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>barriers</measure>
    <time_frame>from enrollment through end of study for all participants</time_frame>
    <description>Identify and assess barriers to access to HIV prevention care including PEP in the period immediately following HIV exposure from a patient collected survey using a qualtric survey tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Network characteristics</measure>
    <time_frame>from enrollment through end of study for all participants</time_frame>
    <description>Analyze the network characteristics that faciliate engagement in HIV prevention services from a patient collected survey using a qualtric survey tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transition barriers</measure>
    <time_frame>from enrollment through end of study for all participants</time_frame>
    <description>Determine and assess to transitioning from PEP to PrEP from a patient collected survey using a qualtric survey tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>from enrollment through end of study for all participants</time_frame>
    <description>Compare and contrast the barriers to access and ongoing retention to PrEP from a patient collected survey using a qualtric survey tool.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Exposure to Human Immunodeficiency Virus (Event)</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Currently approved medications</intervention_name>
    <description>subjects will be treated according to current Department of Health and Human Services (DHHS) Center for Disease control and prevention (CDC), Society for Healthcare Epidemiology of American (SHEA guidelines for nPEP</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HIV negative Men, Women, Transgender Men, Transgender Women age who self identify as having&#xD;
        had an actual or perceived non-occupational exposure to HIV&#xD;
&#xD;
        HIV negative Men, Women, Transgender Men, Transgender Women age who self identify at risk&#xD;
        of acquisition of HIV after having had an actual or perceived non-occupational exposure to&#xD;
        HIV&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Actual or perceived non-occupational exposure to HIV, by self report, within 72 hours&#xD;
             of enrollment and referred for care&#xD;
&#xD;
          -  able and willing to provide informed consent&#xD;
&#xD;
          -  available for 12 months of post expoure follow-up Southern Nevada Ryan White defined&#xD;
             service area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV+ at time of screeing via 4th genderation (Antibody/Antigen) testing&#xD;
&#xD;
          -  Current PEP and/or PrEP product condrainidications as listed in the medication product&#xD;
             insert.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>John (Rob) Phoenix, MSN, APRN</last_name>
    <phone>702-979-1111</phone>
    <email>jphoenixaprn@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christina Madison, PharmD</last_name>
    <phone>702-968-2044</phone>
    <email>cmadison@roseman.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Huntridge Family Clinic</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John (Rob) Phoenix, APRN</last_name>
      <phone>702-979-1111</phone>
      <email>jphoenixaprn@gmail.com</email>
    </contact>
    <investigator>
      <last_name>John Phoenix, APRN</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christina Madison, PharmD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huntridge Family Clinic</investigator_affiliation>
    <investigator_full_name>John Phoenix</investigator_full_name>
    <investigator_title>Clinical Director</investigator_title>
  </responsible_party>
  <keyword>PEP</keyword>
  <keyword>nPEP</keyword>
  <keyword>Post Exposure Prophylaxis</keyword>
  <keyword>non occupational exposure to HIV</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>
  <!-- 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/NCT03775083
org study id: HFC018001
nct id: NCT03775083
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Observational study looking at barriers to care for individuals seeking care, Post Exposure
      Prophylaxis (PEP) after an actual or perceived exposure to HIV. Following PEP treatment
      subjects will be asked about there intent to transition to Pre-Exposure Prophylaxis (PrEP)
      and surveyed about barriers to care or perceptions of care
The primary objective of this study is to assess the rate of engagement in a PEP to PrEP HIV
      provider network for those patients presenting following a non-occupational HIV exposure.

      The development of a referral network and intensive clinical follow up of PEP patients will
      result in more patients appropriately initiating PEP, being referred to appropriate follow
      up, and post exposure transition and maintaining on PrEP (if indicated) at completion of the
      PEP medications.
observational model: Cohort
time perspective: Prospective
measure: rate of engagement
time frame: from enrollment to day 90
description: Assess the rate of engagement in a PEP to PrEP HIV prevention provider network for those patients presenting following a non-occupational HIV exposure
measure: characteristics
time frame: from enrollment through end of study for all participants
description: Describe the characteristics of patients successfully engaging in HIV prevention via a patient collected survey using a qualtric survey.
measure: barriers
time frame: from enrollment through end of study for all participants
description: Identify and assess barriers to access to HIV prevention care including PEP in the period immediately following HIV exposure from a patient collected survey using a qualtric survey tool
measure: Network characteristics
time frame: from enrollment through end of study for all participants
description: Analyze the network characteristics that faciliate engagement in HIV prevention services from a patient collected survey using a qualtric survey tool
measure: transition barriers
time frame: from enrollment through end of study for all participants
description: Determine and assess to transitioning from PEP to PrEP from a patient collected survey using a qualtric survey tool
measure: Retention
time frame: from enrollment through end of study for all participants
description: Compare and contrast the barriers to access and ongoing retention to PrEP from a patient collected survey using a qualtric survey tool.
intervention type: Drug
intervention name: Currently approved medications
description: subjects will be treated according to current Department of Health and Human Services (DHHS) Center for Disease control and prevention (CDC), Society for Healthcare Epidemiology of American (SHEA guidelines for nPEP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John (Rob) Phoenix, MSN, APRN
phone: 702-979-1111
email: jphoenixaprn@gmail.com
last name: Christina Madison, PharmD
phone: 702-968-2044
email: cmadison@roseman.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Huntridge Family Clinic
investigator full name: John Phoenix
investigator title: Clinical Director
mesh term: Acquired Immunodeficiency Syndrome
mesh term: HIV Infections
sharing ipd: No