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GC-CCP: Game Changers for Cervical Cancer Prevention

Sponsor
RAND (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010160
Collaborator
Makerere University (Other), African Palliative Care Association (Other), Rays of Hope Hospice Jinja (Other), Indiana University, Bloomington (Other)
600
Enrollment
2
Arms
15
Anticipated Duration (Months)

Study Details

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:

  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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Game Changers for Cervical Cancer Prevention
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
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 groupIndividual randomization to one of two parallel groups, the intervention or usual care (no intervention) control group
Masking:
Single (Outcomes Assessor)
Masking Description:
The assessment interviewer will be blinded to study arm allocation of the participants at baseline only
Primary Purpose:
Prevention
Official Title:
A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda
Anticipated Study Start Date :
Aug 30, 2024
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
Nov 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

7 weekly group sessions of advocacy training for cervical cancer screening

Behavioral: Game Changers for Cervical Cancer Prevention
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.
Other Names:
  • GC-CCP

    		•
    No Intervention: Wait-list control

    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

    Outcome Measures

    Primary Outcome Measures

    1. cervical cancer screening [past 6 months]

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

    Secondary Outcome Measures

    1. cervical cancer prevention advocacy [past 6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RAND
    • Makerere University
    • African Palliative Care Association
    • Rays of Hope Hospice Jinja
    • Indiana University, Bloomington

    Investigators

    • Principal Investigator: Glenn Wagner, PhD, RAND

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RAND
    ClinicalTrials.gov Identifier:
    NCT06010160
    Other Study ID Numbers:
    • 2023-N0111
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Aug 24, 2023