<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/NCT03230578</url>
  </required_header>
  <id_info>
    <org_study_id>17-237</org_study_id>
    <nct_id>NCT03230578</nct_id>
  </id_info>
  <brief_title>Perspectives on Prescribing Hormonal Contraception Among Rural New Mexicans</brief_title>
  <acronym>PHARM</acronym>
  <official_title>Perspectives on Prescribing Hormonal Contraception Among Rural New Mexicans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</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>
      The goal of this study is to identify the thoughts and perceptions of pharmacy access to&#xD;
      hormonal contraception among rural women and pharmacists. This will be key in order to&#xD;
      address concerns or perceived barriers in order to inform the implementation of this program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are no studies examining New Mexico pharmacists' interest in prescribing hormonal&#xD;
      contraceptives or rural New Mexican women's support for pharmacist prescribed hormonal&#xD;
      contraceptives. However, some states where pharmacists already prescribe contraception have&#xD;
      experienced difficulties in implementing the education, infrastructure, and financial support&#xD;
      necessary to provide hormonal contraception in the community pharmacy setting. Nationwide,&#xD;
      68% of women reported that they would utilize pharmacist prescribed hormonal contraception&#xD;
      and cited benefits such as convenient hours and locations of pharmacies. The goal of this&#xD;
      study is to identify the thoughts and perceptions of pharmacy access to hormonal&#xD;
      contraception among rural women and pharmacists. This will be key in order to address&#xD;
      concerns or perceived barriers in order to inform the implementation of this program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2017</start_date>
  <completion_date type="Actual">June 8, 2018</completion_date>
  <primary_completion_date type="Actual">June 8, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacist interview objective</measure>
    <time_frame>8/1/17-7/16/18</time_frame>
    <description>To explore pharmacist perspectives on providing prescriptions for hormonal contraceptives, specifically identifying perceived barriers and facilitators to implementation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Women interview objective</measure>
    <time_frame>8/1/17-7/16/18</time_frame>
    <description>1.2. To explore women's perspectives on receiving hormonal contraception prescribed by pharmacists.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hypothesis to be tested</measure>
    <time_frame>8/1/17-7/16/18</time_frame>
    <description>Rural women and pharmacists across New Mexico will be supportive of prescriptive authority and pharmacy access to hormonal contraceptives.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>Pharmacists</arm_group_label>
    <description>Actively employed and currently licensed and working in rural counties in New Mexico.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women</arm_group_label>
    <description>Reproductive age, 18-45 years old from rural counties in New Mexico and who are fluent in English.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacists &amp; women's perspectives on pharmacist prescribed hormonal contraception</intervention_name>
    <description>The goal of this study is to identify the thoughts and perceptions of pharmacy access to hormonal contraception among rural women and pharmacists. This will be key in order to address concerns or perceived barriers in order to inform the implementation of this program.</description>
    <arm_group_label>Pharmacists</arm_group_label>
    <arm_group_label>Women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Our study is qualitative and not meant to capture a representative sample of the state's&#xD;
        population, but rather capture a diverse array of opinions regarding hormonal&#xD;
        contraception.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pharmacists: actively employed and currently licensed and working in rural counties in&#xD;
             New Mexico.&#xD;
&#xD;
          -  Women: Reproductive age, 18-45 years old from rural counties in New Mexico and who are&#xD;
             fluent in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pharmacists: decline to participate or work outside the defined rural areas, not&#xD;
             currently employed or licensed.&#xD;
&#xD;
          -  Women: younger than 18 or older than 45, living in urban areas (Albuquerque and Las&#xD;
             Cruces).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eve Espey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico, OB/GYN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eve Espey</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Eve Espey</investigator_full_name>
    <investigator_title>Chair of OB/GYN</investigator_title>
  </responsible_party>
  <keyword>Pharmacists</keyword>
  <keyword>Prescriptions</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/NCT03230578
org study id: 17-237
nct id: NCT03230578
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to identify the thoughts and perceptions of pharmacy access to
      hormonal contraception among rural women and pharmacists. This will be key in order to
      address concerns or perceived barriers in order to inform the implementation of this program.
There are no studies examining New Mexico pharmacists' interest in prescribing hormonal
      contraceptives or rural New Mexican women's support for pharmacist prescribed hormonal
      contraceptives. However, some states where pharmacists already prescribe contraception have
      experienced difficulties in implementing the education, infrastructure, and financial support
      necessary to provide hormonal contraception in the community pharmacy setting. Nationwide,
      68% of women reported that they would utilize pharmacist prescribed hormonal contraception
      and cited benefits such as convenient hours and locations of pharmacies. The goal of this
      study is to identify the thoughts and perceptions of pharmacy access to hormonal
      contraception among rural women and pharmacists. This will be key in order to address
      concerns or perceived barriers in order to inform the implementation of this program.
observational model: Other
time perspective: Cross-Sectional
measure: Pharmacist interview objective
time frame: 8/1/17-7/16/18
description: To explore pharmacist perspectives on providing prescriptions for hormonal contraceptives, specifically identifying perceived barriers and facilitators to implementation.
measure: Women interview objective
time frame: 8/1/17-7/16/18
description: 1.2. To explore women's perspectives on receiving hormonal contraception prescribed by pharmacists.
measure: Hypothesis to be tested
time frame: 8/1/17-7/16/18
description: Rural women and pharmacists across New Mexico will be supportive of prescriptive authority and pharmacy access to hormonal contraceptives.
arm group label: Pharmacists
description: Actively employed and currently licensed and working in rural counties in New Mexico.
arm group label: Women
description: Reproductive age, 18-45 years old from rural counties in New Mexico and who are fluent in English.
intervention type: Other
intervention name: Pharmacists & women's perspectives on pharmacist prescribed hormonal contraception
description: The goal of this study is to identify the thoughts and perceptions of pharmacy access to hormonal contraception among rural women and pharmacists. This will be key in order to address concerns or perceived barriers in order to inform the implementation of this program.
arm group label: Pharmacists
arm group label: Women
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eve Espey, MD
role: Principal Investigator
affiliation: University of New Mexico, OB/GYN
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Eve Espey
investigator title: Chair of OB/GYN