<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/NCT03293290</url>
  </required_header>
  <id_info>
    <org_study_id>1606017882</org_study_id>
    <nct_id>NCT03293290</nct_id>
  </id_info>
  <brief_title>Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks</brief_title>
  <official_title>Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study has two components. The first component is designed to assess and compare the&#xD;
      awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal&#xD;
      justice (CJ) involved women. The second component is designed to evaluate the acceptability&#xD;
      and feasibility of strategically delivering PrEP to CJ involved women and their risk network&#xD;
      members.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Risk networks can be leveraged to maximally disseminate effective interventions to women,&#xD;
      including PrEP, and thereby potentially avert some of the 50,000 annual incident HIV&#xD;
      infections in the U.S. Few studies to date have capitalized on risk networks as a way to&#xD;
      identify and engage high-risk individuals, like CJ-involved women, who could markedly benefit&#xD;
      from PrEP. This study advances the field by: 1) Using an innovative network-based framework&#xD;
      (a non-traditional model of care delivery) to engage a high risk population in PrEP&#xD;
      dissemination as HIV prevention; 2) Incorporating a syndemic approach to PrEP that addresses&#xD;
      HIV prevention in the context of substance use, psychiatric comorbidities, IPV, and stigma;&#xD;
      and 3) Recruiting, enrolling, and retaining high risk networks of CJ-involved women who are&#xD;
      difficult to reach by other means. In doing so, this proposal addresses key funding&#xD;
      priorities of the Gilead Investigator Sponsored Research program, which includes research on&#xD;
      PrEP implementation targeted to high risk populations and delivered in non-traditional&#xD;
      clinical settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2017</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% PrEP uptake</measure>
    <time_frame>Month 1</time_frame>
    <description># starting PrEP/ # enrolled subjects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>% eligible PrEP uptake</measure>
    <time_frame>Month 1</time_frame>
    <description># starting PrEP/ # eligible subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean % PrEP adherence</measure>
    <time_frame>12 months</time_frame>
    <description># PrEP pills taken/# PrEP pills prescribed per month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean TDF level</measure>
    <time_frame>12 months</time_frame>
    <description>TDF level by dried blood spot testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV incidence</measure>
    <time_frame>12 months</time_frame>
    <description>New HIV+ by 4th generation HIV Ag/Ab testing</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>PrEP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For participants who are eligible for PrEP and willing to participate, subjects on PrEP will be followed for 1 year with quarterly assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PrEP</intervention_name>
    <description>Subjects on PrEP will be followed for 1 year with quarterly assessments by trained research assistants. Study visits will take place at in New Haven and Hartford. At every scheduled visit, participants will receive a comprehensive package of preventive services, including a prescription for the next 30-day supply of TDF/FTC (with 2 refills), a symptom screen for acute HIV, risk-reduction counseling, PrEP adherence support, bleach for cleaning injection equipment, and condoms. HIV rapid testing with Orasure® will be performed quarterly; participants testing newly positive for HIV (representing seroconversions) will be followed with confirmatory testing and referred to care as needed.</description>
    <arm_group_label>PrEP</arm_group_label>
    <other_name>TDF/FTC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Index participants reside in, or planning to reside in New Haven or Hartford,&#xD;
             Connecticut,.&#xD;
&#xD;
          -  Criminal justice-involved (anticipate release or have been released from prison or&#xD;
             jail within 6 months, and/or are under or anticipating transfer to correctional&#xD;
             community supervision (i.e. probation or parole)).&#xD;
&#xD;
          -  Self-reported HIV negative.&#xD;
&#xD;
        Eligible and enrolled women will then recruit risk network members through respondent&#xD;
        driven sampling, using vouchers.&#xD;
&#xD;
        Risk network members must:&#xD;
&#xD;
          -  have a unique and valid referral coupon (from Index participant).&#xD;
&#xD;
          -  Reside or planning to reside in New Haven or Hartford, Connecticut.&#xD;
&#xD;
          -  Self-reported HIV negative&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They are unable or unwilling to provide informed consent.&#xD;
&#xD;
          -  Are threatening to staff.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Cis- or trans- female participants are eligible.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaimie Meyer, MD, MS, FACP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Clinical and Community Research, 270 Congress Ave</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV pre-exposure prophylaxis</keyword>
  <keyword>criminal justice</keyword>
  <keyword>women</keyword>
  <keyword>risk networks</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT03293290
org study id: 1606017882
nct id: NCT03293290
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study has two components. The first component is designed to assess and compare the
      awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal
      justice (CJ) involved women. The second component is designed to evaluate the acceptability
      and feasibility of strategically delivering PrEP to CJ involved women and their risk network
      members.
Risk networks can be leveraged to maximally disseminate effective interventions to women,
      including PrEP, and thereby potentially avert some of the 50,000 annual incident HIV
      infections in the U.S. Few studies to date have capitalized on risk networks as a way to
      identify and engage high-risk individuals, like CJ-involved women, who could markedly benefit
      from PrEP. This study advances the field by: 1) Using an innovative network-based framework
      (a non-traditional model of care delivery) to engage a high risk population in PrEP
      dissemination as HIV prevention; 2) Incorporating a syndemic approach to PrEP that addresses
      HIV prevention in the context of substance use, psychiatric comorbidities, IPV, and stigma;
      and 3) Recruiting, enrolling, and retaining high risk networks of CJ-involved women who are
      difficult to reach by other means. In doing so, this proposal addresses key funding
      priorities of the Gilead Investigator Sponsored Research program, which includes research on
      PrEP implementation targeted to high risk populations and delivered in non-traditional
      clinical settings.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: % PrEP uptake
time frame: Month 1
description: # starting PrEP/ # enrolled subjects
measure: % eligible PrEP uptake
time frame: Month 1
description: # starting PrEP/ # eligible subjects
measure: Mean % PrEP adherence
time frame: 12 months
description: # PrEP pills taken/# PrEP pills prescribed per month
measure: Mean TDF level
time frame: 12 months
description: TDF level by dried blood spot testing
measure: HIV incidence
time frame: 12 months
description: New HIV+ by 4th generation HIV Ag/Ab testing
arm group label: PrEP
arm group type: Experimental
description: For participants who are eligible for PrEP and willing to participate, subjects on PrEP will be followed for 1 year with quarterly assessments.
intervention type: Drug
intervention name: PrEP
description: Subjects on PrEP will be followed for 1 year with quarterly assessments by trained research assistants. Study visits will take place at in New Haven and Hartford. At every scheduled visit, participants will receive a comprehensive package of preventive services, including a prescription for the next 30-day supply of TDF/FTC (with 2 refills), a symptom screen for acute HIV, risk-reduction counseling, PrEP adherence support, bleach for cleaning injection equipment, and condoms. HIV rapid testing with Orasure® will be performed quarterly; participants testing newly positive for HIV (representing seroconversions) will be followed with confirmatory testing and referred to care as needed.
arm group label: PrEP
other name: TDF/FTC
criteria: 
gender: Female
gender based: Yes
gender description: Cis- or trans- female participants are eligible.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jaimie Meyer, MD, MS, FACP
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: HIV Infections