<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/NCT03775642</url>
  </required_header>
  <id_info>
    <org_study_id>2017B0412</org_study_id>
    <nct_id>NCT03775642</nct_id>
  </id_info>
  <brief_title>Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica</brief_title>
  <official_title>Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Epidemiology Research and Training Unit of the Jamaica Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of The West Indies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State 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>
      The primary hypothesis is that the intervention video - based on strategies from cognitive&#xD;
      psychology - can correct women's misinformation about long-acting reversible contraception&#xD;
      (LARC) and result in higher use of LARC. While there are no direct benefits to participants&#xD;
      from being in the study, the research could benefit women in general by providing evidence to&#xD;
      help prevent unintended pregnancy. Unlike many interventions that are not feasible for&#xD;
      scaling up once shown to be effective in changing people's behavior, the proposed&#xD;
      intervention has been carefully designed to impose a low burden to clinic staff and require&#xD;
      few resources for translating to wider use. Thus, the investigators expect the intervention&#xD;
      to have high potential for influencing clinical care and research for addressing the overall&#xD;
      goal of reducing unintended pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to&#xD;
      test the effectiveness of the final intervention video.&#xD;
&#xD;
      Participants in the RT will complete the &quot;Enrollment Questionnaire&quot; and then will be&#xD;
      randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm;&#xD;
      n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the&#xD;
      option of receiving routine contraceptive services that follow standard care. After three&#xD;
      months, trained interviewers will contact participants to administer the short &quot;Follow-up&#xD;
      Questionnaire&quot; via telephone. To corroborate participant reporting of contraception use&#xD;
      during follow-up, the investigators also will extract data on LARC use from participant&#xD;
      medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2018</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)</measure>
    <time_frame>within 3 months of enrollment</time_frame>
    <description>Based on survey question on use of the IUD (y/n) and implant (y/n)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported belief about IUD safety</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>&quot;Do you think the IUD is very safe, mostly safe, mostly unsafe, or very unsafe?&quot; Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported belief about implant safety</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>&quot;Do you think the implant is very safe, mostly safe, mostly unsafe, or very unsafe?&quot; Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported attitudes toward LARC-related bleeding patterns</measure>
    <time_frame>3 months after enrollment</time_frame>
    <description>&quot;How do you feel about your bleeding pattern?&quot; Response options consist of &quot;very satisfied, satisfied, neutral, unsatisfied, very unsatisfied.&quot; Responses will be coded as 1-5 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>Contraception Behavior</condition>
  <arm_group>
    <arm_group_label>Intervention video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control video</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention video</intervention_name>
    <description>The intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety.</description>
    <arm_group_label>Intervention video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control video</intervention_name>
    <description>The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration</description>
    <arm_group_label>Control video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  present at the Comprehensive Health Centre;&#xD;
&#xD;
          -  18-25 years of age; and&#xD;
&#xD;
          -  sexually active (defined as ≥1 penile-vaginal act in past month);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known to be pregnant;&#xD;
&#xD;
          -  sterilized;&#xD;
&#xD;
          -  breastfeeding;&#xD;
&#xD;
          -  currently using the IUD or implant; or&#xD;
&#xD;
          -  want pregnancy in the next 12 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria F Gallo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Epidemiology Training Unit</name>
      <address>
        <city>Kingston</city>
        <country>Jamaica</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jamaica</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>April 15, 2020</last_update_submitted>
  <last_update_submitted_qc>April 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Maria F. Gallo, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03775642
org study id: 2017B0412
nct id: NCT03775642
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary hypothesis is that the intervention video - based on strategies from cognitive
      psychology - can correct women's misinformation about long-acting reversible contraception
      (LARC) and result in higher use of LARC. While there are no direct benefits to participants
      from being in the study, the research could benefit women in general by providing evidence to
      help prevent unintended pregnancy. Unlike many interventions that are not feasible for
      scaling up once shown to be effective in changing people's behavior, the proposed
      intervention has been carefully designed to impose a low burden to clinic staff and require
      few resources for translating to wider use. Thus, the investigators expect the intervention
      to have high potential for influencing clinical care and research for addressing the overall
      goal of reducing unintended pregnancy.
The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to
      test the effectiveness of the final intervention video.

      Participants in the RT will complete the "Enrollment Questionnaire" and then will be
      randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm;
      n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the
      option of receiving routine contraceptive services that follow standard care. After three
      months, trained interviewers will contact participants to administer the short "Follow-up
      Questionnaire" via telephone. To corroborate participant reporting of contraception use
      during follow-up, the investigators also will extract data on LARC use from participant
      medical records.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Self-reported initiation of LARC (dichotomous variable for either IUD or implant use vs. neither use)
time frame: within 3 months of enrollment
description: Based on survey question on use of the IUD (y/n) and implant (y/n)
measure: Self-reported belief about IUD safety
time frame: 3 months after enrollment
description: "Do you think the IUD is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
measure: Self-reported belief about implant safety
time frame: 3 months after enrollment
description: "Do you think the implant is very safe, mostly safe, mostly unsafe, or very unsafe?" Responses will be coded as 1-4 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm.
measure: Self-reported attitudes toward LARC-related bleeding patterns
time frame: 3 months after enrollment
description: "How do you feel about your bleeding pattern?" Response options consist of "very satisfied, satisfied, neutral, unsatisfied, very unsatisfied." Responses will be coded as 1-5 (in the order presented) and used in a regression model to determine whether the values differ by randomization arm
arm group label: Intervention video
arm group type: Experimental
description: The intervention video will employ debiasing strategies to correct women's misinformation about the safety of the IUD and implant safety.
arm group label: Control video
arm group type: Placebo Comparator
description: The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration.
intervention type: Behavioral
intervention name: Intervention video
description: The intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety.
arm group label: Intervention video
intervention type: Behavioral
intervention name: Control video
description: The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration
arm group label: Control video
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria F Gallo, PhD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: Jamaica
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Maria F. Gallo, PhD
investigator title: Associate Professor
sharing ipd: Undecided