Game Changers for Cervical Cancer Prevention (GC-CCP)

February 5, 2024 updated by: RAND

A Hybrid Implementation-Effectiveness Trial of Game Changers for Cervical Cancer Prevention in Uganda

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advocacy Training 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: Usual care 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants that has received cervical cancer screening
Time Frame: past 6 months
Receipt of screening via visual inspection of cervix with acetic acid (VIA), among enrolled alter participants
past 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean score on cervical cancer prevention advocacy scale
Time Frame: past 6 months
6-item Self-reported scale of engagement in CC prevention advocacy (each item using a 1-5 scale), among index participants; higher scores reflect greater advocacy
past 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RAND

Collaborators

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

Investigators

  • Principal Investigator: Glenn Wagner, PhD, RAND

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-N0111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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