<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/NCT04423068</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001115</org_study_id>
    <nct_id>NCT04423068</nct_id>
  </id_info>
  <brief_title>Inpatient Adolescent Contraception</brief_title>
  <official_title>Intervention to Facilitate Contraception Provision by Pediatric Hospitalists: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this study is to refine and pilot test the investigators novel&#xD;
      intervention to offer contraception counseling and initiation for hospitalized female&#xD;
      adolescents, focusing on long acting reversible contraception (LARC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two primary objectives in this study. The first objective is to refine the&#xD;
      investigators previously developed general sexual risk reduction intervention (SexHealth II)&#xD;
      to focus on patient-centered contraception counseling and initiation for hospitalized female&#xD;
      adolescents. The second objective is to conduct an open trial to assess feasibility of the&#xD;
      investigators SexHealth II intervention among hospitalized females aged 14-21 years (N=75).&#xD;
      Among key stakeholders (i.e., adolescent participants, parents/guardians, hospitalists and&#xD;
      nurses), the investigators will assess Bowen's feasibility constructs: acceptability, demand,&#xD;
      implementation, practicality, integration, and limited-efficacy testing. The investigators&#xD;
      hypothesize that the SexHealth II intervention will be deemed feasible by female adolescent&#xD;
      participants (i.e., the median score across all feasibility items will be &gt; 2.5.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2020</start_date>
  <completion_date type="Actual">April 4, 2023</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of SexHealth II, an intervention to provide contraception counseling and initiation among hospitalized female adolescents</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators primary outcome is feasibility of the intervention among female adolescent participants, which the investigators will assess by administering a survey with 12 Likert-type items with responses ranging from 0 (strongly disagree) to 4 (strongly agree). The midpoint (neutral) point on the 0-4 scale is 2, and the investigators define &quot;acceptable level of feasibility&quot; as the median feasibility rating in the population exceeding 2.5, meaning at least half the ratings are positive. Thus, the investigators will test the hypothesis that the true median feasibility rating in the population of adolescents from which the sample is drawn is greater than 2.5.&#xD;
The investigators expect the true median is above 2.5. Assuming its value is conservatively 2.75, a sample size of 75 provides 90% power to reject H0 using a two-sided sign test for the population median.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Contraception</condition>
  <condition>Contraceptive Usage</condition>
  <condition>Contraception Behavior</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Overall Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SexHealth II</intervention_name>
    <description>SexHealth II is an intervention that will focus exclusively on provision of hormonal contraception counseling and provision for hospitalized female adolescents</description>
    <arm_group_label>Overall Study</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Contraceptive</intervention_name>
    <description>The investigators will offer initiation of the following contraceptives:&#xD;
Ethinyl Estradiol and Etonogestrel 0.015mg-0.12mg vaginal ring (Nuva Ring) Etonogestrel 68mg subcutaneous implant (Nexplanon) Medroxyprogesterone 150mg/ml 150 mg IM injection Ethinyl Estradiol and Norgestimate (Sprintec) 35mcg-0.25mg tablet Norelgestromin/Ethinyl estradiol transdermal patch (Ortho Evra) Norethindrone 0.35mg tablet&#xD;
Emergency Contraception:&#xD;
Ulipristal 30 mg tablet Levonorgestrel 1.5mg tablet</description>
    <arm_group_label>Overall Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescents who are biologically female and have reproductive potential (14-21 years&#xD;
             old) admitted to the general pediatric hospitalist service will be eligible.&#xD;
&#xD;
          -  A convenience sample of parents/guardians of enrolled participants who are English&#xD;
             speaking will be eligible for post-intervention feasibility survey. Parent consent or&#xD;
             enrollment in the study is not required for female adolescent enrollment.&#xD;
&#xD;
          -  A convenience sample of hospitalists and nurses caring for enrolled participants and&#xD;
             the health educator will be eligible for the post-intervention feasibility study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are determined to be too ill, have severe psychiatric illness or&#xD;
             cognitive impairment (based on hospitalist assessment), are seeking care related to&#xD;
             sexual assault, or are not able to speak English fluently will not be eligible.&#xD;
&#xD;
          -  Parents/guardians, hospitalists, health educator and nurses who are not able to speak&#xD;
