<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/NCT03830567</url>
  </required_header>
  <id_info>
    <org_study_id>OHSU IRB 16158</org_study_id>
    <nct_id>NCT03830567</nct_id>
  </id_info>
  <brief_title>Pharmacists Expand Access to Reproductive heaLthcare</brief_title>
  <acronym>PEARL</acronym>
  <official_title>Pharmacists Expand Access to Reproductive Healthcare: Reducing Unintended Pregnancy Through Pharmacist Prescription of Contraception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laura and John Arnold Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</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>
      Prospective cohort study of women presenting to initiate hormonal contraception, prescribed&#xD;
      by a clinician or pharmacist. Women will be followed for one year to assess contraceptive&#xD;
      continuation and unintended pregnancy rates, as well as measures of safety and acceptability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Direct prescription of hormonal contraception (HC) by pharmacists, without a doctor's visit&#xD;
      or medical prescription, is a strategy to improve access to contraception and reduce&#xD;
      unintended pregnancy. Oregon is the first state in the nation to implement legislation, as of&#xD;
      January 1, 2016, expanding the scope of pharmacists to prescribe short-acting HCs. House Bill&#xD;
      (HB) 2879 allows pharmacists to directly prescribe HC including the patch and pill, without a&#xD;
      medical prescription. Women over 18 years of age can either initiate or continue HCs with a&#xD;
      pharmacist, and women under 18 can continue a prescription.&#xD;
&#xD;
      This prospective cohort study of women presenting to initiate hormonal contraception,&#xD;
      prescribed by a clinician or pharmacist, aims to determine contraceptive continuation and&#xD;
      incident pregnancy rates between women receiving hormonal contraception from a pharmacist&#xD;
      versus other prescriber. Women will be followed for one year to assess contraceptive&#xD;
      continuation and unintended pregnancy rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 27, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Actual">February 2, 2021</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>Contraceptive continuation rates</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of contraceptive continuation assessed through survey at 12 months among women who present for contraception in pharmacies.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">471</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Pharmacist prescription</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinician prescription</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacist prescription</intervention_name>
    <description>Pharmacist prescribed hormonal contraception (initiation or continuation).</description>
    <arm_group_label>Pharmacist prescription</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinician prescription</intervention_name>
    <description>Clinician prescribed hormonal contraception (initiation or continuation).</description>
    <arm_group_label>Clinician prescription</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women presenting to initiate hormonal contraception at a study pharmacy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women presenting to initiate hormonal contraception at a study pharmacy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindications to hormonal contraception&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Unable or unwilling to consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>51 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria I Rodriguez, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Maria Rodriguez, MD, MPH</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Hormonal Contraception</keyword>
  <keyword>Birth Control</keyword>
  <keyword>Pharmacists</keyword>
  <!-- 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/NCT03830567
org study id: OHSU IRB 16158
nct id: NCT03830567
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective cohort study of women presenting to initiate hormonal contraception, prescribed
      by a clinician or pharmacist. Women will be followed for one year to assess contraceptive
      continuation and unintended pregnancy rates, as well as measures of safety and acceptability.
Direct prescription of hormonal contraception (HC) by pharmacists, without a doctor's visit
      or medical prescription, is a strategy to improve access to contraception and reduce
      unintended pregnancy. Oregon is the first state in the nation to implement legislation, as of
      January 1, 2016, expanding the scope of pharmacists to prescribe short-acting HCs. House Bill
      (HB) 2879 allows pharmacists to directly prescribe HC including the patch and pill, without a
      medical prescription. Women over 18 years of age can either initiate or continue HCs with a
      pharmacist, and women under 18 can continue a prescription.

      This prospective cohort study of women presenting to initiate hormonal contraception,
      prescribed by a clinician or pharmacist, aims to determine contraceptive continuation and
      incident pregnancy rates between women receiving hormonal contraception from a pharmacist
      versus other prescriber. Women will be followed for one year to assess contraceptive
      continuation and unintended pregnancy rates.
observational model: Cohort
time perspective: Prospective
measure: Contraceptive continuation rates
time frame: 12 months
description: Percentage of contraceptive continuation assessed through survey at 12 months among women who present for contraception in pharmacies.
arm group label: Pharmacist prescription
arm group label: Clinician prescription
intervention type: Other
intervention name: Pharmacist prescription
description: Pharmacist prescribed hormonal contraception (initiation or continuation).
arm group label: Pharmacist prescription
intervention type: Other
intervention name: Clinician prescription
description: Clinician prescribed hormonal contraception (initiation or continuation).
arm group label: Clinician prescription
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 51 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria I Rodriguez, MD, MPH
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Maria Rodriguez, MD, MPH
investigator title: Associate Professor