<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/NCT03012659</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00019792</org_study_id>
    <nct_id>NCT03012659</nct_id>
  </id_info>
  <brief_title>Contraceptive Equity Study 2016</brief_title>
  <acronym>CES</acronym>
  <official_title>Contraceptive Equity Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Planned Parenthood Federation of America</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Planned Parenthood South Atlantic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Planned Parenthood Federation of America</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the impact of a provider counseling training on&#xD;
      patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10&#xD;
      Planned Parenthood health centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study builds upon prior research on a contraceptive counseling protocol and training&#xD;
      developed and studied by partners at New York University and Planned Parenthood Federation of&#xD;
      America. This contraceptive counseling protocol is informed by the literature on&#xD;
      contraceptive behavior, expertise in decision and communication science, and formative&#xD;
      qualitative research with Planned Parenthood providers and patients. Jaccard et al. (in&#xD;
      press) conducted a cluster randomized control study of the counseling intervention with 10&#xD;
      Planned Parenthood health centers, where staff at intervention sites participated in a&#xD;
      one-day training on the counseling protocol followed by a day of in-clinic shadowing.&#xD;
      Patients were enrolled on-site and contacted for follow-up at six months and 12 months.&#xD;
&#xD;
      Results of this study indicated that patients at intervention sites were more satisfied with&#xD;
      their contraceptive counseling and method choice, and at one or both follow-ups there were&#xD;
      fewer gaps in contraceptive protection, more dual method use, and less non-use of birth&#xD;
      control. There was no significant difference in accurate use of birth control pills.&#xD;
&#xD;
      Planned Parenthood Federation of America (PPFA) adapted and piloted training in this&#xD;
      contraceptive counseling protocol during 2016 with 18 Planned Parenthood affiliated&#xD;
      organizations across the country. This training was integrated into a one-day event that also&#xD;
      included a provider training to address barriers in access to intrauterine devices and&#xD;
      implants. A mixed-methods implementation evaluation was conducted to assess outcomes for&#xD;
      staff and patients and identify challenges in implementation. Preliminary findings from the&#xD;
      program pilot year demonstrated positive trends for outcome measures, produced lessons&#xD;
      learned on implementation challenges, and provided support for new adaptations to the&#xD;
      training program and counseling protocol. The previous pilot year evaluation was designed to&#xD;
      assess patient satisfaction and method choice before and after the training, but could not&#xD;
      answer questions about continued impact on other outcomes of interest. The current study will&#xD;
      use a cluster randomized control design with 10 Planned Parenthood health centers to assess&#xD;
      patient outcomes. Five health centers randomized to the intervention will receive the&#xD;
      contraceptive counseling training. As the control group, the other five health centers will&#xD;
      conduct usual care. Women will be enrolled onsite at the health center and then contacted for&#xD;
      follow-up at approximately 30 and 90 days post-enrollment. Target enrollment is 100 women per&#xD;
      site (1000 total).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">June 29, 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contraceptive Continuation</measure>
    <time_frame>3 months</time_frame>
    <description>Patient-reported contraceptive continuation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Method Satisfaction</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>Patient-reported satisfaction with contraceptive method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual-Use</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>Patient-reported dual-use of condoms plus other method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Missed Pills</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>Number of patient-reported missed oral contraceptive pills among pill users</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Method Switching</measure>
    <time_frame>1 month and 3 months</time_frame>
    <description>Patient-reported method switching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience of counseling best practices during their visit</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient-report of staff implementation of the best counseling practices during their visit</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Access to same-day services for all contraceptive methods</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient report of being offered to start method on same day as their visit (if desired)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1015</enrollment>
  <condition>Contraception Behavior</condition>
  <condition>Contraceptive Usage</condition>
  <condition>Contraceptive Method Switching</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Full-day contraceptive counseling training for health center staff</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Contraceptive Counseling Training</intervention_name>
    <description>Intervention sites will receive:&#xD;
In person training: All staff at an intervention health center will participate in a one-day counseling training.&#xD;
On-site shadowing: Trainers will shadow staff in-clinic the day following the training to observe the counseling implementation and provide additional coaching and support.&#xD;
Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females who have received contraceptive counseling at participating health centers.&#xD;
&#xD;
          -  Ability to understand written and spoken English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hannah R. Simons, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Planned Parenthood Federation of America</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Planned Parenthood South Atlantic</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>contraceptive counseling</keyword>
  <keyword>cluster randomized trial</keyword>
  <keyword>provider counseling training</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contraceptive Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03012659
org study id: Pro00019792
nct id: NCT03012659
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the impact of a provider counseling training on
      patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10
      Planned Parenthood health centers.
