<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/NCT04494477</url>
  </required_header>
  <id_info>
    <org_study_id>PhilliberINclued</org_study_id>
    <nct_id>NCT04494477</nct_id>
  </id_info>
  <brief_title>Evaluation of the Impact of the IN•Clued Curriculum: An LGBTQ Sex ed Program</brief_title>
  <official_title>The Evaluation of IN•Clued - Inclusive Health Care: Youth &amp; Providers Empowered</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philliber Research &amp; Evaluation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Planned Parenthood of the Great Northwest and the Hawaiian Islands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Office of Adolescent Health, HHS</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Philliber Research &amp; Evaluation</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 INclued program was implemented in 16 states across the US. The purpose of this study is&#xD;
      to measure: Nine months after the end of the program and one year after the workshop, are&#xD;
      IN•clued participants less likely to report engaging in risky sexual behavior in the past&#xD;
      three months compared to control group participants?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The IN•clued program for youth consists of a three-hour in-person workshop for youth which&#xD;
      includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room&#xD;
      roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style&#xD;
      booklet, that they may take home. They also receive a list of local healthcare providers that&#xD;
      highlights those that have participated in the IN•clued healthcare provider workshop or have&#xD;
      had training on working with the LGBTQ population. Program youth can also receive text&#xD;
      messages with health tips and reminders to visit a healthcare center.&#xD;
&#xD;
      Workshops take place with LGBTQ youth groups through schools, community-based organizations,&#xD;
      or conferences. Each segment is led by adult facilitators or trained peer educators with&#xD;
      adult facilitator support. These peer educators are from the Planned Parenthood Teen Council&#xD;
      peer education program. Teen Council is a unique peer education program created in 1989 by&#xD;
      PPGNHI. It is a strong and successful peer education program that trains high school youth to&#xD;
      become experts in delivering inclusive, comprehensive sexual health education to their peers&#xD;
      via group and community presentations. If trained peer educators are used, they implement the&#xD;
      intervention with the guidance and oversight of an adult facilitator.&#xD;
&#xD;
      Participants in the control condition receive a benign intervention, which like IN•clued,&#xD;
      meets in a group setting.&#xD;
&#xD;
      Once a site or group is defined, facilitators send implementation forms to Philliber. The&#xD;
      evaluation team reviews the information and asks any needed questions which vary by group or&#xD;
      site. The two groups cannot differ in any significant way (e.g., gender, SES, ethnicity, or&#xD;
      special characteristic such as pregnant and parenting participants). All decisions about&#xD;
      final eligibility are made by the research team. If two groups or sites are similar, they are&#xD;
      approved. If they differ in a significant way, they are not eligible for the study.&#xD;
&#xD;
      Random assignment of the groups does not technically occur until the baseline administration&#xD;
      of the survey is completed as participants can be both added and subtracted from the group&#xD;
      list until the time of survey administration. One facilitator at each location is informed of&#xD;
      the outcome of random assignment before or during the administration of the baseline survey.&#xD;
      This is done so random assignment can occur immediately after surveys are conducted as this&#xD;
      is a one-time workshop and participants do not give assent to participate until this time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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>Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?</measure>
    <time_frame>One year after baseline</time_frame>
    <description>If participants had recent (in the past three months) vaginal sex without a condom or birth control, recent oral sex without protection, or recent anal sex without a condom, they were coded as having engaged in recent unprotected or risky sexual behavior.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1401</enrollment>
  <condition>Teen Pregnancy</condition>
  <condition>STD Prevention</condition>
  <arm_group>
    <arm_group_label>The IN•clued program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The youth control group receives a 10-minute presentation and a list of local sexual healthcare providers, with no indication of which providers have been trained to be more LGBTQ friendly and accepting. This 10-minute presentation is a part of a longer three-hour activity unrelated to sexual health or accessing sexual healthcare. During the three-hour session, the list of approved activities includes but is not limited to:&#xD;
Films by, and for, LGBTQ youth about sexual orientation and gender identity;&#xD;
Community scavenger hunts;&#xD;
Poetry slams;&#xD;
Discussions about relationships; and&#xD;
Activities related to the appreciation of individuals' unique strengths.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The IN•clued program</intervention_name>
    <description>The INclued program as previously described.</description>
    <arm_group_label>The IN•clued program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Youth participants are already in LGBTQ groups, such as gay-straight alliances in&#xD;
             schools or local community groups or those who are recruited to attend a special event&#xD;
             at a community-based organization or conference. Participants must be at least 14 and&#xD;
             preferably younger than 20. Ideally, they are part of the LGBTQ community, although&#xD;
             this is not required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot require ESL support.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ash Philliber, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Philliber Research &amp; Evaluation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Philliber Research &amp; Evaluation</name>
      <address>
        <city>Accord</city>
        <state>New York</state>
        <zip>12404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Philliber Research &amp; Evaluation</investigator_affiliation>
    <investigator_full_name>Ashley Philliber</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>LGBTQ sex education</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/NCT04494477
org study id: PhilliberINclued
nct id: NCT04494477
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The INclued program was implemented in 16 states across the US. The purpose of this study is
      to measure: Nine months after the end of the program and one year after the workshop, are
      IN•clued participants less likely to report engaging in risky sexual behavior in the past
      three months compared to control group participants?
The IN•clued program for youth consists of a three-hour in-person workshop for youth which
      includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room
      roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style
      booklet, that they may take home. They also receive a list of local healthcare providers that
      highlights those that have participated in the IN•clued healthcare provider workshop or have
      had training on working with the LGBTQ population. Program youth can also receive text
      messages with health tips and reminders to visit a healthcare center.

