<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/NCT03029962</url>
  </required_header>
  <id_info>
    <org_study_id>1 TP2AH000035-01-00</org_study_id>
    <nct_id>NCT03029962</nct_id>
  </id_info>
  <brief_title>Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls</brief_title>
  <acronym>Girl2Girl</acronym>
  <official_title>Girl2Girl: Harnessing Text Messaging to Reduce Teenage Pregnancy Among LGB Girls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for Innovative Public Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Office of Adolescent Health, HHS</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>City University of New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for Innovative Public Health Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text&#xD;
      messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB&#xD;
      women ages 14-18 years, nation-wide. The guiding theoretical model is the&#xD;
      Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is&#xD;
      associated with increases in TPP behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An estimated one in four teen women will become pregnant by the time she is 20 years of age.&#xD;
      That said, significant disparity in rates exist for lesbian, gay, bisexual and other sexual&#xD;
      minority women (LGB) versus non-LGB teen women: Research suggests that lesbian and bisexual&#xD;
      teen women are between two and four times more likely to report having been pregnant than&#xD;
      teen women who identified as exclusively heterosexual. Despite this compelling evidence that&#xD;
      lesbian and bisexual adolescent women are at risk for teen pregnancy, programs tailored to&#xD;
      the unique needs of adolescent LGB women are nonexistent. Evidence-based teen pregnancy&#xD;
      prevention (TPP) programs targeting LGB teen women are urgently needed.&#xD;
&#xD;
      The Girl2Girl intervention text messaging-based TPP program designed specifically for LGB&#xD;
      women ages 14-18 years, nation-wide. The investigators will test the intervention in a&#xD;
      randomized control trial (RCT) of 840 LGB teenage women randomly assigned to either the&#xD;
      intervention (n = 420) or control (n = 420) arms. Our primary efficacy outcome measures,&#xD;
      measured at 12-months post-intervention, will be: (a) abstinence from penile-vaginal sex; (b)&#xD;
      condom use during penile-vaginal sex, (c) use of other birth control methods during&#xD;
      penile-vaginal sex, and (d) pregnancy.&#xD;
&#xD;
      If effective, Girl2Girl has promise to be quickly and cost-effectively implemented to scale&#xD;
      to help to curb the spread of teenage pregnancy among women who identify as LGB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">January 12, 2020</completion_date>
  <primary_completion_date type="Actual">January 12, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of protected penile-vaginal sex acts</measure>
    <time_frame>Post-intervention (about 20 weeks after randomization)</time_frame>
    <description>The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 12-months post-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who used other birth control methods</measure>
    <time_frame>Post-intervention (about 20 weeks after randomization)</time_frame>
    <description>The relative difference of teens who used birth control methods other than condoms (e.g., the pill, the patch) in the intervention versus control group at 12-months post-intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who abstained from penile-vaginal sex</measure>
    <time_frame>Post-intervention (about 20 weeks after randomization)</time_frame>
    <description>The relative difference of abstinence (not engaging in vaginal sex) in the intervention versus control group at 12-months post-intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of penile-vaginal sex acts during which a condom was used</measure>
    <time_frame>immediate post-intervention end, 3-, 6-, 9-months post-intervention</time_frame>
    <description>The relative difference of protected penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who used other birth control methods</measure>
    <time_frame>immediate post-intervention end, 3-, 6-, 9-months post-intervention</time_frame>
    <description>The relative difference of teens who used birth control methods other than condoms (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who abstained from penile-vaginal sex</measure>
    <time_frame>immediate post-intervention end, 3-, 6-, 9-months post-intervention</time_frame>
    <description>The relative difference of abstinence (not engaging vaginal sex) in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy</measure>
    <time_frame>Across the 12 months post-intervention</time_frame>
    <description>The percent of teens who have been pregnant since the beginning of the RCT in the intervention versus control group</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intentions to use condoms</measure>
    <time_frame>immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention</time_frame>
    <description>The percent of teens who intend to use condoms if they have penile-vaginal sex in the next year in the intervention versus control group</description>
  </other_outcome>
  <other_outcome>
    <measure>Intentions to use birth control other than condoms</measure>
    <time_frame>immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention</time_frame>
    <description>The percent of teens who intend to use birth control methods other than condoms in the next year for the intervention versus control group</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">948</enrollment>