This study builds upon prior research on a contraceptive counseling protocol and training
      developed and studied by partners at New York University and Planned Parenthood Federation of
      America. This contraceptive counseling protocol is informed by the literature on
      contraceptive behavior, expertise in decision and communication science, and formative
      qualitative research with Planned Parenthood providers and patients. Jaccard et al. (in
      press) conducted a cluster randomized control study of the counseling intervention with 10
      Planned Parenthood health centers, where staff at intervention sites participated in a
      one-day training on the counseling protocol followed by a day of in-clinic shadowing.
      Patients were enrolled on-site and contacted for follow-up at six months and 12 months.

      Results of this study indicated that patients at intervention sites were more satisfied with
      their contraceptive counseling and method choice, and at one or both follow-ups there were
      fewer gaps in contraceptive protection, more dual method use, and less non-use of birth
      control. There was no significant difference in accurate use of birth control pills.

      Planned Parenthood Federation of America (PPFA) adapted and piloted training in this
      contraceptive counseling protocol during 2016 with 18 Planned Parenthood affiliated
      organizations across the country. This training was integrated into a one-day event that also
      included a provider training to address barriers in access to intrauterine devices and
      implants. A mixed-methods implementation evaluation was conducted to assess outcomes for
      staff and patients and identify challenges in implementation. Preliminary findings from the
      program pilot year demonstrated positive trends for outcome measures, produced lessons
      learned on implementation challenges, and provided support for new adaptations to the
      training program and counseling protocol. The previous pilot year evaluation was designed to
      assess patient satisfaction and method choice before and after the training, but could not
      answer questions about continued impact on other outcomes of interest. The current study will
      use a cluster randomized control design with 10 Planned Parenthood health centers to assess
      patient outcomes. Five health centers randomized to the intervention will receive the
      contraceptive counseling training. As the control group, the other five health centers will
      conduct usual care. Women will be enrolled onsite at the health center and then contacted for
      follow-up at approximately 30 and 90 days post-enrollment. Target enrollment is 100 women per
      site (1000 total).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Contraceptive Continuation
time frame: 3 months
description: Patient-reported contraceptive continuation
measure: Method Satisfaction
time frame: 1 month and 3 months
description: Patient-reported satisfaction with contraceptive method
measure: Dual-Use
time frame: 1 month and 3 months
description: Patient-reported dual-use of condoms plus other method
measure: Missed Pills
time frame: 1 month and 3 months
description: Number of patient-reported missed oral contraceptive pills among pill users
measure: Method Switching
time frame: 1 month and 3 months
description: Patient-reported method switching
measure: Patient experience of counseling best practices during their visit
time frame: Baseline
description: Patient-report of staff implementation of the best counseling practices during their visit
measure: Access to same-day services for all contraceptive methods
time frame: Baseline
description: Patient report of being offered to start method on same day as their visit (if desired)
arm group label: Intervention Arm
arm group type: Experimental
description: Full-day contraceptive counseling training for health center staff
arm group label: Control Arm
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: Contraceptive Counseling Training
description: Intervention sites will receive:
In person training: All staff at an intervention health center will participate in a one-day counseling training.
On-site shadowing: Trainers will shadow staff in-clinic the day following the training to observe the counseling implementation and provide additional coaching and support.
Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance.
arm group label: Intervention Arm
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hannah R. Simons, DrPH
role: Principal Investigator
affiliation: Planned Parenthood Federation of America
facility: 
country: United States
responsible party type: Sponsor
mesh term: Contraceptive Agents
sharing ipd: No