<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/NCT01665690</url>
  </required_header>
  <id_info>
    <org_study_id>29923-J</org_study_id>
    <secondary_id>5R01AI068107</secondary_id>
    <nct_id>NCT01665690</nct_id>
  </id_info>
  <brief_title>Washington State Community Expedited Partner Treatment (EPT) Trial</brief_title>
  <official_title>A Community-level RCT of Expedited Partner Treatment for Gonorrhea and Chlamydia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington State, Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Washington State Community Expedited Partner Therapy Trial is a stepped-wedge community&#xD;
      level randomized trial designed to test the hypothesis that a public health program designed&#xD;
      to increase the use of expedited partner therapy can decrease the prevalence of chlamydial&#xD;
      infection in young women and the incidence of gonorrhea in Washington state. The study&#xD;
      intervention will be modeled after and intervention previously evaluated in King County WA&#xD;
      (Golden MR, Sex Transm Dis 2007;598-603). The intervention has two components: 1) promotion&#xD;
      of patient delivered partner therapy (PDPT) use by medical providers in accordance with&#xD;
      Washington state guidelines; and 2) targeted provision of partner services. PDPT use will be&#xD;
      promoted through education and by making medication packs for PDPT available statewide.&#xD;
      Medical providers will refer selected persons with gonorrhea or chlamydial infection for&#xD;
      partner services based on defined criteria associated with failure to ensure partners'&#xD;
      treatment. The intervention will be instituted in four waves separated by 6-9 months. Each&#xD;
      wave will include approximately 6 local health jurisdictions. The order in which health&#xD;
      jurisdictions initiate the intervention will be randomly assigned. The study's primary&#xD;
      endpoint will be the prevalence of chlamydial infection in women age 15-25 tested through&#xD;
      clinics participating in the state's Infertility Prevention Project (IPP) and the incidence&#xD;
      of gonorrhea among women as determined through public health reporting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2007</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test positivity for Chlamydia trachomatis among women age 15-25</measure>
    <time_frame>October 2006 - December 2010</time_frame>
    <description>The proportion of women age 15-25 testing positive for C. trachomatis in clinics participating in the WA State Infertility Prevention Project (IPP). Outcomes will be ascertained during five specified 3 month time periods occuring prior to the initiation of the study intervention in the four successive study waves and at the end of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gonorrhea incidence in women</measure>
    <time_frame>October 2007-December 2010</time_frame>
    <description>The incidence of gonorrhea in women in WA state local health jurisdictions as ascertained through public health reporting. Outcomes will be ascertained during five specified 3 month time periods occuring prior to the initiation of the study intervention in the four successive study waves and at the end of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of recurrent gonorrhea</measure>
    <time_frame>October 2007-Dec 2010</time_frame>
    <description>Proportion of men and women with a second episode of gonorrhea occuring within 6 months of their initial diagnosis as ascertained through public health surveillance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent chlamydial infection</measure>
    <time_frame>October 2006 - December 2010</time_frame>
    <description>Proportion of men and women with a second episode of chlamydial infection occuring within 6 months of their initial diagnosis as ascertained through public health surveillance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported adverse drug reactions</measure>
    <time_frame>July 2007-December 2010</time_frame>
    <description>Adverse drug reactions reported to study staff following ingestion of medication supplied at patient delivered partner therapy. Outcome ascertained through passive surveillance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of patient delivered partner therapy (PDPT) by medical providers</measure>
    <time_frame>July 2007 - December 2010</time_frame>
    <description>Proportion of persons with gonorrhea or chlamydial infection receiving PDPT from their diagnosing medical provider, excluding men who have sex with men</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33222</enrollment>
  <condition>Gonorrhea</condition>
  <condition>Neisseria Gonorrhoeae</condition>
  <condition>Chlamydia Trachomatis</condition>
  <arm_group>
