<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/NCT03756467</url>
  </required_header>
  <id_info>
    <org_study_id>645</org_study_id>
    <nct_id>NCT03756467</nct_id>
  </id_info>
  <brief_title>Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse</brief_title>
  <official_title>Girl Empower: Studying the Impact of Mentorship, Asset Building, Caregiver Discussion Groups, and Cash Transfers on Reducing Girl's Vulnerability to Sexual Exploitation and Abuse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Council</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Bank</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Rescue Committee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>City University of New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Population Council</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>
      Girl Empower (GE) is a program designed to equip girls with the skills and experiences&#xD;
      necessary to make healthy, strategic life choices and to stay safe from sexual exploitation&#xD;
      and abuse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The GE program is unique in its approach because it addresses girls' needs holistically. The&#xD;
      girls' activities will take place in girl-only safe spaces located in their communities and&#xD;
      contains the following components: Mentorship: girls have access to older female mentors.&#xD;
      Mentors both provide weekly group-based and one-to-one interaction with girls as well as&#xD;
      teach them critical skills; Asset building: Girls will have access to life skills and&#xD;
      financial literacy training. This includes setting up savings accounts so girls practice&#xD;
      their financial literacy skills, Monthly caregiver discussion groups among guardians of&#xD;
      program girls, Capacity building and training of local health and psychosocial service&#xD;
      providers to provide quality services to survivors of gender-based violence Intervention&#xD;
      communities will either receive the GE program alone or the GE program with the plus small&#xD;
      cash transfers to the girls' families as an incentive to attendance in weekly sessions (GE+).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>The impact evaluation study is a cluster-randomized controlled trial among 100 communities with three study arms: control (no intervention), GE, and GE+.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The impact evaluation is a cluster-randomized controlled trial with three study arms: control (no program), GE, and GE+. GE refers to the Girl Empower program alone, while GE+ adds small cash transfers to the families of eligible girls as an incentive to increase take-up of GE attendance in weekly sessions. The study team will conduct a baseline survey of all girls age 13-14 and their caregiver in 100 communities in Nimba County, Liberia. Communities will then be randomized, blocking on number of girl in the community and % of girls enrolled in school, to one of the 3 study arms. Two years following the baseline survey (1 year following program completion), the study team will conduct an endline survey in all 100 communities with the same girls and caregivers and compare outcomes in the three study arms.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sexual Violence Index</measure>
    <time_frame>40 weeks</time_frame>
    <description>The primary outcome of interest is an index of sexual violence at the individual level.&#xD;
The index is composed of four questions in the endline survey instrument. The construction of the index, and a detailed description of its components is described in the pre-analysis plan (PAP) document uploaded under the &quot;Analysis Plan&quot; in this registration.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Adolescent Behavior</condition>
  <condition>Sexual Violence</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Girl Empower Program</intervention_name>
    <description>Girl Empower (GE) encourages adolescent girls living in rural areas of Nimba County, Liberia to partake in weekly mentored community-based workshops on life skills, selfcare, and financial literacy.</description>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, eligible girls aged 13 to 14 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly Hallman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Council</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kelly Hallman, Ph.D.</last_name>
    <phone>212-339-0687</phone>
    <email>khallman@popcouncil.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Liberia</name>
      <address>
        <city>Monrovia</city>
        <country>Liberia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Hallman, Ph.D.</last_name>
      <phone>212-339-0687</phone>
      <email>khallman@popcouncil.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Liberia</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent Behavior</keyword>
  <keyword>Sexual Violence</keyword>
  <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/NCT03756467
org study id: 645
nct id: NCT03756467
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Girl Empower (GE) is a program designed to equip girls with the skills and experiences
      necessary to make healthy, strategic life choices and to stay safe from sexual exploitation
      and abuse.
The GE program is unique in its approach because it addresses girls' needs holistically. The
      girls' activities will take place in girl-only safe spaces located in their communities and
      contains the following components: Mentorship: girls have access to older female mentors.
      Mentors both provide weekly group-based and one-to-one interaction with girls as well as
      teach them critical skills; Asset building: Girls will have access to life skills and
      financial literacy training. This includes setting up savings accounts so girls practice
      their financial literacy skills, Monthly caregiver discussion groups among guardians of
      program girls, Capacity building and training of local health and psychosocial service
      providers to provide quality services to survivors of gender-based violence Intervention
      communities will either receive the GE program alone or the GE program with the plus small
      cash transfers to the girls' families as an incentive to attendance in weekly sessions (GE+).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The impact evaluation study is a cluster-randomized controlled trial among 100 communities with three study arms: control (no intervention), GE, and GE+.
primary purpose: Health Services Research
masking: Single (Participant)
masking description: The impact evaluation is a cluster-randomized controlled trial with three study arms: control (no program), GE, and GE+. GE refers to the Girl Empower program alone, while GE+ adds small cash transfers to the families of eligible girls as an incentive to increase take-up of GE attendance in weekly sessions. The study team will conduct a baseline survey of all girls age 13-14 and their caregiver in 100 communities in Nimba County, Liberia. Communities will then be randomized, blocking on number of girl in the community and % of girls enrolled in school, to one of the 3 study arms. Two years following the baseline survey (1 year following program completion), the study team will conduct an endline survey in all 100 communities with the same girls and caregivers and compare outcomes in the three study arms.
measure: Sexual Violence Index
time frame: 40 weeks
description: The primary outcome of interest is an index of sexual violence at the individual level.
The index is composed of four questions in the endline survey instrument. The construction of the index, and a detailed description of its components is described in the pre-analysis plan (PAP) document uploaded under the "Analysis Plan" in this registration.
arm group label: Arm 1
arm group type: No Intervention
description: 1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff
arm group label: Arm 2
arm group type: Experimental
description: 1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up
arm group label: Arm 3
arm group type: Active Comparator
description: 1) the Girl Empower life skills curriculum, facilitated by local mentors; 2) caregiver discussion group, facilitated by IRC staff; and 3) savings account start-up.
intervention type: Behavioral
intervention name: Girl Empower Program
description: Girl Empower (GE) encourages adolescent girls living in rural areas of Nimba County, Liberia to partake in weekly mentored community-based workshops on life skills, selfcare, and financial literacy.
arm group label: Arm 2
arm group label: Arm 3
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kelly Hallman, Ph.D.
role: Principal Investigator
affiliation: Population Council
last name: Kelly Hallman, Ph.D.
phone: 212-339-0687
email: khallman@popcouncil.org
facility: 
status: Recruiting
contact: 
country: Liberia
responsible party type: Sponsor
sharing ipd: No