      Workshops take place with LGBTQ youth groups through schools, community-based organizations,
      or conferences. Each segment is led by adult facilitators or trained peer educators with
      adult facilitator support. These peer educators are from the Planned Parenthood Teen Council
      peer education program. Teen Council is a unique peer education program created in 1989 by
      PPGNHI. It is a strong and successful peer education program that trains high school youth to
      become experts in delivering inclusive, comprehensive sexual health education to their peers
      via group and community presentations. If trained peer educators are used, they implement the
      intervention with the guidance and oversight of an adult facilitator.

      Participants in the control condition receive a benign intervention, which like IN•clued,
      meets in a group setting.

      Once a site or group is defined, facilitators send implementation forms to Philliber. The
      evaluation team reviews the information and asks any needed questions which vary by group or
      site. The two groups cannot differ in any significant way (e.g., gender, SES, ethnicity, or
      special characteristic such as pregnant and parenting participants). All decisions about
      final eligibility are made by the research team. If two groups or sites are similar, they are
      approved. If they differ in a significant way, they are not eligible for the study.

      Random assignment of the groups does not technically occur until the baseline administration
      of the survey is completed as participants can be both added and subtracted from the group
      list until the time of survey administration. One facilitator at each location is informed of
      the outcome of random assignment before or during the administration of the baseline survey.
      This is done so random assignment can occur immediately after surveys are conducted as this
      is a one-time workshop and participants do not give assent to participate until this time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Nine months after the end of the program are IN•clued participants less likely to report engaging in risky sexual behavior in the past three months compared to control group participants?
time frame: One year after baseline
description: If participants had recent (in the past three months) vaginal sex without a condom or birth control, recent oral sex without protection, or recent anal sex without a condom, they were coded as having engaged in recent unprotected or risky sexual behavior.
arm group label: The IN•clued program
arm group type: Experimental
description: The IN•clued program for youth consists of a three-hour in-person workshop for youth which includes lessons about safe sex practices and self-efficacy at healthcare centers, exam room roleplays, and a discussion on patient rights. Youth receive a Zine, or a magazine-style booklet, that they may take home. They also receive a list of local healthcare providers that highlights those that have participated in the IN•clued healthcare provider workshop or have had training on working with the LGBTQ population. Program youth can also receive text messages with health tips and reminders to visit a healthcare center.
arm group label: Control
arm group type: No Intervention
description: The youth control group receives a 10-minute presentation and a list of local sexual healthcare providers, with no indication of which providers have been trained to be more LGBTQ friendly and accepting. This 10-minute presentation is a part of a longer three-hour activity unrelated to sexual health or accessing sexual healthcare. During the three-hour session, the list of approved activities includes but is not limited to:
Films by, and for, LGBTQ youth about sexual orientation and gender identity;
Community scavenger hunts;
Poetry slams;
Discussions about relationships; and
Activities related to the appreciation of individuals' unique strengths.
intervention type: Behavioral
intervention name: The IN•clued program
description: The INclued program as previously described.
arm group label: The IN•clued program
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ash Philliber, PhD
role: Principal Investigator
affiliation: Philliber Research & Evaluation
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Philliber Research & Evaluation
investigator full name: Ashley Philliber
investigator title: Principal Investigator