<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/NCT03269357</url>
  </required_header>
  <id_info>
    <org_study_id>LoWe17</org_study_id>
    <nct_id>NCT03269357</nct_id>
  </id_info>
  <brief_title>LARC Forward Counselling</brief_title>
  <acronym>LOWE</acronym>
  <official_title>Effectiveness of LARC Forward Contraceptive Counseling: LOWE - A Cluster Randomized Intervention Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kristina Gemzell Danielsson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      Training of health care providers and structured LARC forward counseling may contribute to&#xD;
      increased LARC uptake. The hypothesis to be tested is that by introducing LARC forward&#xD;
      counselling an increase in LARC usage will be the result as well as decreased unplanned&#xD;
      pregnancy and abortion. It is expected that the results of this study will highlight the&#xD;
      importance of LARC forward counseling and thus provide the evidence needed to train health&#xD;
      care providers and increase access to LARC in youth clinics, midwifery clinics and for post&#xD;
      abortion contraception.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>
    <intervention_model_description>Cluster randomised trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LARC prescriptions (recorded electronic prescriptions)</measure>
    <time_frame>Evaluated at the index visit to the clinic</time_frame>
    <description>The rate of women who receive a LARC prescription</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LARC placements recorded in patient records</measure>
    <time_frame>Evaluated at 3months follow up (FU)</time_frame>
    <description>The rate of women who has a LARC method placed following the baseline visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contraceptive method used reported by participants</measure>
    <time_frame>Evaluated at 3,6 and 12 months FU</time_frame>
    <description>The rate of women who use a contraceptive method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the chosen contraceptive method reported by participants</measure>
    <time_frame>Evaluated at 3,6 and 12 months FU</time_frame>
    <description>Satisfaction with the prescribed contraceptive method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(Unplanned) pregnancy reported by participants and recorded in patient records</measure>
    <time_frame>Evaluated at 3,6 and 12 months FU</time_frame>
    <description>(Unplanned) pregnancy rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1200</enrollment>
  <condition>Impact of Contraceptive Counselling on LARC Uptake and Unplanned Pregnancy</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Clinics randomized to &quot;intervention&quot; will provide structured LARC centered counselling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine counselling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinics randomized to routine counselling</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LARC forward structured contraceptive counselling</intervention_name>
    <description>Training of health care providers (HCPs), use of information material and counselling tools</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At risk for pregnancy (sexually active with men or anticipate becoming sexually active&#xD;
             in the next 6 months).&#xD;
&#xD;
          -  Do not desire pregnancy .&#xD;
&#xD;
          -  No contraindications to LARC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undergone tubal ligation or other sterilization procedure.&#xD;
&#xD;
          -  Use of contraceptives for other purposes than contraception&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>WHO centre, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 14, 2020</last_update_submitted>
  <last_update_submitted_qc>August 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Kristina Gemzell Danielsson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>LARC</keyword>
  <keyword>contraception</keyword>
  <keyword>counselling</keyword>
  <keyword>unplanned pregnancy</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/NCT03269357
org study id: LoWe17
nct id: NCT03269357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Training of health care providers and structured LARC forward counseling may contribute to
      increased LARC uptake. The hypothesis to be tested is that by introducing LARC forward
      counselling an increase in LARC usage will be the result as well as decreased unplanned
      pregnancy and abortion. It is expected that the results of this study will highlight the
      importance of LARC forward counseling and thus provide the evidence needed to train health
      care providers and increase access to LARC in youth clinics, midwifery clinics and for post
      abortion contraception.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomised trial
primary purpose: Prevention
masking: None (Open Label)
measure: LARC prescriptions (recorded electronic prescriptions)
time frame: Evaluated at the index visit to the clinic
description: The rate of women who receive a LARC prescription
measure: LARC placements recorded in patient records
time frame: Evaluated at 3months follow up (FU)
description: The rate of women who has a LARC method placed following the baseline visit
measure: Contraceptive method used reported by participants
time frame: Evaluated at 3,6 and 12 months FU
description: The rate of women who use a contraceptive method
measure: Satisfaction with the chosen contraceptive method reported by participants
time frame: Evaluated at 3,6 and 12 months FU
description: Satisfaction with the prescribed contraceptive method
measure: (Unplanned) pregnancy reported by participants and recorded in patient records
time frame: Evaluated at 3,6 and 12 months FU
description: (Unplanned) pregnancy rate
arm group label: Intervention
arm group type: Other
description: Clinics randomized to "intervention" will provide structured LARC centered counselling
arm group label: Routine counselling
arm group type: No Intervention
description: Clinics randomized to routine counselling
intervention type: Other
intervention name: LARC forward structured contraceptive counselling
description: Training of health care providers (HCPs), use of information material and counselling tools
arm group label: Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Kristina Gemzell Danielsson
investigator title: Professor
mesh term: Contraceptive Agents
sharing ipd: No