             English fluently will not be eligible for post-intervention feasibility survey.&#xD;
&#xD;
               -  Adults unable to consent - Exclude&#xD;
&#xD;
               -  Individuals who are not yet adults (infants, children, teenagers) - Include&#xD;
&#xD;
               -  Pregnant women - Exclude&#xD;
&#xD;
               -  Prisoners - Exclude&#xD;
&#xD;
               -  Wards of the state - Include&#xD;
&#xD;
        Withdraw Criteria:&#xD;
&#xD;
        - Subjects who are screened and report no sexual activity (past or anticipated&#xD;
        &quot;unlikely&quot;/&quot;very likely&quot; within few weeks to months) will be withdrawn from the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Mercy Hospitals and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Masonbrink AR, Noel-MacDonnell J, Staggs VS, Stancil S, Goggin K, Miller MK. Feasibility of a Contraception Intervention for Hospitalized Adolescents and Young Adults. Hosp Pediatr. 2023 Apr 1;13(4):337-344. doi: 10.1542/hpeds.2022-006996.</citation>
    <PMID>36897226</PMID>
  </results_reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Abbey Masonbrink</investigator_full_name>
    <investigator_title>Physician, Hospital Medicine</investigator_title>
  </responsible_party>
  <keyword>LARC</keyword>
  <keyword>Long acting reversible contraception</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/NCT04423068
org study id: STUDY00001115
nct id: NCT04423068
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The overall goal of this study is to refine and pilot test the investigators novel
      intervention to offer contraception counseling and initiation for hospitalized female
      adolescents, focusing on long acting reversible contraception (LARC).
There are two primary objectives in this study. The first objective is to refine the
      investigators previously developed general sexual risk reduction intervention (SexHealth II)
      to focus on patient-centered contraception counseling and initiation for hospitalized female
      adolescents. The second objective is to conduct an open trial to assess feasibility of the
      investigators SexHealth II intervention among hospitalized females aged 14-21 years (N=75).
      Among key stakeholders (i.e., adolescent participants, parents/guardians, hospitalists and
      nurses), the investigators will assess Bowen's feasibility constructs: acceptability, demand,
      implementation, practicality, integration, and limited-efficacy testing. The investigators
      hypothesize that the SexHealth II intervention will be deemed feasible by female adolescent
      participants (i.e., the median score across all feasibility items will be > 2.5.)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of SexHealth II, an intervention to provide contraception counseling and initiation among hospitalized female adolescents
time frame: 3 months
description: The investigators primary outcome is feasibility of the intervention among female adolescent participants, which the investigators will assess by administering a survey with 12 Likert-type items with responses ranging from 0 (strongly disagree) to 4 (strongly agree). The midpoint (neutral) point on the 0-4 scale is 2, and the investigators define "acceptable level of feasibility" as the median feasibility rating in the population exceeding 2.5, meaning at least half the ratings are positive. Thus, the investigators will test the hypothesis that the true median feasibility rating in the population of adolescents from which the sample is drawn is greater than 2.5.
The investigators expect the true median is above 2.5. Assuming its value is conservatively 2.75, a sample size of 75 provides 90% power to reject H0 using a two-sided sign test for the population median.
arm group label: Overall Study
arm group type: Experimental
intervention type: Behavioral
intervention name: SexHealth II
description: SexHealth II is an intervention that will focus exclusively on provision of hormonal contraception counseling and provision for hospitalized female adolescents
arm group label: Overall Study
intervention type: Drug
intervention name: Contraceptive
description: The investigators will offer initiation of the following contraceptives:
Ethinyl Estradiol and Etonogestrel 0.015mg-0.12mg vaginal ring (Nuva Ring) Etonogestrel 68mg subcutaneous implant (Nexplanon) Medroxyprogesterone 150mg/ml 150 mg IM injection Ethinyl Estradiol and Norgestimate (Sprintec) 35mcg-0.25mg tablet Norelgestromin/Ethinyl estradiol transdermal patch (Ortho Evra) Norethindrone 0.35mg tablet
Emergency Contraception:
Ulipristal 30 mg tablet Levonorgestrel 1.5mg tablet
arm group label: Overall Study
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 21 Years
healthy volunteers: No
facility: 
country: United States
citation: Masonbrink AR, Noel-MacDonnell J, Staggs VS, Stancil S, Goggin K, Miller MK. Feasibility of a Contraception Intervention for Hospitalized Adolescents and Young Adults. Hosp Pediatr. 2023 Apr 1;13(4):337-344. doi: 10.1542/hpeds.2022-006996.
PMID: 36897226
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Abbey Masonbrink
investigator title: Physician, Hospital Medicine
mesh term: Contraceptive Agents
sharing ipd: No