xml: <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/NCT06010160</url>
    </required_header>
    <id_info>
      <org_study_id>2023-N0111</org_study_id>
      <nct_id>NCT06010160</nct_id>
    </id_info>
    <brief_title>Game Changers for Cervical Cancer Prevention</brief_title>
    <acronym>GC-CCP</acronym>
    <official_title>A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RAND</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Makerere University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>African Palliative Care Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rays of Hope Hospice Jinja</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Indiana University, Bloomington</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>RAND</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This randomized controlled trial will evaluate Game Changers for Cervical Cancer Prevention&#xD;
        (GC-CCP) for increasing cervical cancer (CC) screening advocacy among intervention recipients&#xD;
        (index participants) towards female social network members, and uptake of CC screening among&#xD;
        enrolled female social network members (alter participants) who have not previously been&#xD;
        screened. The main research questions are:&#xD;
  &#xD;
          1. Is the GC-CCP network-based peer advocacy intervention superior to usual care (no&#xD;
             intervention) in improving uptake of CC screening among alter participants, across&#xD;
             urban/rural and public/private clinics?&#xD;
  &#xD;
          2. What are the mediators and moderators (among index, alter and network characteristics)&#xD;
             of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention&#xD;
             advocacy among index participants?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized controlled trial will evaluate Game Changers for Cervical Cancer Prevention&#xD;
        (GC-CCP) for increasing cervical cancer (CC) screening among previously unscreened social&#xD;
        network members. The trial will be conducted at 4 study clinics [2 public, 2&#xD;
        private-not-for-profit (PNFP), one each in an urban and rural location]. At each clinic, 40&#xD;
        women screened for CC in the past year will be enrolled in the RCT as index participants&#xD;
        (n=160 index) and randomized to the intervention (in two groups of 10) or wait-list control.&#xD;
        The intervention will consist of 7 weekly group sessions that focus on CC stigma reduction,&#xD;
        sharing of CC screening experience with others, knowledge of CC facts and myths, and skills&#xD;
        building for engagement in CC prevention advocacy with female social network members&#xD;
        (alters). Each index will recruit up to three alters (n~440 alters) at baseline who have not&#xD;
        screened for CC; these index and alter participants will be followed up at months 6 and 12.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2024</start_date>
    <completion_date type="Anticipated">November 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2025</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>Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The assessment interviewer will be blinded to study arm allocation of the participants at baseline only</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>cervical cancer screening</measure>
      <time_frame>past 6 months</time_frame>
      <description>screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cervical cancer prevention advocacy</measure>
      <time_frame>past 6 months</time_frame>
      <description>6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Cervical Cancer</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>7 weekly group sessions of advocacy training for cervical cancer screening</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait-list control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>usual care (no intervention); control participants will be offered the chance to receive the intervention at the conclusion of month 12 follow-up data collection</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Game Changers for Cervical Cancer Prevention</intervention_name>
      <description>The peer advocacy training sessions focus on reduction of internalized stigma, disclosure decision making, education on cervical cancer facts and myths, and building skills for cervical cancer prevention advocacy.</description>
      <arm_group_label>Intervention</arm_group_label>
      <other_name>GC-CCP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  screened for cervical cancer in the past year (index participants only)&#xD;
  &#xD;
            -  is a member of social network of enrolled index participant (social network member&#xD;
               participants only)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  advanced stage cervical cancer (index participants only)&#xD;
  &#xD;
            -  screened for cervical cancer in the past (social network member participants only)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Glenn Wagner, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>RAND</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Glenn Wagner, PhD</last_name>
      <phone>3103930411</phone>
      <phone_ext>7698</phone_ext>
      <email>gwagner@rand.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laura Bogart, PhD</last_name>
      <phone>3103930411</phone>
      <email>lbogart@rand.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>A de-identified dataset will be made available upon review of requests from outside researchers</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Following publication of primary results of the study, for 3 years</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010160
  org study id: 2023-N0111
  nct id: NCT06010160
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This randomized controlled trial will evaluate Game Changers for Cervical Cancer Prevention
        (GC-CCP) for increasing cervical cancer (CC) screening advocacy among intervention recipients
        (index participants) towards female social network members, and uptake of CC screening among
        enrolled female social network members (alter participants) who have not previously been
        screened. The main research questions are:
  
          1. Is the GC-CCP network-based peer advocacy intervention superior to usual care (no
             intervention) in improving uptake of CC screening among alter participants, across
             urban/rural and public/private clinics?
  
          2. What are the mediators and moderators (among index, alter and network characteristics)
             of intervention effects on (a) alter CC screening; and (b) engagement in CC prevention
             advocacy among index participants?
  This randomized controlled trial will evaluate Game Changers for Cervical Cancer Prevention
        (GC-CCP) for increasing cervical cancer (CC) screening among previously unscreened social
        network members. The trial will be conducted at 4 study clinics [2 public, 2
        private-not-for-profit (PNFP), one each in an urban and rural location]. At each clinic, 40
        women screened for CC in the past year will be enrolled in the RCT as index participants
        (n=160 index) and randomized to the intervention (in two groups of 10) or wait-list control.
        The intervention will consist of 7 weekly group sessions that focus on CC stigma reduction,
        sharing of CC screening experience with others, knowledge of CC facts and myths, and skills
        building for engagement in CC prevention advocacy with female social network members
        (alters). Each index will recruit up to three alters (n~440 alters) at baseline who have not
        screened for CC; these index and alter participants will be followed up at months 6 and 12.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: The assessment interviewer will be blinded to study arm allocation of the participants at baseline only
  measure: cervical cancer screening
  time frame: past 6 months
  description: screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants
  measure: cervical cancer prevention advocacy
  time frame: past 6 months
  description: 6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants
  arm group label: Intervention
  arm group type: Experimental
  description: 7 weekly group sessions of advocacy training for cervical cancer screening
  arm group label: Wait-list control
  arm group type: No Intervention
  description: usual care (no intervention); control participants will be offered the chance to receive the intervention at the conclusion of month 12 follow-up data collection
  intervention type: Behavioral
  intervention name: Game Changers for Cervical Cancer Prevention
  description: The peer advocacy training sessions focus on reduction of internalized stigma, disclosure decision making, education on cervical cancer facts and myths, and building skills for cervical cancer prevention advocacy.
  arm group label: Intervention
  other name: GC-CCP
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Glenn Wagner, PhD
  role: Principal Investigator
  affiliation: RAND
  last name: Glenn Wagner, PhD
  phone: 3103930411
  phone ext: 7698
  email: gwagner@rand.org
  last name: Laura Bogart, PhD
  phone: 3103930411
  email: lbogart@rand.org
  responsible party type: Sponsor
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: Yes
  ipd description: A de-identified dataset will be made available upon review of requests from outside researchers
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Following publication of primary results of the study, for 3 years