  <condition>Teenage Pregnancy</condition>
  <arm_group>
    <arm_group_label>Experimental: Girl2Girl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Girl2Girl is a 7-week teenage pregnancy prevention program delivered daily via text messaging to 14-18 year old females who self-identify as lesbian, bisexual, gay, or other sexual minority. In addition to program content, participants are paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, Girl2Genie, which shares information about sex, relationships, and the lesbian, gay, bisexual, transgender (LGBT) community.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Intervention: Health Lifestyle</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 7-weeks in length (Week 7 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Girl2Girl</intervention_name>
    <description>Girl2Girl is a text messaging-based teenage pregnancy prevention program specifically for 14-18 year old LGB adolescent females. Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content is reinforced using brief online videos. The intervention is 7 weeks long. A &quot;booster&quot; is delivered 12-weeks post-intervention end and reviews the topics covered in the intervention. Girl2Girl content is tailored based upon sexual experience (i.e., whether one is abstinent or sexually active) and whether one is same-sex or dually attracted.</description>
    <arm_group_label>Experimental: Girl2Girl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  endorse a non-heterosexual sexual identity (i.e., lesbian/gay, bisexual, queer,&#xD;
             questioning, unsure);&#xD;
&#xD;
          -  be cisgender (i.e., be assigned a female sex at birth and endorse a female gender&#xD;
             identity);&#xD;
&#xD;
          -  be aged 14-18;&#xD;
&#xD;
          -  in high school or equivalent (including those who did not finish school/dropped out);&#xD;
&#xD;
          -  be English speaking;&#xD;
&#xD;
          -  be exclusive owners of a cell phone with an unlimited text messaging plan;&#xD;
&#xD;
          -  have used text messaging for at least six months;&#xD;
&#xD;
          -  intend to have the same cell number for the next six months; and,&#xD;
&#xD;
          -  be able to provide informed assent, including an acceptable score for &quot;capacity to&#xD;
             consent&quot; and the self-safety assessment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not having the capacity to assent&#xD;
&#xD;
          -  not passing the self-safety assessment&#xD;
&#xD;
          -  previously participating in another study activity (with the exception of the baseline&#xD;
             and intervention end survey pilot tests)&#xD;
&#xD;
          -  knowing someone who is already enrolled in the program&#xD;
&#xD;
          -  non-cisgender&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>cisgender / female gender identity</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele L Ybarra, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Innovative Public Health Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Innovative Public Health Research</name>
      <address>
        <city>San Clemente</city>
        <state>California</state>
        <zip>92672-6745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ybarra ML, Parrilla JS, Wolowic J, Rosario M, Goodenow C, Saewyc E. A National, Qualitative Study of Sexual Decision Making by Teenage Girls who are Lesbian, Gay, Bisexual, or who have Another Nonheterosexual Identity. J Pediatr. 2020 Feb;217:177-183. doi: 10.1016/j.jpeds.2019.10.038. Epub 2019 Dec 13.</citation>
    <PMID>31843216</PMID>
  </reference>
  <reference>
    <citation>Doull M, Wolowic J, Saewyc E, Rosario M, Prescott T, Ybarra ML. Why Girls Choose Not to Use Barriers to Prevent Sexually Transmitted Infection During Female-to-Female Sex. J Adolesc Health. 2018 Apr;62(4):411-416. doi: 10.1016/j.jadohealth.2017.10.005. Epub 2017 Dec 28.</citation>
    <PMID>29290373</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Teenage Pregnancy Prevention</keyword>
  <keyword>LGB Girls</keyword>
  <keyword>Text-Messaging</keyword>
  <keyword>Information-Motivation-Behavioral Skills(IMB)Model</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03029962/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>November 11, 2022</submitted>
    <returned>December 9, 2022</returned>
  </pending_results>
  <!-- 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/NCT03029962
org study id: 1 TP2AH000035-01-00
nct id: NCT03029962
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to finalize and rigorously evaluate Girl2Girl, a novel text
      messaging-based teenage pregnancy prevention (TPP) program designed specifically for LGB
      women ages 14-18 years, nation-wide. The guiding theoretical model is the
      Information-Motivation-Behavioral Skills (IMB) Model, which has been used extensively and is
      associated with increases in TPP behavior.
An estimated one in four teen women will become pregnant by the time she is 20 years of age.
      That said, significant disparity in rates exist for lesbian, gay, bisexual and other sexual
      minority women (LGB) versus non-LGB teen women: Research suggests that lesbian and bisexual
      teen women are between two and four times more likely to report having been pregnant than
      teen women who identified as exclusively heterosexual. Despite this compelling evidence that
      lesbian and bisexual adolescent women are at risk for teen pregnancy, programs tailored to
      the unique needs of adolescent LGB women are nonexistent. Evidence-based teen pregnancy
      prevention (TPP) programs targeting LGB teen women are urgently needed.