    <arm_group_label>Intervention period</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study will include 23 WA state local health jurisdictions (LHJ). Each LHJ will be a randomized unit and a unit in which we will measure outcomes. (LHJs are governmental administrative units that usually correspond with a county.) Because this is a stepped-wedge randomized trial, the study will have two groups (intervention and control). However, each LHJ will be in both groups depending on the time period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Period</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The study will include 23 WA state local health jurisdictions (LHJ). Each LHJ will be a randomized unit and a unit in which we will measure outcomes. (LHJs are governmental administrative units that usually correspond with a county.) Because this is a stepped-wedge randomized trial, the study will have two groups (intervention and control). However, each LHJ will be in both groups depending on the time period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient delivered partner therapy</intervention_name>
    <description>The study will provide communities with access to free PDPT for heterosexuals with gonorrhea or chlamydial infection. PDPT will be packaged to meet the requirements of the WA State Board of Pharmacy and will include 1gram of azithromycin, information about STD, condoms, and information about enclosed medication in English and Spanish. PDPT packs for gonorrhea will also include 400mg of cefixime.</description>
    <arm_group_label>Intervention period</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Targeted public health partner services</intervention_name>
    <description>During intervention periods, communities will receive public health partner services (PS) provided by Disease Intervention Specialists (DIS). Diagnosing clinicians will triage their patients to receive PS based on defined criteria associated with not ensuring partners' treatment. PS will include an offer to notify partners for each index case. When DIS notify partners they will offer them the opportunity to obtain free medication at a local pharmacy, at a clinic (as available) or through the mail. DIS will also offer to refer partners for complete evaluations insofar as such care is available in local communities.</description>
    <arm_group_label>Intervention period</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        With reference to the above question about sampling, we will measure PDPT use in a&#xD;
        probability sample of persons with STD. Chlamydial prevalence will be measured in a&#xD;
        sentinel population. Gonorrhea incidence will be based on public health surveillance.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  All non-MSM with gonorrhea or chlamydial infection will be eligible for the study&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MSM&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Golden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington State Department of Health</name>
      <address>
        <city>Olympia</city>
        <state>Washington</state>
        <zip>98504-7890</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Golden MR, Hughes JP, Brewer DD, Holmes KK, Whittington WL, Hogben M, Malinski C, Golding A, Handsfield HH. Evaluation of a population-based program of expedited partner therapy for gonorrhea and chlamydial infection. Sex Transm Dis. 2007 Aug;34(8):598-603. doi: 10.1097/01.olq.0000258319.54316.06.</citation>
    <PMID>17413683</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 15, 2012</last_update_submitted>
  <last_update_submitted_qc>August 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Matthew Golden</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>patient delivered partner therapy</keyword>
  <keyword>expedited partner therapy</keyword>
  <keyword>partner notification</keyword>
  <keyword>gonorrhea</keyword>
  <keyword>chlamydia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlamydia Infections</mesh_term>
    <mesh_term>Gonorrhea</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/NCT01665690
org study id: 29923-J
secondary id: 5R01AI068107
nct id: NCT01665690
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The Washington State Community Expedited Partner Therapy Trial is a stepped-wedge community
      level randomized trial designed to test the hypothesis that a public health program designed
      to increase the use of expedited partner therapy can decrease the prevalence of chlamydial
      infection in young women and the incidence of gonorrhea in Washington state. The study
      intervention will be modeled after and intervention previously evaluated in King County WA
      (Golden MR, Sex Transm Dis 2007;598-603). The intervention has two components: 1) promotion
      of patient delivered partner therapy (PDPT) use by medical providers in accordance with
      Washington state guidelines; and 2) targeted provision of partner services. PDPT use will be
      promoted through education and by making medication packs for PDPT available statewide.
