<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/NCT03246815</url>
  </required_header>
  <id_info>
    <org_study_id>PRO14110416</org_study_id>
    <nct_id>NCT03246815</nct_id>
  </id_info>
  <brief_title>STD Testing in Outpatient Practices</brief_title>
  <acronym>STOP</acronym>
  <official_title>STD Testing in Outpatient Practices-The STOP STDs Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CDC Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for&#xD;
      sexually active young women under the age of 25. Despite these recommendations, many young&#xD;
      women are not being screened for STDs, with some estimates that less than 50% of women&#xD;
      receiving health care are screened for chlamydia. Untreated STDs can lead to important&#xD;
      sequelae to women's reproductive health including pelvic inflammatory disease, infertility&#xD;
      and ectopic pregnancy. One of the most important barriers to widespread STD screening is&#xD;
      provider failure to recognize an opportunity for STD screening. The goal of this study is to&#xD;
      determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member&#xD;
      of the medical practice (who receives an automated alert indicating STD screening should be&#xD;
      offered) will be associated with a higher rate of STD screening in young women attending&#xD;
      primary care practices compared to usual care (where a physician offers screening with no&#xD;
      electronic alert). This study will be performed in UPMC-affiliated primary care practices&#xD;
      (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the&#xD;
      intervention or usual care. The intervention will be an auto-task in the electronic medical&#xD;
      record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer&#xD;
      chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out&#xD;
      manner, to eligible women. Practices assigned to the usual care group will not have the&#xD;
      intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be&#xD;
      compared between the to groups (intervention practices and control practices). Results of&#xD;
      this study may be important to guide national STD screening recommendations and will address&#xD;
      critical barriers to widespread STD screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of STD Screening</measure>
    <time_frame>Day 1</time_frame>
    <description>Rate of screening (Chlamydia and Gonorrhea) in young women attending primary care practices</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Chlamydia and Gonorrhea infections identified</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">6771</enrollment>
  <condition>STD</condition>
  <arm_group>
    <arm_group_label>universal opt-out screening for STDs</arm_group_label>
    <description>Patients who present to primary care practices who employee a universal opt-out strategy to medical assistants or nurses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without universal opt-out screening for STDs</arm_group_label>
    <description>Patients who present to primary care practices who do not employee a universal opt-out strategy to medical assistants or nurses</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Young women at risk for STDs&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women ages 15-24 Sexually Active Receiving care in one of the primary care offices&#xD;
        affiliated with UPMC selected for this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Harold C Wiesenfeld, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee-Womens Hospital of UPMC/associated community clinics</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 9, 2021</last_update_submitted>
  <last_update_submitted_qc>March 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Harold Wiesenfeld</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03246815
org study id: PRO14110416
nct id: NCT03246815
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
National guidelines have recommended routine STD screening (chlamydia and gonorrhea) for
      sexually active young women under the age of 25. Despite these recommendations, many young
      women are not being screened for STDs, with some estimates that less than 50% of women
      receiving health care are screened for chlamydia. Untreated STDs can lead to important
      sequelae to women's reproductive health including pelvic inflammatory disease, infertility
      and ectopic pregnancy. One of the most important barriers to widespread STD screening is
      provider failure to recognize an opportunity for STD screening. The goal of this study is to
      determine whether offering STD screening (chlamydia and gonorrhea) by a non-physician member
      of the medical practice (who receives an automated alert indicating STD screening should be
      offered) will be associated with a higher rate of STD screening in young women attending
      primary care practices compared to usual care (where a physician offers screening with no
      electronic alert). This study will be performed in UPMC-affiliated primary care practices
      (Family Practice, Internal Medicine, OB/GYN, Pediatrics). Practices will be assigned to the
      intervention or usual care. The intervention will be an auto-task in the electronic medical
      record to the non-physician/NP/PA medical staff (medical assistants, LPNs, RNs) to offer
      chlamydia and gonorrhea screening via urine or self-collected vaginal sampling, in an opt-out
      manner, to eligible women. Practices assigned to the usual care group will not have the
      intervention. STD screening rates (# women undergoing STD screening/# eligible women) will be
      compared between the to groups (intervention practices and control practices). Results of
      this study may be important to guide national STD screening recommendations and will address
      critical barriers to widespread STD screening.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Rate of STD Screening
time frame: Day 1
description: Rate of screening (Chlamydia and Gonorrhea) in young women attending primary care practices
measure: Number of Chlamydia and Gonorrhea infections identified
time frame: Day 1
arm group label: universal opt-out screening for STDs
description: Patients who present to primary care practices who employee a universal opt-out strategy to medical assistants or nurses
arm group label: without universal opt-out screening for STDs
description: Patients who present to primary care practices who do not employee a universal opt-out strategy to medical assistants or nurses
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 15 Years
maximum age: 24 Years
last name: Harold C Wiesenfeld, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Harold Wiesenfeld
investigator title: Principal Investigator