      The Girl2Girl intervention text messaging-based TPP program designed specifically for LGB
      women ages 14-18 years, nation-wide. The investigators will test the intervention in a
      randomized control trial (RCT) of 840 LGB teenage women randomly assigned to either the
      intervention (n = 420) or control (n = 420) arms. Our primary efficacy outcome measures,
      measured at 12-months post-intervention, will be: (a) abstinence from penile-vaginal sex; (b)
      condom use during penile-vaginal sex, (c) use of other birth control methods during
      penile-vaginal sex, and (d) pregnancy.

      If effective, Girl2Girl has promise to be quickly and cost-effectively implemented to scale
      to help to curb the spread of teenage pregnancy among women who identify as LGB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of protected penile-vaginal sex acts
time frame: Post-intervention (about 20 weeks after randomization)
description: The relative difference of protected penile-vaginal sex acts in the intervention versus control group at 12-months post-intervention
measure: Number of participants who used other birth control methods
time frame: Post-intervention (about 20 weeks after randomization)
description: The relative difference of teens who used birth control methods other than condoms (e.g., the pill, the patch) in the intervention versus control group at 12-months post-intervention
measure: Number of participants who abstained from penile-vaginal sex
time frame: Post-intervention (about 20 weeks after randomization)
description: The relative difference of abstinence (not engaging in vaginal sex) in the intervention versus control group at 12-months post-intervention
measure: Number of penile-vaginal sex acts during which a condom was used
time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
description: The relative difference of protected penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
measure: Number of participants who used other birth control methods
time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
description: The relative difference of teens who used birth control methods other than condoms (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
measure: Number of participants who abstained from penile-vaginal sex
time frame: immediate post-intervention end, 3-, 6-, 9-months post-intervention
description: The relative difference of abstinence (not engaging vaginal sex) in the intervention versus control group at immediate post-intervention end, 3-, 6-, and 9-months post-intervention
measure: Pregnancy
time frame: Across the 12 months post-intervention
description: The percent of teens who have been pregnant since the beginning of the RCT in the intervention versus control group
measure: Intentions to use condoms
time frame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
description: The percent of teens who intend to use condoms if they have penile-vaginal sex in the next year in the intervention versus control group
measure: Intentions to use birth control other than condoms
time frame: immediate post-intervention end, 3-, 6-, 9-, and 12-months post-intervention
description: The percent of teens who intend to use birth control methods other than condoms in the next year for the intervention versus control group
arm group label: Experimental: Girl2Girl
arm group type: Experimental
description: Girl2Girl is a 7-week teenage pregnancy prevention program delivered daily via text messaging to 14-18 year old females who self-identify as lesbian, bisexual, gay, or other sexual minority. In addition to program content, participants are paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, Girl2Genie, which shares information about sex, relationships, and the lesbian, gay, bisexual, transgender (LGBT) community.
arm group label: No Intervention: Health Lifestyle
arm group type: No Intervention
description: The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 7-weeks in length (Week 7 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.
intervention type: Behavioral
intervention name: Girl2Girl
description: Girl2Girl is a text messaging-based teenage pregnancy prevention program specifically for 14-18 year old LGB adolescent females. Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content is reinforced using brief online videos. The intervention is 7 weeks long. A "booster" is delivered 12-weeks post-intervention end and reviews the topics covered in the intervention. Girl2Girl content is tailored based upon sexual experience (i.e., whether one is abstinent or sexually active) and whether one is same-sex or dually attracted.
arm group label: Experimental: Girl2Girl
criteria: 
gender: Female
gender based: Yes
gender description: cisgender / female gender identity
minimum age: 14 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michele L Ybarra, PhD
role: Principal Investigator
affiliation: Center for Innovative Public Health Research
facility: 
country: United States
citation: Ybarra ML, Parrilla JS, Wolowic J, Rosario M, Goodenow C, Saewyc E. A National, Qualitative Study of Sexual Decision Making by Teenage Girls who are Lesbian, Gay, Bisexual, or who have Another Nonheterosexual Identity. J Pediatr. 2020 Feb;217:177-183. doi: 10.1016/j.jpeds.2019.10.038. Epub 2019 Dec 13.
PMID: 31843216
citation: Doull M, Wolowic J, Saewyc E, Rosario M, Prescott T, Ybarra ML. Why Girls Choose Not to Use Barriers to Prevent Sexually Transmitted Infection During Female-to-Female Sex. J Adolesc Health. 2018 Apr;62(4):411-416. doi: 10.1016/j.jadohealth.2017.10.005. Epub 2017 Dec 28.
PMID: 29290373
responsible party type: Sponsor
sharing ipd: No
provided document: 
submitted: November 11, 2022
returned: December 9, 2022