      Medical providers will refer selected persons with gonorrhea or chlamydial infection for
      partner services based on defined criteria associated with failure to ensure partners'
      treatment. The intervention will be instituted in four waves separated by 6-9 months. Each
      wave will include approximately 6 local health jurisdictions. The order in which health
      jurisdictions initiate the intervention will be randomly assigned. The study's primary
      endpoint will be the prevalence of chlamydial infection in women age 15-25 tested through
      clinics participating in the state's Infertility Prevention Project (IPP) and the incidence
      of gonorrhea among women as determined through public health reporting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Test positivity for Chlamydia trachomatis among women age 15-25
time frame: October 2006 - December 2010
description: The proportion of women age 15-25 testing positive for C. trachomatis in clinics participating in the WA State Infertility Prevention Project (IPP). Outcomes will be ascertained during five specified 3 month time periods occuring prior to the initiation of the study intervention in the four successive study waves and at the end of the study.
measure: Gonorrhea incidence in women
time frame: October 2007-December 2010
description: The incidence of gonorrhea in women in WA state local health jurisdictions as ascertained through public health reporting. Outcomes will be ascertained during five specified 3 month time periods occuring prior to the initiation of the study intervention in the four successive study waves and at the end of the study.
measure: Rates of recurrent gonorrhea
time frame: October 2007-Dec 2010
description: Proportion of men and women with a second episode of gonorrhea occuring within 6 months of their initial diagnosis as ascertained through public health surveillance
measure: Recurrent chlamydial infection
time frame: October 2006 - December 2010
description: Proportion of men and women with a second episode of chlamydial infection occuring within 6 months of their initial diagnosis as ascertained through public health surveillance
measure: Reported adverse drug reactions
time frame: July 2007-December 2010
description: Adverse drug reactions reported to study staff following ingestion of medication supplied at patient delivered partner therapy. Outcome ascertained through passive surveillance.
measure: Use of patient delivered partner therapy (PDPT) by medical providers
time frame: July 2007 - December 2010
description: Proportion of persons with gonorrhea or chlamydial infection receiving PDPT from their diagnosing medical provider, excluding men who have sex with men
arm group label: Intervention period
arm group type: Experimental
description: The study will include 23 WA state local health jurisdictions (LHJ). Each LHJ will be a randomized unit and a unit in which we will measure outcomes. (LHJs are governmental administrative units that usually correspond with a county.) Because this is a stepped-wedge randomized trial, the study will have two groups (intervention and control). However, each LHJ will be in both groups depending on the time period.
arm group label: Control Period
arm group type: No Intervention
description: The study will include 23 WA state local health jurisdictions (LHJ). Each LHJ will be a randomized unit and a unit in which we will measure outcomes. (LHJs are governmental administrative units that usually correspond with a county.) Because this is a stepped-wedge randomized trial, the study will have two groups (intervention and control). However, each LHJ will be in both groups depending on the time period.
intervention type: Other
intervention name: Patient delivered partner therapy
description: The study will provide communities with access to free PDPT for heterosexuals with gonorrhea or chlamydial infection. PDPT will be packaged to meet the requirements of the WA State Board of Pharmacy and will include 1gram of azithromycin, information about STD, condoms, and information about enclosed medication in English and Spanish. PDPT packs for gonorrhea will also include 400mg of cefixime.
arm group label: Intervention period
intervention type: Behavioral
intervention name: Targeted public health partner services
description: During intervention periods, communities will receive public health partner services (PS) provided by Disease Intervention Specialists (DIS). Diagnosing clinicians will triage their patients to receive PS based on defined criteria associated with not ensuring partners' treatment. PS will include an offer to notify partners for each index case. When DIS notify partners they will offer them the opportunity to obtain free medication at a local pharmacy, at a clinic (as available) or through the mail. DIS will also offer to refer partners for complete evaluations insofar as such care is available in local communities.
arm group label: Intervention period
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Golden, MD
role: Principal Investigator
affiliation: University of Washington
facility: 
facility: 
country: United States
citation: Golden MR, Hughes JP, Brewer DD, Holmes KK, Whittington WL, Hogben M, Malinski C, Golding A, Handsfield HH. Evaluation of a population-based program of expedited partner therapy for gonorrhea and chlamydial infection. Sex Transm Dis. 2007 Aug;34(8):598-603. doi: 10.1097/01.olq.0000258319.54316.06.
PMID: 17413683
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Matthew Golden
investigator title: Professor
mesh term: Chlamydia Infections
mesh term: Gonorrhea