<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/NCT03778164</url>
  </required_header>
  <id_info>
    <org_study_id>R01MH115835</org_study_id>
    <nct_id>NCT03778164</nct_id>
  </id_info>
  <brief_title>Improving Prevention Systems to Reduce Disparities for High Priority Populations</brief_title>
  <acronym>FastTrack</acronym>
  <official_title>Improving Prevention Systems to Reduce Disparities for High Priority Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hunter College of City University of New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hunter College of City University of New York</source>
  <oversight_info>
    <has_dmc>Yes</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 project collaborates with the New York City Department of Health and Mental Hygiene (NYC&#xD;
      DOHMH) to develop and test a field-based comprehensive sexual health intervention for&#xD;
      HIV-exposed contacts notified by its Partner Services (i.e., HIV contact tracing) program.&#xD;
      The goal of the study is to develop and test the impact of this new intervention on improving&#xD;
      rates of HIV testing, linkage to HIV prevention/care, and PrEP uptake among highest risk&#xD;
      contacts recently exposed to HIV. We will conduct a 6-month pilot project, followed by a&#xD;
      cross-sectional stepped wedge cluster randomized trial in which 12 clusters of NYC&#xD;
      neighborhoods are exposed to the intervention sequentially, with three clusters moving from&#xD;
      control to intervention every 6 months (n = 1150). Primary outcomes are HIV testing, timely&#xD;
      PrEP/ARV uptake, and linkage to PrEP/HIV care. Secondary outcomes are STD testing and receipt&#xD;
      of STD treatment (if indicated).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 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>
    <intervention_model_description>This study uses a cross sectional stepped wedge cluster randomized design</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptance of HIV Testing</measure>
    <time_frame>1 month</time_frame>
    <description>Whether or not contacts offered testing by the Partner Services program accept HIV testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PrEP/ARV Initiation</measure>
    <time_frame>3 months</time_frame>
    <description>Whether or not contacts start ARV medication in the field or at their referral visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Linkage to PrEP/HIV Care</measure>
    <time_frame>6 months</time_frame>
    <description>Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>STI testing</measure>
    <time_frame>3 months</time_frame>
    <description>Whether or not contacts accept STI testing in the field or at their referral visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1150</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Fast Track Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm refers to the new Partner Services-Sexual Health intervention offered to contacts by the Partner Services program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm refers to the current standard practice for partners contacted by the Partner Services program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fast Track Partner Services-Sexual Health Intervention</intervention_name>
    <description>The Partner Services-Sexual Health Intervention enhances the current standard of care by introducing four service innovations to the DOHMH Partner Services program: (1) enhanced field-based combination HIV and STI testing; (2) immediate field-based ARV/PrEP start; (3) navigation to a sexual health clinic for test results and treatment; and (4) enhanced linkage support to facilitate ongoing PrEP or HIV care.</description>
    <arm_group_label>Fast Track Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Partner Services Standard of Care</intervention_name>
    <description>Participants in neighborhoods that have not yet been assigned to the intervention condition in the stepped wedge trial will receive standard Partner Services components, including field-based HIV testing and referral to clinical sites for HIV prevention or treatment.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Contacts referred to the Partner Services program during the study time period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sarit A Golub, PhD, MPH</last_name>
    <phone>212.396.6304</phone>
    <email>sarit.golub@hunter.cuny.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hunter College of CUNY</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarit A Golub</last_name>
      <phone>121-396-6304</phone>
      <email>sgolub@hunter.cuny.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hunter College of City University of New York</investigator_affiliation>
    <investigator_full_name>Sarit Golub</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03778164
org study id: R01MH115835
nct id: NCT03778164
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This project collaborates with the New York City Department of Health and Mental Hygiene (NYC
      DOHMH) to develop and test a field-based comprehensive sexual health intervention for
      HIV-exposed contacts notified by its Partner Services (i.e., HIV contact tracing) program.
      The goal of the study is to develop and test the impact of this new intervention on improving
      rates of HIV testing, linkage to HIV prevention/care, and PrEP uptake among highest risk
      contacts recently exposed to HIV. We will conduct a 6-month pilot project, followed by a
      cross-sectional stepped wedge cluster randomized trial in which 12 clusters of NYC
      neighborhoods are exposed to the intervention sequentially, with three clusters moving from
      control to intervention every 6 months (n = 1150). Primary outcomes are HIV testing, timely
      PrEP/ARV uptake, and linkage to PrEP/HIV care. Secondary outcomes are STD testing and receipt
      of STD treatment (if indicated).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study uses a cross sectional stepped wedge cluster randomized design
primary purpose: Health Services Research
masking: None (Open Label)
measure: Acceptance of HIV Testing
time frame: 1 month
description: Whether or not contacts offered testing by the Partner Services program accept HIV testing
measure: PrEP/ARV Initiation
time frame: 3 months
description: Whether or not contacts start ARV medication in the field or at their referral visit
measure: Linkage to PrEP/HIV Care
time frame: 6 months
description: Whether or not contacts attend their navigation visit to receive ongoing PrEP or HIV services
measure: STI testing
time frame: 3 months
description: Whether or not contacts accept STI testing in the field or at their referral visit
arm group label: Fast Track Intervention
arm group type: Experimental
description: This arm refers to the new Partner Services-Sexual Health intervention offered to contacts by the Partner Services program
arm group label: Standard of Care
arm group type: Active Comparator
description: This arm refers to the current standard practice for partners contacted by the Partner Services program
intervention type: Other
intervention name: Fast Track Partner Services-Sexual Health Intervention
description: The Partner Services-Sexual Health Intervention enhances the current standard of care by introducing four service innovations to the DOHMH Partner Services program: (1) enhanced field-based combination HIV and STI testing; (2) immediate field-based ARV/PrEP start; (3) navigation to a sexual health clinic for test results and treatment; and (4) enhanced linkage support to facilitate ongoing PrEP or HIV care.
arm group label: Fast Track Intervention
intervention type: Other
intervention name: Partner Services Standard of Care
description: Participants in neighborhoods that have not yet been assigned to the intervention condition in the stepped wedge trial will receive standard Partner Services components, including field-based HIV testing and referral to clinical sites for HIV prevention or treatment.
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sarit A Golub, PhD, MPH
phone: 212.396.6304
email: sarit.golub@hunter.cuny.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Hunter College of City University of New York
investigator full name: Sarit Golub
investigator title: Professor
mesh term: HIV Infections