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Game Changers for Cervical Cancer Prevention (GC-CCP)

Primary Purpose

Cervical Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Game Changers for Cervical Cancer Prevention
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: screened for cervical cancer in the past year (index participants only) is a member of social network of enrolled index participant (social network member participants only) Exclusion Criteria: advanced stage cervical cancer (index participants only) screened for cervical cancer in the past (social network member participants only)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Wait-list control

    Arm Description

    7 weekly group sessions of advocacy training for cervical cancer screening

    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

    Outcomes

    Primary Outcome Measures

    cervical cancer screening
    screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants

    Secondary Outcome Measures

    cervical cancer prevention advocacy
    6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants

    Full Information

    First Posted
    August 17, 2023
    Last Updated
    August 17, 2023
    Sponsor
    RAND
    Collaborators
    Makerere University, African Palliative Care Association, Rays of Hope Hospice Jinja, Indiana University, Bloomington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06010160
    Brief Title
    Game Changers for Cervical Cancer Prevention
    Acronym
    GC-CCP
    Official Title
    A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 30, 2024 (Anticipated)
    Primary Completion Date
    November 30, 2025 (Anticipated)
    Study Completion Date
    November 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RAND
    Collaborators
    Makerere University, African Palliative Care Association, Rays of Hope Hospice Jinja, Indiana University, Bloomington

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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: 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? 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?
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Individual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
    Masking
    Outcomes Assessor
    Masking Description
    The assessment interviewer will be blinded to study arm allocation of the participants at baseline only
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    7 weekly group sessions of advocacy training for cervical cancer screening
    Arm Title
    Wait-list control
    Arm Type
    No Intervention
    Arm 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(s)
    Game Changers for Cervical Cancer Prevention
    Other Intervention Name(s)
    GC-CCP
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    cervical cancer screening
    Description
    screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants
    Time Frame
    past 6 months
    Secondary Outcome Measure Information:
    Title
    cervical cancer prevention advocacy
    Description
    6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants
    Time Frame
    past 6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: screened for cervical cancer in the past year (index participants only) is a member of social network of enrolled index participant (social network member participants only) Exclusion Criteria: advanced stage cervical cancer (index participants only) screened for cervical cancer in the past (social network member participants only)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Glenn Wagner, PhD
    Phone
    3103930411
    Ext
    7698
    Email
    gwagner@rand.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura Bogart, PhD
    Phone
    3103930411
    Email
    lbogart@rand.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Glenn Wagner, PhD
    Organizational Affiliation
    RAND
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    A de-identified dataset will be made available upon review of requests from outside researchers
    IPD Sharing Time Frame
    Following publication of primary results of the study, for 3 years

    Learn more about this trial

    Game Changers for Cervical Cancer Prevention

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